FDA approves Moderna's mRNA flu vaccine for adults 50-64, accelerates senior approval
The U. S. Food and Drug Administration in Washington approved Moderna's mFLUSIVA for adults 50-64 and granted accelerated approval for those 65 and older, citing trial results that showed a modest efficacy increase over standard flu shots.
Earlier, the FDA had approved the same vaccine for all adults over 50, noting that late-stage trial data indicated about a 27% higher efficacy compared with conventional vaccines and required further studies in the oldest age group. The agency’s earlier approval highlighted the vaccine’s higher efficacy in a late-stage trial and imposed a requirement for additional research among seniors.