FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

On August 22, 2025, the FDA suspended the biologics license for Valneva's chikungunya vaccine "Ixchiq" in the United States, effective immediately1234.

The suspension was prompted by multiple serious safety concerns, including reports of chikungunya-like illness in vaccine recipients, over 20 serious adverse events, at least 21 hospitalizations, and 3 deaths (one from vaccine-strain encephalitis)13.

Recent events influencing the decision include four new serious adverse events reported in updated VAERS data, some occurring outside of the populations previously identified as at higher risk24.

The FDA stated that the clinical benefit of Ixchiq had not yet been verified in confirmatory studies and that the overall benefit-risk profile was not favorable under most plausible scenarios13.

Valneva is required to stop shipping and selling Ixchiq in the U.S. immediately as a result of the suspension24.

Sources:

1. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live

2. https://valneva.com/press-release/valneva-announces-fdas-decision-to-suspend-license-of-chikungunya-vaccine-ixchiq-in-the-u-s/

3. https://www.fda.gov/safety/medical-product-safety-information/fda-update-safety-ixchiq-chikungunya-vaccine-live-fda-suspends-biologics-license-fda-safety

4. https://valneva.com/wp-content/uploads/2025/08/20250825FDAIXCHIQUpdatePRENFinal2.pdf