To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04955626

Enrollment

16372

Registered

2021-07-09

Start date

2021-07-01

Completion date

2023-05-25

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2 Infection

Keywords

COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine

Brief summary

Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization. The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19 * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 16 years of age and older * The duration of the study for each participant will be up to approximately 12 months. * The study will be conducted in the United States, Brazil and South Africa Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization. * Blood samples will be collected for troponin testing * The duration of the study for each participant will be up to approximately 2 months. * The study will be conducted in the United States, Germany, Poland and South Africa Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization. * In healthy adults 12 years of age and older * The duration of the study for each participant will be up to approximately 12 months. * The study will be conducted in the United States, Germany and South Africa Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose * Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment * Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization * Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose. * In healthy adults 18 to 55 years of age * The duration of the study for each participant will be up to approximately 12 months. * The study will be conducted in the United States and South Africa Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose * In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization * The duration of the study for each participant will be approximately 6 months. * The study will be conducted in the United States Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose. * In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization * The duration of the study for each participant will be approximately 6 months. * The study will be conducted in Israel

Interventions

BIOLOGICALBNT162b2

Intramuscular Injection

OTHERPlacebo

Intramuscular Injection

BIOLOGICALBNT162b2 OMI

Intramuscular Injection

BIOLOGICALCombination BNT162b2 and BNT162b2 OMI

30-µg (15-µg each) or 60-µg (30-µg each) Site prepared dosing suspension from 1 vial each of diluted BNT162b2 and BNT162b2 OMI Intramuscular Injection

BIOLOGICALCombination (Bivalent) BNT162b2 and BNT162b2 OMI

30-µg (15-µg each) or 60-µg (30-µg each) Preformulated bivalent mixture (no dilution required) presented in a single vial Intramuscular Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Substudy A Inclusion Criteria: * Male or female participants ≥16 years of age at Visit 1 (Day 1) who participated in C4591001. * Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Capable of giving signed informed consent. * Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with the second dose being at least 175 days before Visit 1 (Day 1).

Exclusion criteria

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. * Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study. * Prior receipt of any COVID-19 vaccine other than BNT162b2. * Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. * Receipt of medications intended to prevent COVID-19. * Prior receipt of more than 2 doses of BNT162b2 30 µg. * Participation in other studies involving study intervention within 28 days prior to study entry, other than C4591001, and/or within 28 days of confirmed receipt of BNT162b2 within the study. Substudy B Inclusion Criteria: * Male or female participants 12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least at least 4 months (120 days) before Visit 1 (Day 1) * Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Capable of giving signed informed consent.

Design outcomes

Primary

Measure	Time frame	Description
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	Month 6 (6 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse on Day 7 was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	Month 3 (3 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	Month 3 (3 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	Month 3 (3 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 3 months was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	Month 6 (6 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	Month 6 (6 months after vaccination)	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 6 months was reported in this outcome measure.
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year [PY]) for BNT162b2 was 0.823 and for Placebo was 0.792	Occurrences (number of cases) of first COVID-19 infection in participants after booster dose per 1000 person-year, without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 0.871 and for Placebo was 0.835	Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.098 and for Placebo was 0.932	Occurrences (number of cases) of first COVID-19 infection in participants after booster dose without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.
SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.173 and for Placebo was 0.989	Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.
SSA: Percentage of Participants Reporting Adverse Events	From booster dose (Day 1) to 1 month after booster dose	An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)	BNT162b2 30 mcg, Placebo then BNT162b2 30 mcg: From BNT162b2 dose to 6 months after BNT162b2 dose; Placebo: From placebo dose to unblinding for original placebo participants. Median blinded follow-up period for Placebo group=2.8 months	An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1	Pre-dose on Day 1 (Vaccination 1)	Percentage of participants with elevated troponin I levels before administration of Vaccination 1 were reported in this outcome measure.
SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1	Within 5 days after Vaccination 1	Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 1 were reported in this outcome measure.
SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)	Pre-Vaccination 2 (1 month after Vaccination 1)	Percentage of participants with elevated troponin I levels pre vaccination 2 were reported in this outcome measure.
SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2	Within 5 days after vaccination 2	Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 2 were reported in this outcome measure.
SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2	1 month after Vaccination 2	Percentage of participants with elevated troponin I levels within 1 month after administration of Vaccination 2 were reported in this outcome measure.
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Day 1 up to Day 7 after Vaccination 1	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Day 1 up to Day 7 after Vaccination 2	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Day 1 up to Day 7 after Vaccination 1	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Day 1 up to Day 7 after Vaccination 2	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1	Vaccination 1 up to 1 Month After Vaccination 1	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2	Vaccination 2 up to 1 month after Vaccination 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1	Vaccination 1 up to 1 month after Vaccination 1	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2	Vaccination 2 up to 1 month after Vaccination 2	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Day 1 up to Day 7 after the booster dose	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 cm and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after the booster (third) dose and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Day 1 up to Day 7 after the booster dose	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24 h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose	From booster dose (Day 1) up to 1 month after booster dose	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from booster (third) dose up to 1 month after booster (third) dose were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose	From booster dose (Day 1) up to 6 months after booster dose	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline	At baseline (pre-dose)	GMT of SARS-CoV-2 reference-strain-neutralizing titers at baseline (before the booster dose) was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose	1 month after the booster dose	GMT of SARS-CoV-2 reference-strain-neutralizing titers at 1 month after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose	From baseline to 1 month after the booster dose	GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline to 1 month after the booster dose received in this sub-study was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose	1 month after the booster dose	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month after the booster dose was reported in this outcome measure.
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Day 1 up to Day 7 after Vaccination 1	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection (inj) site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Day 1 up to Day 7 after Vaccination 2	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Day 1 up to Day 7 after Vaccination 3	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 3 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Day 1 up to Day 7 after Vaccination 1	Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C, categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Day 1 up to Day 7 after Vaccination 2	Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C, categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Day 1 up to Day 7 after Vaccination 3	Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1	From Day 1 up to 1 month after last study vaccination	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after last study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2	From first study vaccination (Day 1) up to 1 month after Vaccination 1	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2	From Vaccination 2 up to 1 month after Vaccination 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 2 up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3	From first study vaccination (Day 1) up to 1 month after Vaccination 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3	From Vaccination 3 up to 1 month after Vaccination 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 3 up to 1 month after Vaccination 3 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3	From first study vaccination (Day 1) up to 6 months after last study vaccination	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2	From vaccination 1 (Day 1) up to 6 months after vaccination 1 (participants received 1 dose only); From vaccination 1 up to before vaccination 2 (participants received 2 doses)	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2	From first study vaccination (Day 1) up to 6 months after vaccination 2	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	1 month after Vaccination 1	GMR was calculated based on GMT levels of SSD: Cohort 2: Group 3 and SSD: Cohort 2: Group 4 and reported in statistical analysis section below. GMT of SARS-CoV-2 Omicron strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	1 month after Vaccination 1	Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	1 month after Vaccination 1	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b	For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2	GMR was calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after Vaccination 2 for Group 2 and 1 month after Vaccination 1 for Group 2b was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).
Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	1 month after Vaccination 1	Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.
SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b	For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2	Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below LLOQ, postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after second study vaccination for Group 2 and 1 month after study vaccination for Group 2b was reported in this outcome measure.
SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3	1 month after Vaccination 2	GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMR comparison between GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of SSD Cohort 3: Group 5 to GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of study C4591001 (NCT04368728) Phase 3 BNT162b2 single arm 18-55 years of age, at 1 month after vaccination 2 was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (student's t distribution).
SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3	1 month after Vaccination 2	EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.
SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Day 1 up to Day 7 after study vaccination	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm),severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]).Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions within 7 days after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Day 1 up to Day 7 after study vaccination	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C & \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \> 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	From study vaccination up to 1 Month after study vaccination	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	From study vaccination up to 6 Months after study vaccination	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age	Before study vaccination (pre-dose)	Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.
SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age	3 days after study vaccination	Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.
SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	1 month after study vaccination	GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	1 month after study vaccination	Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.
SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	Before vaccination (pre-dose)	GMT of SARS-CoV-2 Omicron BA.1 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Day 1 up to Day 7 after the study vaccination	Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.
SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Day 1 up to Day 7 after the study vaccination	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C & \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \> 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.
SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	From study vaccination up to 1 Month after study vaccination	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	From study vaccination up to 6 Months after study vaccination	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	Before vaccination (pre-dose)	GMT of SARS-CoV-2 reference-strain-neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	Before vaccination (pre-dose)	GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	Day 7 (7 days after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	Month 1 (1 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	Month 3 (3 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	Month 3 (3 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	Month 3 (3 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	Month 6 (6 month after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	Month 6 (6 months after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	Month 6 (6 months after vaccination)	GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	From before the study vaccination to Day 7 (7 days after vaccination)	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	From before the study vaccination to Day 7 (7 days after vaccination)	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	From before the study vaccination to Day 7 (7 days after vaccination)	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	From before the study vaccination to 1 month after vaccination	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	From before the study vaccination to 1 month after vaccination	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	From before the study vaccination to 1 month after vaccination	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	From before the study vaccination to 3 months after vaccination	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	From before the study vaccination to 3 months after vaccination	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	From before the study vaccination to 3 months after vaccination	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	From before the study vaccination to 6 months after vaccination	GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	From before the study vaccination to 6 months after vaccination	GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	From before the study vaccination to 6 months after vaccination	GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Secondary

Measure	Time frame	Description
SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.182 and for Placebo was 1.011	Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose with and without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate \>= 30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation \<= 93% on room air at sea level, or Horovitz quotient \<300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic BP \<90 mm Hg, diastolic BP \<60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.
SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection	From 7 Days after booster vaccination	Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 and presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.
SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection	From 7 Days after booster vaccination	Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose with and without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 AND presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.
SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose	At baseline and 7 days after the booster dose	GMT of SARS-CoV-2 reference-strain neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose	At baseline and 7 days after booster dose	GMT of SARS-CoV-2 Omicron BA.1- neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	From baseline (before booster dose) to 7 days after the booster dose	GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	From baseline (before booster dose) to 7 days after the booster dose	GMFR of SARS-CoV-2 Omicron BA.1-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).
SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose	7 days after the booster dose	Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to reference strain at 7 days after the booster dose was reported in this outcome measure.
SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose	7 days after the booster dose	Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to Omicron BA.1 strain at 7 days after the booster dose was reported in this outcome measure.
SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age	1 month after study vaccination	GMR based on GMT of SARS-CoV-2 reference strain neutralizing titers was calculated and reported in statistical analysis section. GMT of SARS-CoV-2 Reference strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.105 and for Placebo was 0.951	Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate greater than or equal to \[\>=\]30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation less than or equal to \[\<=\]93% on room air at sea level, or Horovitz quotient \<300 mmHg); 2) respiratory failure (needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic blood pressure \[BP\] \<90 mmHg, diastolic BP \<60 mmHg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.

Countries

Brazil, Germany, Israel, South Africa, United States

Participant flow

Recruitment details

This study was conducted in 6 parts: sub-study A (SSA), sub-study B (SSB), sub-study C (SSC), sub-study D (SSD), sub-study E (SSE) and sub-study F (SSF).

Pre-assignment details

SSA: 10133 participants randomized, 10121 vaccinated and evaluated. SSB: 1487 participants randomized,1485 vaccinated and evaluated. SSC: 140 participants randomized, vaccinated, evaluated. SSD: 1469 participants randomized 1467 vaccinated, 1465vaccinated with 30 mcg BNT162b2 and BNT162b2 OMI and evaluated. SSE: 3020 participants randomized, 3014 vaccinated, 3010 vaccinated with 30 and 60 mcg BNT162b2 and BNT162b2 OMI and evaluated. SSF: 123 participants randomized,122 vaccinated and evaluated.

Participants by arm

Arm	Count
SSA: BNT162b2 30 mcg: Blinded and Open Label Period Participants received one dose (30 microgram) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	5,080
SSA: Placebo: Blinded Period Participants received placebo (normal saline solution of 0.9 percent \[%\] sodium chloride) intramuscularly.	5,041
SSB: BNT162b2 30 mcg Then Placebo Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 1 and received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 28.	753
SSB: Placebo Then BNT162b2 30 mcg Participants received placebo (normal saline solution of 0.9 % sodium chloride) intramuscularly on Day 1 and one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm on Day 28.	732
SSC: BNT162b2 10 mcg Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (10 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	75
SSC: BNT162b2 30 mcg Participants who previously received two booster doses of BNT162b2 prior to enrollment in SSC, received one booster dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	65
SSD: Cohort 1: Group 1 Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	216
SSD: Cohort 1: Group 2 Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly 4 weeks apart in the deltoid muscle of the non-dominant arm.	197
SSD: Cohort 1: Group 2b Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	204
SSD: Cohort 2: Group 3 Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.	315
SSD: Cohort 2: Group 4 Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm. After 3 months, participants upon their consent received optional additional one dose (30 mcg) of BNT162b2 OMI.	323
SSD: Cohort 3: Group 5 Participants received two doses (30 mcg) of BNT162b2 Omicron (OMI) 3 weeks apart intramuscularly in the deltoid muscle of the non-dominant arm. Participants upon their consent received one dose (30 mcg) of BNT162b2 5 months after second dose of BNT162b2 OMI vaccination.	210
SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	30
SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	30
SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg Participants received one dose (60 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.	30
SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	482
SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	159
SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	321
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	305
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	302
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg Participants received one dose (30 mcg) of BNT162b2 OMI intramuscularly in the deltoid muscle of the non-dominant arm.	307
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	307
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	308
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	313
SSF: BNT162b2 30 mcg Participants received one dose (30 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	21
SSF: BNT162b2 60 mcg Participants received one dose (60 mcg) of BNT162b2 intramuscularly in the deltoid muscle of the non-dominant arm.	19
SSF: BNT162b2 OMI 30 mcg Participants received one dose (30 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	21
SSF: BNT162b2 OMI 60 mcg Participants received one dose (60 mcg) of BNT162b2 Omicron (OMI) intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg Participants received a total of 30 mcg bivalent BNT162b2 (15 mcg BNT162b2 and 15 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	20
SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg Participants received a total of 60 mcg bivalent BNT162b2 (30 mcg BNT162b2 and 30 mcg BNT162b2 OMI) as a single dose intramuscularly in the deltoid muscle of the non-dominant arm.	21
Total	16,347

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG014	FG015	FG016	FG017	FG018	FG019	FG020	FG021	FG023	FG024	FG025	FG026	FG027	FG028	FG029
Blinded Period	Adverse Event	0	1	1	1	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Blinded Period	Death	0	2	0	0	0	0	0	2	1	1	0	2	0	0	0	0	0	0	0	0	0	1	0	0	1	1	0	1
Blinded Period	Lost to Follow-up	28	28	7	14	3	2	6	4	5	8	10	32	0	0	12	2	5	0	0	0	0	0	3	1	2	2	2	0
Blinded Period	Medication error	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0
Blinded Period	No longer meets eligibility criteria	1	2	0	1	0	0	0	0	1	0	1	1	0	0	3	0	2	0	0	0	0	0	1	0	0	1	0	0
Blinded Period	Other	54	3	4	2	0	0	2	2	1	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	2	0	0	0
Blinded Period	Participants entered open label period	4,544	4,906	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blinded Period	Physician Decision	1	1	0	3	0	0	1	1	0	0	0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blinded Period	Protocol Violation	5	14	0	1	2	2	0	0	0	4	6	1	0	2	6	4	6	0	1	0	1	0	4	6	5	3	4	3
Blinded Period	Refused further study procedures	0	0	0	0	0	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blinded Period	Withdrawal by parent/guardian	0	0	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blinded Period	Withdrawal by Subject	26	62	14	16	1	2	9	5	3	15	11	7	2	1	11	2	5	0	0	1	0	0	5	1	5	1	4	2
Open-Label Period	Adverse Event	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Death	5	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Did not receive Open-label BNT162b2 30 mcg	0	476	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Lost to Follow-up	109	41	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	No longer meets eligibility criteria	20	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Other	621	429	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Physician Decision	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Protocol Violation	377	48	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Refused further study procedures	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Withdrawal by parent/guardian	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Period	Withdrawal by Subject	135	25	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Placebo: Blinded Period	SSB: BNT162b2 30 mcg Then Placebo	SSB: Placebo Then BNT162b2 30 mcg	SSC: BNT162b2 10 mcg	SSC: BNT162b2 30 mcg	SSD: Cohort 1: Group 1	SSD: Cohort 1: Group 2	SSD: Cohort 1: Group 2b	SSD: Cohort 2: Group 3	SSD: Cohort 2: Group 4	SSD: Cohort 3: Group 5	SSE: Sentinel Cohort (18-55 Years): BNT 30mcg + BNT OMI 30 mcg	SSE: Sentinel Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg	SSE: Sentinel Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg	SSE: Expanded Cohort (18-55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Expanded Cohort (18-55 Years): BNT 15 mcg +BNT OMI 15 mcg	SSE: Expanded Cohort (18 to 55 Years): BNT162b2 OMI 60 mcg	SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	Total	SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSF: BNT162b2 30 mcg	SSF: BNT162b2 60 mcg	SSF: BNT162b2 OMI 30 mcg	SSF: BNT162b2 OMI 60 mcg	SSF: BNT162b2 15 mcg + BNT162b2 OMI 15 mcg	SSF: BNT162b2 30 mcg + BNT162b2 OMI 30 mcg
Age, Customized 85 years and over	9 Participants	12 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	34 Participants	1 Participants	0 Participants	1 Participants	2 Participants	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized Adolescents (12-17 years)	46 Participants	44 Participants	233 Participants	228 Participants	75 Participants	65 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	691 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized Adults (18-64 years)	3859 Participants	3811 Participants	520 Participants	504 Participants	0 Participants	0 Participants	216 Participants	197 Participants	204 Participants	315 Participants	323 Participants	210 Participants	30 Participants	30 Participants	30 Participants	482 Participants	159 Participants	321 Participants	6 Participants	5 Participants	5 Participants	7 Participants	5 Participants	9 Participants	126 Participants	11989 Participants	105 Participants	121 Participants	123 Participants	112 Participants	109 Participants	6 Participants	7 Participants	6 Participants	8 Participants	9 Participants	9 Participants
Age, Customized From 65-84 years	1166 Participants	1174 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	14 Participants	15 Participants	15 Participants	13 Participants	15 Participants	10 Participants	176 Participants	3633 Participants	196 Participants	186 Participants	183 Participants	194 Participants	199 Participants	15 Participants	12 Participants	15 Participants	12 Participants	11 Participants	12 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	86 Participants	92 Participants	4 Participants	6 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	206 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	288 Participants	269 Participants	61 Participants	58 Participants	7 Participants	5 Participants	4 Participants	2 Participants	1 Participants	42 Participants	45 Participants	1 Participants	2 Participants	3 Participants	3 Participants	42 Participants	20 Participants	25 Participants	3 Participants	1 Participants	2 Participants	1 Participants	4 Participants	3 Participants	13 Participants	994 Participants	20 Participants	16 Participants	20 Participants	16 Participants	17 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Black or African American	470 Participants	457 Participants	159 Participants	155 Participants	11 Participants	9 Participants	176 Participants	172 Participants	178 Participants	21 Participants	34 Participants	155 Participants	2 Participants	3 Participants	1 Participants	34 Participants	10 Participants	32 Participants	1 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	19 Participants	2203 Participants	22 Participants	23 Participants	20 Participants	13 Participants	19 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Hispanic/Latino	759 Participants	750 Participants	152 Participants	150 Participants	15 Participants	11 Participants	6 Participants	0 Participants	4 Participants	48 Participants	46 Participants	7 Participants	3 Participants	4 Participants	3 Participants	66 Participants	17 Participants	39 Participants	1 Participants	1 Participants	4 Participants	3 Participants	2 Participants	4 Participants	57 Participants	2369 Participants	38 Participants	44 Participants	46 Participants	45 Participants	44 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Multiracial	209 Participants	197 Participants	24 Participants	12 Participants	1 Participants	0 Participants	10 Participants	11 Participants	6 Participants	10 Participants	12 Participants	22 Participants	1 Participants	0 Participants	0 Participants	12 Participants	2 Participants	8 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	559 Participants	5 Participants	6 Participants	3 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	7 Participants	11 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	34 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Non-Hispanic/non-Latino	4309 Participants	4283 Participants	595 Participants	577 Participants	59 Participants	53 Participants	209 Participants	196 Participants	200 Participants	266 Participants	277 Participants	202 Participants	27 Participants	26 Participants	27 Participants	413 Participants	142 Participants	282 Participants	19 Participants	19 Participants	16 Participants	17 Participants	18 Participants	16 Participants	248 Participants	13937 Participants	264 Participants	263 Participants	261 Participants	263 Participants	269 Participants	21 Participants	19 Participants	21 Participants	20 Participants	19 Participants	21 Participants
Race/Ethnicity, Customized Not reported	22 Participants	13 Participants	13 Participants	7 Participants	1 Participants	0 Participants	9 Participants	4 Participants	8 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	41 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	3998 Participants	4002 Participants	491 Participants	493 Participants	55 Participants	50 Participants	16 Participants	8 Participants	9 Participants	237 Participants	224 Participants	31 Participants	25 Participants	24 Participants	26 Participants	389 Participants	124 Participants	250 Participants	16 Participants	19 Participants	15 Participants	17 Participants	14 Participants	16 Participants	268 Participants	12265 Participants	254 Participants	261 Participants	262 Participants	277 Participants	272 Participants	21 Participants	19 Participants	21 Participants	20 Participants	20 Participants	21 Participants
Sex: Female, Male Female	2624 Participants	2526 Participants	434 Participants	447 Participants	37 Participants	33 Participants	137 Participants	119 Participants	121 Participants	152 Participants	156 Participants	106 Participants	14 Participants	17 Participants	15 Participants	269 Participants	89 Participants	180 Participants	8 Participants	9 Participants	14 Participants	12 Participants	7 Participants	11 Participants	160 Participants	8528 Participants	157 Participants	153 Participants	154 Participants	144 Participants	162 Participants	9 Participants	9 Participants	13 Participants	10 Participants	8 Participants	12 Participants
Sex: Female, Male Male	2456 Participants	2515 Participants	319 Participants	285 Participants	38 Participants	32 Participants	79 Participants	78 Participants	83 Participants	163 Participants	167 Participants	104 Participants	16 Participants	13 Participants	15 Participants	213 Participants	70 Participants	141 Participants	12 Participants	11 Participants	6 Participants	8 Participants	13 Participants	9 Participants	145 Participants	7819 Participants	145 Participants	154 Participants	153 Participants	164 Participants	151 Participants	12 Participants	10 Participants	8 Participants	10 Participants	12 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk	EG019 affected / at risk	EG020 affected / at risk	EG021 affected / at risk	EG022 affected / at risk	EG023 affected / at risk	EG024 affected / at risk	EG025 affected / at risk	EG026 affected / at risk	EG027 affected / at risk	EG028 affected / at risk	EG029 affected / at risk	EG030 affected / at risk	EG031 affected / at risk	EG032 affected / at risk	EG033 affected / at risk	EG034 affected / at risk	EG035 affected / at risk	EG036 affected / at risk	EG037 affected / at risk	EG038 affected / at risk	EG039 affected / at risk
deaths Total, all-cause mortality	5 / 5,080	2 / 5,041	5 / 4,429	0 / 1,453	0 / 1,463	0 / 21	0 / 19	0 / 21	0 / 20	0 / 20	0 / 21	0 / 75	0 / 65	0 / 216	2 / 197	1 / 204	1 / 315	0 / 213	0 / 323	0 / 238	1 / 210	1 / 172	0 / 30	0 / 30	0 / 30	0 / 482	0 / 159	0 / 321	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20	1 / 20	0 / 305	0 / 302	1 / 307	1 / 307	0 / 308	1 / 313
other Total, other adverse events	1,201 / 5,080	202 / 5,041	771 / 4,429	1,180 / 1,453	615 / 1,463	17 / 21	19 / 19	20 / 21	18 / 20	18 / 20	20 / 21	49 / 75	57 / 65	124 / 216	131 / 197	109 / 204	260 / 315	167 / 213	270 / 323	175 / 238	135 / 210	69 / 172	29 / 30	27 / 30	29 / 30	431 / 482	143 / 159	297 / 321	15 / 20	15 / 20	15 / 20	20 / 20	16 / 20	17 / 20	220 / 305	243 / 302	241 / 307	248 / 307	226 / 308	247 / 313
serious Total, serious adverse events	73 / 5,080	42 / 5,041	45 / 4,429	2 / 1,453	2 / 1,463	0 / 21	1 / 19	1 / 21	0 / 20	1 / 20	0 / 21	0 / 75	1 / 65	2 / 216	3 / 197	2 / 204	5 / 315	1 / 213	2 / 323	3 / 238	7 / 210	1 / 172	0 / 30	0 / 30	0 / 30	3 / 482	2 / 159	3 / 321	1 / 20	0 / 20	0 / 20	0 / 20	0 / 20	1 / 20	6 / 305	2 / 302	12 / 307	4 / 307	4 / 308	6 / 313

Outcome results

Primary

Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b

Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.

Time frame: 1 month after Vaccination 1

Population: Evaluable immunogenicity population included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 1, 2b), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 1, 2b), had no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	88.0 Percentage of participants
SSA: Placebo: Blinded Period	Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	59.0 Percentage of participants

Comparison: Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [17.2, 40.3]

Primary

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.173 and for Placebo was 0.989

Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	57.118 Number of first Covid-19 cases/1000 PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	151.668 Number of first Covid-19 cases/1000 PY

Comparison: 2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.95% CI: [49.5, 72.2]

Primary

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

Occurrences (number of cases) of first COVID-19 infection in participants after booster dose with and without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 0.871 and for Placebo was 0.835

Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of Subjects Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	8.037 Number of first Covid-19 cases/1000 PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	148.503 Number of first Covid-19 cases/1000 PY

Comparison: 2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.95% CI: [88.5, 97.9]

Primary

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

Occurrences (number of cases) of first COVID-19 infection in participants after booster dose without past SARS-CoV-2 infection at final analysis were reported in this outcome measure.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.098 and for Placebo was 0.932

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	57.377 Number of first Covid-19 cases/1000 PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population	158.798 Number of first Covid-19 cases/1000 PY

Comparison: 2-Sided CI for Relative Vaccine Efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.95% CI: [51.1, 73.5]

Primary

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

Occurrences (number of cases) of first COVID-19 infection in participants after booster dose per 1000 person-year, without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year [PY]) for BNT162b2 was 0.823 and for Placebo was 0.792

Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. Human Immunodeficiency Virus (HIV) positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	7.290 Number of first Covid-19 cases/1000 PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population	155.303 Number of first Covid-19 cases/1000 PY

Comparison: 2-Sided CI for Relative vaccine efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.95% CI: [89.5, 98.3]

Primary

SSA: Percentage of Participants Reporting Adverse Events

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: From booster dose (Day 1) to 1 month after booster dose

Population: Safety population included all randomized participants who received at least 1 dose of the study intervention. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Percentage of Participants Reporting Adverse Events	26.3 Percentage of participants
SSA: Placebo: Blinded Period	SSA: Percentage of Participants Reporting Adverse Events	7.1 Percentage of participants

Primary

SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)

An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Time frame: BNT162b2 30 mcg, Placebo then BNT162b2 30 mcg: From BNT162b2 dose to 6 months after BNT162b2 dose; Placebo: From placebo dose to unblinding for original placebo participants. Median blinded follow-up period for Placebo group=2.8 months

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)	1.4 Percentage of participants
SSA: Placebo: Blinded Period	SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)	0.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)	1.0 Percentage of participants

Primary

SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: Vaccination 1 up to 1 Month After Vaccination 1

Population: Safety population included all participant who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1	10.4 Percentage of participants

Primary

SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: Vaccination 2 up to 1 month after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Participants who did not receive Vaccination 2 or who received an incorrect vaccine at Vaccination 2 were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2	5.6 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2	7.4 Percentage of participants

Primary

SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Time frame: Vaccination 1 up to 1 month after Vaccination 1

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1	0.3 Percentage of participants

Primary

SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2

Time frame: Vaccination 2 up to 1 month after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for the specified outcome measure and received two doses of study vaccination for SSB.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2	0.1 Percentage of participants

Primary

SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2

Percentage of participants with elevated troponin I levels within 1 month after administration of Vaccination 2 were reported in this outcome measure.

Time frame: 1 month after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2	0.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2	0.3 Percentage of participants

Primary

SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1

Percentage of participants with elevated troponin I levels before administration of Vaccination 1 were reported in this outcome measure.

Time frame: Pre-dose on Day 1 (Vaccination 1)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1	0.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1	0.5 Percentage of participants

Primary

SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)

Percentage of participants with elevated troponin I levels pre vaccination 2 were reported in this outcome measure.

Time frame: Pre-Vaccination 2 (1 month after Vaccination 1)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)	1.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)	0.3 Percentage of participants

Primary

SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1

Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 1 were reported in this outcome measure.

Time frame: Within 5 days after Vaccination 1

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1	1.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1	0.6 Percentage of participants

Primary

SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2

Percentage of participants with elevated troponin I levels within 5 days after administration of Vaccination 2 were reported in this outcome measure.

Time frame: Within 5 days after vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSB.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2	0.3 Percentage of participants

Primary

SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after Vaccination 1

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	4.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	6.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Any	74.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Mild	48.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	5.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Moderate	25.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	1.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	1.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	5.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	0.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	0.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Any	13.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Mild	12.2 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Moderate	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Severe	0 Percentage of participants

Primary

SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after Vaccination 2

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	0.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Any	8.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Mild	6.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Moderate	2.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	1.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	4.6 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Mild	40.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	2.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Severe	0.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Moderate	30.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	5.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Any	71.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	3.4 Percentage of participants

Primary

SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.

Time frame: Day 1 up to Day 7 after Vaccination 1

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	42.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: 38.0 to 38.4 deg C	4.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 to 38.9 deg C	1.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 to 40.0 deg C	0.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	54.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	27.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	25.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	1.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38 deg C	6.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	24.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	17.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	1.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	17.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	10.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	6.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	2.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	7.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	6.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	0.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	27.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	14.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	13.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	12.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	8.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	4.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38 deg C	1.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	0.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: 38.0 to 38.4 deg C	1.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	7.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 to 38.9 deg C	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	0.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 to 40.0 deg C	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	4.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	31.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	5.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	19.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	12.2 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	2.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	28.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	7.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	18.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	3.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	10.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	6.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	1.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	5.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	4.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants

Primary

SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

Time frame: Day 1 up to Day 7 after Vaccination 2

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	17.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: 38.0 to 38.4 deg C	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >38.4 to 38.9 deg C	0.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >38.9 to 40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	17.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	8.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	8.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >=38 deg C	0.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	10.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	7.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	3.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	2.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	1.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	0.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	3.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	2.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	1.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	2.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	2.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	3.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	1.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	1.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	4.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >=38 deg C	4.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	1.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: 38.0 to 38.4 deg C	2.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	29.2 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >38.4 to 38.9 deg C	1.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	1.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >38.9 to 40.0 deg C	0.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	12.2 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: >40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	47.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	15.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	18.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	27.1 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	12.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	39.7 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	8.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	19.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	7.4 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	19.0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	6.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	0.9 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	22.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	13.2 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	8.8 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0.3 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants

Primary

SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose

GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline to 1 month after the booster dose received in this sub-study was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From baseline to 1 month after the booster dose

Population: Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they are randomized, have valid and determinate immunogenicity result for Visit 303 (1 month after booster dose), have blood sample collected within an appropriate window (within 28-42 days after booster dose), and have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose	8.6 Fold rise
SSA: Placebo: Blinded Period	SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose	9.5 Fold rise

Primary

SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline

GMT of SARS-CoV-2 reference-strain-neutralizing titers at baseline (before the booster dose) was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: At baseline (pre-dose)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline	1337.2 Titer
SSA: Placebo: Blinded Period	SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline	1648.4 Titer

Primary

SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose

GMT of SARS-CoV-2 reference-strain-neutralizing titers at 1 month after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: 1 month after the booster dose

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose	11672.4 Titer
SSA: Placebo: Blinded Period	SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose	15680.7 Titer

Primary

SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from booster (third) dose up to 1 month after booster (third) dose were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From booster dose (Day 1) up to 1 month after booster dose

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose	4.0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose	7.7 Percentage of participants

Primary

SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose

Time frame: From booster dose (Day 1) up to 6 months after booster dose

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose	1.5 Percentage of participants

Primary

SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 cm and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after the booster (third) dose and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after the booster dose

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Mild	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Any	2.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Any	56.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Mild	40.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Mild	2.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Moderate	16.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Any	1.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Any	6.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Mild	4.7 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Moderate	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Any	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Mild	6.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Moderate	3.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Any	78.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Mild	46.9 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Moderate	31.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose	Pain at the injection site: Severe	0 Percentage of participants

Primary

SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose

Seroresponse was defined as achieving \>= 4-fold rise from baseline (before the study vaccination). If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month after the booster dose was reported in this outcome measure.

Time frame: 1 month after the booster dose

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose	67.7 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose	66.7 Percentage of participants

Primary

SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24 h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.

Time frame: Day 1 up to Day 7 after the booster dose

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Any	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >=38.0°C to 38.4 deg C	2.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Mild	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Any	41.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Moderate	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Mild	21.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Any	49.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Any	4.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Moderate	20.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Mild	2.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >=38.0 deg C	4.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Moderate	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Mild	22.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Any	24.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Mild	4.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >38.4°C to 38.9 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Moderate	20.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Any	13.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Moderate	25.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Mild	5.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Any	14.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Mild	5.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Moderate	8.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Moderate	9.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Severe	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >38.9°C to 40.0 deg C	1.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Any	37.5 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >=38.0 deg C	6.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >=38.0°C to 38.4 deg C	3.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >38.4°C to 38.9 deg C	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >38.9°C to 40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Any	54.7 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Mild	25.0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Moderate	26.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Severe	3.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Any	53.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Mild	31.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Moderate	20.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Severe	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Any	23.4 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Mild	12.5 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Moderate	10.9 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Chills: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Any	3.1 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Mild	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Moderate	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Any	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Mild	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Mild	20.3 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Moderate	17.2 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Any	15.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Mild	10.9 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Moderate	4.7 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose	Fever: >40.0 deg C	1.6 Percentage of participants

Primary

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: 1 month after Vaccination 1

Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Groups 1, 2b), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Groups 1, 2b), have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	5094.1 Titer
SSA: Placebo: Blinded Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b	1775.6 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]) and the corresponding CI (based on the student t distribution).95% CI: [2.18, 3.78]

Primary

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4

GMR was calculated based on GMT levels of SSD: Cohort 2: Group 3 and SSD: Cohort 2: Group 4 and reported in statistical analysis section below. GMT of SARS-CoV-2 Omicron strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after first study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: 1 month after Vaccination 1

Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 3, 4), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 3, 4), have no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	1929.2 Titer
SSA: Placebo: Blinded Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	1099.6 Titer

Primary

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3

GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMR comparison between GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of SSD Cohort 3: Group 5 to GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers of participants of study C4591001 (NCT04368728) Phase 3 BNT162b2 single arm 18-55 years of age, at 1 month after vaccination 2 was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (student's t distribution).

Time frame: 1 month after Vaccination 2

Population: EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3	2892.2 Titer
SSA: Placebo: Blinded Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3	290.6 Titer

Primary

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b

GMR was calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after Vaccination 2 for Group 2 and 1 month after Vaccination 1 for Group 2b was reported. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).

Time frame: For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2

Population: EIP: all eligible participants received 1st study drug as randomized (Group 2b) or received 2 doses of study drug as randomized with Dose 2 received within 19-42 days after Dose1 (Group 2), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 2b) or 28-42 days after 2nd study vaccination (Group 2), had no other important protocol deviations as determined by clinician. Here 'N'=participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b	4684.3 Titer
SSA: Placebo: Blinded Period	SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b	1775.6 Titer

Primary

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after last study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From Day 1 up to 1 month after last study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1	3.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1	6.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1	2.0 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From first study vaccination (Day 1) up to 1 month after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3	6.7 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from first study vaccination (Day 1) up to 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From first study vaccination (Day 1) up to 1 month after Vaccination 1

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2	4.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2	3.7 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 2 up to 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From Vaccination 2 up to 1 month after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2	2.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2	3.8 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from Vaccination 3 up to 1 month after Vaccination 3 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From Vaccination 3 up to 1 month after Vaccination 3

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received three doses of study vaccination for SSD.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3	0.6 Percentage of participants

Primary

SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2

A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Time frame: From vaccination 1 (Day 1) up to 6 months after vaccination 1 (participants received 1 dose only); From vaccination 1 up to before vaccination 2 (participants received 2 doses)

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2	0.6 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3

Time frame: From first study vaccination (Day 1) up to 6 months after last study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3	0.9 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3	1.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3	1.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3	3.8 Percentage of participants

Primary

SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2

Time frame: From first study vaccination (Day 1) up to 6 months after vaccination 2

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and received two doses of study vaccination for SSD.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2	1.3 Percentage of participants

Primary

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection (inj) site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 1 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after Vaccination 1

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 1 and 'Number Analyzed (n)' signifies participants evaluable for specified rows.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	3.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	8.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	0.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	30.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	46.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	4.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	3.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	1.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	15.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	4.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	5.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	4.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	7.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	2.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	42.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	27.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	14.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	1.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	5.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	1.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	2.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	1.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	0.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	42.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	32.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	4.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	4.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	78.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	59.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	18.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	0.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	7.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	2.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	8.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	5.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	3.1 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	16.4 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	2.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	0.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	8.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	6.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	1.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	61.5 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	78.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	4.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	3.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	2.2 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Moderate	26.1 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Mild	27.7 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	6.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Severe	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	11.3 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Any	54.3 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Any	5.4 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Injection site pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	3.2 Percentage of participants

Primary

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 2 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after Vaccination 2

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 2 and 'Number Analyzed (n)' signifies participants evaluable for specified rows and received two doses of study vaccination for SSD. Participants of SSD: Cohort 1: Group 1 did not receive Vaccination 2 and therefore were not analyzed for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Mild	29.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	8.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Moderate	10.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	5.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Any	40.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	7.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	1.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	5.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Moderate	18.9 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	3.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	4.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	2.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	2.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Any	74.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Mild	55.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Any	70.6 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	4.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Severe	0.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Mild	57.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Moderate	12.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	0.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	5.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	6.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	4.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	5.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	3.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Any	4.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Any	34.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Mild	21.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Injection site pain: Moderate	13.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	9.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants

Primary

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after Vaccination 3 and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after Vaccination 3

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 3. Participants of SSD: Cohort 1: Group 1, Group 2 and SSD Cohort 2: Group 3, Group 4 did not receive Vaccination 3 and therefore were not analyzed for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Swelling: Any	10.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Redness: Any	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Redness: Mild	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Redness: Moderate	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Swelling: Mild	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Swelling: Moderate	7.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Pain at the injection site: Any	39.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Pain at the injection site: Mild	19.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Pain at the injection site: Moderate	18.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Pain at the injection site: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3	Pain at the injection site: Grade 4	0 Percentage of participants

Primary

SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b

Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below LLOQ, postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after second study vaccination for Group 2 and 1 month after study vaccination for Group 2b was reported in this outcome measure.

Time frame: For Cohort 1 Group 2b:1 month after Vaccination 1; for Cohort 1 Group 2: 1 month after Vaccination 2

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b	80.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b	59.0 Percentage of participants

Primary

SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4

Seroresponse: achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse 1 month after first study vaccination was reported in this outcome measure.

Time frame: 1 month after Vaccination 1

Population: Evaluable immunogenicity population (EIP) included all eligible randomized participants who received 1st study intervention to which they were randomized (Group 3, 4), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 1st study vaccination (Group 3, 4), had no other important protocol deviations as determined by clinician. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	62.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4	39.3 Percentage of participants

Primary

SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3

EIP:eligible participants received 2 doses of study drug as randomized with Dose2 received within 19-42 days after Dose1 (SSD Cohort 3:Group 5), had valid determinate immunogenicity result from blood sample collected within 28-42 days after 2nd study vaccination, had no other important protocol deviations as determined by clinician. Data of eligible participants from Study C4591001 Phase 3 BNT162b2 single arm 18-55 years was included for comparison.'N'=participants evaluable for outcome measure.

Time frame: 1 month after Vaccination 2

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3	86.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3	80.8 Percentage of participants

Primary

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C, categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.

Time frame: Day 1 up to Day 7 after Vaccination 1

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 1.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	20.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	4.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	10.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	10.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	0.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	15.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	0.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	5.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	5.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	5.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	11.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	4.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	8.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	32.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	9.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	18.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	15.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	12.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	7.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	1.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	30.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	8.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	12.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	15.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	6.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	6.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	7.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	11.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	2.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	8.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	6.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	2.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	26.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	13.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	1.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	6.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	27.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	14.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	2.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	9.4 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	16.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	4.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	1.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	28.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	7.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	4.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	2.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	5.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	1.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	16.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	10.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	1.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	27.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	16.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	10.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	0.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	10.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	8.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	2.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	3.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	2.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	1.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	6.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	5.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	1.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	13.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	6.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	10.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	5.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	27.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	18.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	1.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	2.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	12.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	8.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	17.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	14.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	34.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	1.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	7.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	3.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	1.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	23.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	0.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	2.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	2.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	13.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	47.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	34.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	10.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	64.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	4.8 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	8.8 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	31.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	26.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	3.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	18.4 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	1.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	2.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	7.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	1.6 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	1.6 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	28.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	7.2 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	10.2 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	29.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	60.5 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	11.5 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	9.2 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	2.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	45.1 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	0.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	28.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	16.8 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	3.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	10.5 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	1.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	3.9 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	7.2 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	2.0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	17.4 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	15.1 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	26.3 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	25.7 Percentage of participants
SSD: Cohort 2: Group 4	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	15.1 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Any	14.0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Moderate	12.9 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Any	39.2 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >=38.0 deg C to 38.4 deg C	1.1 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Mild	10.2 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Severe	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Mild	16.7 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Moderate	1.6 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Mild	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Any	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Any	12.4 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: Unknown	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Severe	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Mild	3.8 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Moderate	16.7 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Moderate	22.0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Vomiting: Any	2.2 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.9 deg C to 40.0 deg C	1.1 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Moderate	7.0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Moderate	3.8 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Severe	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Mild	3.8 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Mild	7.0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >38.4 deg C to 38.9 deg C	2.7 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Moderate	8.6 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Fatigue: Severe	0.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Any	19.9 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Diarrhea: Any	8.1 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	New or worsened muscle pain: Mild	6.5 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Headache: Any	27.4 Percentage of participants

Primary

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

Time frame: Day 1 up to Day 7 after Vaccination 2

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants who received Vaccination 2 and 'n' signifies participants evaluable for specified rows and received two doses of study vaccination for SSD. Participants of SSD: Cohort 1: Group 1 did not receive Vaccination 2 and therefore were not analyzed for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	7.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	10.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.4 deg C-38.9 deg C	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	5.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	5.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	11.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	24.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	3.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	13.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Unknown	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>=38.0 deg C-38.4 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	7.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	17.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	10.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.9 deg C-40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	2.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	5.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	5.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	12.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	1.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Any	1.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	60.9 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	14.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Unknown	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	7.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	6.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.9 deg C-40.0 deg C	1.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	1.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Any	5.1 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	10.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.4 deg C-38.9 deg C	1.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	10.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	21.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	0.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	13.3 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	26.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>=38.0 deg C-38.4 deg C	2.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	39.8 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	8.2 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	1.5 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	1.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	9.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	27.6 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	32.0 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	17.9 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	9.7 Percentage of participants
SSA: Placebo: Blinded Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	27.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	54.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	1.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	1.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	5.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	6.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	6.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	5.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	0.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	26.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	14.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	11.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	12.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	6.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Any	6.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>=38.0 deg C-38.4 deg C	3.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.4 deg C-38.9 deg C	1.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.9 deg C-40.0 deg C	0.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>40.0 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Unknown	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	26.9 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	25.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	2.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	37.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	18.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	17.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	2.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	19.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	12.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Any	27.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Moderate	4.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Mild	13.5 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Mild	4.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Any	8.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Any	19.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Moderate	12.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Moderate	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Severe	1.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Mild	4.3 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Diarrhea: Any	6.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Mild	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Mild	10.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Mild	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Any	7.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Moderate	9.2 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>=38.0 deg C-38.4 deg C	0.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Any	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Vomiting: Any	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.4 deg C-38.9 deg C	1.4 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Moderate	3.6 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>38.9 deg C-40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Mild	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Headache: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever:>40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened joint pain: Any	5.7 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Chills: Moderate	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	Fever: Unknown	0 Percentage of participants
SSD: Cohort 2: Group 3	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2	New or worsened muscle pain: Grade 4	0 Percentage of participants

Primary

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3

Systemic events were recorded in e-diary. Fever: oral temperature \>= 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Vomiting: mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, severe: required intravenous hydration and Grade 4: ER visit/hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit/hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.

Time frame: Day 1 up to Day 7 after Vaccination 3

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N'= participants who received vaccination 3. Participants of SSD: Cohort 1: Group 1, Group 2 and SSD Cohort 2: Group 3, Group 4 did not receive Vaccination 3 and therefore were not analyzed for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fever: >38.9 deg C to 40.0 deg C	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fatigue: Moderate	18.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fatigue: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Headache: Mild	9.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Headache: Moderate	14.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Chills: Any	9.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Chills: Mild	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Chills: Severe	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Vomiting: Mild	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fever: Any	2.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fever: >=38.0 deg C to 38.4 deg C	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fever: >38.4 deg C to 38.9 deg C	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fatigue: Any	22.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fatigue: Mild	3.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Headache: Any	25.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Headache: Severe	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Chills: Moderate	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Vomiting: Any	2.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Vomiting: Moderate	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Diarrhea: Any	1.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Diarrhea: Mild	1.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Diarrhea: Moderate	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened muscle pain: Any	14.9 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened muscle pain: Mild	4.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened muscle pain: Moderate	10.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened joint pain: Any	9.1 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened joint pain: Mild	3.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened joint pain: Moderate	5.2 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened joint pain: Severe	0.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3	New or worsened joint pain: Grade 4	0 Percentage of participants

Primary

SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination

GMR calculated based on GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: 1 month after study vaccination

Population: EIP: all eligible randomized participants who received study intervention to which they were randomized, had valid and determinate immunogenicity result within 28-42 days after study vaccination, had no other important protocol deviations as determined by the clinician. 'N' = participants evaluable for this outcome measure. As pre-specified in the protocol, this outcome measure was not planned to be analyzed in ''SSE: Expanded Cohort (\> 55 Years): BNT162b2 60 mcg''.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	455.8 Titer
SSA: Placebo: Blinded Period	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	1014.5 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	1435.2 Titer
SSD: Cohort 2: Group 3	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	711.0 Titer
SSD: Cohort 2: Group 4	SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination	900.1 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.95% CI: [1.65, 3]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.95% CI: [2.38, 4.16]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.95% CI: [1.17, 2.08]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.95% CI: [1.45, 2.68]

Primary

SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From study vaccination up to 1 Month after study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	13.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	13.3 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	7.7 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	6.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	9.3 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	5.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	5.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	6.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	8.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	3.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	6.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	10.4 Percentage of participants

Primary

SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination

Time frame: From study vaccination up to 6 Months after study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	1.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0.9 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	5.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	3.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination	1.9 Percentage of participants

Primary

SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age

Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.

Time frame: 3 days after study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention. As pre-specified in the protocol, this outcome measure was planned to be analyzed only in the Sentinel Cohort in participants of 18 to 55 years of age.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants

Primary

SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age

Percentage of participants with elevated troponin I levels before study vaccination were reported in this outcome measure.

Time frame: Before study vaccination (pre-dose)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age	0 Percentage of participants

Primary

SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu=0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm),severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]).Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit/hospitalization for severe pain). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions within 7 days after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after study vaccination

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	30.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	6.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	90.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	60.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	6.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	6.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	6.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	76.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	6.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	83.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	33.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	3.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	60.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	96.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	13.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	20.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	4.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	82.9 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	9.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	8.1 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	55.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	4.4 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	3.8 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	26.0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	1.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.2 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	13.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	6.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	67.7 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	4.4 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	4.4 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	1.9 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	2.5 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	81.0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	7.0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	45.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	39.4 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	86.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	1.6 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	6.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	11.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	6.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	4.4 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	70.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	55.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	70.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	65.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	65.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	55.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	75.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	100.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	60.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	65.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	45.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	40.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	85.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	8.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	3.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	51.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	4.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	60.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	6.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	6.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	17.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	6.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	71.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	7.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	53.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	13.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	4.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	6.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	3.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	66.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	52.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	13.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	8.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	3.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	70.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	6.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	4.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	5.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	10.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	44.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	4.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	25.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	5.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	6.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	52.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	58.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	4.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	4.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	7.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	2.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	3.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	12.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	67.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	7.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	5.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	55.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	2.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	3.2 Percentage of participants

Primary

SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination

Seroresponse was defined as achieving \>= 4-fold rise from baseline (before study vaccination). If baseline measurement is below lower limit of quantification (LLOQ), postvaccination measure of \>= 4 × LLOQ is considered seroresponse. Exact 2-sided CI, based on Clopper and Pearson method was used. Percentage of participants achieving seroresponse at 1 month was reported in this outcome measure.

Time frame: 1 month after study vaccination

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	57.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	76.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	86.1 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	71.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination	67.9 Percentage of participants

Comparison: Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [9.3, 29.7]

Comparison: Difference in proportions, expressed as a percentage (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [19.4, 38.5]

Comparison: Difference in proportions, expressed as a percentage (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [4, 24.9]

Comparison: Difference in proportions, expressed as a percentage (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.95% CI: [0.1, 21.4]

Primary

SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to 38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C & \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity) and Grade 4 (ER visit or hospitalization). Vomiting: mild: 1-2 times in 24 h, moderate: \> 2 times in 24h, severe: required intravenous hydration and Grade 4: ER or hospitalization for hypotensive shock. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h and Grade 4: ER visit or hospitalization for severe diarrhea. Grade 4 were classified by investigator or medically qualified person. Exact 95% CI was based on Clopper and Pearson method.

Time frame: Day 1 up to Day 7 after study vaccination

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	23.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	43.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	46.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	10.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	20.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	16.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	40.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	3.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	3.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	20.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	6.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	10.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	66.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	23.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	13.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	20.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	3.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	6.7 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	30.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	3.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	6.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	33.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	30.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	63.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	20.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	3.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	23.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	13.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	30.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	23.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	3.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	16.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	3.3 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	10.0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	26.7 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	23.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	26.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	40.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	23.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	6.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	30.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	40.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	3.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	23.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	10.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	20.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	13.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	13.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	60.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	13.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	70.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	23.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	46.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	25.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	24.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	4.2 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	20.4 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.4 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	3.1 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	39.8 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	9.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	12.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	25.4 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	4.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	44.0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	12.5 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0.4 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	2.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	21.3 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	35.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	3.1 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	53.5 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	73.8 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	2.1 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	3.8 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	18.3 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	12.5 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	27.7 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	14.6 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0.2 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	10.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	15.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	9.5 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	19.0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	20.9 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.1 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	6.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.9 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	3.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	15.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	68.4 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	32.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0.6 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	20.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	34.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	1.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	36.7 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	50.0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	1.3 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	27.8 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	11.4 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	29.1 Percentage of participants
SSD: Cohort 2: Group 4	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	18.8 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	4.7 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	77.5 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	22.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	2.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	4.4 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	2.8 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.3 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	1.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	8.1 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	57.5 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	6.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	19.4 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	24.1 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	3.8 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	2.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	27.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	12.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	38.4 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	10.0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	14.1 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	17.8 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	9.1 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	3.4 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	27.5 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	46.9 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	42.2 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	17.8 Percentage of participants
SSD: Cohort 3: Group 5	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	25.9 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	45.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	40.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	55.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	45.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	65.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	40.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	45.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	50.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	10.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	15.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	35.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	70.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	30.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	5.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	20.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	25.0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Sentinel Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	23.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	9.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	19.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	21.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	10.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	11.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	45.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	1.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	8.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	4.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	26.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	15.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	3.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	10.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	16.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	5.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	26.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	16.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	52.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	24.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	14.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	25.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	10.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	1.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	23.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	38.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	7.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	22.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	9.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	6.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	14.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	3.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	5.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	20.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	13.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	8.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	1.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	52.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	29.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	36.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	22.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	25.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	8.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	6.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	23.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	11.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	12.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	12.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	16.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	9.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	7.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	3.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	2.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	8.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	19.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	12.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	2.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	2.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	15.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	12.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	30.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	4.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	9.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	11.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	25.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	10.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	20.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	36.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	2.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	14.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	30.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	24.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	58.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	2.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	9.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT162b2 OMI 60 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	11.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	6.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	8.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	13.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	9.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	23.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	33.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	9.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	3.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	5.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	11.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	4.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	18.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	9.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	29.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	13.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	22.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	49.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	1.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 15 mcg + BNT OMI 15 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	7.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	13.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	14.1 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	8.0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40 deg C	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	10.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	23.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	6.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	27.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	5.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	36.5 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	28.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	1.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	10.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	57.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	24.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	18.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.4 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	1.3 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	27.2 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	12.8 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	7.7 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	1.9 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0.6 Percentage of participants
SSE: Expanded Cohort (> 55 Years): BNT 30 mcg +BNT OMI 30 mcg	SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants

Primary

SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination

GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to Day 7 (7 days after vaccination)

Population: All-available immunogenicity population included all randomized or assigned participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.5 Fold rise
SSA: Placebo: Blinded Period	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	2.9 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	6.8 Fold rise
SSD: Cohort 2: Group 3	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	8.6 Fold rise
SSD: Cohort 2: Group 4	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	4.3 Fold rise
SSD: Cohort 3: Group 5	SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	9.8 Fold rise

Primary

SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Day 7 (7 days after vaccination)

Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	146.1 Titer
SSA: Placebo: Blinded Period	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	101.6 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	217.1 Titer
SSD: Cohort 2: Group 3	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	315.2 Titer
SSD: Cohort 2: Group 4	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	337.8 Titer
SSD: Cohort 3: Group 5	SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7	222.9 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.4, 1.56]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.93, 3.43]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [1.22, 4.55]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\]- BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.76, 2.89]

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [1.2, 4.53]

Primary

SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination

GMT of SARS-CoV-2 Omicron BA.1 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: Before vaccination (pre-dose)

Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	41.7 Titer
SSA: Placebo: Blinded Period	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	33.2 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	32.0 Titer
SSD: Cohort 2: Group 3	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	36.8 Titer
SSD: Cohort 2: Group 4	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	78.8 Titer
SSD: Cohort 3: Group 5	SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination	21.5 Titer

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination

GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 1 month after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	10.1 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	5.4 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	20.4 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	18.4 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	13.0 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	21.1 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination

GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 3 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	5.9 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	3.3 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	13.5 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	17.9 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	6.5 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	12.0 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination

GMFR of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 6 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	5.8 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	6.9 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	33.1 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	46.9 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	7.5 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	12.6 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination

GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 1 month after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	5.9 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	4.7 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	7.5 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	9.8 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	6.7 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	9.5 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination

GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 3 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	8.6 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	7.4 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	16.0 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	18.5 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	7.2 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	9.4 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination

GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 6 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	7.5 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	16.6 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	32.0 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	55.7 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	10.2 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	13.0 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination

GMFR of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to Day 7 (7 days after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	2.8 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	2.8 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.6 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.2 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	2.9 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	4.7 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination

GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 1 month was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 1 month after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	8.6 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	5.0 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	7.2 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	11.3 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	6.7 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination	8.6 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination

GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 3 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 3 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	5.0 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	3.2 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	5.6 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	8.6 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	3.2 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination	4.5 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination

GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to 6 months was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to 6 months after vaccination

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	2.6 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	3.6 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	6.3 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	12.6 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	3.4 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination	3.9 Fold rise

Primary

SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination

GMFR of SARS-CoV-2 reference-strain-neutralizing titers before vaccination to Day 7 was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From before the study vaccination to Day 7 (7 days after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.5 Fold rise
SSA: Placebo: Blinded Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.1 Fold rise
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.4 Fold rise
SSD: Cohort 2: Group 3	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	4.8 Fold rise
SSD: Cohort 2: Group 4	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	3.4 Fold rise
SSD: Cohort 3: Group 5	SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination	6.3 Fold rise

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	420.0 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	188.1 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	699.4 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	675.6 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	1024.0 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1	477.7 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.85, 3.59]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 3 (3 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	247.3 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	118.5 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	461.4 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	711.0 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	512.0 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3	285.6 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.64, 3.62]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.1 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 6 (6 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	239.6 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	229.5 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	1058.4 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	1722.2 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	588.1 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6	284.0 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.72, 7.1]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Day 7 (7 days after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	75.5 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	56.6 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	73.0 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	76.1 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	123.6 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7	70.7 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.73, 1.84]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1

GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	157.6 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	85.7 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	151.0 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	230.7 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	284.0 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	147.0 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.68, 2.39]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 3 (3 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	222.9 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	132.8 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	322.5 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	458.9 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	296.2 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	141.3 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.43, 2.33]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 6 (6 months after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	203.2 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	265.5 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	645.1 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	1305.2 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	430.5 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	187.4 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.63, 6.89]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7

GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at Day 7 were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Day 7 (7 days after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	1917.2 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	1241.4 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	1472.3 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	1499.2 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	2702.4 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7	1845.8 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.61, 2.09]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1

GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 1 month were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	4674.1 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	2048.4 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	3327.0 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	3565.8 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	5404.7 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1	2521.4 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.51, 1.8]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3

GMR was calculated based on the GMT of SARS-CoV-2 Omicron reference strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 3 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 3 (3 month after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	2896.3 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	1290.2 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	2610.3 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	2949.6 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	2610.3 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3	1474.8 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.38, 1.59]

Primary

SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6

GMR was calculated based on the GMT of SARS-CoV-2 Omicron BA.1 strain-neutralizing titers and reported in statistical analysis. GMTs of SARS-CoV-2 reference strain neutralizing titers at 6 months were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

Time frame: Month 6 (6 months after vaccination)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	1424.5 Titer
SSA: Placebo: Blinded Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	1371.0 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	2756.4 Titer
SSD: Cohort 2: Group 3	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	3956.5 Titer
SSD: Cohort 2: Group 4	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	2702.4 Titer
SSD: Cohort 3: Group 5	SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6	1097.5 Titer

Comparison: GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.95% CI: [0.68, 4.75]

Primary

SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination

GMT of SARS-CoV-2 Omicron BA.4/BA.5 strain neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: Before vaccination (pre-dose)

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	27.1 Titer
SSA: Placebo: Blinded Period	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	18.0 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	20.2 Titer
SSD: Cohort 2: Group 3	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	23.4 Titer
SSD: Cohort 2: Group 4	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	42.2 Titer
SSD: Cohort 3: Group 5	SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination	15.0 Titer

Primary

SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination

GMT of SARS-CoV-2 reference-strain-neutralizing titers before vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: Before vaccination (pre-dose)

Population: All-available immunogenicity population included all randomized participants who received the study intervention with a valid and determinate immunogenicity result after vaccination.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	541.1 Titer
SSA: Placebo: Blinded Period	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	382.4 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	437.5 Titer
SSD: Cohort 2: Group 3	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	315.2 Titer
SSD: Cohort 2: Group 4	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	803.4 Titer
SSD: Cohort 3: Group 5	SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination	256.0 Titer

Primary

SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after study vaccination were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From study vaccination up to 1 Month after study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	10.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	9.5 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	10.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination	0 Percentage of participants

Primary

SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination

Time frame: From study vaccination up to 6 Months after study vaccination

Population: Safety population included all participants who received at least 1 dose of the study intervention.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	5.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	4.8 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	5.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination	0 Percentage of participants

Primary

SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination

Local reactions were recorded by participants in e-diary. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (necrosis \[swelling\] or necrosis/exfoliative dermatitis \[redness\]). Grade 4 were classified by investigator or medically qualified person. Percentage of participants reporting local reactions after study vaccination and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented.

Time frame: Day 1 up to Day 7 after the study vaccination

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	19.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	52.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	71.4 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	19.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	15.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	21.1 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	94.7 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	52.6 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	36.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	19.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	90.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	66.7 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	23.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	35.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	15.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	80.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	45.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	20.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	75.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	55.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	20.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	15.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Moderate	33.3 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Any	28.6 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Mild	23.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Any	28.6 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Mild	57.1 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Redness: Mild	23.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Any	90.5 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Pain at the injection site: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination	Swelling: Grade 4	0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7

Time frame: Day 7 (7 days after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	52.4 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	44.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	71.4 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	85.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	55.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7	90.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	85.7 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	61.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	90.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	85.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	90.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1	85.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3

Time frame: Month 3 (3 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	65.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	50.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	75.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	84.2 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	70.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3	89.5 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6

Time frame: Month 6 (6 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	42.9 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	47.4 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	85.7 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	90.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	65.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6	85.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7

Time frame: Day 7 (7 days after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	33.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	43.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	42.9 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	40.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	40.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7	61.9 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	75.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	61.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	66.7 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	95.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	80.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1	85.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3

Time frame: Month 3 (3 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	75.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	61.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	85.7 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	84.2 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	63.2 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3	85.7 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6

Time frame: Month 6 (6 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	52.4 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	50.0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	85.7 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	90.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	70.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6	75.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7

Time frame: Day 7 (7 days after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	52.4 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	55.6 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	61.9 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	80.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	55.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7	80.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1

Time frame: Month 1 (1 month after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	81.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	61.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	85.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	85.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	70.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1	75.0 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3

Time frame: Month 3 (3 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	65.0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	55.6 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	65.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	78.9 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	55.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3	63.2 Percentage of participants

Primary

SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6

Time frame: Month 6 (6 months after vaccination)

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	42.9 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	42.1 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	61.9 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	85.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	55.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6	50.0 Percentage of participants

Primary

SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination

Time frame: Day 1 up to Day 7 after the study vaccination

Population: Safety population included all participants receiving at least 1 dose of study intervention. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	23.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	19.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	28.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	47.6 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	14.3 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	4.8 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	19.0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	9.5 Percentage of participants
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	14.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	15.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	36.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	21.1 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	26.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	15.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	42.1 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	31.6 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	15.8 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	10.5 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	5.3 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: Placebo: Blinded Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	23.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	23.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	23.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	14.3 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	28.6 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	9.5 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	4.8 Percentage of participants
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	42.9 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	20.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	25.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	30.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	55.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	20.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	10.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	55.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	35.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	15.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	40.0 Percentage of participants
SSD: Cohort 2: Group 3	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	15.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	15.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	5.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	10.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	50.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	20.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	40.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	25.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	35.0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSD: Cohort 2: Group 4	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	5.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Mild	9.5 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Any	38.1 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Any	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Moderate	19.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.4 deg C to 38.9 deg C	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Mild	23.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Mild	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Any	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Mild	23.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Any	28.6 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Any	57.1 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Mild	19.0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Moderate	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C to 38.4 deg C	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Moderate	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Chills: Any	14.3 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Vomiting: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Moderate	33.3 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Diarrhea: Mild	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Any	9.5 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Mild	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Headache: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >= 38.0 deg C	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Moderate	4.8 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >40.0 deg C	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fatigue: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Grade 4	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	Fever: >38.9 deg C to 40.0 deg C	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened muscle pain: Severe	0 Percentage of participants
SSD: Cohort 3: Group 5	SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination	New or worsened joint pain: Grade 4	0 Percentage of participants

Secondary

SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection

Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose with and without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 AND presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.

Time frame: From 7 Days after booster vaccination

Population: Evaluable efficacy population included eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection	0 Number of 1st severe Covid19cases/1000PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection	0 Number of 1st severe Covid19cases/1000PY

Secondary

SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection

Occurrence (number of cases) of first severe COVID-19 infection based on CDC definition after booster dose without past SARS-CoV-2 infection is reported. CDC definition: confirmed COVID-19 and presence of at least 1 of the following: 1) hospitalization; 2) admission to an intensive care unit; 3) intubation or mechanical ventilation; 4) death.

Time frame: From 7 Days after booster vaccination

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection	0 Number of 1st severe Covid19cases/1000PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection	0 Number of 1st severe Covid19cases/1000PY

Secondary

SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population

Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose with and without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate \>= 30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation \<= 93% on room air at sea level, or Horovitz quotient \<300 mm Hg); 2) respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic BP \<90 mm Hg, diastolic BP \<60 mm Hg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.182 and for Placebo was 1.011

Population: Evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	0 Number of 1st severe Covid19cases/1000PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	1.978 Number of 1st severe Covid19cases/1000PY

Comparison: 2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.95% CI: [-355.5, 100]

Secondary

SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population

Occurrence (number of cases) of first severe COVID-19 infection based on FDA definition after booster dose without past SARS-CoV-2 infection is reported. FDA definition: confirmed COVID-19 and presence of at least 1 of the following: 1) clinical signs at rest indicative of severe systemic illness (respiratory rate greater than or equal to \[\>=\]30 breaths per minute, heart rate \>= 125 beats per minute, oxygen saturation less than or equal to \[\<=\]93% on room air at sea level, or Horovitz quotient \<300 mmHg); 2) respiratory failure (needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation); 3) evidence of shock (systolic blood pressure \[BP\] \<90 mmHg, diastolic BP \<60 mmHg, or requiring vasopressors); 4) significant acute renal, hepatic, or neurologic dysfunction; 5) admission to an intensive care unit; 6) death.

Time frame: From 7 Days after booster vaccination to end of surveillance period, total surveillance time (in 1000 person-year) for BNT162b2 was 1.105 and for Placebo was 0.951

Population: SSA evaluable efficacy population included all eligible randomized participants who received the booster vaccination as randomized and had no other important protocol deviations as determined by the clinician. HIV positive participants were excluded from this analysis. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	0 Number of 1st severe Covid19cases/1000PY
SSA: Placebo: Blinded Period	SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population	2.103 Number of 1st severe Covid19cases/1000PY

95% CI: [-358.6, 100]

Secondary

SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose

GMFR of SARS-CoV-2 Omicron BA.1-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From baseline (before booster dose) to 7 days after the booster dose

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	19.7 Fold rise
SSA: Placebo: Blinded Period	SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	20.2 Fold rise

Secondary

SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose

GMFR of SARS-CoV-2 reference-strain-neutralizing titers from baseline (before the booster dose) to 7 days after the booster dose was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the student's t distribution).

Time frame: From baseline (before booster dose) to 7 days after the booster dose

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	8.2 Fold rise
SSA: Placebo: Blinded Period	SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose	10.2 Fold rise

Secondary

SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose

GMT of SARS-CoV-2 Omicron BA.1- neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: At baseline and 7 days after booster dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Baseline	68.2 Titer
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Day 7	1356.4 Titer
SSA: Placebo: Blinded Period	SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Baseline	131.1 Titer
SSA: Placebo: Blinded Period	SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Day 7	2655.7 Titer

Secondary

SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose

GMT of SARS-CoV-2 reference-strain neutralizing titers at baseline and 7 days after the booster dose was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: At baseline and 7 days after the booster dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Baseline	1846.7 Titer
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Day 7	15193.4 Titer
SSA: Placebo: Blinded Period	SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Baseline	2230.4 Titer
SSA: Placebo: Blinded Period	SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose	Day 7	22689.7 Titer

Secondary

SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose

Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to Omicron BA.1 strain at 7 days after the booster dose was reported in this outcome measure.

Time frame: 7 days after the booster dose

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose	77.6 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose	74.5 Percentage of participants

Secondary

SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose

Seroresponse was defined as achieving \>= 4-fold rise from before booster dose. If the baseline measurement is below the lower limit of quantification (LLOQ), the postvaccination measure of \>= 4 × LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method was used. Percentage of participants achieving seroresponse to reference strain at 7 days after the booster dose was reported in this outcome measure.

Time frame: 7 days after the booster dose

Arm	Measure	Value (NUMBER)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose	71.2 Percentage of participants
SSA: Placebo: Blinded Period	SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose	68.1 Percentage of participants

Secondary

SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age

GMR based on GMT of SARS-CoV-2 reference strain neutralizing titers was calculated and reported in statistical analysis section. GMT of SARS-CoV-2 Reference strain-neutralizing titers at 1 month after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Time frame: 1 month after study vaccination

Population: Evaluable immunogenicity population was analyzed. Participants without evidence of prior infection were included in the analysis. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Participants were analyzed only in Expanded cohort \>55 years BNT162b2 30 mcg, BNT162b2 15 mcg + BNT162b2 OMI 15 mcg and BNT162b2 30 mcg + BNT162b2 OMI 30 mcg, as pre-specified in protocol.

Arm	Measure	Value (GEOMETRIC_MEAN)
SSA: BNT162b2 30 mcg: Blinded and Open Label Period	SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age	5998.1 Titer
SSA: Placebo: Blinded Period	SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age	5933.2 Titer
SSA: Original Placebo/BNT162b2 30 mcg: Open Label Period	SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age	7816.9 Titer

Source: ClinicalTrials.gov · Data processed: Jul 27, 2026

To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

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Brief summary

Related papers

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Study design

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Outcome results

Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population

SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population

SSA: Percentage of Participants Reporting Adverse Events

SSA: Percentage of Participants Reporting Serious Adverse Events (SAE)

SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1

SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2

SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1

SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2

SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2

SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1

SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1)

SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1

SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2

SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose

SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline

SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose

SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose

SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose

SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose

SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose

SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3

SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3

SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2

SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2

SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3

SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2

SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3

SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3

SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b

SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4

SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3

SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination

SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination

SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination

SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age

SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age

SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination

SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination

SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination