The Food and Drug Administration will convene an advisory panel next month to review Moderna's experimental mRNA flu vaccine, a decision that signals a return to more predictable regulatory practices following the dismissal of former Commissioner Marty Makary.
The panel is scheduled to meet June 18 to evaluate the safety and efficacy of Moderna's MFLUSIVA shot, according to a Federal Register notice published Thursday. The agency must make a final decision by August 5, ahead of the upcoming flu season.
The review marks a turnaround from February, when the FDA initially refused to accept Moderna's application. That rejection, issued by then-top vaccine regulator Vinay Prasad, cited what he described as flaws in the company's research design. Application refusals are uncommon, and the episode drew sharp criticism from Moderna, Wall Street, and the broader biotech industry, which viewed it as evidence of a hostile environment for mRNA vaccines under Health Secretary Robert F. Kennedy Jr.
Moderna has invested hundreds of millions of dollars and years of development into the vaccine. The company's frustration over the initial refusal echoed complaints from other biotech firms about a lack of consistency and transparency in the FDA's review process under Makary. While Makary publicly advocated for faster, more flexible reviews, companies said those promises rarely materialized.
The announcement of the panel review comes just days after Makary's ouster, which some observers see as a catalyst for a more stable regulatory climate. The shift may also affect other pending drug and vaccine reviews, including those in areas like prior authorization reform, which has been a focus of bipartisan scrutiny.
The FDA's decision on MFLUSIVA will be closely watched by investors and public health officials, as it could set a precedent for future mRNA-based vaccines beyond COVID-19. The agency's willingness to convene an advisory panel suggests a return to standard review procedures that industry leaders have long demanded.
