On June 18, 2026, independent advisors for the Food and Drug Administration (FDA) voted 9-0 in favor of approving Moderna's seasonal mRNA flu vaccine, known as mRNA-1010 and branded as mFlusiva. This decision followed an all-day meeting of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), during which members reviewed data and presentations, including a supportive analysis from FDA scientists.
Data from a Phase 3 trial involving over 40,000 adults aged 50 and older indicated that the mRNA vaccine was approximately 27% more effective against seasonal flu compared to a standard flu shot. Additionally, a smaller Phase 3 trial with nearly 3,000 participants aged 65 and older demonstrated that the vaccine elicited stronger immune responses than the high-dose flu vaccine typically recommended for this age group. The safety profile of the vaccine was reported to be generally favorable.