Valneva's IXCHIQ Vaccine License Suspended in US Over Serious Adverse Events

Valneva SE's chikungunya vaccine IXCHIQ has been suspended in the US by the FDA due to four new reports of serious adverse events consistent with the illness. The suspension is effective immediately, and the company will stop shipping and selling the vaccine in the US. Valneva is committed to maintaining the highest safety standards and will continue to engage with health authorities globally. The company is evaluating the financial impact but has not modified its revenue guidance at this time.

Valneva SE, a specialty vaccine company, has announced that the United States Food and Drug Administration (FDA) has suspended the license for its chikungunya vaccine, IXCHIQ®. The suspension, effective immediately, requires Valneva to stop shipping and selling the vaccine in the United States. This decision follows the FDA's August 6, 2025, removal of its temporary pause on the use of IXCHIQ® in individuals aged 60 and above, based on a thorough investigation of reported serious adverse events (SAEs) [1].

The suspension is based on four new reports of serious adverse events consistent with chikungunya-like illness. Three of these cases occurred among elderly individuals aged 70 to 82, with one requiring hospitalization for two days. The remaining case involved a 55-year-old individual. Valneva is currently analyzing these cases in detail and will take appropriate actions in accordance with the FDA's procedures [2].

Valneva remains committed to maintaining the highest safety standards and will continue to engage with health authorities globally. The company is evaluating the financial impact of the suspension but has not modified its revenue guidance at this time. The sales of IXCHIQ® contributed to 7.5 million euros of Valneva's total sales of 91 million euros in the first half of 2025. The majority of these sales were from a non-recurring delivery of doses to combat the chikungunya epidemic in La Réunion [1].

The chikungunya virus, transmitted by Aedes mosquitoes, causes fever, severe joint pain, and other symptoms. Since its reemergence in 2004, it has caused significant outbreaks worldwide, with over 3.7 million cases reported in the Americas between 2013 and 2023. The World Health Organization (WHO) considers chikungunya a major public health risk due to its rapid spread and severe impact on affected populations [1].

Valneva, with a strong focus on developing and commercializing vaccines, continues to pursue its mission to provide effective solutions to global health challenges. The company's portfolio includes the only advanced candidate vaccine against Lyme disease, a tetravalent vaccine against Shigellosis, and candidates against Zika and other global health threats [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/25/3138190/0/fr/Valneva-annonce-la-d%C3%A9cision-de-la-FDA-de-suspendre-la-licence-d-IXCHIQ-aux-%C3%89tats-Unis.html
[2] https://valneva.com/press-release/valneva-announces-fdas-decision-to-suspend-license-of-chikungunya-vaccine-ixchiq-in-the-u-s/