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Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
01 July 2022
Peter Marks , M.D., Ph.D.
Acting Director
Office of Vaccines Research and Review 
Food and Drug Administr ation
Center for Biologics 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 AND/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
COMIRNATYCOVID-19mRNAVaccine(BNT162/PF-07302048)
RevisedUnited States Package Insert (PI)forCOMIRNATY in Individuals 12 
Years of Age and Older 
Dear Dr.Marks,
Reference i s made to the Biologics License 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 made to the sBLA to extend licensure of COMIRNA TY toadolescents 12
through 15 years of age s ubmitted to BLA 125742 /45on 16 Dec ember2021.
Additional reference is made tothe 29 June 2022email correspond ence from Captain 
MichaelSmith,Ph.D.,(CBER) toGosia Mineo (Pfizer Inc.)requesting Pfizer/BioNTechto 
make revisions tothe USPIforCOMIRNATYin individuals ≥12 years of agewith a 
replacement of thedatepreviously submitted to BLA 125742 /45 on 13 May 2022for the 
PBS/Sucrose and Tris/Sucrose versions.
The present submission providesthe revised PI with a replacement of the date as requested 
by CBERfor both thePBS/Sucrose 
and Tris/Sucrose versions in Module 1.14.1:
PBS/Sucrose USPI:
Track Change ( Word)
FDA-CBER-2022-5812-0073162
Peter Marks,M.D., Ph.D., ActingDirector Page 2 of 2
BLA 125742 01 July2022
Pfizer Co nfidential
Page 2Annotated ( Word)
Tris/SucroseUSPI:
Track Change ( Word)
Annotated ( Word)
This submission ha s beenscanned for viruses using McAfee VirusS canEnterprise Versio n
8.8 and is virus free. The submission i s being sent via the Gateway.
Shouldyou haveany questions regarding t his submission, or require additionalinformation,
pleasecontact me via phoneat or via e-mail at .
Sincerely,
Gosia Mineo, MS
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-2022-5812-0073163