EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

EMA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people. Many of the people affected also had other illnesses and the exact cause of these adverse events and their relationship with the vaccine have not yet been determined. So far 17 serious adverse events, including two cases resulting in death, have been reported worldwide in people aged between 62 and 89 years who received the vaccine. Given that studies on Ixchiq mainly involved people below 65 years of age and the vast majority of serious cases concerned people 65 years of age and above, the Committee is temporarily recommending restricting the use of vaccine. As a temporary measure while an in-depth review is ongoing, Ixchiq must not be used in adults aged 65 years and above. Ixchiq vaccination can continue in people under 65 years of age, in accordance with official recommendations. In addition to the new restriction, the Committee is also reminding healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment. Persons with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses, regardless of age. The PRAC will now review all available data to assess the benefits and risks of the vaccine and make a recommendation on whether to change the terms of its marketing...