Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Page 20467]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#abc2c5cfded8dfd9d285c9c2c4c7c4ccc2c8d8ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="5831363c2d2b2c2a21763a313734373f313b2b183e3c397630302b763f372e">[email protected]</span></a>, 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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv</a>. For further information about
MRESVIA (Respiratory Syncytial Virus Vaccine), go to the Center for
Biologics Evaluation and Research Approved Products website at <a href="https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information">https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information</a>.
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
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