An FDA advisory panel has recommended approval of Moderna’s mRNA-based flu vaccine, mFlusiva, for adults ages 50-64, and adults 65 and older if a specific condition is met.
The vaccine was about 27% more effective than a standard flu shot in a late-stage trial, an FDA official said at a June 18 panel meeting. If approved by the FDA, it would be the first messenger RNA flu vaccine available.
The panel recommended approval for adults 65 and older on the condition that Moderna conduct an additional clinical trial after the vaccine reaches the market. The vaccine also must receive FDA approval and a recommendation from the CDC before becoming available.
The recommendation comes as federal health officials continue to scrutinize mRNA technology. In 2025, HHS canceled nearly $500 million in federal contracts for mRNA vaccine development, citing data that mRNA vaccines had not shown strong protection against upper respiratory infections including flu. The decision terminated 22 projects and closed the door on new mRNA vaccine approvals through HHS’ Biomedical Advanced Research and Development Authority.
Moderna said its vaccine can move from strain selection to rollout in two to three months, compared with about six months for traditional flu vaccines. That faster timeline could be especially relevant given the World Health Organization’s recommendation earlier this year to update all three viral strains in 2026 flu vaccines, driven by a new A(H3N2) variant against which current vaccines offered only partial protection. Supporters of the mRNA technology say the shorter production window could allow manufacturers to update vaccines later in the season to better match circulating influenza strains.
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