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Medscape

Suspend Use of Chikungunya Vaccine in Adults Aged 60+

Healthcare providers should pause in their use of the chikungunya live vaccine (Ixchiq) while investigation of serious neurologic, cardiac, and other adverse events in vaccine recipients is ongoing, according to a safety communication issued jointly by the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC). A total of 17 serious adverse events, two of which resulted in deaths, have been reported as of May 7, 2025, according to the communication. The events occurred in adults aged 62-89 years who received the live chikungunya vaccine worldwide during postmarketing availability. Six of the events occurred in the United States. Most of the serious adverse events associated with the chikungunya vaccine in the United States and overseas that have been reported to the Vaccine Adverse Event Reporting System (VAERS) have occurred in patients with underlying medical conditions and may not be causally linked to the vaccine, according to the communication. Some of the serious adverse events reported are consistent with complications from chikungunya disease, and the FDA-approved vaccine prescribing information warns that severe or prolonged chikungunya-like adverse reactions may occur. In clinical trials comparing the vaccine with placebo, severe chikungunya-like reactions were observed in 1.6% of vaccine patients vs none of placebo patients. Postmarketing reports of adverse events included one death from encephalitis. The FDA approved the vaccine for the prevention of chikungunya virus in adults aged 18 years or older who are at increased risk for exposure, and the vaccine contains a live, though weakened, version of the virus, according to the communication. Approximately 80,000 doses of the vaccine have been distributed worldwide to date. The FDA and CDC will continue to evaluate postmarketing safety reports, and the agencies recommend that healthcare providers refrain from administering the vaccine to adults aged 60 years or older while the investigations are ongoing. Healthcare providers are advised to report any adverse events in recipients of the chikungunya vaccine to VAERS.