FDA set to initiate the review of Moderna’s seasonal influenza vaccine submission

Moderna has recently announced that in response to a prior Refusal-to-File letter, they have engaged with the U.S. FDA in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, 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, along with a post-marketing requirement to conduct an additional study in older adults.

In addition, following this submission of the amended application, the FDA has accepted the biologics license application for review and assigned a Prescription Drug User Fee Act goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for 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,” 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.”

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Related Topics and Keywords

influenza, Moderna, seasonal influenza