FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

Independent advisors for the Food and Drug Administration voted 9-0 on Friday to recommend the approval of Moderna's seasonal mRNA flu vaccine, designated mRNA-1010 and branded as mFlusiva. This decision followed an attempt by a Trump appointee at the FDA to prevent the vaccine from being reviewed. During an all-day meeting, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed data and presentations, including a supportive assessment from FDA scientists. Data from a Phase 3 trial involving over 40,000 adults aged 50 and older indicated that the mRNA vaccine demonstrated approximately 27% greater effectiveness against seasonal flu compared to a standard flu shot. Furthermore, a separate Phase 3 trial with nearly 3,000 participants aged 65 and older showed that mFlusiva generated a stronger immune response than the high-dose flu vaccine currently recommended for this demographic. The vaccine's safety profile was also reported as generally favorable.