Flu Season, FDA accepts Moderna flu vaccine

Moderna Inc. (MRNA) announced that the U.S. Food and Drug Administration has accepted its biologics license application for mRNA-1010, an investigational seasonal influenza vaccine, for review.

The FDA assigned a Prescription Drug User Fee Act goal date of August 5, 2026, for the review process. The acceptance follows a Type A meeting between Moderna and the FDA’s Center for Biologics Evaluation and Research after the agency initially issued a Refusal-to-File letter.

Moderna proposed a regulatory pathway based on age groups, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older. The accelerated approval would include a post-marketing requirement to conduct an additional study in older adults.

If approved, mRNA-1010 would be available for U.S. adults 50 years of age and older for the 2026/2027 flu season. The vaccine has been accepted for review in the United States, Europe, Canada and Australia, with additional submissions planned for 2026.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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.”