The Food and Drug Administration has reversed its position and will now review Moderna’s mRNA-based influenza vaccine application after initially declining to act on the company’s submission.

Previously, the vaccine manufacturer stated that the agency had refused to review its investigational flu vaccine application. To advance the process, Moderna proposed a regulatory pathway based on age, seeking full approval for adults aged 50 to 64 years and accelerated approval for those 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. If approved, mRNA-1010 would be available for U.S. adults aged 50 years and older—including those 65 and older—for the 2026/2027 flu season.

Moderna CEO Stéphane Bancel expressed appreciation for the FDA’s engagement in a “constructive Type A meeting” that led to advancing the application, stating: “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 reversal follows the FDA’s initial rejection of Moderna’s application because the company had not adhered to clear guidance from 2024 requiring clinical trials comparing its product with CDC-recommended flu vaccines. Health and Human Services Department spokesman Andrew Nixon confirmed that the agency held meetings with Moderna, which resulted in the amended application being accepted. Nixon added: “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”

Moderna has agreed to add a confirmatory study for older adults using a high-dose flu shot after the mRNA vaccine is approved. The company also reported that mRNA-1010 has been accepted for review in the United States, Europe, Canada, and Australia, with potential approvals expected by 2026 pending ongoing regulatory processes.

Financial analysts noted the development comes after uncertainty regarding Moderna’s path to breakeven by 2028. William Blair indicated in a February 11 note that the company had previously reworked earnings models following the FDA’s initial rejection. Jefferies recently stated that by 2027-2028, Moderna could launch seven or more products across respiratory, oncology, and rare disease areas, with continued cost reductions potentially enabling cash breakeven by 2028.