Valneva’s Chikungunya Vaccine IXCHIQ® Suspended In U.S. Halts IXCHIQ® Shipments Following FDA Safety Action

Valneva SE, a specialty vaccine company, announced that the U.S. Food and Drug Administration (FDA) has suspended the license for IXCHIQ®, its chikungunya vaccine, following four newly reported serious adverse events (SAEs) consistent with chikungunya-like illness. The suspension, effective immediately, halts all U.S. sales and shipments of the vaccine. This action comes shortly after the FDA had lifted a prior pause on IXCHIQ® use in individuals aged 60 and above, based on earlier safety investigations. 

Thomas Lingelbach, Valneva’s Chief Executive Officer, said, “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. We aim to continue providing IXCHIQ® to all countries where the product is licensed and continue our efforts with our partners to accelerate vaccine access in low-and middle-income chikungunya-endemic countries especially in response to any current or future chikungunya outbreaks, ensuring the vaccine reaches those most in need.”

The FDA’s latest decision was driven by updated data from the Vaccine Adverse Event Reporting System (VAERS), which identified four additional SAEs, including three in elderly patients aged 70 to 82 years and one in a 55-year-old. One case required short hospitalization, while the others were consistent with symptoms observed during prior clinical trials and post-marketing surveillance, particularly among elderly populations. Valneva emphasized that IXCHIQ®’s Prescribing Information already includes warnings for older patients with underlying health conditions and noted it is actively investigating the cases.

Valneva stated it remains committed to the highest safety standards and will continue cooperating with health authorities globally where IXCHIQ® is licensed. While the company is assessing the financial implications of a potential permanent withdrawal in the U.S., it has not revised its revenue guidance. IXCHIQ® generated €7.5 million of the company’s €91 million product sales in H1 2025, largely from one-time vaccine deliveries to address the chikungunya outbreak in La Réunion.