PRAC Warns of Ixchiq Vaccine Aseptic Meningitis Risk in Healthy Young Adults
Summary
PRAC completed its review of a safety signal of aseptic meningitis with Ixchiq (live attenuated chikungunya vaccine) and recommended updating the product information to reflect that serious side effects such as aseptic meningitis have also been observed in healthy young adults. Previously, most reported cases had occurred in older people (over 65 years of age) or those with multiple long-term conditions. PRAC is also conducting a periodic safety update report assessment concluding in June 2026.
Healthcare providers administering Ixchiq should ensure patients are counselled on the symptoms of aseptic meningitis (confusion, sleepiness, fever, headache, seizures, neck stiffness) and advised to seek immediate medical attention if these occur post-vaccination. The product information update broadens the known-risk population from older and multimorbid patients to include healthy young adults.
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What changed
PRAC completed its review of a safety signal for aseptic meningitis with Ixchiq and recommended updating the vaccine's product information to reflect that serious side effects such as aseptic meningitis have been observed in healthy young adults. Previously, most cases occurred in people over 65 or those with multiple long-term conditions.\n\nHealthcare providers administering Ixchiq should advise patients to seek immediate medical attention if they develop symptoms of meningitis (confusion, sleepiness, fever, headache, seizures, neck stiffness) after vaccination. The ongoing PSUR assessment concluding in June 2026 will evaluate whether new safety information impacts the benefit-risk balance.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
PRAC March 2026: warning about the known risk of aseptic meningitis after administration of the Ixchiq vaccine
date: 03/04/2026 During its March 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended an update to the vaccine’s product information to reflect that serious side effects, such as aseptic meningitis, have also been observed in healthy young adults.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) 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 how often the side effects occur). Symptoms include confusion, sleepiness, fever, headache, seizures and neck stiffness. Anyone who develops these symptoms after receiving Ixchiq should seek medical attention immediately.
Ixchiq’s product information will now be updated to reflect that serious side effects, such as aseptic meningitis, have also been observed in healthy young adults. Previously, most reported cases had occurred in older people (over 65 years of age) or people with multiple long-term medical conditions.
PRAC is also carrying out an evaluation of Ixchiq in the context of a regular 6-monthly PSUR (periodic safety update report) assessment, which will conclude in June 2026. This will allow assessing whether newly available information relating to the risk of aseptic meningitis, or any other emerging safety information, has an impact on the balance of benefits and risks of Ixchiq.
As for any medicine, the safety of Ixchiq is closely monitored and the recommendations for use will be updated if new, relevant information becomes available.
The vaccine Ixchiq is available in Belgium.
More information is available on the EMA website.
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Last updated on
03/04/2026
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