PRAC warns about known risk of aseptic meningitis with chikungunya vaccine Ixchiq

Update to product information recommended to reflect recent evidence

EMA’s safety committee (PRAC) has completed its review of a safety signal of aseptic meningitis with Ixchiq (live attenuated chikungunya vaccine) and has recommended an update to the vaccine’s product information to reflect the most recent evidence related to this known risk.

The safety signal was started following a reported case of aseptic meningitis which occurred in a healthy young adult following vaccination with Ixchiq. Aseptic meningitis is an inflammation of the membranes that surround the brain and spinal cord, typically caused by viruses rather than bacteria.

Aseptic meningitis as well as encephalopathy and encephalitis (other disorders of the nervous system) are already listed in the product information of Ixchiq as known side effects with an unknown frequency (meaning that the available data do not allow estimating…