Moderna’s mRNA flu vaccine passes FDA AdCom, review underway

Moderna's mRNA-1010 (mFlusiva) influenza vaccine successfully passed the US FDA Advisory Committee (AdCom) review. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously determined that the vaccine's benefits outweigh its risks, with both votes for adults aged 50-64 and 65 years and older ending 9-0 in Moderna's favor. In Phase III clinical trials, mRNA-1010 achieved 26.6% higher relative effectiveness compared to standard-dose seasonal influenza vaccine. The FDA set a review goal date of August 5, 2026. Moderna's shares rose 3.5% to $63.96 following the vote. The positive decision marks a turnaround for Moderna after the FDA rejected its application in February, citing lack of a properly conducted study.