125742 S75 M1 response 20aug2021

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BNT162b2
BLA STN 125742/0
M 1.11. 4Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to 20 August CBER Information Request Regarding Label for Identification 
of BLA Lots and Dear HCP Letter
20 August 2021
090177e197dd9261\Approved\Approved On: 20-Aug-2021 21:19 (GMT)
FDA-CBER-2021-5683-0951277
BNT162b2
BLA STN 125742/0
M 1.11. 4Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2LIST OF ABBREVIATIONS
Abbreviation Term
BLA Biologics License Application
CBER Center for Biologics Evaluation and Research
COVID -19 coronavirus disease 2019
FDA United States Food and Drug Administration
HCP Health Care Provider
SARS -CoV -2 severe acute respiratory  syndrome coronavirus 2
090177e197dd9261\Approved\Approved On: 20-Aug-2021 21:19 (GMT)
FDA-CBER-2021-5683-0951278
BNT162b2
BLA STN 125742/0
M 1.11. 4Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 31.INTRODUCTION
Reference is made to BLA STN 125742/0 for the Pfizer -BioNTech COVID -19 Vaccine for 
active immunization to prevent COVID -19 caused by  SARS -CoV -2 in individuals ≥16 y ears 
of age.
The purpose of this document is to respond to CBER’s Information R equest communicated 
from Ramachandra Naik, PhD (CBER) to Elisa Harkins Tull (Pfizer I nc.)via email on 
20August 2021, requesting information the label for identification of BLA lots and the Dear 
HCP letter.
CBER’s comments/requests in bold italics are followed b y the Sponsor’s responses below.
2.CBER REQUEST S
2.1. CBER Request 1 
Our review of the information provided in your BLA STN 125742 for COMIRNATY 
(COVID- 19 mRNA V accine), for active immunization to prevent COVID -19 caused by 
SARS -CoV-2 in individuals 16 years of age and older, is ongoing.  Please see the attached 
for CBER’s comments and revisions regarding the information included in amendment 64 
(dated August 19, 2021) about the label to include with the vaccine tray package and the 
draft Dear HCP Letter.
Please refer to our August 20, 2021, 2:08 PM email communication rega rding lots that 
you consider to be BLA- compliant, and confirm that EUA -labeled “lots in the field” will 
not be listed at cvdvaccine -us.com/resources until they are released by CBER.
Please provide your response in an Amendment to STN 125742/0, as soon as possible. 
Response
Pfizer /BioNTech has updated the Dear HCP Letter and the graphic regarding identification of 
the BLA lot s. The revised Dear HCP L etter-COMI RNATY Lots and Graphic –
Recommendation –Identification of BLA Lots graphic are attached. 
Pfize r/BioNTech confirms that EUA -labeled “lots in the field” will not be listed on
cvdvaccine -us.com/resources until they  are released by  CBER.
090177e197dd9261\Approved\Approved On: 20-Aug-2021 21:19 (GMT)
FDA-CBER-2021-5683-0951279
Document Approval Record
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090177e197dd9261\Approved\Approved On: 20-Aug-2021 21:19 (GMT)
FDA-CBER-2021-5683-0951280