Valneva SE announced that the U.S. Food and Drug Administration (FDA) has suspended the license for its chikungunya vaccine IXCHIQ, following reports of four new serious adverse events (SAEs) linked to the vaccine. The decision is effective immediately, requiring Valneva to halt all shipments and sales of IXCHIQ in the U.S.
The suspension comes less than a month after the FDA lifted a recommended pause on the vaccine’s use in adults aged 60 and older. That earlier pause was lifted after an investigation found no new safety concerns beyond those already known. However, updated data from the Vaccine Adverse Event Reporting System (VAERS) revealed four additional cases of serious illness consistent with chikungunya-like symptoms—three involving patients aged 70 to 82, and one involving a 55-year-old. All incidents occurred outside the United States.
Valneva stated that the reported cases reflect known risks, especially in elderly patients with underlying health conditions, which are already highlighted in the vaccine’s U.S. Prescribing Information. The company is currently conducting a detailed investigation and may pursue further steps in response to the FDA’s action.
CEO Thomas Lingelbach reaffirmed Valneva’s commitment to safety and emphasized the ongoing global need for a chikungunya vaccine:
“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.”
IXCHIQ remains licensed in other countries, and Valneva said it plans to continue distributing the vaccine where it remains authorized, including in chikungunya-endemic regions.
Despite the setback in the U.S., the company has not adjusted its 2025 revenue guidance. In the first half of the year, IXCHIQ generated €7.5 million in sales, largely due to a one-time shipment to support outbreak response in La Réunion.
Valneva is continuing to work with regulators and health authorities worldwide as it evaluates the long-term implications of the FDA’s decision.