FDA Drafts New Framework to Spur Universal Flu Vaccines

A senior official at the U.S. Food and Drug Administration said the agency is drafting a new regulatory framework for influenza vaccines aimed at addressing shortcomings in current seasonal shots and paving the way for a universal flu vaccine. The initiative, disclosed on 25 July, would update how candidates are evaluated and approved, with an emphasis on broader and longer-lasting protection against multiple flu strains. In outlining the effort, the official likened French drugmaker Valneva SE to “the Sarepta of vaccines,” suggesting the company could play a prominent role in next-generation flu immunizations much as Sarepta Therapeutics has in rare-disease gene therapy. No timeline for completing the framework was provided, but the move signals the FDA’s intention to accelerate innovation ahead of the 2025-26 flu season.