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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
13August 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
COVID -19 mRNA Vaccine ( BNT162/PF -07302048 )
Response to FDA 11August 2021 Information Request Regarding the Saline
Diluent
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.
Reference is also made to CBER’s 05 August 2021 I nformation Request on saline diluent
and to Pfizer/BioNTech’s response submitted on 09 August 2021. Specifically , this response
also includes an amendment to Response 3 on information on the 10 mL container closure
information.
Further reference is made to the Agency Information Request received on 11August 2021
regarding the diluent . The requested information is provided in Response to 11 August 2021
FDA I nformation Request -Diluent in Module 1.11.1.
FDA-CBER-2021-5683-1149575
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 13August 2021
Pfizer Confidential
Page 2Should 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] .
Sincerel y,
Elisa Harkins
Global Regulatory Lead
Global Reg ulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149576