FDA panel votes 9–0 for Moderna's mRNA flu shot despite earlier block attempt

An independent FDA advisory committee (VRBPAC) voted unanimously to recommend approval of Moderna’s seasonal mRNA flu vaccine, mRNA-1010, marketed as mFlusiva. The endorsement came after a Trump appointee at the agency had initially tried to keep the vaccine from being reviewed at all, making the unanimous outcome notable against the backdrop of internal agency conflict. FDA’s own scientists also issued a supportive review ahead of the vote.

The clinical case was strong. A Phase 3 trial of more than 40,000 adults aged 50 and up showed the mRNA shot was roughly 27 percent more effective against seasonal flu than a standard vaccine, while a smaller trial of nearly 3,000 people aged 65 and older found it produced stronger immune responses than the high-dose shot currently recommended for that group. Safety data were generally favorable.

Beyond efficacy, committee members highlighted the strategic value of the mRNA platform—the same technology behind Moderna’s COVID-19 vaccines. Its speed allows vaccines to be reformulated quickly to match circulating strains each season and positions manufacturers to respond faster to emerging or pandemic flu strains in the future.