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BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1
BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to CBER 20 August Information Request –
Study C4591001 Frequency of Adverse Events by Age Group and Overall By Study 
Period in Blinded Follow -up
20 August 2021
090177e197dda203\Approved\Approved On: 20-Aug-2021 22:26 (GMT)
FDA-CBER-2021-5683-0950399
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
Reference is made to BLA STN 125742/0 for COVID- 19 mRNA Vaccine (COMI RNATY), 
for active immunization to prevent COVID -19 caused by  SARS -CoV -2 in individuals 
≥16years of age and to CBER’s Information Request received via email on 20 August 2021 .
CBER requests are presented in bold italics followed b y Pfizer -BioNTech response in plain 
text.
2.REQESTS
2.1.Request 1
Please complete the following table to summarize the numbers and percentages of 
BNT162b2 and placebo rec ipients, by age group and study period, who reported the 
indicated categories of unsolicited adverse events during blinded follow -up in study 
C4591001. Please use denominators of the corresponding population in each column and 
please do not report percent ages in 100/PY. 
Response
The requested table is provided as Table 1.
090177e197dda203\Approved\Approved On: 20-Aug-2021 22:26 (GMT)
FDA-CBER-2021-5683-0950400
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 3Table 1.Number (%) of Subjec ts Reporting at Least 1 Adverse Event After Dose 1 - Blinded Placebo -Controlled 
Follow -up Period – Phase 2/3 Subjects ≥16 Years of Age – Safety Population
BNT162b2 (30 µg) Placebo
≥16- 55 Years
(Na=12995)>55 Years
(Na=8931 )Total
(Na=21926)≥16-55 Years
(Na=13026)>55 Years
(Na=8895)Total
(Na=21921)
Adverse Event nb(%) nb(%) nb(%) nb(%) nb(%) nb (%)
From  Dose 1 through 1 Month after Dose 2
Any unsolicited adverse event 4233 (32.6) 2384 (26.7) 6617 (30.2) 1871 (14.4) 1177 (13.2) 3048 (13.9)
Unsolicited non -serious adverse events 4207 (32.4) 2350 (26.3) 6557 (29.9) 1855 (14.2) 1141 (12.8) 2996 (13.7)
Serious adverse events 52 (0.4) 75 (0.8) 127 (0.6) 49 (0.4) 67 (0.8) 116 (0.5)
Withdraw al due to unsolicited adverse events 19 (0.1) 13 (0.1) 32 (0.1) 20 (0.2) 16 (0.2) 36 (0.2)
Death 0 (0.0) 3 (0.0) 3 (0.0) 2 (0.0) 3 (0.0) 5 (0.0)
From  Dose 1 to cutoff date or participant 
unblinding (whichever is earlier)c
Any unsolicited adverse event 4396 (33.8) 2551 (28.6) 6947 (31.7) 2136 (16.4) 1432 (16.1) 3568 (16.3)
Unsolicited non -serious adverse events 4347 (33.5) 2471 (27.7) 6818 (31.1) 2086 (16.0) 1347 (15.1) 3433 (15.7)
Serious adverse events 103(0.8) 165(1.8) 268(1.2) 117(0.9) 151(1.7) 268(1.2)
Withdraw al due to unsolicited adverse events 22(0.2) 23(0.3) 45(0.21) 28(0.2) 23(0.3) 51(0.2)
Death 3(0.0) 12(0.1) 15(0.1) 4(0.0) 10(0.1) 14(0.1)
a.     N = number of subjects in the specified group. This value is the denominator for the percentage calculations. 
b.     n = Number of subjects reporting at least 1 occurrence of the specified event category. For "any event," n = number of subjects rep orting at least 1 occurrence of any event.
c. Cutoff date: 13 March 2021; unblinding date varied depending on subject contact date for unblinding.
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Document Approval Record
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