The FDA has approved Moderna's mFlusiva, the first mRNA-based flu vaccine, for adults age 50 and older. This new vaccine uses the same technology that helped end the COVID-19 pandemic and showed 27% fewer flu cases in clinical trials compared to traditional flu shots.
- The FDA approved mFlusiva, the first mRNA flu vaccine made with technology similar to COVID-19 vaccines
- Clinical trial of 40,000 people showed 27% fewer flu cases among those who received mFlusiva compared to traditional flu vaccines
- The vaccine is approved for adults ages 50 and older, with full approval for ages 50-64 and accelerated approval for ages 65+
- mRNA vaccines can be manufactured faster than traditional vaccines, allowing quicker response if the flu virus mutates
- Common side effects include temporary injection site pain, fever, headache, and fatigue, occurring slightly more frequently than traditional flu shots
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.
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.
