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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
01March2022
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 CBER23 February 2022 Information Request (IR)R egarding
Cumulative Analysis of Post -Authorization Adverse Event Reports in
Individuals Aged Between 12 and 15 Year of Age
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 made to 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 CBER ’s23February 2022IRreceived via
email from Captain Mike Smith , PhD, (CBER)to Kathleen Collins (Pfizer Inc.) regarding the
Cumulative Analy sis of Post -Authorization Adverse Event Reports in Individuals Aged
Between 12 and 15 Year of Age, submitted to BLA 125742/45 on 16 December 2021.The
response to CBER ’s23 February2022comments is provided inModule 1.11.3.
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 the Gateway.
Should 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 .
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0073142
Peter Marks, M.D., Ph.D., Acting Office Director Page 2of 2
BLA 125742 01March2022
Pfizer Confid ential
Page 2Sincerely,
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.
FDA-CBER-2022-5812-0073143