Valneva’s Chikungunya Shot Suspended by FDA

The United States Food and Drug Administration (FDA) has suspended Valneva SE’s license for IXCHIQ, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness. The suspension is effective immediately and requires Valneva to stop shipping and selling IXCHIQ in the United States.

The decision to suspend IXCHIQ is based on updated VAERS data (Vaccine Adverse Event Reporting System), which now includes four additional SAEs that occurred outside the United States. Of the four reported cases, three occurred in individuals aged 70 to 82 years, including one hospitalization of an 82-year-old individual who was discharged after two days; the remaining case occurred in a 55-year-old individual.

Valneva is continuing to investigate these cases in detail and, if warranted, will pursue further steps in connection with the FDA’s decision in accordance with applicable statutory procedures.

Thomas Lingelbach, Valneva’s CEO, commented, “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.”

Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ license in the United States, but is not modifying its revenue guidance at this time. Sales of IXCHIQ contributed €7.5 million to the Company’s €91 million total product sales in the first half of 2025, a significant portion of which was the result of one-time delivery of vaccine doses to combat the chikungunya outbreak in La Reunion.