FDA Approves Moderna's mRNA Flu Vaccine mFlusiva for Adults 50 and Older
The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older. This approval marks a significant advancement in influenza vaccine development, leveraging mRNA technology to potentially shorten production times compared to traditional vaccines. The vaccine has received full approval for individuals aged 50 to 64, while those aged 65 and older have been granted accelerated approval, pending further clinical trials. The decision follows positive results from late-stage clinical trials involving over 40,000 participants across 11 countries, demonstrating mFlusiva's efficacy. The vaccine is expected to be available for the upcoming flu season, although its distribution may be impacted by the lack of a formal recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP).