PV Bulletin

Ixchiq (Chikungunya vaccine (live)) - Safety measures following PRAC review

PRAC recommends safety measures for Ixchiq due to risk of aseptic meningitis and serious side effects in elderly.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

PRAC recommended safety measures for Ixchiq, including updated product information and guidance for elderly use, based on the risk of aseptic meningitis and serious side effects.

Why it matters

This affects the benefit-risk profile of Ixchiq, particularly in elderly patients, and may require updates to labeling and risk minimization activities.

Action needed

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

Single event

Regulatory action details

Action type
PRAC recommendation
Publication date
2026-06-05
Safety issue
Implementation of safety measures following a PRAC review regarding the risk of aseptic meningitis and serious side effects in elderly populations (VR/0000347283).

Affected products

  • Ixchiq
    Valneva

PV internal implications

Updated product information and guidance for use in elderly populations.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 5, 2026

Full briefing

Practical implication

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

EMA's PRAC concluded a review of Ixchiq (chikungunya vaccine) and recommended implementation of safety measures, including updates to product information and guidance for use in elderly populations, due to risks of aseptic meningitis and serious side effects.

What changed: PRAC recommended safety measures for Ixchiq, including updated product information and guidance for elderly use, based on the risk of aseptic meningitis and serious side effects.

Why it matters: This affects the benefit-risk profile of Ixchiq, particularly in elderly patients, and may require updates to labeling and risk minimization activities.

Practical implication: Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#firecrawl-agent#regulatory-extraction#Other#European Medicines Agency (EMA)#PRAC recommendation

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