Valneva Responds To European Medicine Agency’s Recommendation Against The Use Of IXCHIQ® In Elderly People

Valneva SE, a specialty vaccine company, has announced that the European Medicines Agency (EMA) has begun a review of its chikungunya vaccine, IXCHIQ®, due to reports of serious adverse events (SAEs) in individuals aged 65 and older. As a precautionary step, the EMA has temporarily suspended the use of the vaccine in this age group while the review is ongoing. For people aged 12 to 64, the EMA has maintained its current recommendations, and the vaccine remains available for use. The decision to initiate the review was made following a plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on May 5, 2025. 

It is based on 17 reports of serious adverse events from around the world, which included two deaths. These incidents involved elderly individuals with pre-existing medical conditions and/or those taking other medications. To date, more than 40,000 doses of IXCHIQ® have been administered globally. The EMA has stated that the exact causes of these adverse events, and their potential link to the vaccine, are still under investigation. In the meantime, healthcare professionals are being reminded that IXCHIQ® should not be given to individuals with weakened immune systems due to illness or medical treatments, in accordance with the product’s official prescribing information (Summary of Product Characteristics).

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a statement, “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. 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.”

Valneva had previously reported changes to vaccination guidance in both the United States and France. On April 16, 2025, the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) recommended caution when administering the vaccine to people aged 65 and older. Similarly, on April 25, 2025, France’s national health authority, Haute Autorité de Santé (HAS), suspended its recommendation for the vaccine in older adults as part of a vaccination campaign in La Réunion, which had prioritized people in this age group with underlying health conditions. The campaign is continuing for adults aged 18 to 64. Despite the ongoing review and temporary restrictions for older adults, Valneva continues to emphasize the overall positive risk-benefit profile of IXCHIQ® for the majority of individuals who may be exposed to chikungunya.