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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
20August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
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THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
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INC OR ITS AFFILIATED COMPANIES. THIS
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Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Follow-Up Response to FDA 1 9 August 2021 Information Request
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID-19 mRNA Vaccine (BNT162/P F-07302048) developed by BioNTec h and Pfizer
under BB-IND1 9736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
Reference is a lso made to the Response to FDA 1 3 August 2021 and 19 Information
Requests. The purpose of this submission is to respond to CBER’s 19 August 2021
Information Request, rec eived via email from CaptainMichael Smith, PhD (CBER). The
requestis for clarification of the study completion date and final report submission date for
PMC Study C4591014. TheResponse to FDA 19 August 2021 Informa tion Request is
provided in Mod ule 1.11.3.
Should you have any questions re garding this subm ission, or requireadditionalinformation,
pleasecontact meviaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
Sincerely,
FDA-CBER-2021-5683-0950386
Marion Gru ber, Ph.D., Director Page2of 2
BLA125742 20August2021
Pfizer Confid ential
Page 2ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramachandra S. Naik, Ph.D.
Captain Micha el Smith, Ph.D.
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0950387