Valneva's Chikungunya Vaccine IXCHIQ Gets EMA Approval for Elderly Use

Valneva's single-dose chikungunya vaccine IXCHIQ® has had its temporary restriction on use in people over 65 lifted by the European Medicines Agency (EMA). The agency concluded a review of the vaccine, citing that it is effective at triggering antibody production against the chikungunya virus, particularly beneficial for older people at increased risk of severe disease. The vaccine is contraindicated for people with weakened immune systems.

The European Medicines Agency (EMA) has lifted a temporary restriction on the use of Valneva's single-dose chikungunya vaccine, Ixchiq, in adults aged 65 and above. The decision follows a thorough review by the EMA's safety committee, which concluded that the vaccine is effective in generating immunity against the chikungunya virus, particularly beneficial for older adults at increased risk of severe disease [1].

The EMA's safety committee had temporarily suspended the use of Ixchiq among the elderly in May as a precautionary measure following the occurrence of serious side effects in some elderly people with underlying medical conditions [2]. The review found that while serious adverse events, including two deaths, were reported in people aged 62 to 89, the vaccine remains effective in generating immunity. The committee recommends that Ixchiq should now be reserved for situations where there is a significant risk of chikungunya infection, after careful benefit-risk assessment [1].

The agency warned against administering Ixchiq to patients with compromised immune systems. Valneva did not immediately respond to Reuters' request for a comment. The agency will update product information to reflect the new recommendations [1].

Chikungunya is a mosquito-borne viral 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 [3]. The disease has caused large-scale outbreaks around the world since 2004, with over 110 countries in Asia, Africa, Europe, and the Americas reporting cases [3].

Valneva, a specialty vaccine company, develops, manufactures, and commercializes prophylactic vaccines for infectious diseases. Ixchiq was authorized in the European Union in June 2024 and, in March 2025, the European Commission granted a label extension in adolescents 12 years of age and older [2].

References:
[1] https://wiky.com/2025/07/11/europe-lifts-restriction-on-valnevas-chikungunya-vaccine-for-elderly-adults/
[2] https://www.globenewswire.com/news-release/2025/07/11/3114143/0/en/Valneva-Announces-Lifting-of-European-Medicines-Agency-s-Temporary-Restriction-on-Use-of-Chikungunya-Vaccine-IXCHIQ-in-Elderly.html
[3] https://jvi.asm.org/content/jvi/88/20/11644.full.pdf