Moderna flu shot clears FDA review, despite gaps in clinical data

FDA staff found no major deficiencies in Moderna’s experimental mRNA flu vaccine, mFlusiva (mRNA-1010).

Briefing documents released ahead of a June 18 advisory committee meeting describe the review as generally favorable.

Agency scientists identified specific evidence gaps regarding data collected from only a single flu season.

The review also noted a lack of information on vaccine performance in frail, elderly, or immunocompromised populations.

Moderna’s vaccine met all primary goals in clinical trials with a safety profile the agency deemed acceptable.

The advisory panel will vote on whether the vaccine's benefits outweigh risks for adults aged 50 and older.