Company says regulators agreed to review revised application following high-priority meeting.
By yourNEWS Media Newsroom
Moderna announced Wednesday that the Food and Drug Administration will move forward with reviewing its investigational mRNA flu vaccine after initially declining to do so.
The development follows a disclosure last week in which Moderna said the FDA’s Center for Biologics Evaluation and Research (CBER) had informed the company it would not initiate a review of the application, according to a company statement. Moderna subsequently requested a Type A meeting with the agency, a designation reserved for high-priority regulatory discussions, to clarify a path forward.
In a letter cited by the company, CBER Director Vinayak Prasad said the earlier refusal was tied to Moderna’s decision to use a standard-dose seasonal flu vaccine—already licensed—as the comparator in its study. He referenced the absence of an “adequate and well-controlled” trial using a comparison that “does not reflect the best-available standard of care.”
Following discussions with regulators, Moderna said it proposed a revised regulatory strategy that would involve different approval pathways by age group. According to CNN, the company is now seeking full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older. The accelerated pathway would include a post-marketing requirement for an additional study focused on older adults.
Moderna said that if the vaccine is approved, it could become available for individuals 50 and older during the 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.”
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