Ixchiq
Authorised
This medicine is authorised for use in the European Union
Chikungunya vaccine (live)
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ixchiq is a vaccine used to help protect adults against disease caused by the chikungunya virus.
Ixchiq contains a strain of chikungunya virus that has been attenuated (weakened).
The medicine can only be obtained with a prescription and should be used according to official recommendations issued at national level by public health bodies.
The recommended dose is one injection into the muscle of the upper arm.
Vaccinated people should continue to apply personal protection measures against mosquito bites after vaccination.
For more information about using Ixchiq, see the package leaflet or contact your doctor or pharmacist.
Ixchiq is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease. Ixchiq contains a strain of chikungunya virus that has been attenuated (weakened) so that it does not cause disease. When a person is given Ixchiq, the immune system recognises the weakened virus as ‘foreign’ and makes antibodies against it. If the person later comes into contact with the chikungunya virus, the immune system will be able to fight off the virus more effectively and so help to protect the person against chikungunya.
Ixchiq is effective at triggering the production of antibodies against chikungunya virus, which is expected to reduce the risk of getting chikungunya.
The benefits of Ixchiq were assessed in two main studies involving around 4,500 adults.
In one main study, over 4,000 people were given Ixchiq or placebo (a dummy treatment). The study looked at whether Ixchiq could trigger a level of antibodies expected to provide protection in about 400 of them. The target level of antibodies expected to provide protection was based on data from animal studies and information from people who were previously exposed to chikungunya virus and who had developed immunity. One month after the injection, nearly 99% of people who received Ixchiq had reached the target level of antibodies, compared with none of those who received placebo. Follow-up data showed that two years after vaccination, this target level was maintained in 97% of people who received Ixchiq.
Another main study involving around 360 people who all received Ixchiq showed similar results, with 98% of people reaching the target level of antibodies one month after injection.
Based on these results, although no data were available on how well Ixchiq protects people against the disease, the vaccine is expected to offer some protection.
For the full list of side effects and restrictions with Ixchiq, see the package leaflet.
The most common side effects with Ixchiq (which may affect more than 1 in 10 people) include leucopenia, neutropenia and lymphopenia (low levels of white blood cells, including neutrophils and lymphocytes, as seen in blood tests), headache, fatigue, myalgia (muscle pain), joint pain (arthralgia), elevated liver enzymes as seen in blood tests, fever, nausea (feeling sick), and tenderness, pain, erythema (redness), induration (hardening) or swelling at the site of injection.
Ixchiq must not be given to people who are immunodeficient or immunosuppressed (people with a weakened immune system) due to a disease or a treatment, such as people who are being treated with chemotherapy for a cancer, have an inherited immune deficiency, are taking a long-term immunosuppressive treatment (a treatment which reduces the activity of the immune system) or people with HIV who have a severely weakened immune system.
At the time of approval, there was no vaccine available to protect against chikungunya. Therefore, Ixchiq was addressing an unmet medical need. Ixchiq triggers an immune response against chikungunya virus in adults that is maintained for at least 2 years after vaccination. At the time of approval, there were no data showing that Ixchiq protects against chikungunya. Nevertheless, the immune response induced by the vaccine is expected to provide some protection. The company marketing Ixchiq will conduct studies in areas where the chikungunya virus circulates to evaluate how well Ixchiq protects vaccinated people against the disease. In terms of safety, the vaccine has side effects similar to those seen with other vaccines containing live, attenuated viruses.
The European Medicines Agency therefore decided that Ixchiq’s benefits are greater than its risks and it can be authorised for use in the EU.
The company marketing Ixchiq must carry out a study to assess the effectiveness of Ixchiq in adults living in areas where the chikungunya virus is spreading.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ixchiq have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ixchiq are continuously monitored. Suspected side effects reported with Ixchiq are carefully evaluated and any necessary action taken to protect patients.
Ixchiq received a marketing authorisation valid throughout the EU on 28 June 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ixchiq
- Active substance
- Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated
- International non-proprietary name (INN) or common name
- Chikungunya vaccine (live)
- Therapeutic area (MeSH)
- Chikungunya virus
Pharmacotherapeutic group
VaccinesTherapeutic indication
IXCHIQ is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years and older.
The use of this vaccine should be in accordance with official recommendations.
News on Ixchiq
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