The European Medicines Agency (EMA) has initiated a safety review of Valneva's IXCHIQ® chikungunya vaccine and temporarily suspended its use in individuals over 65 years old following reports of serious adverse events in elderly recipients. The vaccine remains recommended for people aged 12 to 64 years while the investigation continues.
The decision came after a May 5, 2025 meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), prompted by 17 reports of serious adverse events worldwide, including two deaths among elderly people with significant underlying medical conditions and/or co-medications. To date, more than 40,000 doses of IXCHIQ® have been administered globally.
The EMA emphasized that the exact cause of these serious adverse events and their relationship with the vaccine have not yet been determined. Health authorities are reminding healthcare professionals that IXCHIQ® must not be administered to immunocompromised individuals, as specified in the vaccine's Summary of Product Characteristics.
Global Regulatory Response
This European action follows similar precautionary measures in other regions. On April 16, 2025, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended a precaution for IXCHIQ® use in persons aged 65 and over.
France's national public health agency, the Haute Autorité de Santé (HAS), suspended its recommendation for the vaccine in the elderly on April 25, 2025. This decision affected an ongoing vaccination campaign in La Réunion that had prioritized people aged 65 and older with comorbidities. The French vaccination campaign continues for people aged 18 to 64.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, addressed the situation: "We are deeply concerned by the reports of adverse events experienced by elderly individuals. Valneva remains committed to upholding the highest safety standards and respects the precautionary measures taken by authorities as investigations continue."
Dr. Jaramillo added that the company will "continue to monitor all reported serious adverse events and fully cooperate with health authorities while also actively exploring a potential update to the product's indication."
Despite these safety concerns in the elderly population, Valneva stated that it "continues to see a positive risk-benefit in the vast majority of people with potential exposure to the disease."
About Chikungunya Disease
Chikungunya virus (CHIKV) is transmitted through the bites of infected Aedes mosquitoes, causing fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain from chikungunya can be debilitating and may persist for weeks to years in some patients.
The disease has spread rapidly since 2004, with outbreaks reported in over 110 countries across Asia, Africa, Europe, and the Americas. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas alone, creating a significant economic burden that is expected to grow with climate change as mosquito vectors expand their geographic range.
The World Health Organization has identified chikungunya as a major public health concern, highlighting the importance of effective prevention strategies despite the current safety review.
About Valneva
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases with unmet medical needs. The company applies expertise across multiple vaccine modalities to provide first-, best-, or only-in-class vaccine solutions.
In addition to IXCHIQ®, Valneva's portfolio includes three proprietary travel vaccines and a pipeline featuring the only Lyme disease vaccine candidate in advanced clinical development (partnered with Pfizer), the most clinically advanced Shigella vaccine candidate, and vaccine candidates against the Zika virus and other global public health threats.
