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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
02May 2022
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 THE LICENSING AN D/OR
REGISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
Re:BLA 125742/45
COMIRNATY COVID-19mRNAVaccine(BNT162/PF-07302048)
Response to FDA20 April 2022 Information Request
Revised Pharmacovigilance Plan (PVP) Dated 29 April 2022 Version1.4.1
Dear Dr.Marks,
Reference i s made to the Biologics L icense Appli cation(BLA) 125742 for COMIRNATY
(COVID-19 mRNA Vaccine )developed by Pfizerand BioNTech 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 COMIRNA TY to
adolescents 12 through 15 y ears of age submitted to BLA 125742 on 16 Dec ember2021.
Additional reference is made tothe email correspond ence from Captain Micha el Smith,
Ph.D.(CBER) toKathleen Collins (Pfizer Inc.)on 20April 2022 requesting
Pfizer/BioNTech torevisethePVP(Version 1.4, dated December 15, 2021) toincludeboth
Tris/Sucrose and PB S/Sucrose formulations and submit to CBER by 04 May 2022.
The present submission providesan updated PVP , version1.4.1 dated 29 April2022, Clean
copyand Track Changes copy whichincorporate both Tris/Sucrose and PB S/Sucrose
formulations in Module 1.16.1.
This submission has been scanned for vir uses using McAfee VirusS can Enterprise Version
8.8 and is virus free . The submission i s being sent via theGateway.
FDA-CBER-2022-5812-0073154
Peter Marks, M.D., Ph.D., ActiveOffice Director Page 2of 2
BLA 125742 02 May2022
Pfizer Confid ential
Page 2Should you have any quest ions regarding t his submission, or r equire additi onal informatio n,
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: Meghan MaguireThon, Ph.D.
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0073155