A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects

A Phase II, Open-label, Rollover Trial to Evaluate the Safety and Immunogenicity of One or Two Boosting Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 Trial Subjects, or Two Boosting Doses of Comirnaty in BNT162-04 Trial Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04949490

Enrollment

137

Registered

2021-07-02

Start date

2021-07-26

Completion date

2022-09-16

Last updated

2024-09-19

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

Conditions

COVID-19, SARS-CoV-2 Infection

Keywords

Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS-CoV-2, Prevention of COVID-19 disease

Brief summary

Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern \[VOC\] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants. Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty were randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty were offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.

Detailed description

Group A trial participants were randomized 2:1 to BNT162b2s01:Comirnaty. Group B trial participants were allocated to trial treatment without active randomization and selected participants were asked to participate in the detailed immunogenicity assessment based on their parent trial cohort.

Interventions

BIOLOGICALBNT162b2s01

intramuscular (IM) injection

BIOLOGICALBNT162b2

IM injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Had given informed consent by signing 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 (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial. * Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials. * Remained overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the participants' new baseline unless required for eligibility. Note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia. * Agreed not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (Day 50). * Less than 18 months have passed since their last IMP injection in their parent trial. * If they received 30 μg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is ≥24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial. * If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is ≥12 weeks after their last IMP injection. * Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to day 1 (baseline). Participants who screen-fail on this criterion may be rescreened.

Exclusion criteria

* Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials. * Have had a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP. * Have had a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to day 1/IMP injection in this trial. Participants who screen-fail on this criterion may be rescreened. * Have received a live or live attenuated vaccine within 30 days prior to day 1/IMP injection, or any other vaccination within 14 days prior to day 1/IMP injection. Participants who screen-fail on this criterion may be rescreened. * Have had an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.

Design outcomes

Primary

Measure	Time frame	Description
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Up to 26 weeks after the first IMP injection	For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval Dose 1 up to 28 days after Dose 1. For other SAEs and AESIs, the data refers to the interval Dose 1 up to 26 weeks after Dose 1. A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.	Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.	Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Group A: Up to 28 days after Dose 1. Group B: Up to 28 days after Dose 1 and up to 28 days after Dose 2.	A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.

Secondary

Measure	Time frame	Description
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).	For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2	For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).	For Group A participants and Group B participants (except transplant subjects). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Up to 26 weeks after the first IMP injection (Dose 1)	For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351. The 'Total' arm for Group A include all participants from the two Group A arms/groups.
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2	For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.

Countries

Germany

Participant flow

Recruitment details

This rollover study (BNT162-14) has enrolled BNT162-01 (NCT04380701) or BNT162-04 (NCT04537949) study participants meeting all inclusion/exclusion criteria defined in the study protocol. The first participant was enrolled on 26 JUL 2021. The last visit of the last participant was on 16 SEP 2022.

Pre-assignment details

All enrolled participants were allocated to treatment. Participants of the Group B immunology subset are also included in the respective Group B arms. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).

Participants by arm

Arm	Count
Group A Comirnaty Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1. BNT162b2: intramuscular (IM) injection	21
Group A BNT162b2s01 Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1. BNT162b2s01: IM injection	44
Group B Non-transplant Participants Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection	61
Group B Transplant Participants Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection	11
Total	137

Withdrawals & dropouts

Period	Reason	FG002	FG003	FG004	FG005
Group A and Group B	Non-study SARS-COV-2 vaccination	0	2	0	0
Group A and Group B	Withdrawal by Subject	1	0	0	0
Subset Group B Immunogenicity Evaluation	Non-study SARS-COV-2 vaccination	0	0	0	2
Subset Group B Immunogenicity Evaluation	Withdrawal by Subject	0	0	1	0

Baseline characteristics

Characteristic	Group A Comirnaty	Group A BNT162b2s01	Group B Non-transplant Participants	Group B Transplant Participants	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	16 Participants	11 Participants	0 Participants	31 Participants
Age, Categorical Between 18 and 65 years	17 Participants	28 Participants	50 Participants	11 Participants	106 Participants
Age, Continuous Group A	53.91 years STANDARD_DEVIATION 15.13	55.81 years STANDARD_DEVIATION 15.2	—	—	55.19 years STANDARD_DEVIATION 15.09
Age, Continuous Group B	—	—	49.17 years STANDARD_DEVIATION 16.72	50.88 years STANDARD_DEVIATION 11.92	49.43 years STANDARD_DEVIATION 16.02
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	44 Participants	61 Participants	11 Participants	136 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	21 Participants	42 Participants	61 Participants	11 Participants	135 Participants
Region of Enrollment Germany	21 Participants	44 Participants	61 Participants	11 Participants	137 Participants
Sex: Female, Male Female	9 Participants	20 Participants	29 Participants	5 Participants	63 Participants
Sex: Female, Male Male	12 Participants	24 Participants	32 Participants	6 Participants	74 Participants
Weight Group A	76.76 kg STANDARD_DEVIATION 10.8	76.73 kg STANDARD_DEVIATION 13.45	—	—	76.74 kg STANDARD_DEVIATION 12.57
Weight Group B	—	—	76.79 kg STANDARD_DEVIATION 13.86	74.14 kg STANDARD_DEVIATION 10.93	76.38 kg STANDARD_DEVIATION 13.42

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 / 21	0 / 44	0 / 65	0 / 61	0 / 11	0 / 72	0 / 22	0 / 11	0 / 33
other Total, other adverse events	3 / 21	7 / 44	10 / 65	4 / 61	7 / 11	11 / 72	4 / 22	7 / 11	11 / 33
serious Total, serious adverse events	0 / 21	2 / 44	2 / 65	1 / 61	4 / 11	5 / 72	0 / 22	4 / 11	4 / 33

Outcome results

Primary

The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)

For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval Dose 1 up to 28 days after Dose 1. For other SAEs and AESIs, the data refers to the interval Dose 1 up to 26 weeks after Dose 1. A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).

Time frame: Up to 26 weeks after the first IMP injection

Population: Safety set, i.e., all participants who received at least one dose of IMP.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group A Comirnaty	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	0 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	2 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	1 Participants
Group A BNT162b2s01	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	1 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	2 Participants
Group A Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	1 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	1 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	4 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	5 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	1 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group B Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Immunology Subset Non-transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	4 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Immunology Subset Transplant Participants	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related TESAE	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TEAESI	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any TESAE	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related AESI	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any SAE	4 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any related SAE	0 Participants
Group B Immunology Subset Total	The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)	Any AESI	0 Participants

Primary

The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants

A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.

Time frame: Group A: Up to 28 days after Dose 1. Group B: Up to 28 days after Dose 1 and up to 28 days after Dose 2.

Population: Safety set, i.e., all participants who received at least one dose of IMP.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group A Comirnaty	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	1 Participants
Group A Comirnaty	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	8 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	14 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	1 Participants
Group A Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	22 Participants
Group A Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	2 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any TEAE	5 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any grade >=3 TEAE	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	0 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	5 Participants
Group B Transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	6 Participants
Group B Transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any grade >=3 TEAE	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any TEAE	2 Participants
Group B Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any TEAE	7 Participants
Group B Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE	0 Participants
Group B Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 2 up to 28 days after Dose 2; Number of participants with any grade >=3 TEAE	0 Participants
Group B Total	The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants	Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE	11 Participants

Primary

The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.

Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.

Time frame: Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.

Population: Safety set, i.e., all participants who received at least one dose of IMP.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group A Comirnaty	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	20 Participants
Group A Comirnaty	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	1 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	41 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	2 Participants
Group A Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	61 Participants
Group A Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	3 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	3 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any local reaction	20 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 local reaction	4 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	21 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 local reaction	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	10 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	1 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any local reaction	5 Participants
Group B Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 local reaction	4 Participants
Group B Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any local reaction	25 Participants
Group B Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction	31 Participants
Group B Total	The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction	4 Participants

Primary

The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.

Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.

Population: Safety set, i.e., all participants who received at least one dose of IMP.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group A Comirnaty	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	18 Participants
Group A Comirnaty	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	4 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	9 Participants
Group A BNT162b2s01	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	33 Participants
Group A Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	51 Participants
Group A Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	13 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any systemic reaction	17 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 systemic reaction	7 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	20 Participants
Group B Non-transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	2 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	8 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	0 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any systemic reaction	4 Participants
Group B Transplant Participants	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 systemic reaction	0 Participants
Group B Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction	2 Participants
Group B Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction	28 Participants
Group B Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 systemic reaction	7 Participants
Group B Total	The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.	Dose 2 up to 7 days after Dose 2: Number of participants with any systemic reaction	21 Participants

Secondary

Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2

For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.

Time frame: From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2

Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day 1 of Dose 1)	730.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1 of Dose 1)	599.1 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4 (Day 29) of Dose 1	7937.6 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA)- Week 12 (Day 85) of Dose 1	5065.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12 (Day 85) of Dose 1	11988.6 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26 (Day 182) of Dose 1	10602.6 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26 (Day 182) of Dose 1	19644.7 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 1 pre Dose 2	3633.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4 (Day 29) post Dose 2	13625.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4 (Day 29) post Dose 2	34242.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12 (Day 85) post Dose 2	12265.4 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26 (Day 182) post Dose 2	10833.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8 of Dose 1	4328.8 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8 of Dose 1	5078.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4 (Day 29) of Dose 1	6616.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Day 1 pre Dose 2	5822.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8 post Dose 2	12441.7 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8 post Dose 2	22067.6 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12 (Day 85) post Dose 2	24015.7 Titer
Group A Comirnaty	Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26 (Day 182) post Dose 2	13468.1 Titer

Secondary

Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351

For Group A participants and Group B participants (except transplant subjects). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.

Time frame: Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).

Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)	3209.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 12	178167.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4	NA Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Baseline (Day 1)	7164.8 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 12	11106.8 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12	23883.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12	50709.2 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4	NA Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Day 8	520744.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8	NA Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Day 8	22903.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 4	394493.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8	NA Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Baseline (Day 1)	566.5 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)	2216.1 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 26	142683.7 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26	27732.0 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 26	9829.9 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26	14309.8 Titer
Group A Comirnaty	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 4	18959.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4	NA Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)	2594.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8	48945.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Day 8	21244.0 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 4	21082.1 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4	NA Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12	28535.3 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12	NA Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 12	305041.0 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 26	6967.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 26	91825.4 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)	2161.4 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Baseline (Day 1)	588.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Baseline (Day 1)	9267.9 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8	NA Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Day 8	480042.7 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 4	362296.9 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 12	14367.3 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26	8670.5 Titer
Group A BNT162b2s01	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26	17049.8 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8	NA Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 4	20371.6 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Baseline (Day 1)	581.5 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26	11355.5 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Baseline (Day 1)	8528.4 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 12	12998.8 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Day 8	21766.4 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 12	247480.6 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain variant B.1.351 (ELISA) - Week 26	8386.3 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4	NA Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8	NA Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12	26627.5 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Day 8	492832.1 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26	22155.2 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 26	116420.8 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12	NA Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein variant B.1.351 (ELISA) - Week 4	372400.7 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)	2178.9 Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4	NA Titer
Group A Total	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)	2779.1 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26	34032.7 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)	1634.4 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 3	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)	2135.4 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 7	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8	45270.4 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8	48805.7 Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 7	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 3	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12	NA Titer
Group B Non-transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 4	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 7	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 26	38865.2 Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 7	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 4	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Baseline (Day 1)	1636.2 Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 26	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Day 8	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 3	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 12	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Day 8	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Week 12	NA Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG RBD Domain reference strain (ELISA) - Baseline (Day1)	2056.4 Titer
Group B Transplant Participants	Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351	Response antibody titers IgG S Protein reference strain (ELISA) - Week 3	NA Titer

Secondary

Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351

For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.

Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Day 8	285.1 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Baseline (Day 1)	21.4 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 4 (Day 29)	271.3 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 26 (Day 182)	336.2 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 4 (Day 29)	570.2 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Day 8	640.0 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Baseline (Day1)	NA Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 26 (Day 182)	140.2 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 12 (Day 85)	122.9 Titer
Group A Comirnaty	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 12 (Day 85)	371.2 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 26 (Day 182)	129.5 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Baseline (Day 1)	21.3 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Baseline (Day1)	NA Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Day 8	349.0 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Day 8	330.2 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 4 (Day 29)	509.3 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 26 (Day 182)	132.0 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 4 (Day 29)	325.1 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 12 (Day 85)	282.1 Titer
Group A BNT162b2s01	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 12 (Day 85)	259.4 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 12 (Day 85)	194.0 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 26 (Day 182)	135.1 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Day 8	314.9 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Day 8	424.5 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 12 (Day 85)	313.9 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 26 (Day 182)	218.4 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Baseline (Day 1)	21.3 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 4 (Day 29)	528.2 Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Baseline (Day1)	NA Titer
Group A Total	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers variant B.1.351 - Week 4 (Day 29)	306.6 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Baseline (Day 1)	15.6 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 4 (Day 29)	1789.7 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 26 (Day 182)	659.8 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 3 (Day 22)	1085.6 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Day 8	729.3 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 7	1386.0 Titer
Group B Non-transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 12 (Day 85)	1348.3 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 3 (Day 22)	1183.0 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Baseline (Day 1)	13.3 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 4 (Day 29)	1868.1 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 26 (Day 182)	710.1 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 7	1429.2 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Day 8	1093.4 Titer
Group B Transplant Participants	Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351	Response neutralizing antibody titers reference strain - Week 12 (Day 85)	1301.3 Titer

Secondary

Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2

Time frame: From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2

Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 26 (Day 182) of Dose 1	108.9 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Day 1 pre Dose 2	47.6 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Day 8 post Dose 2	142.5 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 4 (Day 29) post Dose 2	452.5 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 12 (Day 85) post Dose 2	142.5 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 26 (Day 182) post Dose 2	127.0 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Day 1 of Dose 1	NA Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Day 8 of Dose 1	48.3 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 4 (Day 29) of Dose 1	124.4 Titer
Group A Comirnaty	Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2	Week 12 (Day 85) of Dose 1	80.0 Titer

Secondary

SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain

For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351. The 'Total' arm for Group A include all participants from the two Group A arms/groups.

Time frame: Up to 26 weeks after the first IMP injection (Dose 1)

Population: Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.

Arm	Measure	Group	Value (NUMBER)
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response neutralizing antibody titers - GMT ratio	2.1 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG RBD Domain - GMT ratio	2.2 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG S Protein - GMT ratio	0.3 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG RBD Domain - GMT ratio	3.1 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG S Protein - GMT ratio	0.4 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response neutralizing antibody titers - GMT ratio	3.0 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG RBD Domain - GMT ratio	3.9 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response neutralizing antibody titers - GMT ratio	2.2 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response neutralizing antibody titers - GMT ratio	3.1 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG RBD Domain - GMT ratio	2.9 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG RBD Domain - GMT ratio	1.5 GMT ratio
Group A Comirnaty	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response neutralizing antibody titers - GMT ratio	2.4 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response neutralizing antibody titers - GMT ratio	1.1 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response neutralizing antibody titers - GMT ratio	3.0 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG RBD Domain - GMT ratio	3.7 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG S Protein - GMT ratio	0.3 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG RBD Domain - GMT ratio	2.3 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response neutralizing antibody titers - GMT ratio	1.6 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG RBD Domain - GMT ratio	2.6 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response neutralizing antibody titers - GMT ratio	1.1 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG RBD Domain - GMT ratio	2.0 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response neutralizing antibody titers - GMT ratio	1.0 GMT ratio
Group A BNT162b2s01	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG RBD Domain - GMT ratio	1.2 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response neutralizing antibody titers - GMT ratio	1.3 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG RBD Domain - GMT ratio	1.4 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG RBD Domain - GMT ratio	2.5 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG S Protein - GMT ratio	0.3 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 26 (Day 182) - Response neutralizing antibody titers - GMT ratio	1.6 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response neutralizing antibody titers - GMT ratio	1.6 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response antibody titers IgG RBD Domain - GMT ratio	3.7 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response antibody titers IgG RBD Domain - GMT ratio	2.8 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 1 - Response neutralizing antibody titers - GMT ratio	3.0 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 4 (Day 29) - Response neutralizing antibody titers - GMT ratio	1.7 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG RBD Domain - GMT ratio	2.0 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Week 12 (Day 85) - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio
Group A Total	SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain	Day 8 - Response antibody titers IgG S Protein - GMT ratio	0.2 GMT ratio

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)

The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants

The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.

The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.

Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2

Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351

Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351

Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2

SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain