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New kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine

Compiled Aug 7

1

What happened

The FDA approved a new mRNA-based flu vaccine called mFlusiva, made by Moderna, for adults age 50 and older

2

The detail

mFlusiva is the first flu vaccine made with mRNA technology, the same platform used in COVID-19 vaccines

3

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

4

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

5

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

6

By the numbers

50 age threshold · 65 age threshold for accelerated approval · 40,000 study participants · 27% reduction in flu cases

7

Still unresolved

Moderna is conducting an additional study for the 65-and-older accelerated approval, the outcome of which is not yet known

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