Date of Publication: 13-Mar-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently concluded a safety review regarding Ixchiq, a live attenuated vaccine used to prevent Chikungunya virus disease.
The committee is recommending an update to the vaccine’s product information to better reflect recent evidence concerning the risk of aseptic meningitis.
What is the New Evidence?
The safety review was triggered by a reported case of aseptic meningitis in a healthy young adult following vaccination.
While neurological conditions like aseptic meningitis, encephalopathy, and encephalitis were already listed as potential side effects of Ixchiq, they were previously observed primarily in: Older adults (over 65 years of age) and Individuals with multiple long-term underlying medical conditions.
The upcoming update to the product information will now explicitly state that these serious side effects can also occur in healthy younger populations.
Ongoing Monitoring
The PRAC is currently conducting a broader evaluation of Ixchiq as part of a regular six-month Periodic Safety Update Report (PSUR), expected to conclude in June 2026. This assessment will determine if this new data, or any other emerging safety information, affects the overall benefit-risk balance of the vaccine.
As with all authorized medicines, the safety of Ixchiq remains under continuous surveillance. Recommendations for its use will be updated further if more relevant information becomes available to ensure the highest level of patient safety.
KEYWORDS: Safety Signal, Safety Surveillance, Adverse Drug Reactions
REFERENCE: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2026