The U.S. Food and Drug Administration’s (FDA) independent vaccine advisory panel is set to review and vote on whether the benefits of Moderna’s influenza vaccine, mFlusiva, outweigh its potential risks in older adults. Moderna is seeking full approval for the vaccine in adults aged 50 to 64 and accelerated approval for those aged 65 and older. The company has also committed to conducting additional studies and providing further data on the vaccine’s effectiveness in seniors if approval is granted.
The review comes after the FDA reversed its earlier stance on the application. Previous agency officials had raised concerns over the design of Moderna’s clinical trials, arguing that participants aged 65 and older were not compared against the preferred high-dose flu vaccine. The vaccine’s evaluation has also attracted attention following leadership changes at the FDA, with Acting Commissioner Kyle Diamantas working to restore stability and strengthen relations with the biotechnology industry.
According to briefing documents released ahead of the meeting, FDA reviewers said immune-response data may support the vaccine’s effectiveness in adults aged 65 and above, although concerns remain regarding immunocompromised and very frail older individuals who were not included in the trials. If approved, mFlusiva would become the first mRNA-based seasonal flu vaccine available in the United States, competing with existing products from major vaccine manufacturers. The FDA is expected to make its final decision by August 5.
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