Federal Register #FDA-2026-N-4162

FDA Advisory Committee Meeting on Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) by Moderna TX Inc.

This opportunity is a public advisory committee meeting hosted by the Food and Drug Administration (FDA) to review the safety and effectiveness of MFLUSIVA, an mRNA influenza vaccine manufactured by Moderna TX Inc. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Center for Biologics Evaluation and Research - OEM Mentioned: - Moderna TX Inc. (manufacturer of MFLUSIVA) - Products/Services Requested: - No products or services are being requested for purchase - The meeting is focused on regulatory review and advice regarding MFLUSIVA for individuals aged 50 and older - Unique/Notable Requirements: - Public advisory committee meeting held virtually - Public docket established for comments - Discussion centers on regulatory issues for the vaccine's use in older adults - Place of Performance/Delivery: - Virtual meeting - FDA offices in Rockville, MD and Silver Spring, MD listed as contracting offices

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the safety and effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) manufactured by Moderna TX Inc. The meeting will be held virtually on June 18, 2026, from 8:30 a.m. to 4:00 p.m. Eastern Time. The FDA has established a public docket for comments, which will be accepted until June 17, 2026. The meeting aims to provide advice and recommendations to the FDA on regulatory issues related to this vaccine.

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