Card stack
New kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine
Compiled Aug 7
What happened
The FDA approved a new mRNA-based flu vaccine called mFlusiva, made by Moderna, for adults age 50 and older
The detail
mFlusiva is the first flu vaccine made with mRNA technology, the same platform used in COVID-19 vaccines
The detail
The FDA granted full approval for use in people ages 50-64 based on a study showing 27% fewer flu cases compared with a different common flu vaccine
The detail
For people 65 and older, the FDA granted accelerated approval based on a smaller study showing a strong immune response compared with an existing high-dose vaccine for seniors
How it unfolded
Earlier this year: A then-top FDA official blocked Moderna's application for mFlusiva · Days later: The FDA changed course after Moderna publicly challenged the ruling · In June: A panel of independent advisers to the FDA unanimously recommended the vaccine's approval · Late Wednesday: Moderna said it expects some of the new vaccine to be available soon at select retailers
By the numbers
50 age threshold · 65 age threshold for accelerated approval · 40,000 study participants · 27% reduction in flu cases
Still unresolved
Moderna is conducting an additional study for the 65-and-older accelerated approval, the outcome of which is not yet known

