Other safety alerts
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| European Union: EMA starts review of Ixchiq (live attenuated chikungunya vaccine) |
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European Medicines Agency (EMA) announces that EMA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.
Many of the people affected also had other illnesses and the exact cause of these adverse events and their relationship with the vaccine have not yet been determined. So far 17 serious adverse events, including two cases resulting in death, have been reported worldwide in people aged between 62 and 89 years who received the vaccine. Given that studies on Ixchiq mainly involved people below 65 years of age and the vast majority of serious cases concerned people 65 years of age and above, the Committee is temporarily recommending restricting the use of vaccine.
As a temporary measure while an in-depth review is ongoing, Ixchiq must not be used in adults aged 65 years and above. Ixchiq vaccination can continue in people under 65 years of age, in accordance with official recommendations.
In addition to the new restriction, the Committee is also reminding healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment. Persons with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses, regardless of age.
The PRAC will now review all available data to assess the benefits and risks of the vaccine and make a recommendation on whether to change the terms of its marketing authorisation.
Chikungunya is a mosquito-borne disease caused by the chikungunya virus. It is mostly present in tropical and subtropical regions. Symptoms include fever, painful joints, headache, muscle pain, joint swelling and rash. Most patients recover within a week, but some develop joint pain for several months or longer and a small proportion of patients may develop severe acute disease, which can lead to multiorgan failure. Ixchiq was authorised as a single-dose vaccine for chikungunya on 28 June 2024.
Information for healthcare professionals:
- EMA’s safety committee (PRAC) is reviewing Ixchiq following reports of serious adverse events in elderly people.
- So far 17 serious cases have been reported in people from 62 to 89 years of age, two of which resulted in death. One of the fatal cases concerned an 84-year-old man who developed encephalitis. The second concerned a 77-year-old man with Parkinson's disease whose difficulty with swallowing worsened and may have caused aspiration pneumonia.
- The two fatal cases occurred in the French overseas department of La Réunion, where a vaccination campaign is underway following a recent chikungunya outbreak.
- Given that studies on Ixchiq mainly involved people below 65 years of age and the vast majority of the serious cases concerned persons 65 years of age and above, the Committee is temporarily recommending restricting the use of vaccine. While an in-depth review is ongoing, Ixchiq will be contraindicated in adults aged 65 years and above.
- In addition, EMA is reminding healthcare professionals that Ixchiq is contraindicated in people who are immunodeficient or immunosuppressed because of disease or medical treatment. These include patients with congenital immunodeficiency, haematological cancers and solid tumours, patients with HIV infection who are severely immunocompromised and patients receiving chemotherapy or long-term immunosuppressive therapy.
- A direct healthcare professional communication (DHPC) will be sent to relevant healthcare professionals. The DHPC will also be published on a dedicated page on EMA’s website.
- The product information for Ixchiq will be updated with the latest recommendation for adults 65 years of age and above.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-starts-review-ixchiq-live-attenuated-chikungunya-vaccine
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, May 8, 2025
Issued at HKT 16:00 |
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