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

The U.S. Food and Drug Administration has made a significant decision to review drugmaker Moderna’s application for approval of a seasonal flu vaccine, marking a reversal from their earlier stance. Moderna announced in a statement on Wednesday that the FDA’s Center for Biologics Evaluation and Research will allow the application for the vaccine candidate, mRNA-100, to proceed to review.

This change comes after the FDA initially sent Moderna a “refusal to file” letter last week, rejecting the application due to concerns about a 40,000-person clinical trial. The trial had found Moderna’s new vaccine to be more effective in adults aged 50 and older than one of the standard flu shots currently in use. However, the FDA raised issues regarding the trial’s exclusion of another brand recommended specifically for people 65 and older.

Following discussions with Moderna, the FDA accepted a revised regulatory approach and an amended application, leading to the decision to review the vaccine candidate. In a high-priority meeting, Moderna revised its application to seek full vaccine approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older. The company also committed to conducting an additional study on the drug’s use in older adults.

The FDA is expected to reach a decision by August, with Moderna aiming to make the approved vaccine available for adults aged 50 and above for the 2026-27 flu season. Moderna’s chief executive, Stéphane Bancel, expressed appreciation for the FDA’s engagement and stated their commitment to providing a new option for flu protection to America’s seniors pending FDA approval.

In addition to the FDA review, the vaccine candidate is also being evaluated in Europe, Canada, and Australia. Following the announcement of the FDA’s decision to review the application, shares of Moderna rose by 5.9% in late morning trading.

As this development unfolds, it is clear that Moderna’s efforts to bring a new flu vaccine to market are progressing, with potential implications for flu prevention in the upcoming seasons. The collaboration between the FDA and Moderna highlights the importance of rigorous regulatory processes in ensuring the safety and efficacy of new medical treatments.

This article was edited by Aimee Picchi and contributed to by The Associated Press. For more updates and news, stay tuned to CBS News.