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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
02February 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
Document Control 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 ELICENSING AN D/OR
REG ISTRATION 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
COMIR NATY COVID -19mRNA Vaccine (BNT16 2/PF-07302048)
Response to 19 January 2022 Information Request Regarding Datasets for
Adolescents 12 Through 15 Years of Age
Dear Dr. Marks ,
Reference is made to the Biologics L icense Appli cation (BLA) 125742 for COMI RNATY
(COVID -19 mRNA Vaccine )developed by BioNTech and Pfizer for the preven tion of
COVID -19 caused by SARS- CoV -2in individuals ≥16 years of age issued on 23 August
2021. Reference is mad e to the sBLA submitted on 16 Dec 2021 to extend licensure of
COMI RNATY to adolescents 12 through 15 y ears of age.
The purpose of this submission is to respond to CBER ’s19January 2022information request
received via emai l from Captain Mike Smith, PhD , (CBER )to Kathleen Collins (Pfizer I nc.)
regarding Datasets for Adolesc ents 12 Through 15 Years of Age . The requested informati on
is provided in theResponse to CBER ’s19January 2022comments regarding Datasets for
Adolescents 12 Through 15 Years of Age inModule 1.11.3.
This submission has been scanned for vir uses us ing Mc Afee VirusS can Ente rprise Version
8.8 and is virus free . The submission i s being sent via the Gateway .
Should you haveany questions regarding t his submi ssion, or requi re additional informa tion,
pleasecontact me via phone a t or via e -mail at .
Sincerel y,
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0073140
Peter Ma rks, M.D., Ph.D., Acting Office Directo r Page 2of 2
BLA 1257 42 02February 2022
Pfizer Confid ential
Page 2Kathleen 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-2022-5812-0073141