FDA Will Review Moderna’s mRNA Flu Shot Application, Reversing Its Previous Decision

The Food and Drug Administration will review pharmaceutical company Moderna’s application for a flu vaccine made with mRNA technology after all.

The Trump administration previously refused to review the company’s application for a new flu vaccine, claiming last week that Moderna had failed to present an “adequate and well-controlled” study.

But the agency has reversed course, Moderna announced Wednesday.

“We look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu,” Stéphane Bancel, chief executive officer of Moderna, said in a press release.

If approved, the vaccine could reach the public by August and would be available for adults ages 50 and older for the coming flu season.

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To advance its application, Moderna said it met with the FDA and agreed to conduct further studies for adults 65 and older — an area the FDA had raised concerns about last week.

“Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older,” Moderna said in the release, adding that additional studies will be conducted after the first shot is administered to people.

The Department of Health and Human Services, under Robert F. Kennedy Jr., has moved to limit mRNA technology, which was used to develop COVID-19 vaccinations. In August of last year, HHS announced the end of federal funding for mRNA vaccine research. Medical and public health professionals have repeatedly raised concerns about Kennedy spreading misinformation about mRNA technology and vaccines generally.

HHS confirmed Moderna’s announcement to NOTUS but did not comment on Kennedy’s past positions.

“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” said Andrew Nixon, a spokesperson for HHS. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”