The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA technologyWASHINGTON -- The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. Still, Moderna said, the FDA did agree to let the study proceed as originally planned. It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions. Moderna has requested an urgent meeting with FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada and Australia.

Source: ABC News February 11, 2026 00:52 UTC