Valneva says EMA started Ixchiq review after reports of SAEs

Valneva (VALN) announced that the European Medicines Agency has started a review of Valneva’s single-dose live attenuated chikungunya vaccine Ixchiq based on reports of serious adverse events in elderly people. “As a temporary measure, while this review is ongoing, EMA has suspended the use of the vaccine for individuals over 65 years old. EMA has maintained current recommendations for Ixchiq for people from 12 to 64 years of age. The decision was taken following a plenary meeting of the Pharmacovigilance Risk Assessment Committee on May 5, 2025 and is based on reports of 17 SAEs worldwide (including two deaths) in elderly people with significant underlying medical conditions and/or co-medications. To date, over 40,000 doses of Ixchiq have been used worldwide. Additionally, EMA highlighted that the exact cause of these serious adverse events and their relationship with the vaccine have not yet been determined and is reminding healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatments, as stated in Ixchiq’s Summary of Product Characteristics. Valneva previously reported on changes to recommendations for use of Ixchiq in the U.S. and France. On April 16, 2025, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended a precaution related to the use of Valneva’s chikungunya vaccine Ixchiq in persons aged 65 and over. On April 25, 2025, within the framework of the ongoing vaccination campaign initiated in La Reunion at the beginning of April prioritizing people aged 65 and older with comorbidities, France’s national public health agency, the Haute Autorite de Sante, suspended its recommendation for use of the vaccine in that age range pending further investigation. The vaccination campaign is maintained for people aged 18 to 64 years of age,” the company stated. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said: “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.” The company added that it “continues to see a positive risk-benefit in the vast majority of people with potential exposure to the disease.”