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Moderna Flu Shot Gets FDA Green Light
6 Aug
Summary
- Moderna's mRNA flu vaccine approved for seniors aged 50+.
- The shot showed 26.6% more effectiveness than standard vaccines.
- New vaccine uses mRNA technology for faster strain updates.
The U.S. Food and Drug Administration has approved Moderna's mFlusiva, a messenger RNA-based vaccine for seasonal flu, specifically targeting individuals aged 50 and older. This landmark approval offers a new tool in public health's fight against influenza.
The vaccine received traditional approval for adults aged 50 to 64 and accelerated approval for those 65 and older. Moderna committed to further studies to confirm the vaccine's benefit in the older demographic.
Late-stage trials involving over 40,000 participants indicated that mFlusiva was 26.6% more effective than a licensed standard-dose flu vaccine. It also demonstrated stronger antibody responses compared to Sanofi's high-dose vaccine in adults aged 65 and above.
Moderna's vaccine employs mRNA technology, which prompts the body to produce influenza antigens. This approach could enable faster vaccine updates to counter evolving strains, distinguishing it from conventional egg-based flu shots.
Analysts anticipate that mFlusiva will not generate substantial revenue until the latter half of 2027, as Moderna missed the contracting cycle for the upcoming U.S. flu season. The company aims for this vaccine, along with a future COVID-flu combination shot, to offset declining COVID vaccine revenues.
This approval comes after previous scrutiny of vaccine applications by the FDA, including Moderna's earlier withdrawal of a combo shot application. The agency is working to rebuild industry confidence following past controversies.
