
FDA panel backs first-of-its-kind flu vaccine using mRNA technology
On Jun. 18, 2026, a new kind of flu vaccine moved a step closer to the U.S. market as federal health advisers recommended approval of the first made with the same mRNA technology that was key to ending the COVID-19 pandemic.
The Food and Drug Administration (FDA) is evaluating Moderna’s new shot, dubbed mFlusiva, for older Americans ahead of the winter flu season. Moderna is seeking full approval for the vaccine’s use in people ages 50 to 64 — along with authorization for use in those 65 and older while it conducts additional testing.
The FDA’s independent advisory committee evaluated Moderna’s studies of the vaccine and voted unanimously that its benefits appear to outweigh any risks for both age groups. The FDA will consider that recommendation in making a final decision by early August.
Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.
In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared with those given another routinely used vaccine brand. In a smaller study of people 65 and older, Moderna’s shot also generated a strong protective immune response compared with a high-dose flu vaccine already recommended for that age group.
Severe flu cases in the U.S. generally rise in years when the flu shot doesn’t closely match the circulating virus. Moderna officials noted that flu strains for each fall’s vaccines now are chosen several months earlier than the yearly recipe update for COVID-19 shots that mostly are mRNA-based — and there can be a mismatch if the flu virus mutates after the recipe is made.
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. The latter reactions are common in a variety of vaccines, but occurred somewhat more often than with Moderna’s flu shots. The FDA said that’s typical of mRNA vaccines.
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Source: Associated Press
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