Today, the Commission has adopted a decision to temporarily amend the EU marketing authorisation of the Chikungunya virus vaccine (IXCHIQ), in line with the European Medicine Agency’s safety Committee (PRAC) recommendation, issued on 7 May. The decision will advise against the use of the vaccine in people over 65 years of age, due to reported cases of serious adverse effects in older individuals.
The vaccine remains authorised for use for people between 12 and 64 years old. Healthcare professionals will be alerted of this new restriction via a direct healthcare professional communication, which the EMA will also publish on its website. The use of the vaccine was never recommended for use in individuals who are immunodeficient or immunosuppressed due to disease or medical therapy.
The IXCHIQ vaccination was granted EU authorisation in June 2024, as an effective protection against Chikungunya – a serious mosquito-borne disease. However, following reports from France of serious adverse reactions in people over 65, the EMA has started a scientific review of available data related to the vaccine.
Today’s Commission decision to restrict the use of the vaccine will apply, while an in-depth review of the data on the reported adverse effects is carried out by EMA. The Commission has asked the EMA to conclude the review by the end of September 2025.
The Commission decision will be available soon at:
More information:
