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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
15March 2022
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
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 TH E LICENSING AN D/OR
REG ISTRATION 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
COMIR NAT Y COVID -19mRNA Vaccine (BNT16 2/PF-07302048)
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) 125742 for COMI RNATY
(COVID -19 mRNA Vaccine )developed by Pfizer and BioNTech for the preven tion of
COVID -19 caused by SARS- CoV -2in individuals ≥16 years of age issued on 23 August
2021. Reference is also made to the sBLA to extend licensure of COMIRNATY to
adolescents 12 through 15 y ears of age submitted to BLA 125742 on 16 Dec ember 2021.
Additional reference is made to the EUA (Emergency Use Authorization) 27034 for Pfizer -
BioNTech COVID -19 Vaccine re-issued 3 January 2022 .
Reference is also made to the email correspondence from Dr. Ramachandra S. Naik, Ph.D.,
(CBER) to Ms. Elis aHarkins T ull (Pfizer I nc.)on 20 Jan uary 2022 citing FDA agreement on
the data requirements support ing Pfizer /BioNTech ’s plan to submit the sBLA to add a
booster dose for individuals ≥ 16 years old with 6 months safety data post -Dose 3 .
The purpose of this submission is to submit a Request for Comments and Advice (Module
1.12.4) request ing feedback from FDA on the acceptability ofapplying for licensure of a
booster dose for adolescent s 12 throug h 15 years of agein the same sBLA planned to appl y
forlicensure of a booster dose for individuals 1 6years of age and olde r asa single
submission.
FDA-CBER-2022-5812-0073146
Peter Ma rks, M.D., Ph.D., Acti veOffice D irecto r Page 2of 2
BLA 1257 42 15March 2022
Pfizer Confid ential
Page 2Pfizer/BioNTech respectfully request feedback from the Agency regardi ngthe acceptability
of the aforem entioned proposal by22 March 2022.
This submission ha s been scanned for vir uses us ing Mc Afee VirusS can Ente rprise Version
8.8 and is virus free . The submission i s being sent via the Gateway .
Should you have any quest io ns regarding this submission, or r equire a dditional info rmation,
please contact me via phone at or via e-mail at .
Sincerel y,
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-2022-5812-0073147