After a three-month review, the FDA and EMA have cleared continued use of IXCHIQ in adults 60+, adding new safety warnings for elderly individuals with chronic conditions.
Updated News- August 7, 2025: Valneva SE announced that The US Food and Drug Administration (FDA) has lifted its recommended pause on the use of its chikungunya vaccine IXCHIQ in adults 60 years and older, following updated safety evaluations and parallel action from the European Medicines Agency (EMA). The Prescribing Information (PI) has been updated to include reports of serious adverse events (SAEs), primarily in older individuals with multiple comorbidities, observed during a mass vaccination campaign in La Réunion. While IXCHIQ remains indicated for adults 18+ at high risk of CHIKV exposure, the FDA emphasized caution, especially in low-risk US travelers, and reiterated contraindications for immunocompromised individuals. The Warnings and Precautions section now highlights the SAE risk, particularly for patients over 65 with chronic conditions. FDA reviews are ongoing for potential label expansion to adolescents and incorporation of long-term immunity data.
Previous News- May 12, 2025: The FDA and Centers for Disease Control and Prevention (CDC) have jointly recommended a pause in the use of Valneva’s single-dose chikungunya vaccine, IXCHIQ, for individuals aged 65 and older. This precautionary measure follows reports of serious adverse events (SAEs) in elderly individuals with underlying medical conditions, including one fatality, during the ongoing vaccination campaign in La Réunion, France. These cases were reported through the Vaccine Adverse Event Reporting System (VAERS), though a causal relationship with the vaccine has not been established.2
The FDA has lifted its pause on IXCHIQ use in adults 60 and older, following updated safety evaluations and similar action by the EMA.
The vaccine's label now includes warnings about serious adverse events primarily seen in older adults with multiple health issues.
IXCHIQ remains recommended for high-risk individuals aged 18+, while use in low-risk travelers and immunocompromised patients is discouraged.
To date, over 40,000 doses of IXCHIQ have been administered worldwide. The vaccine remains authorized for use in individuals aged 18 to 60 in the US and for those aged 12 to 64 in Europe. In France, the national public health agency, Haute Autorité de Santé (HAS), continues to recommend vaccination for individuals aged 18 to 64 in La Réunion, where a significant chikungunya outbreak is ongoing.2
Valneva is collaborating with health authorities to investigate these SAEs and has committed to providing timely information about all known adverse events. The company maintains that the benefits of IXCHIQ outweigh the risks for the majority of individuals aged 18 to 60. Further updates will be provided as evaluations are concluded.2
Chikungunya virus is a mosquito-borne disease that causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain can be debilitating and may persist for weeks to years. Since its re-emergence in 2004, chikungunya has been identified in over 110 countries, with more than 3.7 million cases reported in the Americas between 2013 and 2023. The World Health Organization has highlighted chikungunya as a major public health problem.
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