Other safety alerts
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| European Union: Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted |
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European Medicines Agency (EMA) announces that EMA’s human medicines committee (CHMP) endorsed the recommendation of the Agency’s safety committee (PRAC) following a review of serious side effects of Ixchiq (a live attenuated chikungunya vaccine).
The previous temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review, will now be lifted.
However, 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.
Ixchiq was authorised in the European Union in June 2024. At the start of the review, around 36,000 doses of the vaccine had been used worldwide. The product information for Ixchiq will be updated with the latest recommendations.
Serious side effects with the vaccine were reported mainly in people 65 years of age 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 leading to hospitalisation and death.
Many of the serious side effects reported are similar to symptoms of chikungunya infection and include fever, malaise (feeling unwell), loss of appetite and confusion, which can lead to falls. Chikungunya-like symptoms are mostly mild, but some adults (about 2 people in 100) may develop more severe symptoms.
The review also considered cases of encephalitis (inflammation of the brain) with symptoms such as confusion, sleepiness, fever and headache. Cases of encephalitis are rare and the frequency with which they occur is not known.
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.
The vaccine should therefore only be given when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks.
Healthcare professionals are reminded that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment. People with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses such as Ixchiq.
The vaccine is already contraindicated in people with weakened immune systems, and the contraindication remains in place.
Information for healthcare professionals
• The temporary contraindication for people aged 65 years and above, which was in place during the review, has now been lifted.
• The vaccine should only be given when there is a significant risk of acquiring chikungunya infection and after a careful consideration of the benefits and risks.
• A review of safety data has revealed 28 cases of serious side effects with Ixchiq which occurred mainly in people aged 65 years and older and in those with multiple chronic or uncontrolled medical conditions, such as cardiovascular diseases, diabetes mellitus or chronic kidney disease.
• Among the side effects are encephalitis and chikungunya-like symptoms, which may lead to the worsening of the patients’ medical conditions or a deterioration in their general health. Three of the cases reported resulted in death.
• Older people may derive the most benefit from vaccination as this group is at higher risk of serious or complicated chikungunya disease.
A direct healthcare professional communication (DHPC) will be sent to healthcare professionals prescribing or administering the medicine.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted-0
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 since 8 May 2025, with the latest update posted on 12 Jul 2025.
Ends/ Saturday, July 26, 2025
Issued at HKT 12:00
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