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BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 1BNT162b2
BLA STN 1257 42/0
Response to CBER 25 June2021 Clinical Information Request
July2021
090177e197779ef8\Approved\Approved On: 02-Jul-2021 15:04 (GMT)
FDA-CBER-2021-5683-0950077
BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
On 25June 2021, Pfizer /BioNTech received the following C linical Information R equestfrom 
the FDAregarding Stud y BNT162 -01submitted toSTN 125742/0.
The FDA’s request in bold italics isfollowed by  Pfizer/BioNTech’s response below.
2.CLINICAL INFORMATION REQUEST
2.1.FDA Information Request Item1
We have the following comment regarding the document titled “bnt162 -01-interim3-
report-body”:
We note that possible numerical inconsistencies in Table 14.3.1-1.3 -3 page (1241/2151) 
titled “Frequency of subjects with solicited local reactions by grade -BNT162b2” for t he 
older subjects enrolled in BNT162- 01 who received 30 mcg dose of the investigational 
product.  
Please clarify and provide summary tables for the cohorts (older and younger subjects) 
who received 30 mcg dose of BNT162 for both solicited local and system ic adverse 
reactions.  In the table, please present solicited AEs (local and systemic) for the 7 days 
following each 30 mcg dose of the investigational vaccine.  
A suggested format for the summary table is below.
Please provide a response by 2 July 2021.
Response
We have re -reviewed all solicited local and s ystemic reactogenicity  data in the tables and 
have not identified inconsistencies in the results from the older and younger subjects who 
received 30 µg dose of BNT162. Our analy sis includes every  solicited reaction of any  
severity for each subject, not just the worst grade of solicited reaction per subject. 
Consequently , there may  be more total events per sy mptom than number of subjects exposed. 
Based on your request for clarification of the Tables 14.3.1-1.3- 3, pages (1241/2151), we 
anticipate that CBER wishes us to provide new tables based on worst grade per participant 
per reactogenicity  event (solicited AEs), so as each participant is counted only  once per 
symptom. 
We are accordingl y submitting new tables for solicited AEs (local and s ystemic) for the 
sevendays following each 30 µg dose of the investigational vaccine summarizing: 1) the 
frequency  of subjects with solicited local reactions by  worst grade and 2) the frequency  of 
subjects with solicite d systemic reactions by  worst grade for y ounger (n=12) and older 
(n=12subjects) (Appendix 1). 
The data in these tables is consistent with the previously  supplied tables “bnt162 -01-
interim3-report-body,” Tables 14.3.1-1.3- 3, pages (1241/2151), titled “Frequency  of subjects 
with solicited local reactions by  grade -BNT162b2.” 
090177e197779ef8\Approved\Approved On: 02-Jul-2021 15:04 (GMT)
FDA-CBER-2021-5683-0950078
BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 3There were 3 severe s ystemic reactions after the 1st (prime) injection and 2 severe s ystemic 
reactions after the second (boost) injection as previously  shown in tables which included all 
reactogenicity  events post both first and second injections without selecting for worst grade.
3.APPENDIX
Appendix 1.  BNT162-01 Local and Sy stemic Solicited AEs Summary  Table
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090177e197779ef8\Approved\Approved On: 02-Jul-2021 15:04 (GMT)
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