Document text
Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
16August2021
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 FDA13August2021 Information Request s
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 ’s13August2021 Information
Requests, received via email fromCaptain Mi chael Smith , PhD(CBER). Thereq uests are
regardingduration of follow-up in Study C4591001 for subjects ≥16 y ears of age.Upon
receiving the queries Pfizer/BioNTech request edadditional clari ficationin relation to
question 3 which was alsoprovided on the same da yby CBER. Subsequently,
Pfizer/BioN Tech receivedan additional question also related to the efficacy population. The
Response to FDA 13 August2021Information Requ estis provided in Module 1.11.3.
Should you have any questions re garding this submis sion, or requi readditionalinformation,
pleasecontact me vi aphone at215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark [email protected] .
Sincerely,
FDA-CBER-2021-5683-0950315
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 16August2021
Pfizer Confidential
Page 2ElisaHarkins
Global RegulatoryLead
Global Regulatory Affairs –Vaccines
CC:Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-0950316