Food and Drug Administration Reverses Moderna Flu Vaccine

The U.S. United States — Food and Drug Administration (United States — Food and Drug Administration) initially rejected Moderna's application for its mRNA-based flu vaccine (mRNA-1010) on February 3, citing concerns about the trial's control arm for older patients. This unusual move, influenced by Dr. Vinay Prasad, drew national attention and caused a temporary dip in Moderna's prospects. Following a high-priority 'Type A' meeting, Moderna revised its application, seeking full approval for adults aged 50-64 and accelerated approval for those 65 and older, along with a commitment to conduct a post-marketing study. The United States — Food and Drug Administration subsequently reversed its decision on February 18, agreeing to review the application, with a decision expected by August 5. This reversal led to a significant increase in Moderna's stock price. The event unfolds against a backdrop of increased scrutiny on mRNA technology by federal health officials, led by U.S. Health Secretary Robert F. Kennedy Jr., who has been critical of mRNA vaccines and announced a halt in federal funding for their development. Stéphane Bancel, Moderna's CEO, expressed appreciation for the United States — Food and Drug Administration's engagement and highlighted the potential availability of the vaccine for the 2026-2027 flu season. The vaccine is also under review in Europe, Canada, and Australia.