Moderna's mRNA Flu Vaccine Backed by FDA Advisers

FDA advisers have unanimously backed Moderna’s mRNA seasonal influenza vaccine, mFluSiva, for adults 50 and older, concluding its benefits outweigh risks and setting up a possible approval decision by August 5.

If approved, it would become the first U.S. seasonal flu vaccine using mRNA technology. Reviewers cited trial data showing stronger protection than standard-dose flu shots in adults 50–64 and robust immune responses in adults 65+.

The committee also noted mRNA platforms could improve readiness for emerging strains due to faster update timelines. Moderna is seeking traditional approval for younger older adults and accelerated approval for seniors pending further studies. Read more from Reuters here.