docs/August-25-2022-Approval-Letter-COMIRNATY.txt

FDA U.S. FOOD & DRUG
ADMINISTRATION
Our ST: BL 125742/175
SUPPLEMENT APPROVAL
BioNTech Manufacturing GmbH
Attention: Adrienne Stafford
Pfizer Inc.
4300 Oak Park Road
Sanford, NC 27330
August 25, 2022
Dear Ms. Stafford:
We have approved your request received on June 10, 2022, to supplement your Biologics License Application (BLA) under section 351 (a) of the Public Health Service Act for COVID-19 Vaccine, mRNA (COMIRNATY), manufactured at the Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Purs), Pharmacia & Upjohn Company LLC, Kalamazoo, Michigan (Pfizer, Kalamazoo) and Hospira, Inc., McPherson, Kansas (Pfizer, McPherson) facilities, to include the introduction of the Monovalent Tris/Sucrose (30 mcg) Single Dose Vial with 0.48 mL Fill Volume to be filled on b) (4)
(b) (4) and (b) (4)
filling lines at the Purs, Belgium
location, and associated labeling changes.
LABELING
We hereby approve the draft content of labeling including the Package Insert submitted under amendment 5, dated August 25, 2022.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from 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 registration and listing system, (eLIST) as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
Content of labeling must be identical to the Package Insert submitted on
August 25, 2022. Information on submitting SPL files using LIST 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/GuidanceComplianceRegulatoryInformation/Guida nces/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
All final labeling should be submitted as Product Correspondence to this BLA, ST BL 125742, at the time of use and include implementation information on Form FDA 356h.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 2 - ST BL 125742/175 - Adrienne Stafford
ADVERTISING AND PROMOTIONAL LABELING
You may submit two draft copies of the 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 advertising 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 comparative promotional claim or claim of superiorit 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 applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
We will include information contained in the above-referenced supplement in your BLA file.
Sincerely,
Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research