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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
17June 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)
Response to 9 June 2021 Information Request
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 prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age. Further reference is made to the request for Pediatric Research
Equit yAct(PREA )milestone dates for studies C4591001 and C 4591007 sent via email from
Captain Mic hael Smith on 9June 2021. The requested PREA mil estone dates are provided
below.
Study C4591001: Ages 12 Through 17 Years
Final Protocol Submission: 22 April 2020
Study Completion: 31 May 2023
Final Report Submission: 31 October 2023
Study C4591007: 11 y ears of age and y ounger
Final Protocol Submission: 18 December 2020
Study Completion: 31 August 2023
Final Report Submission: 29 February 2024
FDA-CBER-2021-5683-0950051
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 17June 2021
Pfizer Confid ential
Page 2Should 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,
Elisa 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-2021-5683-0950052