STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm

The U.S. Food and Drug Administration (FDA) has indicated a willingness to consider Moderna's experimental flu vaccine, known as mRNA-1010, ahead of an upcoming advisory committee meeting. This development suggests a potential shift in the regulatory landscape for mRNA-based influenza vaccines. Moderna's vaccine aims to provide broad protection against multiple influenza strains. The company has been conducting clinical trials to assess its efficacy and safety. The advisory committee meeting will provide an independent review of the data, offering recommendations to the FDA regarding the vaccine's approval. The FDA's openness to this technology could pave the way for new vaccine platforms to enter the market, potentially offering advantages over traditional flu vaccines. This follows earlier news that the FDA reversed its opposition to UniQure's experimental Huntington's disease therapy, allowing the company to seek U.S. approval.