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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
16March2022
Peter Marks , M.D., Ph.D.
Active Office Director
Office of Vaccines Research and Review
Food and Drug Administr ation
Center for Bi ologics Evaluation and Research
DocumentControl 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 TH E LICENSING AN D/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 125742/45
COMIRNATYCOVID-19mRNAVaccine(BNT162/PF-07302048)
Withdrawal of a Request for Comments and Advice – sBLA Booster Dose for
Children 12 Through 15 Years of Age
Dear Dr.Marks,
Reference i s made to the Biologics L icense Appli cation(BLA) 12 5742 for COMIRNATY
(COVID-19 mRNA Vaccine )developed by Pfizerand BioNTech for theprevention of
COVID-19 caused by SARS-CoV-2in individuals ≥16 years of age issuedon 23 August
2021.Reference is also madeto the sBLA to extend licensure of COMIRNATY to
adolescents 12 through 15 y ears of age submitted to BLA 125742 on 16 Dec ember2021.
Additional reference is made to the EUA (Emergency Use Authorization) 27034 for Pfizer -
BioNTech COVID -19 Vaccine re-issued 3 January 2022.
Reference is made to submission on 15March 2022 (Sequence 0273) requestingfeedback
from FDA on the acceptability ofapplying for licensure of a booster dose for adolescent s 12
through 15years ofagein the same sBLAplanned to appl yforlicensure of a booster dose
for individuals 1 6years of age and olderas a single submission.
The purpose of this submission is to formallywithdraw the request from the BLA .Instead
the submission will be made to the IND 019736 (SN 0723) on 16 March 2022
Pfizer/BioNTech respectfully request feedback from the Age ncy regardingthe acceptability
of the aforem entionedproposal by22 March2022.
FDA-CBER-2022-5812-0073148
Peter Marks, M.D., Ph.D., ActiveOffice Director Page 2of 2
BLA 125742 16March2022
Pfizer Confid ential
Page 2This submission ha s beenscanned for vir uses using McAfee VirusS can Enterprise Version
8.8 and is virus free . The submission i s being sent via the Gateway.
Should you have any questio ns regarding this submission, or require additional informa tion,
please contact me via phone at or via e-mail at .
Sincerely,
Kathleen Collins
Senior Director
Global Regulatory Affairs
CC: Ramac handra S. Naik, Ph.D .
CC: Laura Got tschalk,Ph.D.
CC: Captain M ichael Smith, Ph.D.
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0073149