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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
19August 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 PRIOR WRITTEN CONSENT
OF PFIZER INC.
Re: BLA 125742.0
COVID -19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA 18August 2021 Information Request : DBSQC C omments
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 18 August 2021, the Agency sentanInformation Request regarding the recent submission
on August 16th(Commitment to FDA 13 August 2021 I nformation Request Regarding
Implementing New Method for Endotoxin) and August 17th(Response to FDA 13 August
2021 I R regarding test methods, the lot re lease process, and the lot release protocol
template) . O
n 17 August 2021, the Agency and Pfizer met via teleconference to obtain
clarity on the given request. The Response to 18 August 2021 Information Request :
DBSQC Comments is provided inModule 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-2021-5683-1149926
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 19August 2021
Pfizer Confidential
Page 2Sincerel y,
Elisa H arkins
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-2021-5683-1149927