Valneva must immediately cease U.S. shipments and sales of Ixchiq, a vaccine for chikungunya virus. The FDA recently lifted a pause on dosing of Ixchiq, but the agency’s new safety alert is based on an assessment that found the vaccine appears to be causing chikungunya-like illness in recipients.

Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva’s Ixchiq (Chikungunya Vaccine, Live).

The FDA suspended Valneva’s U.S. license for its chikungunya vaccine Ixchiq due to serious safety concerns, multiple hospitalizations, and deaths linked to chikungunya-like illness.