The U.S. Food and Drug Administration has approved mFlusiva, an mRNA-based influenza vaccine developed by Moderna, marking the first such vaccine authorized for seasonal flu.
The approval covers two age groups with different regulatory pathways: traditional approval for adults aged 50 to 64, and accelerated approval for adults 65 years and older.
Accelerated approval allows earlier access based on surrogate endpoints, such as immune response data, while requiring the company to conduct further studies to confirm clinical benefit.
Traditional approval for the younger group indicates the FDA found substantial evidence of effectiveness and safety from adequate and well-controlled trials.
The vaccine uses messenger RNA technology to instruct cells to produce hemagglutinin proteins from targeted influenza strains, differing from traditional egg-based or cell-based manufacturing methods.
Regulatory documents indicate the decision was based on immunogenicity data comparing mFlusiva to licensed comparator vaccines.
Post-marketing studies will continue to evaluate real-world effectiveness and safety, particularly in the older adult population covered by accelerated approval.
The authorization expands the range of vaccine platforms available for seasonal influenza prevention in the United States.
U.S. FDA approves first mRNA flu shot from Moderna
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