FDA Advisory Committee Recommends Approval of Moderna's mRNA Flu Vaccine

An FDA vaccine advisory committee voted unanimously Thursday to recommend approval of Moderna's mRNA flu vaccine for adults aged 50 and older. The vaccine, called mFlusiva, is intended for two groups: people 50 to 64 and those 65 and older. In a late-stage trial, it prevented influenza about 27 percent more effectively than standard flu shots.

The committee reviewed safety and efficacy data before making its recommendation. For adults 65 and older, the panel requested an additional post-market study due to higher flu complication risks in that group. Side effects reported in the trial were similar to those of existing vaccines, including injection-site pain, fatigue, muscle aches, and fever.

No unusual safety issues were identified that altered the benefit-risk assessment.

Moderna told the committee it can move from strain selection to vaccine distribution in two to three months, compared with about six months for some traditional methods. The mRNA approach uses genetic instructions to prompt cells to produce a viral protein, allowing faster updates if circulating strains change.

If granted final approval, the vaccine would become the first mRNA-based flu shot available worldwide. The committee noted that faster production timelines could improve strain matching in seasons when the virus shifts rapidly.