New EMA decision on the Ixchiq vaccine: Restriction for people over 65 years of age lifted

Recently, the Pharmacovigilance Risk Assessment Committee (EMA) of the European Medicines Agency announced that it has completed the review of Ixchiq, which, according to reports, has serious side effects. In a published statement, it stated that the restriction for people 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 who was it developed for?

The US Food and Drug Administration (FDA) has approved Ixchiq, the first Chikungunya vaccine containing an attenuated Chikungunya virus, for people aged 12 and above. The vaccine is intended to protect against Chikungunya, a viral disease transmitted by mosquitoes. The vaccine is only available by prescription and prepares the immune system to defend against the disease.

In two main studies on the efficacy of the Ixchiq vaccine, it was found that it effectively stimulates the formation of antibodies.

Why did the EMA introduce a temporary restriction for people aged 65 and above?

Studies on Ixchiq have shown serious side effects in people over 65 years of age or with pre-existing conditions, prompting the EMA to investigate the vaccine. As part of this investigation, it was decided not to use the vaccine in people over 65 years of age.

Why was the restriction lifted? Current EMA assessment

The reports listed side effects such as deterioration in health status, impairment of general health, and even deaths. However, the studies conducted by the EMA concluded that the vaccine can be beneficial for older people with a high risk of severe Chikungunya infection and should be used with careful consideration of the benefits and risks.

How safe is the Ixchiq vaccine for the elderly?

The side effects of the Ixchiq vaccine occurred most frequently in the elderly and people with chronic diseases. The most common side effects are fever, fatigue (discomfort), loss of appetite, and confusion, which can lead to falls. In rare cases, cases of encephalitis (brain inflammation) have been observed.

The assessment found that this vaccine, which effectively triggers the production of antibodies against the Chikungunya virus, is of greater benefit to the elderly during a severe Chikungunya disease and can be used.

What does the statement of the European Medicines Agency mean?

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC) recommends administering the vaccine, considering the benefits, in cases where there is a risk of Chikungunya infection. The data show that serious side effects of the Ixchis vaccine can occur under the following conditions.

• People aged 65 and above
• People with cardiovascular diseases
• People with diabetes
• People with one or more chronic or uncontrollable diseases such as chronic kidney disease

The Pharmacovigilance Risk Assessment Committee also points out that older people may benefit more from vaccination, as they are the group with the highest risk of Chikungunya infection.