The European Medicines Agency has suspended Valneva's Ixchiq chikungunya vaccine for use in elderly patients following reports of serious adverse events, including two deaths, in people aged 62 to 89 years who received the vaccine.
Safety Investigation Underway
The EMA is investigating whether Ixchiq is safe to use in the elderly following reports of 17 serious adverse events in the target age group. The safety review comes after two cases resulted in death among patients aged 62 to 89 years who received the vaccine.
This regulatory action follows similar measures taken by US and French authorities last month regarding Ixchiq's use in people over 65 years of age, indicating a coordinated international response to emerging safety signals.
Regulatory Context
The suspension represents a significant development for Valneva's chikungunya vaccine program, as elderly populations are often considered a priority group for vaccination due to increased vulnerability to infectious diseases. The EMA's decision to suspend use in this population while conducting a safety review demonstrates the agency's commitment to patient safety and ongoing pharmacovigilance.
The investigation will likely examine the relationship between age and adverse event risk, as well as the benefit-risk profile of the vaccine in elderly populations compared to younger age groups. The outcome of this safety review will be crucial for determining the future use of Ixchiq in elderly patients across the European Union.
