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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
18August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics 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 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 FDA17August2021 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 Pfi zer
under BB-IND1 9736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of thissubmission is to respond to CBER ’s17August2021 Information
Request, received via email fromRamachandra Naik, PhD (CBER). The follow-up
comments are regarding safety-related Postmarketing Requirement and Postmarketing
Commitment studies. TheResponse to FDA 17August2021Information Requ estis
provided inModule 1.11.3.
Should you have any questions re garding this submis sion, or req uireadditionalinformation,
pleasecontact me vi aphone at215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark [email protected] .
Sincerely,
ElisaHarkins
FDA-CBER-2021-5683-0950360
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 18August2021
Pfizer Confidential
Page 2Global RegulatoryLead
Global Regulatory Affairs –Vaccines
CC:Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-0950361