FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine Application
The FDA has reversed its earlier decision and will now review Moderna's application for an mRNA-based flu vaccine, potentially allowing its availability for the upcoming flu season.
The U.S. Food and Drug Administration (FDA) has reversed its previous decision and agreed to review Moderna's application for an mRNA-based influenza vaccine. This change follows a meeting between the FDA and Moderna, during which the company proposed a revised regulatory approach. Moderna is now seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, with a commitment to conduct additional studies in the older age group.
Moderna's CEO, Stéphane Bancel, expressed appreciation for the FDA's engagement and stated that, pending approval, the company looks forward to making the flu vaccine available later this year to provide seniors with a new option for flu protection.
The FDA has set a target date of August 5, 2026, to complete its review. If approved, the vaccine could be available for the 2026-2027 flu season.
This decision comes after the FDA's initial refusal to review the application, citing concerns that Moderna's clinical trial did not compare the vaccine against the highest-dose flu vaccines recommended for older adults. The agency's reversal follows further discussions and a revised application from Moderna.
Following the announcement, Moderna's stock experienced a significant increase, reflecting investor optimism about the vaccine's potential approval and market availability.