Moderna says FDA refuses its application for new mRNA flu vaccine
February 10, 2026
The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA technology. The company announced the news on Tuesday. The FDA’s decision reflects heightened scrutiny under Health Secretary Robert F. Kennedy Jr., who has criticized mRNA technology. Moderna received a “refusal-to-file” letter, objecting to its clinical trial methods. The FDA said the trial didn’t compare the new shot to the best available standard of care. Moderna has requested an urgent meeting with the FDA and noted it has applied for approval in Europe, Canada and Australia.