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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Our STN: BL 125742/45 SUPPLEMENT APPROVAL
PMR FULFILLED
BioNTech Manufacturing GmbH July 8, 2022 Attention: Gosia Mineo, M.S. Pfizer, Inc. 1 Pfizer Way 190/004/4405 Pearl River, NY 10965 Dear Ms. Mineo: We have approved your request received on De cember 16, 2021, to supplement your
Biologics License Application (BLA) submitte d under section 351(a) of the Public Health
Service Act for COVID-19 Vaccine, mRNA (C OMIRNATY), manufactured at the Pfizer
Manufacturing Belgium NV, Puurs, Belgiu m (Pfizer, Puurs), Pharmacia & Upjohn
Company LLC, Kalamazoo, Michigan (Pfi zer, Kalamazoo) and Hospira, Inc.,
McPherson, Kansas (Pfizer, McPherson) fa cilities, to include use in adolescents 12
through 15 years of age for active immuni zation to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respirator y syndrome coronavirus 2 (SARS-CoV-
2). The review of this supplement was associated with the follo wing National Clinical Trial
number: 04368728. LABELING We hereby approve the draft content of Package Insert labeling, submitted under
amendment 13, dated July 1, 2022. CONTENT OF LABELING As soon as possible, but no later than 14 days fr om the date of this letter, please submit
the final content of labeling (21 CFR 601. 14) in Structured Product Labeling (SPL)
format via the FDA automated drug registrati on and listing system (eLI ST), as described
at http://www.fda.gov/ForIndustry/DataSt andards/StructuredProductLabeling/
default.htm . Content of labeling must be identical to the Package Insert submitted on
July 1, 2022. Information on submitting SPL files using eLIST may be found in the
guidance for industry SPL Standard for Content of Labeling Technical Qs and As at
http://www.fda.gov/downloads/Drugs/Guidan ceComplianceRegulatoryInformation/Guida
nces/UCM072392.pdf .
The SPL will be accessible via publicly available labeling repositories.
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All final labeling should be submitted as Product Correspondence to this BLA, STN
125742, at the time of use and include implem entation information on Form FDA 356h.
ADVERTISING AND PROM OTIONAL LABELING
You may submit two draft copies of t he proposed introductory advertising and
promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling
Branch at the following address:
Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Ave. WO71–G112 Silver Spring, MD 20993-0002
You must submit copies of your final adverti sing and promotional labeling at the time of
initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR
601.12(f)(4)). All promotional claims must be consistent with and not contrary to approved labeling.
You should not make a comparat ive promotional claim or clai m of superiority over other
products unless you have substantial evidence or substantial clinical experience to
support such claims (21 CFR 202.1(e)(6)).
Please submit an amendment to all pending supplemental applic ations for this BLA that
include revised labeling incor porating a revised content of labeling that includes these
changes. FULFILLED POSTMARKETING REQUIREMENT This submission fulfills your postmarke ting requirement #1 identified in the
August 23, 2021, approval letter for BLA ST N 125742/0 for COVID-19 Vaccine, mRNA.
The requirement addressed in this submission is as follows:
1. Deferred pediatric Study C4591001 to eval uate the safety and effectiveness of
COMIRNATY in children 12 year s through 15 years of age.
Final Protocol Submission: October 7, 2020 Study Completion: May 31, 2023 Final Report Submission: October 31, 2023
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PEDIATRIC REQUIREMENTS
Under the Pediatric Research Equity Act (PR EA) (21 U.S.C. 355c), all applications for
new active ingredients, new indications, new dosage forms, new dosing regimens, or
new routes of administration are required to contain an assessment of the safety and
effectiveness of the product for the claimed i ndication in pediatric patients unless this
requirement is waived, deferred, or inapplicable. We note that you have fulfilled the pediatri c study requirement for ages 12 through 15
years for this application. We will include information contained in the abo ve-referenced supplement in your BLA
file.
Sincerely, Doran Fink, M.D., Ph.D. Acting Deputy Director Office of Vaccines Re search and Review
Center for Biologics Evaluation and Research