MRESVIA RSV Vaccine Approval Under Material Threat Medical Countermeasure Priority Review Voucher

Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.

Legal Status

Notice

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

A Notice by the Food and Drug Administration on 04/16/2026

• 1.

1.

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-3500 Document Citation 91 FR 20467 Document Number 2026-07369 Document Type Notice Page 20467
  (1 page) Publication Date 04/16/2026 Published Content - Document Details

• PDF Official Content

  • View printed version (PDF) Official Content

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-3500 Document Citation 91 FR 20467 Document Number 2026-07369 Document Type Notice Page 20467
  (1 page) Publication Date 04/16/2026 Published Content - Document Details

• Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
  headings within the legal text of Federal Register documents.
  This repetition of headings to form internal navigation links
  has no substantive legal effect.

  • AGENCY:
  • ACTION:
  • SUMMARY:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION: Enhanced Content - Table of Contents

• Public Comments Enhanced Content - Public Comments This feature is not available for this document.

Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data Additional information is not currently available for this document.

Enhanced Content - Regulations.gov Data

- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2026-07369 Email Email this document to a friend Enhanced Content - Sharing

• Print Enhanced Content - Print
  • Print this document Enhanced Content - Print
• Other Formats Enhanced Content - Other Formats This document is also available in the following formats:

JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.

Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2026-07369 as it appeared on Public Inspection on
04/15/2026 at 8:45 am.

It was viewed
28
times while on Public Inspection.

If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.

Public Inspection
Published Document: 2026-07369 (91 FR 20467) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings Document headings vary by document type but may contain
the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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

Published Document: 2026-07369 (91 FR 20467)