Valneva's Ixchiq Vaccine Suspended in US Over Serious Side Effects.

The US FDA has suspended the license for the Ixchiq vaccine against chikungunya due to reports of "serious adverse events," particularly in older patients. The suspension is effective immediately, and Valneva, the French maker of the vaccine, is evaluating the financial impact but has not modified its revenue guidance. Chikungunya is a mosquito-borne virus that could be a future pandemic threat, and public health experts warn of the risk of a major epidemic.

The United States Food and Drug Administration (FDA) has suspended the license for Valneva SE's Ixchiq vaccine against chikungunya, effective immediately, due to reports of serious adverse events (SAEs). The suspension follows the FDA's decision on August 6, 2025, to remove its recommended pause in the use of Ixchiq in individuals aged 60 and older, based on an investigation of reported SAEs, primarily among elderly individuals with multiple underlying health conditions [1].

Four new reports of SAEs consistent with chikungunya-like illness have been reported, including three cases in individuals aged 70 to 82 years, one of whom required hospitalization [1]. Valneva believes the symptoms observed in these cases are consistent with those previously reported during clinical trials and post-marketing experience, particularly among the elderly. The company is continuing to investigate these cases and is committed to upholding the highest safety standards [1].

Valneva is evaluating the potential financial impact of a permanent withdrawal of the Ixchiq license in the United States but has not modified 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 [1].

Chikungunya is a mosquito-borne viral disease that causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain can be debilitating and can persist for weeks to years. The disease has caused large-scale outbreaks around the world since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [1].

Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases. The company's Ixchiq vaccine is one of three proprietary travel vaccines currently marketed by the company. Valneva is also involved in the development of vaccines against Lyme disease, Shigella, Zika virus, and other global public health threats [1].

References:
[1] https://finance.yahoo.com/news/valneva-announces-fda-decision-suspend-050000615.html
[2] https://www.marketscreener.com/news/fda-halts-valneva-s-chikungunya-vaccine-ixchiq-in-the-us-after-reports-of-serious-side-effects-ce7c50dbde80f32c