U.S. Withdraws One Chikungunya Vaccine Approval

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

On August 22, 2025, the FDA media release stated CBER's decision is based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients.

Approved in 2023, this vaccine was initially approved by the FDA under the accelerated approval pathway for the prevention of disease caused by the chikungunya virus (CHIKV) in adults at increased risk of exposure to CHIKV.

Currently, over 100 countries 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 commercial availability of the single-dose VIMKUNYA® remain unchanged in the United States.