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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
11August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics 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 THE 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
COVID -19 mRNA Vaccine (B NT162/PF-07302048)
Response to FDA 10August 2021 Information Request
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTech and P fizer
under BB -IND 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The purpose of this submission is to respond to CBER ’s28July 2021 Infor mation Request
received via email from Ramachandra S. Naik , PhD (CBER ). Further reference is made to
the response submitted on 03 August 2021 regarding post marketing safety studies. The
Response to FDA 10August 2021 Information Requ estis provided in Modu le 1.11.3.
Should y ou have any questions re garding t his submis sion,or requireadditional inform ation,
pleas e contact me vi aphone at 215-280-5503; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul [email protected] .
Sincerel y,
Elisa Harkins
Global R egulatory Lead
FDA-CBER-2021-5683-0950211
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 11August 2021
Pfizer Confid ential
Page 2Global R egulator y Aff airs –Vaccine s
CC:Rama chandr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950212