FDA advisory committee votes 9-0 for Moderna's mRNA flu vaccine in both age groups

The FDA's vaccine advisory committee voted 9-0 that the benefits of mRNA-1010 outweigh its risks for adults 50 to 64, and also voted 9-0 for adults 65 and older. The vote came ahead of the August 5 PDUFA date and is non-binding, so the FDA still decides. Panel members acknowledged evidence limitations flagged in FDA staff briefing documents but judged that they did not outweigh the case for the vaccine.

• Vote 9-0 for adults 50 to 64 and 9-0 for adults 65 and older
• PDUFA goal date remains August 5, 2026
• Advisory votes are non-binding; the FDA makes the final decision
• Reactogenicity is a trade-off, with more solicited reactions than some comparators