FDA Approves Moderna Influenza Vaccine mFlusiva

The U.S. Food and Drug Administration (FDA) approved mFlusiva, an mRNA influenza vaccine developed by Moderna, on August 5. This first mRNA-based influenza vaccine is approved for use in individuals aged 50 years and older for the prevention of influenza disease caused by influenza A and B viruses.

The approval was supported by results from randomized clinical trials. In individuals aged 50 to 64 years old, mFlusiva demonstrated higher efficacy compared with a standard-dose influenza vaccine. The vaccine also demonstrated a stronger immune response compared with a high-dose influenza vaccine in individuals aged 65 years and older, for whom it received accelerated approval. Overall, mFlusiva was generally well tolerated, with no major safety concerns identified in the trials. Following the FDA approval, Moderna expects mFlusiva to become available in the U.S. during the 2026–2027 influenza season.

Read more about the approval news from the U.S. FDA, Access Newswire and the Associated Press.