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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
19July 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologic s Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGISTR ATION 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 ( BNT1 62/PF-0 7302048)
General Cor respondence
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTech and Pfizer
under BB -IND 19736 for the preve ntion of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
Further reference is made to the Agency ’s Filing Notification for BLA 12 5742 dated 15 July
2021 sent via email from Dr. Laura Gottshalk, CBER, OVRR to Ms. Elisa Harkins , Pfizer
Inc. on 16 July 2021.
I am writing on behalf of Pfizer and BioNTech t o waive our rights to the mid -and late -cycle
review meetings for BLA 125742 .
Should y ou have any questions re garding t his submission, or re quire additional inform ation,
pleas e contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e -mail at
elisa.hark instul [email protected] .
Sincerel y,
FDA-CBER-2021-5683-0780570
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 19July 2021
Pfizer Confid ential
Page 2Elisa H arkins
Global Regul atory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Nai k, Ph.D.
FDA-CBER-2021-5683-0780571