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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
03August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
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 THE 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.
SN0433
Re: Covid-19 Vaccine (BNT162/PF -07302048) BB- IND 19736
Request for Com ments and Advice –Adolescent (12-15 Years of Age)
Supplemental BLA Proposal
Dear Dr. Gruber ,
Reference is made to BB- IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioNTech are developing for t heindication of active immunization to
prevent corona virus disease 2 019 (COVID -19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS -CoV -2).The IND was effective on 29 April 2020 .
Reference is also made to the Biologics L icense Application (BLA) 125742 submitted 19
May 2021 for the COVID -19 mRNA Vaccine (BNT162; PF -07302048), developed b y
BioNTech and Pfizer under BB- IND 19736 for the prevention of COVID -19 caused b y
SARS -CoV -2 in individuals ≥16 years of age.
The present submission provides a Request for C omment sandAdvice (Modul e 1.12.4)
regarding a proposal to submit a supplemental Biologi csLicense Application (sBLA) to
extend the age group to include adolescents 12 throu gh15 years of ag e.
Pfizer/BioNTech respectfully request feedback from the Agency regarding the acceptability
of our proposed datasets to support a sBLA no later than 17August 2021 .
This submission has been scanned for vir uses us ing McAfee VirusS can Ente rprise Version
8.8and is virus free . The submission is be ing sent via the Gateway .
FDA-CBER-2022-5812-0236055
Marion Gruber, Ph.D. , Director Page 2of 2
BB-IND 19736 03August 2021
Pfizer Confid ential
Page 2Should you have an y questions regarding t his submi ssion, or requi re additional informa tion,
pleasecontact me via phone a t 212-733-2613 ; via fac simile at 845 -474-3500; or via e- mail at
neda. [email protected] .
Sincerel y,
Neda Aghajani Me mar, Pharm.D.
Director
Pfizer G lobal Regulatory Affairs
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph .D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2022-5812-0236056