Moderna says FDA will now review its new flu vaccine, reversing earlier decision

The U.S. Food and Drug Administration has reversed an earlier decision and said it will review drugmaker Moderna’s application for approval of a seasonal flu vaccine, the company said in a statement Wednesday. 

The FDA’s Center for Biologics Evaluation and Research notified Moderna that the agency will allow the application for the vaccine candidate, mRNA-100, to proceed to review, the drugmaker said. 

This marks a reversal for the FDA, which last week sent Moderna a so-called “refusal to file” letter rejecting the application. The dispute centered on a 40,000-person clinical trial that found Moderna’s new vaccine was more effective in adults aged 50 and older than one of the standard flu shots used today.

The FDA, part of the U.S. Department of Health and Human Services (HHS), on Wednesday told CBS News that subsequent discussions with Moderna “led to a revised regulatory approach and an amended application, which FDA accepted.” 

“FDA will maintain its high standards during review and potential licensure stages as it does with all products,” HHS spokesperson Andrew Nixon told CBS News. 

In the FDA’s initial, rare, “refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older.

In a high-priority, or “Type A,” meeting with the FDA, Moderna revised its application to seek full vaccine approval for adults aged 50 to 64 and accelerated approval for adults aged 65 and older. The drugmaker also agreed to conduct an additional study of the drug’s use by older adults.

The FDA is expected to make a decision by August, and Moderna said it aims to make the approved vaccine available to adults 50 and up for the 2026-27 flu season.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna chief executive Stéphane Bancel said in a statement Wednesday. “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 vaccine candidate is also under review in Europe, Canada and Australia.  

Shares of Moderna rose $2.57, or 5.9%, to $46.50 in late morning trading.