Moderna’s mRNA flu vaccine gets FDA approval: Here's what's different

By
FOX Local
Published August 6, 2026 10:00 AM CDT

FILE: Patient gets flu shot in Old Lyme, Connecticut.  (Photo by Steven E. Frischling/Bloomberg via Getty Images)

The Brief

    • The FDA approved Moderna’s mRNA flu vaccine, which uses the same technology that produced COVID-19 vaccines.
    • The FDA granted full approval for mFlusiva’s use in people ages 50 to 64, and also granted accelerated approval for the shot for people 65 or older while the company does more studies. 
    • mFlusiva’s approval comes months after a top FDA official blocked the company’s application amid heightened scrutiny under Health Secretary Robert F. Kennedy Jr., a vaccine skeptic.

The Food and Drug Administration has approved a new flu vaccine made with the same mRNA technology that was used for the COVID-19 shots. 

The approval came Wednesday after the FDA had initially declined to even review Moderna’s application, according to The New York Times. 

What is mFlusiva? 

Big picture view:

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. 

According to Moderna, the FDA granted what’s called accelerated approval for the shot for people 65 or older while the company does more studies. 

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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.

Timeline:

Moderna said it expects some doses of its new version to be available soon at select retailers.

How is mFlusiva different? 

Why you should care:

There are already multiple flu shot options in the U.S., including three for people 65 or older. Still, thousands of Americans die from the flu every year and older adults are among the most vulnerable.

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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 manufacture 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.

FDA changes course on mFlusiva

Dig deeper:

The FDA’s approval comes months after a top agency official blocked the company’s application amid heightened scrutiny under Health Secretary Robert F. Kennedy Jr., a vaccine skeptic. The FDA changed course days later after Moderna publicly challenged the ruling — and in June a panel of independent advisers to the FDA unanimously recommended the vaccine's approval.

The Source: This report includes information from The Associated Press.

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