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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
13 May2022
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 
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)
Response to FDA’s 10 May 2022 Information Request Regarding Package Insert
(PI)forCOMIRNATY in Individuals 12 Years of Age and Older 
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 Mike Smith,Ph.D.,
(CBER) toKathleen Collins (Pfizer Inc.)on 10 May2022requesting Pfizer/BioNTechto 
provide additional revisions to the PIforCOMIRNATYin individuals ≥12 years of age
submitted to BLA 125742 /45 on 29 April 2022 for PBS/Sucrose and Tris/Sucrose version of 
the PIby16 May 2022. 
The present submission providesa revised PI  for both thePBS/Sucrose and Tris/Sucrose 
versionsin response to FDA ’s 10 May 2022 request in Module 1.14.1:
PBS/Sucrose USPI:
Track Change ( Word)
Annotated ( PDF)
FDA-CBER-2022-5812-0073160
Peter Marks, M.D., Ph.D., ActiveOffice Director Page 2 of 2
BLA 125742 13 May2022
Pfizer Co nfidential
Page 2Clean copy (PDFand Word)
Tris/SucroseUSPI:
Track Change ( Word)
Annotated ( PDF)
Clean copy (PDFand Word)
This submission ha s beenscanned for vir uses using McAfee VirusS canEnterprise Version
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,
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-2022-5812-0073161