Moderna says FDA reversing course, will review mRNA flu shot

Moderna said Wednesday that the Food and Drug Administration is reversing course, and will now review the company's mRNA flu shot.

The reversal comes after Moderna said last week that the FDA’s Center for Biologics Evaluation and Research told the company that it would not initiate a review of the investigational mRNA vaccine. Moderna then requested a Type A meeting with the FDA, which is a high-priority discussion, to “understand” a path forward.

CBER Director Vinayak Prasad said in a letter that the refusal was because Moderna chose a standard-dose seasonal flu vaccine that has already been licensed as a comparison, according to the company. He cited the lack of an "adequate and well-controlled" study with a comparison that "does not reflect the best-available standard of care."

Moderna said Wednesday that it has since met with the FDA and “proposed a revised regulatory approach” with different pathways by age, CNN reported.

The company is now “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” according to Moderna.

If the vaccine receives FDA approval, then it could be available for people ages 50 and older for the upcoming 2026-2027 flu season.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement. “Pending FDA approval, 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.”