FDA reverses its stance on Moderna flu vaccine review

Moderna, Inc. said that U.S. regulators have agreed to review its biologics license application for an investigational seasonal influenza vaccine, potentially positioning the product for availability ahead of the 2026–2027 flu season.

The company said the U.S. Food and Drug Administration, through its Center for Biologics Evaluation and Research, accepted the amended submission for mRNA-1010 following a Type A meeting that addressed issues raised in a previous Refusal-to-File letter. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of Aug. 5, 2026.

Moderna’s revised regulatory approach seeks full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older, with a requirement to conduct an additional post-marketing study in the older population. If approved, the vaccine would be indicated for U.S. adults age 50 and older.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, the company’s chief executive officer. “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.”

The mRNA-1010 application has also been accepted for regulatory review in Europe, Canada and Australia, with additional submissions planned in 2026. The company said it expects potential initial approvals in 2026, subject to the outcome of ongoing regulatory evaluations.