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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
21August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl Center
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WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
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WITH THE LICENSING AND/OR
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Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Response to FDA 21 August 2021 Information Request Regarding Dear HCP
Letter
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 2021 for
the COVID-19 mRNA Vaccine ( BNT162/PF-07302048) developed by BioNTec h and Pfizer
under BB -IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
Reference is al so made to the R esponse to FDA 20 August 2021 Information Request. The
purpose of this submission is to respond t o CBER’s 21 August 2021 request for revision to
the submitted Dear HCP letter, received via email from Ramachandra Naik , Ph.D.(CBER).
TheUpdated Dear H CPLetteris provided in Module 1.11.4.
Should you have any questions re garding this submission, or requireadditionalinformation,
pleasecontact me viaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
Sincerely,
FDA-CBER-2021-5683-0950424
Marion Gru ber, Ph.D., Director Page2 of 2
BLA125742 21August2021
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-2021-5683-0950425