Key facts
- An FDA advisory panel is reviewing Moderna's mRNA flu vaccine, mFlusiva.
- The vaccine is seeking approval for adults aged 50 and older.
- Moderna's vaccine uses mRNA technology, which allows for faster manufacturing.
- A previous dispute involved an FDA official questioning the comparative study design.
- FDA staff reviewers noted a lack of data on very frail and immunocompromised individuals.
U.S. health advisers are debating Moderna's mFlusiva, a novel flu vaccine utilizing mRNA technology, similar to that used for COVID-19 vaccines. The Food and Drug Administration advisory committee is reviewing the vaccine for potential approval for adults aged 50 and older, ahead of the winter flu season. Moderna seeks traditional approval for individuals aged 50 to 64 and accelerated approval for those 65 and older, pending further testing. The mRNA technology allows for faster manufacturing compared to traditional vaccines, potentially aiding in rapid adaptation to new flu strains. A prior dispute arose when a top FDA official questioned Moderna's comparative study design, suggesting a comparison with high-dose vaccines for seniors. Moderna challenged this, citing prior FDA approval of the study design and a separate study showing similar antibody responses to high-dose vaccines. FDA staff reviewers noted the vaccine's effectiveness in older adults but raised concerns about data for very frail individuals and those with compromised immune systems.