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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
18August202 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 )
Commitment as Follow-up to Teleconference with
FDA on 17August 2021
Regarding Andover PAI Response
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 ≥16 years of age.
On 13 August 2021, the Agency senta request for a meeting with DMPQ subject matter
experts and the Pfizer Inc. representatives to discuss Pfizer’s Response provided via email on
01 August 2021 (formal submission 02 August 2021) to the FDA Form 483issued to Pfizer’s
Andover facility on 23 July 2021. On 17August 2021, the Agency and Pfizer met via
teleconference to discuss the 483 Response . The information and commitment sthe Agency
requested of Pfizer during that meeting areprovided in Amendment to Andover COVID-19
BLAFDA 483 Response in 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-2021-5683-1149877
Marion Gruber, Ph.D., Director Page 2of 2
BLA125742 18August2021
Pfizer Confidential
Page 2Sincerely,
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.
CC: John Eltermann, R.Ph.
CC: Kathleen Jones
CC: Christian Lynch
FDA-CBER-2021-5683-1149878