125742 S4 M1 response 18 may 2021 datasets

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BNT162b2
BLA STN 125742/0
M 1.11.3Response to FDA Information Request
1BNT162b2
BLASTN 125742/0
Response to CBER 18 May 2021 Information Request Regardin gDatasets
May2021 
090177e19712a0c4\Approved\Approved On: 19-May-2021 18:00 (GMT)
FDA-CBER-2021-5683-0780567
BNT162b2
BLA STN 125742/0
M 1.11.3Response to FDA Information Request
21.INTRODUCTION
Reference is made to Amendment 132 (dated 09 April 2021) to EUA 27034 to extend 
emergency  use authorization of the Pfizer -BioNTech COVID- 19 vaccine to individuals 
12-15 years of age . Further reference is made to the teleconference held on 08 April 2021,
and Roll 1 of BLA STN 125742/0 (dated 06 May  2021).The purpose of th e current
document is to respond to CBER’s 18 May 2021 Infor mation Request regarding datasets that 
was provided by Captain MichaelSmith, PhD (CBER) to Pfizer via email.
2.CBER COMMENT SAND PFIZER -BIONTECH’S RESPONSES
The BLA review committee h as the below IR for you regarding datasets.
Reference is made to amendment 132 (dated April 9, 2021) to your EUA 27034, the 
teleconference held on April 8, 2021, and roll 1 of your BLA STN 125742/0 (dated May 
6,2021).
2.1.CBER Comment 1
Please confirm that the datasets submitted in the EUA 27034-amendment 132 are identical 
to the datasets submitted to BLA STN 125742/0.
Response
Pfizer/BioNTech confirm that the datasets submitted in the EUA 27034 -amendment 132 are 
identical to the datasets submitted to BL A STN 125742/0.  
2.2.CBER Comment 2
Please confirm that the datasets submitted as SDTM -SUPPL and ADaM -SUPPL contain 
the reactogenicity data changes as requested (including flags) in the teleconference held 
on April 8, 2021 and nothing addition al.
Response
Pfizer/BioNTech confirm that the datasets submitted as SDTM- SUPPL and ADaM -SUPPL 
contain the reactogenicity  data changes as requested (including flags) in the teleconference 
held on 08 April 2021 and nothing additional.
2.3.CBER Comment 3
Please clarify what data was changed in the supplemental EX and DM datasets.
Response
No data were changed in the supplemental EX and DM datasets. They  were included in the 
supplemental package because these two datasets would be required for pinnacle 21 check in 
case FDA wants to run its own check .
090177e19712a0c4\Approved\Approved On: 19-May-2021 18:00 (GMT)
FDA-CBER-2021-5683-0780568
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090177e19712a0c4\Approved\Approved On: 19-May-2021 18:00 (GMT)
FDA-CBER-2021-5683-0780569