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 people aged 12 years and older against disease caused by the chikungunya virus. Chikungunya is a viral disease that mosquitoes can pass to humans.
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. These include use of mosquito repellents and nets, wearing clothing that covers most of the body and sleeping in screened or air-conditioned rooms.
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.
Adults
Ixchiq was shown to be effective at triggering the production of antibodies against the chikungunya virus in two main studies involving around 4,500 adults. This is expected to reduce the risk of getting disease caused by the chikungunya virus.
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 people. 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 given Ixchiq had reached the target level of antibodies, compared with none of those given 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.
Adolescents
In a main study involving adolescents aged 12 to 17 years of age, around 99 % (248 out of 251) of those who were not previously infected with the chikungunya virus and were given Ixchiq reached the target level of antibodies 28 days after vaccination compared with around 2% (1 out of 41) of those given placebo. Six months after vaccination, this target level was maintained in 99% of those given Ixchiq compared with 0% given placebo.
For the full list of side effects and restrictions with Ixchiq, see the package leaflet.
The most common side effects with Ixchiq in adults and adolescents (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, tiredness, myalgia (muscle pain), joint pain (arthralgia), elevated liver enzymes as seen in blood tests, fever, nausea (feeling sick), and tenderness and pain at the site of injection, tiredness, nausea, arthralgia, neutropenia, leucopenia and lymphopenia. Elevated liver enzymes, as seen in blood tests, may also affect more than 1 in 10 adults.
Ixchiq must not be given to people who are immunodeficient or immunosuppressed (people with a weakened immune system) due to a disease or treatment. This includes people receiving chemotherapy for cancer, those who have an inherited immune deficiency, those taking long-term immunosuppressive treatment (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. Similarly, the vaccine triggers a robust immune response in adolescents that is maintained for at least 6 months after vaccination.
There are some uncertainties regarding the effectiveness of the vaccine due to the lack of data on how well Ixchiq protects against chikungunya. However, the immune response triggered by Ixchiq indicates that the vaccine is expected to provide some protection against disease caused by the chikungunya virus.
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 safety profile of the vaccine in adolescents is similar to that seen in adults.
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 and adolescents 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
Latest procedure affecting product information:
II/0001
28/03/2025
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 12 years and older.
The use of this vaccine should be in accordance with official recommendations.
News on Ixchiq
This page was last updated on