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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
21August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
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 THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
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OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Response to FDA 21August 2021 Information Request
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID-19 mRNA Vaccine (BNT162/P F-07302048) developed by BioNTec h and Pfizer
under BB-IND1 9736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of this submission is to respond to CBER’s 21 August 2021 Information
Request, rec eived via email from CaptainMichael Smith , PhD (CBER). Pfize r/BioNTech is
requested to review and re-submit the list of Postmarketing Requirement and Postmarketing
Commitment studies and dates with a commitment to conduct all of these studies in the
timeframes noted. TheResponse to FDA 21August 2021 I nformatio n Requestis provided in
Module 1.11.3.
Should you have any questions re garding this subm ission, or requireadditionalinformation,
pleasecontact meviaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
Sincerely,
FDA-CBER-2021-5683-0950405
Marion Gru ber, Ph.D., Director Page2of 2
BLA125742 21August2021
Pfizer Confid ential
Page 2ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramachandra S. Naik, Ph.D.
Captain Micha el Smith, Ph.D.
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0950406