EMA lifts temporary ban on chikungunya vaccine Ixchiq following safety review
Ella Day | July 18, 2025 | News story | Medical Communications | Committee for Medicinal Products for Human USE, European Medicines Agency (EMA), Ixchiq, Pharmacovigilance Risk Assessment Committee (PRAC), Vaccine, Virology, chikungunya
After completing a safety review of Ixchiq – a vaccine for chikungunya – the European Medicines Agency’s (EMA) safety committee has agreed to lift the temporary restriction on its use in people aged 65 years and older. However, the vaccine should now only be used in individuals of all ages where there is a significant risk of infection and after careful consideration of benefits and risks.
Ixchiq, authorised in the EU in 2024, is effective at triggering antibody production against the chikungunya virus, a mosquito-borne disease that can cause debilitating joint pain and has no known cure. The vaccine is especially important for older people, who are at higher risk of severe illness.
The review followed 28 reported cases of serious adverse effects, mainly in people aged 65 and over or with multiple chronic illnesses. Reported side effects resembled chikungunya symptoms, including fever, malaise, confusion and, in rare cases, encephalitis. Three deaths were recorded. These findings led the Pharmacovigilance Risk Assessment Committee (PRAC) to conclude that vaccination should be reserved for situations where the infection risk outweighs potential harm.
Updated product information and a direct healthcare professional communication will advise prescribers of the revised recommendations.
The PRAC’s findings will be forwarded to the Committee for Medicinal Products for Human Use for a final opinion before a legally binding decision by the European Commission.
Ella Day
18/7/25
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