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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
21 September 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
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THAT IS DISCLOSED ONLY IN CONNECTION
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Re: BLA 125742/ 13
COMIRNATY (COVID -19 mRNA Vaccine)
BLA Post -marketing Requirement and Post -Marketing Commitment -
Notification of Submission of Final C4591007 S ubstudy Prot ocols to IND 19736
Dear Dr. Gruber ,
Reference is made to the Biologics License Application (BLA) 125742 for COMI RNATY
(COVID -19 mRNA V accine), developed b y BioNTech and Pfizer for the prevention of
COVID -19 caused b y SARS -CoV -2 in individuals ≥16 y ears of age issued on 23 August
2021 .
Reference is made also made to BB -IND 19736 for the COVID -19 Vaccine (BNT162; PF -
073020 48), which Pfizer and BioNTech are developing for the indication of active
immunization to prevent coronavirus disease 2019 (COVID -19) caused by sever eacute
respiratory syndrome cor onavirus 2(SARS -CoV -2). The IND was effective on 29 April
2020.
The pres ent submission is to noti fy CBER that the following C4591007 sub study final
protocol swere submitted to BB-IND 19736 as protocol amendments to meet Post -marketing
Commitment 11 (1) and Post -marketing R equirement 8(2), both listed in the 23 August 2021
BLA STN 125742 /0approval letter:
(1)Study C4591007 enti tled, “A Phase 1, Open- Label Dose -Finding Study to Evaluate
Safety , Tolerabilit y, and immunogen icity and Phase 2/3 Placebo Controll ed,
Observer -Blinded Sa fety, Tolerability ,and Immunogenicity Study of a S ARS-CoV-2
RNA Vaccine Candidate Against COVID -19 in Heal thy Children and Young
FDA-CBER-2021-5683-0951554
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 21September 2021
Pfizer Confid ential
Page 2Adults,” submitted to the BB- IND 19736 in protocol amendment 2 on 10 August
2021 (SN 0443)
(2)Substudy C4591007 enti tled, “A Phase 1, Open- Label Dose -Finding Study to
Evaluate Saf ety, Tolerability , and immunogen icity and Phase 2/3 Placebo Controll ed,
Observer -Blinded Sa fety, Tolerability ,and Immunogenicity Study of a SARS -CoV -2
RNA Vaccine Candidate Against COVID -19 in Heal thy Children and Young
Adults,” submitted to the BB- IND 19 736 inprotocol amendment 3on 14 September
2021 (SN 0487)
This submission has been s cann ed for vir uses us ing McAfee VirusS can Ente rprise Versi on
8.8and is vir us free. The submission i s being sent via the Gateway .
Should you have any quest ions regarding this submission, or requir e add itional information,
please contact me via phone at 214-918-5262 or via e-mail at Amit [email protected] .
Sincerel y,
Amit Patel
Director
Global Regulatory Affairs -Vaccines
CC: Ramac handra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph .D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-0951555