Following similar actions by France and the European Union, U.S. health authorities are urging a pause in the use of Valneva’s chikungunya vaccine, Ixchiq, in older adults.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a temporary suspension of Ixchiq’s use in individuals aged 60 and older while investigations into serious adverse events (SAEs) continue on both sides of the Atlantic.
This joint advisory builds on the CDC’s April recommendation to administer the vaccine with caution in people aged 65 and above, according to a press release issued by Valneva on Monday. The European Medicines Agency (EMA) has also restricted the use of Ixchiq in older adults and those with weakened immune systems.
The EMA launched a safety review of the vaccine following reports of 17 serious adverse events, including two deaths, among recipients aged 62 to 89. The review began shortly after a similar move by French health authorities.
“As noted by the FDA and CDC, these adverse events may not be causally linked to the vaccine. However, a thorough evaluation is critical to ensure the safe use of Ixchiq, which has been administered in more than 40,000 doses globally,” Valneva stated in its latest response to the U.S. recommendation.
The company said it is coordinating with health authorities worldwide and expects structured reviews of post-marketing safety data in all regions where Ixchiq is approved.
Last month, Brazil became the first endemic country to grant marketing authorization for Ixchiq. The vaccine is also approved in the U.S., Canada, and the European Union.
Valneva emphasized its commitment to safety and collaboration with regulatory bodies, promising timely updates on all known serious adverse events. According to the company, most reported safety concerns have occurred in older individuals with pre-existing health conditions.
Despite the current scrutiny, Valneva is standing by Ixchiq. The vaccine was the first to receive FDA approval for chikungunya prevention in November 2023 and is intended for adults at increased risk of exposure to the virus, which is spread by mosquitoes in tropical regions.
