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BNT162b2
5.2 Tabular Listing of Clinical Studies
PFIZER CONFIDENTIAL
Page 11.TABULAR LISTING OF C LINICAL STUDIES INCL UDED IN THE 
SUBMISSION
Information is provided for the clinical study included in the present supplemental 
submission data for COMI RNATY (BNT162b2 ). 
Details provided in the table include study  objectives, brief description of the design of the 
study , dose regimens, number of participants vaccinated, a brief description of the study  
population, and the ty pe of Clinical Study  Report ( CSR). Da ta are included for adolescents 
12 through 15 years of age .
Prior C4591001 clinical study  reports relevant to adolescents 12 -15 years of age have been 
submitted, including the following (synopses linked) :
Module 5.3.5.1 C4591001 Final Anal ysis Interim CSR Synopsis
Module 5.3.5.1 C4591001 Adolescent Interim CSR Synopsis
Module 5.3.5.1 C4591001 6- Month Update Interim CSR Synopsis
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 2Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
C4591001
Phase 3
(United States)BioNTech 
(Pfizer)Phase 3Objective s:
•Efficacy: To 
describe the efficacy 
of prophylactic 
BNT162b2 against 
confirmed COVID 19 
occurring from 7 days 
after the second dose 
through the blinded 
follow -up period in 
participants without, 
and with and without, 
evidence of infection 
before vaccination
• Immunogenicity
To demonstrate the 
noninferiority of the
immune response to 
prophylactic
BNT162b2 in 
participants 12 to 15
years of age compared 
to participants 16 to 25 
years of age
• Safety: To define the 
safety profile of 
prophylactic 
BNT162b2 in 
participants 12 to 15 
years of age in Phase 3Phase 3: 
BNT162b2 
(30 µg)
Placeb obPhase 3:
2260 (12 -15 
years of age) 
randomized 1:1Phase 3c
Participants 12 -15 
years of age:
BNT162b2 Group :
Sex:
Male: 567
Female:564
Age (years) :  
Mean/m edian :
13.6/14.0
Min, m ax:
12, 15
Race:
White: 97 0
Black or African 
American : 52
American Indian or 
Alaska native: 4
Asian: 72
Native Hawaiian or 
other Pacific 
Islander: 3
Multiracial: 2 4
Not reported: 6
Racial 
Designation:
Japanese: 5Start 
Date: 
April 2020 
(ongoing)Adolescent 
6-Month Update
CSR Synopsis
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 3Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
Placebo Group:
Sex:
Male: 585
Female:544
Age (years) :  
Mean/m edian :
13.6/14.0
Min, m ax:
12, 15
Race:
White: 962
Black or African 
American : 57
American Indian or 
Alaska native: 3
Asian: 71
Native Hawaiian or 
other Pacific 
Islander: 0
Multiracial: 29
Not reported: 7
Racial 
Designation:
Japanese: 2
Phase 2/3
Immunobridging 
Subset 12- 15 
years of aged:
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 4Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
BNT162b2 Group :
Sex:
Male: 106
Female:103
Age (years) :  
Mean/m edian :
13.5/14.0
Min, m ax:
12, 15
Race:
White: 184
Black or African 
American : 16
American Indian or 
Alaska native: 1
Asian: 5
Native Hawaiian or 
other Pacific 
Islander: 0
Multiracial: 3
Not reported: 0
Racial 
Designation:
Japanese: 1
Placebo Group:
Sex:
Male: 21
Female:15
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 5Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
Age (years) :  
Mean/m edian :
13.4/13.0
Min, m ax:
12, 15
Race:
White: 31
Black or African 
American : 3
American Indian or 
Alaska native: 0
Asian: 1
Native Hawaiian or 
other Pacific 
Islander: 0
Multiracial: 1
Not reported: 0
Racial 
Designation:
Japanese: 0
Phase 2/3 
Immunobridging
Subset 16 -25 
years of aged:
BNT162b2 Group :
Sex:
Male: 92
Female:94
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 6Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
Age (years) :  
Mean/m edian :
20.6/21.0
Min, m ax:
16, 25
Race:
White: 147
Black or African 
American : 15
American Indian or 
Alaska nati ve: 3
Asian: 10
Native Hawaiian or 
other Pacific 
Islander: 3
Multiracial: 6
Not reported: 2
Racial 
Designation:
Japanese: 0
Placebo Group:
Sex:
Male: 14
Female:18
Age (years) :  
Mean/m edian :
20.3/19.5
Min, m ax:
16, 25
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BNT162b2
5.2 Tabular Listing of Clinical Studies
CONFIDENTIAL
Page 7Table 1. Listing of All Clinical Studies Included in This Submission
Protocol No.
Phase
(Country)Sponsor
(Agent)Study Design and 
Objective(s)aTreatm ent 
GroupsNo. of 
ParticipantsDem ographics
(by Phase )Study 
Start/
StatusStudy Synopsis
Race:
White: 28
Black or African 
American : 2
American Indian or 
Alaska native: 1
Asian: 1
Native Hawaiian or 
other Pacific 
Islander: 0
Multiracial: 0
Not reported: 0
Racial 
Designation:
Japanese: 0
a.Primary study objectives specific to the analyses for the interim 6-month update adolescent CSR.
b.Participants 12-15 years of age who originally received placebo and became eligible for receipt of BNT162b2 had an opportunity to receive 
BNT162b2 as part of the study.
c.C4591001 safety population, cutoff date: 02 September 2021.
d.C4591001 Dose 2 evaluable immunogenicity population, cutoff date: 13 March 2021.
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Document Approval Record
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