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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
30July2021
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 FDA27 July2021 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-IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of thissubmission is to respond to CBER ’s27July2021 Information Request to
Pfizer, received via email fromCaptainMichael Smith , PhD(CBER).The requests are
regarding assessment of vaccine effectiveness . The Response to FDA 27July2021
Information Requ estis provided inModule 1.11.3.
Should you have any questions re garding this submis sion, or re quireadditionalinformation,
pleasecontactme viaphone at215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark [email protected] .
Sincerely,
ElisaHarkins
Global Regulatory Lead
FDA-CBER-2021-5683-0950152
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 30 July2021
Pfizer Confid ential
Page 2Global Regulatory Affairs –Vaccines
CC:Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-0950153