Document ID: FDA-2019-N-0895-0004
Agency: fda
Document Type: Notice
Title: Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Posted Date: 2022-02-17T05:00Z

[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Page 9064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03426]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0895]

Issuance of Priority Review Voucher; Material Threat Medical 
Countermeasure Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of a priority review voucher to the sponsor of a material 
threat medical countermeasure (MCM) product application. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century 
Cures Act (Cures Act), authorizes FDA to award priority review vouchers 
to sponsors of approved material threat MCM product applications that 
meet certain criteria. FDA is required to publish notice of the award 
of the priority review voucher. COMIRNATY (COVID-19 Vaccine, mRNA) was 
approved on August 23, 2020, and a license was issued to BioNTech 
Manufacturing GmbH. FDA has determined that COMIRNATY (COVID-19 
Vaccine, mRNA) meets the criteria for a material threat MCM priority 
review voucher, which has been issued to BioNTech Manufacturing GmbH.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a material 
threat MCM priority review voucher to the sponsor of an approved 
material threat MCM product application. Under section 565A of the FD&C 
Act (21 U.S.C. 360bbb-4a), which was added by the Cures Act (Pub. L. 
114-255), FDA will award priority review vouchers to sponsors of 
approved material threat MCM product applications that meet certain 
criteria upon approval of those applications. FDA has determined that 
COMIRNATY (COVID-19 Vaccine, mRNA) meets the criteria for a material 
threat MCM priority review voucher, which has been issued to BioNTech 
Manufacturing GmbH. COMIRNATY is indicated for active immunization to 
prevent coronavirus disease 2019 (COVID-19) caused by severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years 
of age and older.
    For further information about the material threat MCM Priority 
Review Voucher Program and for a link to the full text of section 565A 
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation. For further information about COMIRNATY 
(COVID-19 Vaccine, mRNA) go to the Center for Biologics Evaluation and 
Research Approved Vaccine Products website at https://www.fda.gov/vaccines-blood-biologics/vaccines/approved-vaccine-products.

    Dated: February 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03426 Filed 2-16-22; 8:45 am]
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