Document text
Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
10Aug 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE S ECRET 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 PRI OR
WRITTEN CONSENT OF PFIZER INC.
Re: BLA 125742
COVID -19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA ’s06August 2021 IR Comments Regarding Two Drug Product
(DP) Documents
Dear Dr. Gruber,
Reference is made to the Biologics License Application (BLA) submitted 1 8May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed b y BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused b y SARS -CoV -2in
individuals ≥16 y ears of age.
On 06Aug 2021, the Agency sentan Information Request regarding validation of assay
methods and l ot release .The requested information is provided in Response to 06 Aug 2021
FDA IR Regarding tw o drug product (DP) documents in Module 1.11.1.
Should y ou have any questions regarding this submission, or require additional information,
please contact me via phone at 215 -280-5503; via facsimile at 845-474- 3500; or via e -mail at
[email protected] .
FDA-CBER-2021-5683-1149523
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 10August 2021
Pfizer Confidential
Page 2Sincerel y,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149524