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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
29April2022
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 Preliminary R equested C hanges and C omments on the
Package Insert for COMIRNATY 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.
Reference is made to theemailcorrespondence from Dr. Ra m Ramachandra (CBER) to Gosia 
Mineo(Pfizer Inc.)  on 11 April 2022 that updates to the PBS/Sucrose label woul d apply to 
the Tris/Sucrose label andsubmit the labels for Tris /Sucrose formulation to the sBLA, at the 
stage of final label negotiations using the PBS/Sucrose label
Additional reference is made to
the email correspond ence from Dr. Laura Gottschalk, Ph.D.,
(CBER) toKathleen Collins (Pfizer Inc.)on 20April 2022requesting Pfizer/BioNTech to 
provide a revised p ackage insertforCOMIRNATY in individuals 12 years of age and older
addressingFDA’s comments and suggested edits by 29 April 2022.
The present submission providesa revised package insert in response to FDA’sPreliminary
requested changes and comments. The re vised pack age inserts are provided in Module 
1.14.1:
FDA-CBER-2022-5812-0073152
Peter Marks, M.D., Ph.D., ActiveOffice Director Page 2 of 2
BLA 125742 29 April2022
Pfizer Confid ential
Page 2Track Change ( Word)
Annotated ( PDF)
Clean copy (PDFand Word)
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.
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.
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(b) (6)
FDA-CBER-2022-5812-0073153