New kind of flu shot is on the way as the FDA approves Moderna's
mRNA-based vaccine
[August 07, 2026]
By LAURAN NEERGAARD
WASHINGTON (AP) — The Food and Drug Administration has approved a new
kind of flu vaccine for older people, the first made with the same mRNA
technology that was key to ending the COVID-19 pandemic, manufacturer
Moderna said.
The shot, named mFlusiva, is intended for adults age 50 or older. Other
brands of flu shots already have begun arriving in pharmacies ahead of
fall vaccination season, and Moderna said late Wednesday that it expects
some of its new version to be available soon at select retailers.
While there already are multiple flu vaccine options in the U.S.,
including three specifically recommended for people age 65 or older,
tens of thousands of Americans die from influenza every year and older
adults are among the most vulnerable.
Flu vaccines must be updated annually to best match circulating strains
of the virus. Vaccines made with the Nobel Prize-winning mRNA technology
are faster to manufacturer than other types, and experts say this
additional option might help if the shape-shifting flu virus mutates in
a way that requires suddenly brewing new doses.

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 Moderna said the FDA granted full
approval for mFlusiva’s use in people ages 50 to 64, based on a
study of 40,000 people that found 27% fewer flu cases among people
who got the new shot compared with those who got a different common
flu vaccine brand. For people 65 or older, the Cambridge,
Massachusetts-based manufacturer said the FDA granted what’s called
accelerated approval for the shot -- based on a smaller study
showing it generated a strong immune response compared with an
existing high-dose vaccine for seniors – while it conducts an
additional study.
Moderna’s data showed no major safety issues
although the shot did cause some temporary reactions including
injection site pain, fever, headache, tiredness and aches that
occurred somewhat more than with today’s flu shots.
The FDA action comes after a highly unusual public dispute over
mFlusiva earlier this year. A then-top FDA official blocked the
company’s application, a sign of the agency’s heightened vaccine
scrutiny under Health Secretary Robert F. Kennedy Jr. Days later,
the agency changed course after Moderna publicly challenged the
ruling — and in June a panel of independent advisers to the FDA
unanimously recommended the vaccine's approval.
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