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

The suspension follows the FDA’s decision on August 6, 2025¹ to remove its recommended pause² in the use of IXCHIQ^® in individuals 60 years of age and older based on a thorough investigation of reported SAEs, primarily among elderly individuals with multiple underlying health conditions. The sudden subsequent 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 believes all cases describe symptoms consistent with those previously reported during clinical trials and post marketing experience, particularly among the elderly individuals for whom the vaccine’s Prescribing Information (PI) includes warnings and precautions. Valneva is continuing to investigate these cases in detail and if warranted will pursue further steps in connection with FDA’s decision in accordance with applicable statutory procedures.

Valneva is committed to upholding the highest safety standards and will continue to engage proactively with health authorities in all territories where IXCHIQ^® is licensed.

Thomas Lingelbach, Valneva’s Chief Executive Officer, 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.