epocrates
Chikungunya vaccine to be withdrawn from U.S. market amid new safety concerns
Valneva has voluntarily withdrawn its biologics license application (BLA) and Investigational New Drug (IND) application for the chikungunya vaccine Ixchiq in the U.S. after FDA suspended its license in August 2025 and subsequently placed the IND on clinical hold. The action follows a newly reported serious adverse event in a younger adult who had received three concomitant vaccines, including Ixchiq. While the event may be plausibly related, causality remains undetermined. No clinical studies are currently vaccinating participants. According to its press release, Valneva is seeking more information and plans to continue post‑marketing clinical activities pending further regulatory discussions.
Sources:
(2025, August 6). FDA. FDA update on the safety of Ixchiq (Chikungunya vaccine, live). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live
(2026, January 19). Valneva SE. Valneva Provides Update on Chikungunya Vaccine IXCHIQ [Press release]. https://valneva.com/press-release/valneva-provides-update-on-chikungunya-vaccine-ixchiq/