FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine
The FDA has agreed to review Moderna's mRNA-based flu vaccine after initially declining the application, potentially allowing the vaccine to be available before the next flu season.
The U.S. Food and Drug Administration (FDA) has reversed its earlier decision and will now review Moderna's application for its mRNA-based flu vaccine. This change comes after the agency initially declined to consider the application, citing concerns over the study's design.
Moderna is seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The FDA has set August 5 as the target date for completing its review, which could allow the vaccine to be available before the next flu season.
Moderna's CEO, Stéphane Bancel, expressed appreciation for the FDA's engagement, stating,
"We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review."
The FDA's initial refusal had intensified concerns about potential shifts in U.S. vaccine policy under the current administration. Health Secretary Robert F. Kennedy Jr., a known critic of mRNA technology, recently oversaw the cancellation of a $500 million federal contract intended to support the development of mRNA vaccines targeting bird flu and other high-risk strains.
The FDA had previously rejected Moderna's application, stating that the company should have administered a higher-strength vaccine to older participants in the control group of its clinical trial. FDA Commissioner Dr. Marty Makary noted that the initial rejection was due to Moderna not following the agency's earlier guidance, a contention that Moderna disputes.