U.S. Withdraws One Chikungunya Vaccine Approval — Vax-Before-Travel

The U.S. FDA’s Center for Biologics Evaluation and Research (CBER) just lately suspended the biologics license for Valneva Austria GmbH’s live-attenuated IXCHIQ vaccine.

On August 22, 2025, the FDA media release acknowledged CBER’s resolution is predicated on severe security issues associated to the vaccine, which seems to be inflicting chikungunya-like sickness in vaccine recipients.

Approved in 2023, this vaccine was initially authorised by the FDA below the accelerated approval pathway for the prevention of illness brought on by the chikungunya virus (CHIKV) in adults at elevated danger of publicity to CHIKV.

Currently, over 100 nations have reported CHIKV infections.

Thomas Lingelbach, Valneva’s Chief Executive Officer, commented in a press release on August 25, 2025, “As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool for addressing and preventing outbreaks of this devastating illness.”

The FDA’s approval and industrial availability of the single-dose VIMKUNYA® stay unchanged within the United States.