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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
06 August 202 1
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
’s03 August 2021 Information Request
Regarding CMC -related comments and requests for additional information.
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 by SARS-CoV-2in
individuals ≥16 years of age.
On 03 August 2021, the Agency sentan Information Request regarding CMC -related
comments and arequest for additional information. The requested information is provided in
Response to 0 3 August 2021FDA IRin Module 1.11.1.
Should you 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-2021-5683-1149483
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 06August2021
Pfizer Confidential
Page 2Sincerely,
Elisa Harkins
Global Re gulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramachandra S. Naik, Ph.D.
CC: Michael Smith, Ph.D.
CC: Laura Gottschalk, Ph.D.
FDA-CBER-2021-5683-1149484