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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
11August 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 ’s05August 2021 Information Request Regarding Facilities
Dear Dr. Gruber,
Reference is made to the Biologics License Application (BLA) submitted 18 May 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 05August 2021, the Agency sentan Information Request regarding facilities .The
requested information is provided in Response to 05 Aug 2021 FDA Information R equest -
Facilities Questions in Module 1.11.1.
Reference is also made to the submission on 30 July 2021 in response to CBER’s 26 July
2021 I nformation Request regarding manufacturing and equipment to Pfizer, received via
email from Laura Gottschalk, PhD (CBER/OVRR). Specificall y, this response also includes
a follow -up to response 16e oninformation for portable tank .
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] .
(b) (4)
FDA-CBER-2021-5683-1149544
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 11August 2021
Pfizer Confidential
Page 2Sincerel y,
Elisa Harkins
Globa l Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149545