COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
Ribonucleic acid (RNA) vaccine, Vaccine, Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Brief summary
This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5. The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged \>55 years was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone after which a safety review was performed after all participants received Dose 2 in this cohort. BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) was co-administered (as a single injection). BNT162b4 alone was administered as a single injection.
Interventions
BIOLOGICALBNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b4 5 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b4 10 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b4 15 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b4 30 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b2 Monovalent (OMI XBB.1.5) 30 mcg
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Sponsors
Pfizer
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Dose 1 was given observer-blind for Cohorts 1 to 4 and open-label for Cohort 5. Dose 2 was given open-label for Cohorts 1 to 5.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(applicable to all dose groups unless specified otherwise): * Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures. * Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, e.g., to follow good practices to reduce their chances of being infected or spreading COVID-19, and other requirements of the trial. This included that they were able to understand and follow trial-related instructions. * Were aged 18 years and older at randomization (Cohorts 1-4) or 18 to 55 years (Cohort 5), had a body mass index over 18.5 kg/m\^2 and under 35 kg/m\^2 (Cohorts 1-4) and under 30 kg/m\^2 (Cohort 5), and weighed at least 50 kg at Visit 0. * Were healthy, in the clinical judgment of the investigator based on participant-reported medical history data, and physical examination, 12-lead ECG, vital signs, and clinical laboratory test outcomes at Visit 0. * Note: Healthy participants with pre-existing stable disease (e.g., obesity), defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 84 days before Visit 0, could be included. * Agreed not to enroll in another trial with an IMP starting from Visit 0 and until 168 days (Cohorts 1-4) and 90 days (Cohort 5) after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 168 days after the participant's first IMP dose had passed before they consented to Dose 2, they should have agreed to not enroll in another trial from the time of consent to Dose 2 until 168 days after receiving Dose 2 of the IMP. * Agreed not to be vaccinated with: * Non-trial vaccines (except COVID-19 vaccines, as per next sub-bullet) starting 28 days prior to the Dose 1 and until 28 days after receiving of the last IMP dose. Seasonal influenza vaccine is allowed; however, it should be given at least 14 days before or after any administration of IMP. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consented to continue Dose 2, they should not have been vaccinated with non-trial vaccines starting from the time of consent to Dose 2 and until 168 days after receiving the Dose 2 of the IMP. * Non-trial COVID-19 vaccines starting at least 90 days prior to the Visit 1 and until completion of the participant's last trial visit (Cohorts 1-4) and until 28 days post-Dose 2 (Cohort 5 only). * Had been vaccinated with at least three doses of an RNA-based COVID-19 vaccine authorized in the United States (US) before Visit 0. The last COVID-19 RNA vaccine dose must have been administered at least 90 days before Visit 1. * Note: Documented confirmation of prior COVID-19 vaccine receipt must be obtained prior to randomization (Cohorts 1-4) or prior to Visit 1 (Cohort 5 only). * Had negative human immunodeficiency virus (HIV) -1 and HIV-2 test results at Visit 0. * Had negative Hepatitis B surface antigen test results at Visit 0. * Had negative anti-Hepatitis C virus (HCV) antibodies, or negative HCV polymerase chain reaction test results if the anti-HCV was positive at Visit 0. * Participants of childbearing potential (POCBP) that had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test result at Visit 0 and negative urine pregnancy test results prior to receiving Dose 1, additionally for Cohort 5 only, a negative urine pregnancy test result prior to receiving Dose 2. Participants born female that were postmenopausal or permanently sterilized (verified by medical records) were not considered POCBP. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): POCBP that had a negative urine pregnancy test results prior to receiving Dose 2. * POCBP who agreed to practice a highly effective form of contraception and required their male sexual partners to use condoms with a spermicidal agent, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only) : If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have a negative urine β-HCG pregnancy test result at Visit 7 and agree to practice a highly effective form of contraception and required their male sexual partners to use condoms with a spermicidal agent, starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP. * POCBP who agreed not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consented to continue Dose 2, they should have agreed not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from the time they consented to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP. * Men who were sexually active with partners of childbearing potential and who had not had a verified vasectomy (documented in medical records) that agreed to use condoms with a spermicidal agent and to practice a highly effective form of contraception with their sexual partners born female starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have agreed to use condoms with a spermicidal agent and to practice a highly effective form of contraception with their sexual partners born female starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP. * Men who were willing to refrain from sperm donation, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have agreed to refrain from sperm donation, starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP. Inclusion Criteria (Dose 2 groups, Cohorts 1-4 only): Participants were eligible to receive Dose 2 if all of the following criteria (in addition to inclusion criteria above) apply: * Had given informed consent by signing and dating the ICF reflecting the respective protocol version before administration of Dose 2. * Had enrolled in a dose cohort and received Dose 1 of BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) in this trial. * Were healthy in the opinion of the investigator based on a brief (symptom-directed) physical examination.
Exclusion criteria
(applicable to all dose groups unless specified otherwise): * Breastfeeding or intending to become pregnant starting with Visit 0 until 28 days after receiving the last dose of trial IMP or intending to father children starting with Visit 0 until 28 days after receiving the last trial IMP dose. * History of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a participant who had an anaphylactic adverse reaction to pertussis vaccine as a child). * Current or history of the following medical conditions: 1. Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent US National Heart, Lung, and Blood Institute asthma management guidelines. 2. Diabetes mellitus type 1 or type 2, or new onset of Diabetes mellitus type 1 or 2 from the administration of Dose 1, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes). 3. Hypertension: * If a person had been found to have elevated blood pressure or hypertension during screening or previously, excluded for blood pressure that is not well controlled. Well controlled blood pressure was defined as consistently \<=140 mm Hg systolic and \<= 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm Hg systolic and ≤90 mm Hg diastolic at Visit 0. * If a person did not have a history of elevated blood pressure or hypertension previously or during screening, also excluded for systolic blood pressure ≥150 mm Hg at Visit 0 or diastolic blood pressure ≥100 mm Hg at Visit 0. Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of worsening hypertension since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2. 4. Any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2. 5. A diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2. 6. Seizure disorders: History of seizure(s) within the past 3 years. Also excluded if participant had used medications in order to prevent or treat seizure(s) at any time within the past 3 years. 7. Screening 12-lead ECG that was consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. Exclusion pertaining to Dose 2 (all cohorts): Only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant ECG will have a repeat 12-lead ECG prior to Dose 2. * Note: ECG changes including but not limited to: paroxysmal or sustained atrial or ventricular arrhythmias, atrioventricular block (grade 2-3) or bundle branch block, diffuse ST-segment elevation or PR-segment inversion, QTcF interval (QT interval corrected by the Fridericia formula) \>450 ms in men and \>460 ms in women, changes supporting myocardial infarction and/or myocardial ischemia. Exclusion pertaining to Dose 2 (all cohorts): Subjects who had a repeat ECG prior to Dose 2 and had a change or new onset that, in the opinion of the investigator, will not receive Dose 2. * Current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. Exclusion pertaining to Dose 2 (Cohorts 1-4): Participants who had a change or new onset psychiatric illness. * Current or history of the following diseases associated with immune dysregulation: * Primary immunodeficiencies. * History of solid organ or bone marrow transplantation. * Asplenia: any condition resulting in the absence of a functional spleen. * Currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. Exclusion pertaining to Dose 2 (Cohorts 1-4): Participants who had a change or new onset immunodeficiency. * Received any non-trial IMP within 28 days before Visit 0 or Visit 7 (Cohorts 1-4) and (Cohort 5) within 28 days before Dose 1 and Dose 2 (except seasonal influenza vaccine, which should be given at least 14 days before or after any administration of IMP). * Received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for \>=14 days at a dose of \>=20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. Inhaled/nebulized (except high doses as per
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | At Day 7 post-dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure. |
| Number of Participants With Solicited Local Reactions- Post Dose 2 | Up to 7 days post-dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B, as these Cohorts did not receive Dose 2 of the study drugs. |
| Number of Participants With Solicited Systemic Events- Post Dose 1 | Up to 7 days post-dose 1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. |
| Number of Participants With Solicited Systemic Events- Post Dose 2 | Up to 7 days post-dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. |
| Number of Participants With Adverse Events (AEs)-Post Dose 1 | Up to 28 days post-dose 1 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. |
| Number of Participants With Adverse Events (AEs)-Post Dose 2 | Up to 28 days post-dose 2 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. |
| Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. |
| Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | Up to 6 to 7 months post-dose 2 for Cohorts 2 to 4; and up to 3 months post-dose 2 for Cohort 5 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | At Day 3 post-Dose 1; at Day 7 post-dose 1 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | At Day 3 post-Dose 1; at Day 7 post-dose 1 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only abnormal clinically significant data was reported in the outcome measure. |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | At Day 7 post-dose 2 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only clinically significant abnormal data was reported in the outcome measure. |
| Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | At Day 3 post-Dose 1; at Day 7 post-dose 1 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. |
| Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | At Day 7 post-dose 2 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. |
| Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | At Day 3 post-dose 1; at Day 7 post-dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure. |
| Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | At Day 7 post-dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure. |
| Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | At Day 3 post-dose 1; at Day 7 post-dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure. |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | At Day 7 post-dose 2 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. |
| Number of Participants With Solicited Local Reactions- Post Dose 1 | Up to 7 days post-dose1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | At Pre-dose 2 and Day 28 post-dose 2 | GMTs for SARS-CoV-2 neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | At Pre-dose and Day 28 post-dose 1 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | At Pre-dose 2 and Day 28 post-dose 2 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | At Pre-dose 2 and Day 28 post-dose 2 | GMTs for SARS-CoV-2 Omicron XBB1.5 strain were measured by valid assay method. |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | From pre-dose 1 to 28 days post-dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | From pre-dose 2 to 28 days post-dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 5 and Comparator Cohorts A and B. |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | From pre-dose 1 to 28 days post-dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2 | From pre-dose 2 to 28 days post-dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | From Pre-dose 2 to Day 28 post-dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | At Day 28 post-dose 1 | Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose). |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | At Day 28 post-dose 2 | Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose). |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | At Day 28 post-dose 1 | Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose). |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2 | At Day 28 post-dose 2 | Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose). |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | At Day 28 post-dose 2 | Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose). |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | At Pre-dose and Day 28 post dose-1 | GMTs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1. | 46 |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 45 |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 45 |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 45 |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 46 |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) Participants aged \>55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 45 |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. | 22 |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. | 59 |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) Participants aged \>55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. | 30 |
| Total | 383 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Randomized but not dosed | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 10.02 | 40.2 years STANDARD_DEVIATION 10.67 | 40.6 years STANDARD_DEVIATION 9.67 | 67.3 years STANDARD_DEVIATION 5.72 | 40.9 years STANDARD_DEVIATION 10.57 | 67.1 years STANDARD_DEVIATION 7.14 | 37.9 years STANDARD_DEVIATION 11.78 | 38.9 years STANDARD_DEVIATION 10.84 | 67.5 years STANDARD_DEVIATION 6.57 | 48.8 years STANDARD_DEVIATION 15.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 16 Participants | 18 Participants | 11 Participants | 14 Participants | 11 Participants | 13 Participants | 22 Participants | 6 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 29 Participants | 27 Participants | 34 Participants | 32 Participants | 34 Participants | 9 Participants | 36 Participants | 24 Participants | 251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 41 Participants | 37 Participants | 40 Participants | 41 Participants | 39 Participants | 44 Participants | 20 Participants | 50 Participants | 26 Participants | 338 Participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 27 Participants | 25 Participants | 24 Participants | 27 Participants | 11 Participants | 31 Participants | 20 Participants | 224 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 18 Participants | 20 Participants | 22 Participants | 18 Participants | 11 Participants | 28 Participants | 10 Participants | 159 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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 44 | 0 / 44 | 0 / 46 | 0 / 59 | 0 / 21 | 0 / 43 | 0 / 45 | 0 / 29 |
| other Total, other adverse events | 3 / 48 | 1 / 44 | 1 / 44 | 6 / 46 | 1 / 59 | 0 / 21 | 4 / 43 | 10 / 45 | 1 / 29 |
| serious Total, serious adverse events | 0 / 48 | 1 / 44 | 1 / 44 | 1 / 46 | 1 / 59 | 0 / 21 | 2 / 43 | 1 / 45 | 0 / 29 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)-Post Dose 1
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment.
Time frame: Up to 28 days post-dose 1
Population: Analysis was performed on safety set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 11 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 4 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 8 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 6 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 8 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 5 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 1 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 13 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 1 | 5 Participants |
Primary
Number of Participants With Adverse Events (AEs)-Post Dose 2
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment.
Time frame: Up to 28 days post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 3 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 9 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 3 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 5 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Adverse Events (AEs)-Post Dose 2 | 2 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1
Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only abnormal clinically significant data was reported in the outcome measure.
Time frame: At Day 3 post-Dose 1; at Day 7 post-dose 1
Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 3 post dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 3 post dose 1 | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 3 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 3 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 1 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 3 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 1 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 1 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 3 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 3 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | High Sensitivity C Reactive Protein- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Aspartate Aminotransferase- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Total Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Glucose- Day 7 post dose 1 | 1 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Amylase- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Troponin I Type 3- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Indirect Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Albumin- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Direct Bilirubin- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alkaline Phosphatase-Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Alanine Aminotransferase- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Lipase- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Urea Nitrogen- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Gamma Glutamyl Transferase- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Creatinine- Day 7 post dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | C Reactive Protein- Day 7 post dose 1 | 0 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2
Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Time frame: At Day 7 post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Direct Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Gamma Glutamyl Transferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Troponin I Type 3-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Aspartate Aminotransferase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Total Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Glucose-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Urea Nitrogen-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | High Sensitivity C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Indirect Bilirubin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Amylase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Albumin-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Lipase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alkaline Phosphatase-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | C Reactive Protein-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Creatinine-Day 7 post-dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Alanine Aminotransferase-Day 7 post-dose 2 | 0 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1
Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Time frame: At Day 3 post-Dose 1; at Day 7 post-dose 1
Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophils- Day 3 post dose-1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophils- Day 3 post dose-1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophils- Day 3 post dose-1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophils- Day 3 post dose-1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 1 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 1 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophils- Day 3 post dose-1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hematocrit- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Hemoglobin- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Lymphocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Erythrocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Eosinophils- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Neutrophils- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Platelets- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Basophil-Day 7 post dose-1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Leukocytes- Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Monocytes- Day 7 post-dose 1 | 0 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2
Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure.
Time frame: At Day 7 post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 3 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 1 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Leukocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Platelets-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Eosinophils-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Erythrocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hemoglobin-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Lymphocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Hematocrit-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Monocytes-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Basophils-Day 7 post dose-2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Neutrophils-Day 7 post dose-2 | 0 Participants |
Primary
Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2
Participants with only clinically significant new ECG abnormalities were reported in the outcome measure.
Time frame: At Day 7 post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | 0 Participants |
Primary
Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1
Participants with only clinically significant new ECG abnormalities were reported in the outcome measure.
Time frame: At Day 3 post-Dose 1; at Day 7 post-dose 1
Population: Analysis was performed on safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 3 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Day 7 post-dose 1 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Time frame: Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5
Population: Analysis was performed on safety set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 1 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 1 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Time frame: Up to 6 to 7 months post-dose 2 for Cohorts 2 to 4; and up to 3 months post-dose 2 for Cohort 5
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 1 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 1 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 1 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | 0 Participants |
Primary
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Time frame: At Day 3 post-dose 1; at Day 7 post-dose 1
Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 1 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 1 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 3 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Lipase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Direct Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Amylase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Albumin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Indirect Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Creatinine: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Total Bilirubin: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Aspartate Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alanine Aminotransferase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Alkaline Phosphatase: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Glucose: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | Urea Nitrogen: Baseline Grade 0 to Grade >=3 Day 7 post-dose 1 | 0 Participants |
Primary
Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Time frame: At Day 7 post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Creatinine-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hypoglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Aspartate aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Indirect Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Serum amylase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alkaline phosphatase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Blood urea nitrogen-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Lipase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Alanine aminotransferase-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Total Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Hyperglycemia-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Direct Bilirubin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | Albumin-Baseline Grade 0 to Grade >=3 | 0 Participants |
Primary
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Time frame: At Day 3 post-dose 1; at Day 7 post-dose 1
Population: Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 2 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 3 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Platelet count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Eosinophils-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Hemoglobin-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3: Day 7 post-Dose 1 | 0 Participants |
Primary
Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2
The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade \>=3 were reported in the outcome measure.
Time frame: At Day 7 post-dose 2
Population: Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 2 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 2 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Neutrophil count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Platelet count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Hemoglobin-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Eosinophils-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell increased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Lymphocytes count decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | Leukocytes-White blood cell decreased-Baseline Grade 0 to Grade >=3 | 0 Participants |
Primary
Number of Participants With Solicited Local Reactions- Post Dose 1
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling.
Time frame: Up to 7 days post-dose1
Population: Analysis was performed on safety set that included all participants who received at least one dose of investigational medicinal product (IMP). Here, overall number of participants analyzed signifies participants with available data for the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 7 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 5 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 30 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 30 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 5 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 3 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 5 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 5 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 29 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 4 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 4 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 30 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 2 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 41 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 33 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 13 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 1 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 4 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 35 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 3 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Pain | 16 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Erythema/Redness | 3 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 1 | Induration/Swelling | 2 Participants |
Primary
Number of Participants With Solicited Local Reactions- Post Dose 2
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B, as these Cohorts did not receive Dose 2 of the study drugs.
Time frame: Up to 7 days post-dose 2
Population: Analysis was performed on dose 2 safety set, that is, all participants who received two doses of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 2 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 23 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 2 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 2 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 18 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 4 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 23 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 2 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 3 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 29 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 3 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 24 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Pain | 11 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Induration/Swelling | 1 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Local Reactions- Post Dose 2 | Erythema/Redness | 0 Participants |
Primary
Number of Participants With Solicited Systemic Events- Post Dose 1
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever.
Time frame: Up to 7 days post-dose 1
Population: Analysis was performed on safety set that included all participants who received at least one dose of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 21 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 10 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 7 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 24 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 3 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 16 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 10 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 20 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 11 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 9 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 3 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 13 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 16 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 22 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 8 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 16 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 20 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 3 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 6 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 2 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 15 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 5 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 9 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 21 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 8 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 13 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 4 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 27 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 5 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 2 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 21 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 27 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 7 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 12 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 13 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 3 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 6 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 12 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 18 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 8 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 5 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 3 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 0 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 2 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 8 Participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 0 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 15 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 19 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 3 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 8 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 6 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 3 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 3 Participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 21 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fever | 1 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Vomiting | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Diarrhea | 3 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Headache | 8 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Fatigue | 8 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Myalgia | 4 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Arthralgia | 0 Participants |
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 1 | Chills | 5 Participants |
Primary
Number of Participants With Solicited Systemic Events- Post Dose 2
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever.
Time frame: Up to 7 days post-dose 2
Population: Analysis was performed on dose 2 safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 9 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 1 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 12 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 13 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 7 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 7 Participants |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 1 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 12 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 2 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 6 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 10 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 4 Participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 14 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 2 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 10 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 16 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 1 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 9 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 3 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 5 Participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 14 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 7 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 20 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 16 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 19 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 2 Participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 3 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 12 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 7 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 4 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 0 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 5 Participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 14 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fever | 1 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Myalgia | 5 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Headache | 3 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Fatigue | 8 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Arthralgia | 4 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Diarrhea | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Chills | 2 Participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Number of Participants With Solicited Systemic Events- Post Dose 2 | Vomiting | 0 Participants |
Secondary
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1).
Time frame: From pre-dose 1 to 28 days post-dose 1
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 5.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 3.4 ratio |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 2.9 ratio |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 3.3 ratio |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 2.3 ratio |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 3.4 ratio |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 4.2 ratio |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 3.7 ratio |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | 3.6 ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 5 and Comparator Cohorts A and B.
Time frame: From pre-dose 2 to 28 days post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | 2.2 ratio |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | 2.0 ratio |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | 2.1 ratio |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | 2.6 ratio |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | 2.8 ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1).
Time frame: From pre-dose 1 to 28 days post-dose 1
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 5.4 ratio |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 4.5 ratio |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 4.4 ratio |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 3.1 ratio |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 5.8 ratio |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 5.9 ratio |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 4.3 ratio |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | 5.4 ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2).
Time frame: From pre-dose 2 to 28 days post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2 | 4.4 ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2
GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2).
Time frame: From Pre-dose 2 to Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | 5.6 ratio |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | 7.8 ratio |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | 4.9 ratio |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | 6.5 ratio |
Secondary
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1
GMTs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Time frame: At Pre-dose and Day 28 post dose-1
Population: Analysis was performed on Immunogenicity per protocol set that is all participants who received the planned dose of the IMP on Day 1 and who have at least one valid immunogenicity assessment within an appropriate window and have no major protocol deviations that can confound immunogenicity data. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 3310.0 titers |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 12666.7 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 4561.4 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 13017.3 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 3031.5 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 9571.7 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 6245.1 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 14553.1 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 3052.9 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 10326.7 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 2267.0 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 10126.2 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 12767.2 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 3579.9 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | Pre-dose | 4034.9 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | 28 days post-dose 1 | 14628.7 titers |
Secondary
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2
GMTs for SARS-CoV-2 neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Time frame: At Pre-dose 2 and Day 28 post-dose 2
Population: Analysis was performed on Immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for the analysis at the specified time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 5940.9 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 5717.3 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | 28 days post-dose 2 | 10032.4 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | 28 days post-dose 2 | 7329.5 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 3559.2 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 5751.4 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | 28 days post-dose 2 | 12884.0 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 3862.0 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | 28 days post-dose 2 | 7782.0 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | 28 days post-dose 2 | 6294.6 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 3551.6 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 5238.7 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | Pre-Dose-2 | 5490.6 titers |
Secondary
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1
GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method.
Time frame: At Pre-dose and Day 28 post-dose 1
Population: Analysis was performed on immunogenicity per protocol set. Here, number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 881.7 titers |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 5540.9 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1475.9 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 6801.2 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1125.3 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 4690.6 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1948.8 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 6303.1 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1067.2 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 5913.9 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 625.2 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 3907.0 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 6323.4 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1485.1 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | Pre-dose | 1213.0 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | 28 days post-dose 1 | 6552.0 titers |
Secondary
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2
GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
Time frame: At Pre-dose 2 and Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and 0 in the number analyzed field signifies that no participants were available for the analysis at the specified time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2597.0 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | 28 days post-dose 2 | 6506.3 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2502.1 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 1750.6 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2089.7 titers |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2179.6 titers |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 1663.4 titers |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2649.8 titers |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | Pre-dose-2 | 2610.0 titers |
Secondary
Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2
GMTs for SARS-CoV-2 Omicron XBB1.5 strain were measured by valid assay method.
Time frame: At Pre-dose 2 and Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 28 days post-dose 2 | 2493.1 titers |
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Pre-dose-2 | 353.3 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 28 days post-dose 2 | 3325.2 titers |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Pre-dose-2 | 356.8 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Pre-dose-2 | 608.2 titers |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 28 days post-dose 2 | 3042.7 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Pre-dose-2 | 335.2 titers |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 28 days post-dose 2 | 1935.9 titers |
Secondary
Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Time frame: At Day 28 post-dose 1
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 32.5 percentage of participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 30.8 percentage of participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 35.7 percentage of participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 20.0 percentage of participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 38.5 percentage of participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 43.9 percentage of participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 50.0 percentage of participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | 41.4 percentage of participants |
Secondary
Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Time frame: At Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts, 1, 5 and Comparator Cohorts A and B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | 24.0 percentage of participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | 16.0 percentage of participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | 32.1 percentage of participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | 23.1 percentage of participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | 27.3 percentage of participants |
Secondary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Time frame: At Day 28 post-dose 1
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 52.5 percentage of participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 46.2 percentage of participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 47.6 percentage of participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 30.0 percentage of participants |
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 59.0 percentage of participants |
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 61.0 percentage of participants |
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 44.6 percentage of participants |
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | 55.2 percentage of participants |
Secondary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Time frame: At Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2 | 44.0 percentage of participants |
Secondary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2
Seroresponse was defined as achieving \>=4-fold rise from baseline (that is, pre-dose).
Time frame: At Day 28 post-dose 2
Population: Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 64.0 percentage of participants |
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 77.8 percentage of participants |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 50.0 percentage of participants |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | 72.7 percentage of participants |