Other safety alerts
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| European Union: Ixchiq: Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Ixchiq, a live attenuated chikungunya vaccine, following reports of serious side effects.
The temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review, will now be lifted.
However, PRAC concluded that, for people of all ages, the vaccine should only be given when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks.
Serious side effects with the vaccine were reported mainly in people 65 years and older and in those with several underlying medical conditions. These side effects led to a worsening of the patients’ medical conditions or a deterioration in their general health, in some cases resulting in hospitalisation.
While most serious side effects occurred in older people, Ixchiq is effective at triggering the production of antibodies against the chikungunya virus which may be of particular benefit for older people who are at increased risk of severe chikungunya infection.
Healthcare professionals are reminded that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment as they are at greater risk of having complications from vaccines containing live attenuated viruses.
The product information for Ixchiq will be updated with the latest recommendations following the review.
Ixchiq was authorised in the European Union (EU) in June 2024. At the start of the PRAC review, around 36,000 doses of the vaccine had been used worldwide.
A direct healthcare professional communication (DHPC) will be sent to healthcare professionals prescribing, dispensing or administering the medicine. The DHPC will also be published on a dedicated page on the EMA website.
More information is available in EMA’s public health communication.
Please refer to the following websites in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2025 and
http://www.ema.europa.eu/en/news/ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by EMA, the United States Food and Drug Administration and the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 8 May 2025, 13 May 2025, 10 Jun 2025 and 19 Jun 2025.
Ends/Saturday, Jul 12, 2025
Issued at HKT 12:00
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