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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
04May2022
Peter Marks , M.D., Ph.D.
Active Office Director
Office of Vaccines Research and Review
Food and Drug Administr ation
Center for Bi ologics Evaluation and Research
DocumentControl Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH TH E LICENSING AN D/OR
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INC OR ITS AFFILIATED COMPANIES. THIS
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Re:BLA 125742/45
COMIRNATYCOVID-19mRNAVaccine(BNT162/PF-07302048)
Response to FDA 22 April 2022 Information Request (IR)Regarding Study
Protocol for Study C4591022 -Postmarketing C ommitment (PMC) #10
Dear Dr.Marks,
Reference i s made to the Biologics L icense Appli cation(BLA) 125742 for COMIRNATY
(COVID-19 mRNA Vaccine )developed by BioNTech and Pfizer for theprevention of
COVID-19 caused by SARS-CoV-2in individuals ≥16 years of age issuedon 23 August
2021.Reference is also madeto the sBLA to extend licensure of COMIRNATY to
adolescents 12 through 15 y ears of age submitted to BLA 125742 on 16 Dec ember2021.
The purpose of thissubmission is to respond to FDA22April2022IRreceived via email
from Captain Mike Smith , PhD, (CBER)to Kathleen Collins (Pfizer Inc.)and GosiaMineo
(Pfizer Inc.)regarding a request to revise the study protocol for Study C4591022 entitled
“Pfizer-BioNTech COVID -19 Vaccine Exposure during Pregnancy: A Non- Interventional
Post-Approval Safety Study of Pre gnancy and Infant Outcomes in the Organiza tion of
Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry ”which is a
Postmarketing Commitment (PMC) #10 as described in the STN BLA 125742/0 approval
letter.
Theresponse to FDA22April2022IRis provided inModule 1.11.3.
This submission ha s beenscanned for vir uses using McAfee VirusS can Enterprise Version
8.8 and is virus free . The submission i s being sent via the Gateway.
FDA-CBER-2022-5812-0073156
Peter Marks, M.D., Ph.D., ActiveOffice Director Page 2of 2
BLA 125742 04May 2022
Pfizer Confid ential
Page 2Should you have any quest ions regarding this submission, or r equi re additional informa tion,
please contact me via phone at or via e-mail at .
Sincerely,
Kathleen Collins
Senior Director
Global Regulatory Affairs
CC: Ramac handra S. Naik, Ph.D .
CC: Laura Got tschalk,Ph.D.
CC: Captain M ichael Smith, Ph.D.
CC: Megha n MaguireThon, Ph.D.
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0073157