US FDA approves first mRNA flu shot from Moderna
The US FDA has granted approval for Moderna's mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older. This marks the first time an mRNA vaccine has been approved for seasonal influenza, though analysts do not expect significant revenue until 2027.
Why it matters
This approval validates the potential of mRNA technology beyond Covid-19 and introduces a new competitor into the seasonal flu vaccine market.
Moderna has agreed to run an additional study and submit more data in adults 65 and older to confirm the vaccine’s benefit in that age group.
Listen WASHINGTON - The US Food and Drug Administration has approved Moderna’s flu vaccine for people aged 50 and older, the company said on Aug 5, marking the first approval of a messenger RNA-based vaccine for seasonal flu.
The shot, mFlusiva, was given a traditional approval for adults aged 50 to 64, and an accelerated approval for those 65 years and older.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Moderna said in a statement.
The approval was based on data from a late-stage trial involving more than 40,000 adults aged 50 and older, which showed the shot was 26.6 per cent more effective than a licensed standard-dose flu vaccine.
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