FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel

FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency.

The Food and Drug Administration will convene an advisory committee on Thursday to discuss whether the vaccine's benefits outweigh its risks for adults aged 50 to 64 and those 65 and older.

While reviewers did not find any major deficiencies, they identified gaps that leave the vaccine's efficacy-particularly in older adults-unclear, casting doubt on its path to approval.