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Moderna Once-Rebuffed mRNA Flu Shot to Face Scrutiny From FDA AdComm

on May 22, 2026

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The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for June 18 to review Moderna's mRNA flu shot, MFLUSIVA, which was previously rebuffed in February with a refusal-to-file letter.

Sources:

FDA Reverses Refusal-to-File on mRNA Flu Vaccine -

US FDA to hold expert committee meeting to review Moderna's flu ...

Ad Comm Meeting Planned For Hotly Debated mRNA Flu Vaccine

FDA to review Moderna's mRNA flu shot ahead of 2026-27 flu seaon

FDA refuses to review Moderna's mRNA flu vaccine - BioPharma Dive

Moderna says FDA refuses its application for new mRNA ...

FDA reverses course, refuses to review Moderna's application for ...

Moderna says FDA refused its application for new mRNA flu vaccine

FDA Reverses Course on Moderna's mRNA Flu Shot Application ...

FDA to Hold Review Meeting for Moderna's Flu Vaccine - Morningstar

Moderna says FDA will now review its new flu vaccine, reversing ...

Moderna's once-rebuffed mRNA flu shot to face scrutiny from FDA ...

Moderna's (MRNA) Flu Vaccine Set for FDA Advisory Panel Review

Moderna says the FDA will consider its new flu shot after resolving a public dispute

Advisory Committees downsides Injection of therapeutic agent June 18 2026 mRNA flu United States Food and Drug Administration

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