Valneva's Ixchiq Approved for Elderly Chikungunya Patients

EMA has maintained current recommendations for Ixchiq for people from 12 to 64 years of age. The decision was taken following a  recent plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on May 5, 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 (SmPC).

Dr. Juan Carlos Jaramillo, 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 continues to see a positive risk-benefit in the vast majority of people with potential exposure to the disease.