Key facts
- The FDA will review Moderna's mRNA flu vaccine application for individuals aged 50 and older.
- The agency had previously refused to review the application, citing concerns about the Phase 3 study's control arm.
- Moderna proposed a revised regulatory approach, seeking full approval for ages 50-64 and accelerated approval for ages 65+.
- The FDA's review deadline is set for August 5, 2026.
- Moderna CEO Stephane Bancel stated the company looks forward to making the vaccine available later this year.
The U.S. Food and Drug Administration (FDA) has reversed its earlier decision and will now review Moderna's application for an mRNA flu vaccine. The agency had initially refused to review the application, citing concerns that Moderna's Phase 3 study was not "adequate and well-controlled," particularly regarding the comparator arm for older adults. This reversal followed a public outcry and constructive engagement between Moderna and the FDA's Center for Biologics Evaluation and Research (CBER).
Moderna is seeking full FDA approval for its mRNA-1010 vaccine for adults aged 50 to 64 and accelerated approval for those 65 and older, with a post-marketing study requirement. The FDA has set a review deadline of August 5, 2026. Moderna CEO Stephane Bancel expressed gratitude for the FDA's willingness to advance the application, stating the company anticipates making the vaccine available later this year to offer seniors a new protection option against influenza.
The FDA's initial refusal had caused confusion among Moderna executives and shaken confidence in the vaccine market, with reports suggesting vaccine manufacturers were cutting jobs and research in the U.S. amid perceived anti-vaccine sentiment under the current administration. Experts like Michael Osterholm expressed uncertainty about the reasons for the FDA's policy shift, emphasizing the need for consistent regulatory processes for vaccine developers.