The U.S. Food and Drug Administration has suspended the biologics license for Valneva’s chikungunya vaccine, Ixchiq, following reports of serious safety concerns including chikungunya-like illness in vaccine recipients and an attributed death. This decision requires an immediate halt in shipments and sales of the vaccine in the U.S., marking a significant setback for Valneva. These developments come less than two years after the vaccine was cleared under accelerated approval.