Federal Register #Docket No. FDA-2026-N-3447

FDA Approval of MNEXSPIKE COVID-19 Vaccine under Rare Pediatric Disease Priority Review Voucher Program

This notice announces the FDA's approval of MNEXSPIKE, a COVID-19 mRNA vaccine, under the rare pediatric disease priority review voucher program. - Government Buyer: - Food and Drug Administration (FDA), under the Department of Health and Human Services - OEMs and Vendors: - MNEXSPIKE (COVID-19 Vaccine, mRNA) - Products/Services Requested: - MNEXSPIKE COVID-19 Vaccine, mRNA - No specific part numbers or quantities provided - Unique or Notable Requirements: - Approval is part of the FDA's rare pediatric disease priority review voucher program, incentivizing development of treatments for rare pediatric diseases - MNEXSPIKE met the criteria for voucher redemption as outlined in the Federal Food, Drug, and Cosmetic Act - No additional products, services, or vendors are mentioned - No specific delivery or performance requirements beyond regulatory approval

Description

The Food and Drug Administration (FDA) announces the approval of MNEXSPIKE (COVID-19 Vaccine, mRNA) as a product redeeming a rare pediatric disease priority review voucher. This voucher program, authorized by the Federal Food, Drug, and Cosmetic Act, awards priority review vouchers to sponsors of approved rare pediatric disease product applications meeting specific criteria. MNEXSPIKE was approved on May 30, 2025, and meets the criteria for redeeming such a voucher. The notice serves to inform the public of this approval and voucher redemption.

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