Business
Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly
Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva’s single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) 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 recommenda
About this update from Valneva Se
[{"type":"image","alt":"VALNEVA","displaySize":"","headline":null,"caption":"VALNEVA","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":44,"url":"https://media.zenfs.com/en/globenewswire.com/29df7eb71c048b91fe66a95a1cd8b1d6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9l2h5dKc1PlSY26lXUAWsA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/29df7eb71c048b91fe66a95a1cd8b1d6","width":300,"height":44}},"lazy":false},{"type":"text","content":"Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva’s single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) 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.","length":556,"tagName":"p"},{"type":"text","content":"The decision was taken following a plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) 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.","length":343,"tagName":"p"},{"type":"text","content":"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).","length":374,"tagName":"p"},{"type":"text","content":"Valneva previously reported on changes to recommendations for use of IXCHIQ® in the U.S.1 and France2. On April 16, 2025, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended a precaution related to the use of Valneva’s chikungunya vaccine IXCHIQ® in persons aged 65 and over.","length":347,"tagName":"p"},{"type":"text","content":"On April 25, 2025, wit...