Valneva Shares Key Update On IXCHIQ® Recommendations For Older Adults In The U.S.

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have advised healthcare providers in the United States to temporarily stop using the chikungunya vaccine IXCHIQ® in adults over the age of 65. This precautionary measure is being taken while authorities investigate reports of serious adverse reactions in this age group. This decision follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP), which had advised adding a warning for people over 65 regarding the vaccine’s use. 

Similarly, the European Medicines Agency (EMA) has also suspended the use of IXCHIQ® in individuals over 65 while its own investigation is ongoing. So far, over 40,000 doses of the vaccine have reportedly been administered worldwide. Most of the adverse events being reviewed were reported through the U.S. Vaccine Adverse Event Reporting System (VAERS), and many involved older adults who already had serious health conditions and were receiving other medical treatments.

Juan Carlos Jaramillo, Valneva's Chief Medical Officer, said in a statement, “We reiterate our support for the precautionary measures that have been taken and our commitment to continue monitoring all reported serious adverse events, particularly from the ongoing vaccination campaign in Réunion, as no new serious adverse events have been reported outside of this vaccination campaign aimed at combating the ongoing epidemic. We will continue to proactively engage with global regulatory authorities as these important assessments continue over the coming months.”

Although the FDA and CDC have clarified that not all adverse events may be directly linked to the vaccine, a thorough review is necessary to ensure its safety for all age groups. Investigations are underway in all regions where the vaccine is approved, and a comprehensive update will be provided once the safety evaluations are complete. Despite the temporary pause for older adults, the vaccine continues to be recommended for adults aged 18 to 60 years in the U.S., and for those aged 12 to 64 years in the EU. 

In France, the public health authority (Haute Autorité de Santé, or HAS) is continuing its vaccination campaign for individuals aged 18 to 64 to help control the current chikungunya outbreak in Réunion. The company behind IXCHIQ® is cooperating with global health agencies and remains confident in the overall benefit-risk profile of the vaccine, especially for those at risk of chikungunya infection.