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CONCURRENCE PAGE
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Application #: STN: BL 125742 /8
Communication Name: Notification
Communication ID: WR LTR- OBE Safety Related
Drafted by: Christopher Okoye : 09/27/2021
Review /Concurrence History:
Craig Zinderman: 09/29/2021
Lori Austin -Hansberry : 09/29/2021
cc: CBER Electronic Repository
END OF CONCURRENCE PAGE
The letter begins on the next page
FDA-CBER-2021-5683-1072433
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
Our STN: BL 125742/8 September 29, 2021
BioNTech Manufacturing GmbH
Attention: Amit Patel
235 East 42ndStreet
New York, New York 10017
Re: Request for Waiver under Title 21 Codeof Federal Regulations 600.90(a)
Dear Amit Patel:
In the letter dated September 15, 2021, BioNTech Manufacturing GmbH requests an
extension of the first reporting period for Lot Distribution Reporting (LDR) for
COMIRNATY [COVID-19 mRNA Vaccine (nucleoside modified)], Biologics License
Applications (BLA) 125742/0 from September 2021 to January 2022. BioNTech also
requests to align the BLA LDR reporting requirement with quarterly reporting per the
Emergency Use (EUA) as outlined in the re-authorization issued on August 23, 2021.
BioNTech requests a temporary waiver of four months to allow additional time to set
up the required electronic systems needed for submission of LDR in SPL format. The
additional time will allow for routine reporting in the appropriate format. BioNTech
states the information needed to support both the BLA and EUA reporting
requirements is similar and therefore alignment between the reporting period for the
BLA and EUA is requested. The 1stEUA quarterly report was provided to FDA in July
2021. BioNTech proposes to submit the first BLA LDR with the January 2022 EUA
report.
On June 10, 2014, FDA issued a final rule which, among other things, amended the
requirements as to biological LDRs required under Title 21 of the Code of Federal
Regulations 600.81 (21 CFR 600.81). Specifically, under this rule, applicants are
required to submit LDRs to FDA in an electronic format that the Agency can process,
review and archive (79 FR 33072). This reporting requirement was in effect as of June
10, 2015. Please note that the rule does not change the content of these reports1.
Based upon our review, BioNTech request for extension of the first reporting period for
Lot Distribution Reporting (LDR) for COMIRNATY [COVID-19 mRNA Vaccine
(nucleoside modified)] is GRANTED. Therefore, as of the date of this letter and per 21
CFR 600.90 (b), the reporting interval of your first LDR will include the first 3 months
following the initial approval of COMIRNATY and this first LDR will be submitted in
1See FDA Guidance for Industry: “Electronic Submission of Lot Distribution Reports, March 2015.” FDA
Guidance available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/electronic-submission-lot-distribution-reports
FDA-CBER-2021-5683-1072434
Page 2 – STN 125742/8 – Amit Patel
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.govJanuary 2022, and thus, remain in compliance with the distribution reporting
requirements per 21 CFR 600.81. Your request to waive the submission of monthly
BLA LDR in lieu of submission of quarterly LDR to align with the EUA LDR reporting
requirements is DENIED.
Also, please note that this letter in no way affects your other reporting responsibilities
under our regulations, except as specifically outlined in this letter.
If you have any questions, please contact Lori Austin-Hansberry, Senior Regulatory
Project Manager, at [email protected].
Sincerely,
Craig Zinderman, MD, MPH
Associate Director for Medical Policy
Office of Biostatistics and Epidemiology
Center for Biologics
Evaluation and Research
FDA-CBER-2021-5683-1072435