Document text
Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
03 August202 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’s 26 July 2021 IR Comments Regarding
Manufacturing and Equipment
, Including the Remaining Supporting
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 -19 caused b y SARS-CoV-2 in
individuals ≥16years of age.
Reference is also made to thesubmission on 30 July 2021 in response to CBER’s 26 July
2021 Information Request regarding manufacturing and equipment to Pfizer, received via
email from Laura Gottschalk, P hD (CBER/OVRR). Due to the file size of some of the
attachments for Response 10, not all the support ingdocuments were submitted on 30 July
2021.
Specificall y, this response includesthe remaining supporting documents in response to
CBER’s 26 July 2021 Information Reque st regarding manufacturing and equipment , for
response #10 . The present submission provides Follow-up Response to 26 Jul y2021 FDA
Query #10in Module 1.11.1.
FDA-CBER-2021-5683-1149480
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 03August2021
Pfizer Confidential
Page 2Should 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] .
Sincerely,
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-2021-5683-1149481