FDA Advisory Panel Votes 9–0 to Back Moderna's mRNA Flu Vaccine

FDA Advisory Panel Votes 9–0 to Back Moderna's mRNA Flu Vaccine — PDUFA August 5

VRBPAC unanimously recommended MFLUSIVA (mRNA-1010) for adults 50 and older via two pathways — traditional approval for ages 50–64, accelerated approval for 65+ — in the first advisory review of an mRNA influenza vaccine.

FDA & Regulatory Desk Saturday, 20 June 2026 · 2 min read

An FDA advisory committee voted nine to zero on June 18, 2026, to recommend licensure of mRNA-1010 — Moderna’s investigational quadrivalent mRNA influenza vaccine, proposed brand name MFLUSIVA — for adults aged 50 years and older, with two distinct regulatory pathways applied to different age strata.

What the Data Showed

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed pivotal efficacy and safety data from the Phase 3 P304 trial (NCT06602024), which enrolled adults across two influenza seasons. The trial assessed protection against laboratory-confirmed influenza caused by A(H1N1)pdm09, A(H3N2), B/Victoria, and B/Yamagata lineages.

The committee voted on two separate questions, addressing each pathway individually. In both cases, the vote was nine in favor and zero against, with no abstentions.

Different Pathways for Different Age Groups

For adults aged 50 to 64, the committee considered traditional approval, supported by vaccine efficacy data meeting pre-specified primary endpoints. For adults 65 and older, the committee considered accelerated approval, supported by immunogenicity bridging data using hemagglutination inhibition (HAI) titers as a surrogate endpoint. Under accelerated approval, Moderna would be required to conduct a confirmatory trial demonstrating clinical benefit in the ≥65 cohort.

The dual-pathway structure reflects the challenges of running classical efficacy trials in older adults, where immunosenescence limits both absolute efficacy and trial feasibility. Accelerated approval provides a regulatory mechanism to expand access while confirmatory evidence matures.

MFLUSIVA uses the same lipid nanoparticle mRNA delivery platform as Moderna’s COVID-19 vaccine. Safety data across two pivotal seasons showed reactogenicity consistent with the known profile of mRNA vaccines.

Regulatory Context

FDA is not bound by advisory committee recommendations but follows them in the large majority of cases. The PDUFA target action date for MFLUSIVA is August 5, 2026. If licensed, MFLUSIVA would be the first mRNA-based influenza vaccine approved in the United States, extending the platform beyond COVID-19 into a disease that causes an estimated 12,000 to 52,000 deaths annually in the U.S.

VRBPAC meeting, June 18, 2026. P304 trial: ClinicalTrials.gov NCT06602024. PDUFA: August 5, 2026.

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VRBPAC voted 9 to 0 on June 18, 2026, to recommend licensure of mRNA-1010 (MFLUSIVA) for adults 50+, with traditional approval for 50–64 and accelerated approval for 65+.

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The P304 pivotal trial (NCT06602024) enrolled adults across two influenza seasons and assessed efficacy against influenza A(H1N1), A(H3N2), B/Victoria, and B/Yamagata.

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The PDUFA target action date for MFLUSIVA is August 5, 2026.

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After publication, a separate AI panel re-verifies every edition against these same sources. The running claim-confirmation rate and every correction are public on the accuracy ledger.