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The Food and Drug Administration (FDA) late Wednesday approved the nation’s first mRNA flu vaccine, manufactured by drugmaker Moderna.
The agency approved the shot for two separate age groups; people age 50 to 64, and for 65 years and older. Moderna said it will conduct a postmarket clinical trial to confirm the effectiveness in the older group.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
According to the company, late-stage trials found the vaccine to be about 27 percent more effective than a standard-dose flu shot for people 50 and older.
In a smaller study of people ages 65 and older, the mRNA shot generated a strong protective immune response compared with an existing high-dose flu vaccine already recommended for that age group.
Moderna said it expects to have the vaccine available for eligible populations in the U.S. for the 2026-2027 respiratory virus season.
The flu kills tens of thousands of people a year, and older populations are the most vulnerable. While there are currently vaccines on the market specifically meant for older populations, they take longer to manufacture and are not as flexible as the mRNA platform in targeting a specific strain of virus.
It takes two to three months from when the seasonal strain is picked to when the mRNA shots start rolling out, according to Moderna, about half the time of a traditional vaccine.
That extended delay gives the virus time to evolve, potentially making the vaccine less effective.
If needed, vaccines using mRNA can also be updated later in the year to better match the prevalent strain.
The approval of Moderna’s vaccine was not guaranteed.
Health and Human Services Secretary Robert F. Kennedy Jr. has repeatedly criticized mRNA technology, calling the COVID vaccines “the deadliest vaccine ever made.” Last year, his department canceled nearly $500 million in funding for mRNA vaccine research.
A top FDA official earlier this year initially refused to review the vaccine before the agency reversed course a week later under pressure.
Former agency vaccine chief Vinay Prasad said the application was rejected because of Moderna’s decision to compare its vaccine to a standard flu shot in adults 65 and up, rather than the high-dose shot. Moderna said FDA had initially signed off on the trial design.
Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Kennedy.
The next steps for the new vaccine aren’t clear.
The vaccine needs to be formally recommended by the Centers for Disease Control and Prevention’s (CDC) vaccine panel — the Advisory Committee on Immunization Practices — but a federal judge has blocked it from meeting under its current membership.
The vaccine could still be prescribed without the panel meeting, but insurers may not cover it.
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