The U.S. Food and Drug Administration has reversed its prior position and accepted Moderna’s biologics license application for its mRNA-based influenza vaccine, initiating a formal review process.
Previously, the agency had declined to review Moderna’s application for an “investigational influenza vaccine.” Following submission of an amended application, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending approval, mRNA-1010 would be available for U.S. adults aged 50 and older—including those 65 and above—for the 2026/2027 flu season under a proposed regulatory pathway that includes full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, alongside a post-marketing requirement for an additional study in older adults.
Moderna CEO Stéphane Bancel stated the company “appreciates the FDA’s engagement in a constructive Type A meeting” and expressed confidence that the vaccine would be available later this year to provide seniors with a new option against influenza.
The agency had previously rejected Moderna’s initial application because the company refused to follow clear 2024 guidance requiring testing its product against a CDC-recommended flu vaccine to compare safety and efficacy. Health and Human Services Department spokesman Andrew Nixon confirmed that after a meeting with Moderna, the company amended its submission, which the FDA has now accepted for review.
Moderna confirmed it will conduct a confirmatory study in older adults using a high-dose flu shot following the mRNA vaccine’s market availability. The company expects potential approvals for mRNA-1010 in 2026 across the United States, Europe, Canada and Australia, with further submissions planned for 2026.
