Marks Declaration, Exhibit 3: Supplement Approval (Dear Mr. Patel; Case 2:21-cv-00702-CLM, Document 41-3)
- Date
- 2021-12-17
Summary
Document 41-3 in Case 2:21-cv-00702-CLM, stamped by the U.S. District Court, N.D. of Alabama, filed December 17, 2021 and labeled Marks Declaration Exhibit 3. It reproduces a U.S. Food & Drug Administration supplement approval letter dated December 16, 2021, STN BL 125742/36, addressed to BioNTech Manufacturing GmbH, with Pfizer Inc. in the address block. The letter approves a request received November 18, 2021 to supplement the Biologics License Application for COVID-19 Vaccine, mRNA (COMIRNATY) to include a new 30 microgram dose formulation (Tris/Sucrose) manufactured at a Pfizer facility in Puurs, Belgium. It approves draft labeling content and sets requirements for submitting final labeling within 14 days and for advertising and promotional labeling under 21 CFR 601.12(f)(4). The letter closes with the signature block of Jerry P. Weir, Director of the Division of Viral Products.
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“Marks Declaration, Exhibit 3: Supplement Approval (Dear Mr. Patel; Case 2:21-cv-00702-CLM, Document 41-3).”
Original at archive.org, dated 2021-12-17. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2021-12-17-covid-era-misc-0263bef2-1/
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Case 2:21-cv-00702-CLM Document 41-3 Filed 12/17/21 Page 1 of 3 FILED
2021 Dec-17 PM 01:50
U.S. DISTRICT COURT
N.D. OF ALABAMA
Marks Declaration
Exhibit 3
Case 2:21-cv-00702-CLM Document 41-3 Filed 12/17/21 Page 2 of 3
Our STN: BL 125742/36 SUPPLEMENT APPROVAL
BioNTech Manufacturing GmbH
Attention: Amit Patel December 16, 2021
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Patel:
We have approved your request submitted and received on November 18, 2021, to
supplement your Biologics License Application (BLA) under section 351(a) of the Public
Health Service Act for COVID-19 Vaccine, mRNA (COMIRNATY), to include a new
30 microgram dose formulation (Tris/Sucrose) of COMIRNATY manufactured at the
Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility.
LABELING
We hereby approve the draft content of labeling including the Package Inserts
submitted under amendment 10, dated December 13, 2021, and the draft carton and
container labels submitted under amendment 6, dated December 9, 2021.
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 Inserts submitted on
December 13, 2021. 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/GuidanceComplianceRegulatoryInformation/Guida
nces/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND CONTAINER LABELS
Please electronically submit final printed carton and container labels identical to the
carton and container labels submitted on December 9, 2021, according to the guidance
for industry Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/providing-regulatory-submissions-electronic-format-certain-human-
pharmaceutical-product-applications.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Case 2:21-cv-00702-CLM Document 41-3 Filed 12/17/21 Page 3 of 3
Page 2 – STN BL 125742/36 – Amit Patel
All final labeling should be submitted as Product Correspondence to this BLA, STN BL
125742, at the time of use and include implementation information on Form FDA 356h.
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 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 applications for this BLA that
include revised labeling incorporating a revised content of labeling that includes this
change.
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
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