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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
16December 2021
Peter Mark, M.D., Ph.D.
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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WITH THE LICENSING AN D/OR
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INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
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OTHER PURPOSE WITHOUT THE PRIOR
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Re: BLA 125742/45
COMIRNATY (COVID -19 mRNA Vaccin e)
Supplemental Biologics License Application (sBLA) - Adolescent s 12 t hrough 15
Years of Age
Request for Priority Review Designation
Dear Dr. Marks,
Referen ce is ma de to the Biologics License Applicatio n (BLA) 125742 for COMI RNATY
(COVID -19 mRNA Vaccine) approved 23 August 2021 for the prevention of coronav irus
disease 2019 ( COVID -19) caused b y severe acute respiratory syndro me coronavirus 2
(SARS -CoV -2)in individuals 16 years of age and older .The purp ose of this sBLA is to
extend licensure of COMIRNATY to adolescents 12 through 15 years of age. The proposed
indication is active immunization to prevent COVID -19caused b y SARS -CoV -2in
individua ls 12 years of age and older .
BioNTech and Pfizer are reque sting Priority Review Designation for this sBLA. It meets the
criteria for Priority Review Desig nation, as outlined in the 2014 Guidance for In dustry:
Expedit ed Programs for Serious Conditions –Drugs and Biologics because COMI RNATY
prevents a se rious and life-threatening condition (COVID -19) and, if approved , would
provide significa nt improvement in safet y and effectiveness because ther e are currentl y no
vaccines licensed for the prev ention o f COVID -19 in the US for adolescent s 12 t hrough 15
years of age. The Request for Priority Review Designation is provided in Module 1.2.
This sBLA is being submitted as a complete application and the table of contents is attached
to this cover letter . Any reference not included with this submission is available upon
FDA-CBER-2022-5812-0073134
Peter Mark , M.D.,Ph.D. , Director Page 2of 4
BLA 12574 2/45 16December 2021
Pfizer Confid ential
Page 2request. This submission is provided in electronic Common Technical Document (e CTD)
format.
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 .
Shouldyou have an y questions reg arding this submi ssion , or require additional inform ation,
pleasecontact me via phone a t 214-918-5262or via e-mail at Amitkumar.Patel@pfizer. com.
Sincerel y,
Amit Pate l
Director
Global Regulatory Affairs -Vaccines
CC: Rama chandra S. Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2022-5812-0073135
Peter Mark , M.D.,Ph.D. , Director Page 3of 4
BLA 12574 2/45 16December 2021
Pfizer Confid ential
Page 3sBLA 125742/45 Table of Contents
MODULE 1
1 Administrative Inform ation and Prescribing Inform ation
1.1 Form s
FDA 356h Form: Application F orm
FDA 3674 F orm: Certifica tion of Compliance with ClinicalTrials.gov
1.2 Cover Letters
Cover Lett er
Request for Priority Review D esignation
1.3 Administrative Inform ation
1.3.1 Contact /Sponsor/Applicant In form ation
1.3.1.4 Transfer of Obligation
Transfer of Obligation
1.3.3 Debarment Certification
Debarment Certificat ion
1.3.4 Financial Certification and Disclosure
Finan cial Certification and Disclosure –Summary Note
Finan cial Certification and Disclosu re –Bias S tatement
Finan cial Certification and Disclosure –Form 3454
Finan cial Certification and Disclosure –Form 3455
1.3.5 Patent and Exclus ivity
1.3.5.3 Exclusivity Claim
Notice of Claimed Exclusivity
1.14 Labeling
1.14.1 Draft Labeling
1.14.1. 2Annotated Draft Labeling Text
Annotated Draft Label ing Text (Word, PDF)
1.14.1.3 Draft Labeling Text
Draft Labeling Text ( Word, PDF , SPL )
1.16 Risk Managem ent Plan (PVP)
1.16.1 Pharm acovigil ance Plan
MODULE 2
2 CTD S UMMARIES
2.2 Introduc tion t o Summary
2.5 Clinical Overview
MODULE 5
5 C LINICAL STUDY REPORTS
5.2 Tabular Listing of All Clinical Studies
Tabular Listing
Listing of Clinical Sites and CVs
5.3 Clinical Study Reports
5.3.5 Reports of Efficacy and Safety Studies
5.3.5. 1 Repo rts of Controlled Clinica l Studies Pertinent to the Cla imed Indication
C4591001 -A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study
to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS -CoV -2 RNA Vacci ne
Candidates Against COVID -19 in Healthy Individuals
C4591001 –Interim Adolescents CSR
C4591001 –Interim Adolescents CSR (6-monthUpdate )
C4591001 –Case Report Forms
C4591001 –AdaM and SDTM Datasets
C4591001 –508 Com pliant Tables (Wor d, PDF )
FDA-CBER-2022-5812-0073136
Peter Mark , M.D.,Ph.D. , Director Page 4of 4
BLA 12574 2/45 16December 2021
Pfizer Confid ential
Page 45.3.6 Reports of P ost-marketing Experience
Cumulat ive Analysis of Post -Authorization Adverse Event Reports of PF -07302048 (BNT162b2)
Received through 30 September 2021 in Individuals Aged Betw een 12 and 15 Years of Age
5.4 Literature References
FDA-CBER-2022-5812-0073137