Document ID: FDA-2019-N-0895-0005
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 9057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03420]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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. FDA has determined that SPIKEVAX 
(COVID-19 Vaccine, mRNA), meets the criteria for a material threat 
priority review voucher, which has been issued to ModernaTX, Inc., the 
holder of the biologics license application.

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 
SPIKEVAX (COVID-19 Vaccine, mRNA), meets the criteria for a material 
threat MCM priority review voucher. SPIKEVAX 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 18 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 SPIKEVAX, 
(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. 2022-03420 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P