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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
06 Aug 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’s 04Aug 2021 IR Comments Regarding Potency Assay for
Determination of IVE by Flow Cytometry
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 04 Aug 2021, the Agency sentan Information Request regarding validation of assay
methods and l ot release .The requested information is provided in Response to 04 Aug 2021
FDA I nformation Request regarding the potency assay for determination of IVE by flow
cytometry in Module 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-2021-5683-1149500
Marion Gruber, Ph.D., Director Page 2of 2
BLA 125742 06 August 2021
Pfizer Confidential
Page 2Sincerel y,
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-2021-5683-1149501