Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)

[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Page 20467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-07369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-3500]


Notice of Approval of Product Under Priority Review Voucher; 
Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA 
(Respiratory Syncytial Virus Vaccine)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
approval of a product redeeming a material threat medical 
countermeasure (MCM) priority review voucher. The Federal Food, Drug, 
and Cosmetic Act (FD&C 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 issuance of material threat MCM priority review vouchers 
as well as the approval of products redeeming a priority review 
voucher. FDA has determined that MRESVIA (Respiratory Syncytial Virus 
Vaccine), approved May 31, 2024, meets the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 
industry.biologics@fda.hhs.gov, 240-402-7911.

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product 
redeeming a material threat MCM priority review voucher. Under section 
565A of the FD&C Act (21 U.S.C. 360bbb-4a), FDA will report the 
issuance of material threat MCM priority review vouchers and the 
approval of products for which a voucher was redeemed. FDA has 
determined that MRESVIA (Respiratory Syncytial Virus Vaccine), meets 
the redemption criteria.
    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/21st-century-cures-act-mcm-related-cures-provisions#prv. For further information about 
MRESVIA (Respiratory Syncytial Virus Vaccine), go to the Center for 
Biologics Evaluation and Research Approved Products website at https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07369 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P