125742 S9 M1 response 29jun2021

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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 29June2021 Clinical Information Request
July2021
090177e197761bcb\Approved\Approved On: 02-Jul-2021 08:26 (GMT)
FDA-CBER-2021-5683-0950055
BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
On 29June 2021, Pfizer /BioNTech received the following C linical Information R equestfrom 
the FDAregarding Study C4591001 submitted to STN 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
Please provide the maximum date (latest date) of randomization for participants included 
in the reactogenicity subset for Study C4591001.  Our evaluation of the datasets indicates 
that the maximum date of randomization (RANDDT) and vaccination date 
01(VAX101DT) for participants included in the reactogenicity subset is January 8, 2021. 
If based on your analyses, this date should be different, please provide guidance to the 
datasets and the appropriate flags we can use to confirm your results within the data sets.
Response
Based on the e Sub data submitted for BLA,in Study C4591001, the maximum date of 
randomization (RANDDT) and vaccination date 01 (VAX101DT) for participants included 
in the reactogenicity  subset is:
VAX101DT =08JAN2021 and RANDDT=08JAN2021 for participants ≥16 y ears of age .
VAX101DT =01FEB2021 and RANDDT=12JAN2021 for participants 12 through 15 years 
of age.
090177e197761bcb\Approved\Approved On: 02-Jul-2021 08:26 (GMT)
FDA-CBER-2021-5683-0950056
Document Approval Record
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090177e197761bcb\Approved\Approved On: 02-Jul-2021 08:26 (GMT)
FDA-CBER-2021-5683-0950057