EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects.

The previous temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review, will now be lifted.

However, the Committee concluded that, for people of all ages, the vaccine should only be given when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks.

What the safety data show

Serious side effects with the vaccine were reported mainly in people 65 years of age and older and in those with several underlying medical conditions. These side effects led to a worsening of the patients’ medical conditions or a deterioration in their general health, in some cases leading to hospitalisation and death.

Many of the serious side effects reported are similar to symptoms of chikungunya infection and include fever, malaise (feeling unwell), loss…