Federal Register #Docket No. FDA-2026-N-3500

FDA Approval of MRESVIA RSV Vaccine under MCM Priority Review Voucher Program

This notice announces the FDA's approval of MRESVIA, a Respiratory Syncytial Virus Vaccine, under the Material Threat Medical Countermeasure Priority Review Voucher program. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM/Vendor: - MRESVIA (manufacturer of the approved vaccine) - Product Approved: - MRESVIA Respiratory Syncytial Virus Vaccine - No part numbers or purchase quantities specified - Notable Requirements: - Approval granted through redemption of a Material Threat Medical Countermeasure (MCM) Priority Review Voucher - Supports development of medical countermeasures for material threats - No additional unique technical or delivery requirements specified

Description

The Food and Drug Administration (FDA) announces the approval of MRESVIA, a Respiratory Syncytial Virus Vaccine, which redeems a material threat medical countermeasure (MCM) priority review voucher. This voucher program incentivizes the development of medical countermeasures for material threats by granting priority review status. The approval date for MRESVIA is May 31, 2024, and the notice serves to inform the public of the redemption of the priority review voucher under the Federal Food, Drug, and Cosmetic Act.

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