New EMA Decision on the Ixchiq Vaccine: Restriction for Individuals Over 65 Years of Age Lifted
Recently, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) announced the completion of its review of Ixchiq, which had reportedly caused serious side effects. In a published statement, it declared that the restriction for individuals over 65 years of age would be lifted.
The live-attenuated Chikungunya vaccine Ixchiq was evaluated by the committee, considering its benefits and risks, and it was decided that it should be administered.
What is the Ixchiq vaccine and for whom was it developed?
The U.S. Food and Drug Administration (FDA) has approved Ixchiq, the first Chikungunya vaccine containing an attenuated Chikungunya virus, for individuals aged 12 years and older. The vaccine is intended to protect against Chikungunya, a mosquito-borne viral disease. The vaccine is available by prescription only and prepares the immune system to defend against the disease.
Two pivotal studies on the efficacy of the Ixchiq vaccine demonstrated its effectiveness in stimulating antibody production.
Why did the EMA implement a temporary restriction for individuals aged 65 and older?
Studies on Ixchiq revealed serious side effects in individuals over 65 years of age or with pre-existing conditions, prompting the EMA to conduct an investigation into the vaccine. As part of this investigation, it was decided not to administer the vaccine to individuals over 65 years of age.
Why was the restriction lifted? Current EMA Assessment
Reports indicated adverse effects such as deterioration of health, impairment of general health, and even fatalities. However, studies conducted by the EMA concluded that the vaccine could be beneficial for elderly individuals at high risk of severe Chikungunya infection and should be used with careful consideration of its benefits and risks.
How safe is the Ixchiq vaccine for elderly individuals?
The side effects of the Ixchiq vaccine were most frequently observed in elderly individuals and those with chronic diseases. The most common side effects include fever, asthenia (malaise), loss of appetite, and confusion, which can lead to falls. In rare cases, instances of encephalitis (brain inflammation) have been observed.
The assessment concluded that this vaccine, which effectively induces the production of antibodies against the Chikungunya virus, offers greater benefit for elderly individuals during severe Chikungunya disease and can be utilized.
What is the significance of the European Medicines Agency's statement?
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommends administering the vaccine, considering its benefits, in cases where there is a risk of Chikungunya infection. Data indicate that serious side effects of the Ixchiq vaccine may occur under the following conditions.
- Individuals aged 65 years and older
- Individuals with cardiovascular diseases
- Individuals with diabetes
- Individuals with one or more chronic or uncontrollable diseases such as chronic kidney disease
The Safety Committee also notes that older individuals may derive greater benefit from vaccination, as they represent the group at highest risk for Chikungunya infection.
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