The FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva’s live-attenuated chikungunya vaccine, Ixchiq, granted under accelerated approval less than two years ago. This decision follows reports of serious safety issues, including cases of chikungunya-like illness and one death directly attributed to the vaccine. The suspension highlights regulatory challenges in monitoring vaccines using accelerated pathways and emphasizes safety vigilance.