FDA approves Moderna's mRNA flu vaccine for adults 50+

While multiple flu vaccine options exist, including those for individuals 65 and older, influenza remains a significant cause of death, particularly among older adults. The mRNA technology allows for faster manufacturing compared to traditional vaccines, which experts believe could be beneficial if the rapidly mutating flu virus requires sudden updates to vaccine doses.

Moderna stated that the FDA granted full approval for mFlusiva's use in individuals aged 50 to 64, based on a study of 40,000 participants that demonstrated a roughly 27% reduction in flu cases when compared to another commonly used flu vaccine. For those aged 65 and older, the FDA granted accelerated approval, contingent on a postmarketing study, based on data showing a strong immune response compared to an existing high-dose vaccine for seniors.

Moderna's data indicated no major safety concerns, though some temporary reactions such as injection site pain, fever, headache, tiredness, and aches were reported at a slightly higher rate than with current flu shots.

The FDA's decision followed an unusual public dispute earlier this year when a top FDA official initially blocked the application. The agency reversed its stance after Moderna publicly challenged the ruling, and an independent advisory panel unanimously recommended the vaccine's approval in June.