FDA and CDC Recommend Pause in Use of Ixchiq Vaccine for Individuals 60 and Older

On May 12, the FDA and the CDC announced that they are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine.

The announcement stated, “As of May 7, 2025, 17 serious adverse events, including two that resulted in death, have been reported in individuals 62 through 89 years of age who received Ixchiq during postmarketing use globally. Six of these reports have been from the United States (U.S.). Most U.S. and foreign serious adverse events that have been reported to the Vaccine Adverse Event Reporting System (VAERS), co-managed by FDA and CDC, have been in individuals with underlying chronic medical conditions. Adverse events reported to VAERS may not be causally related to vaccination. Approximately 80,000 doses of Ixchiq have been distributed globally.”

Further, “Some of the postmarketing reports include adverse events that are consistent with severe complications of chikungunya disease, resulting in hospitalization; one person died from encephalitis. The FDA-approved Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.”

Severe chikungunya-like reactions occurred in 1.6% of Ixchiq vaccine recipients, including two hospitalizations and some cases lasting over 30 days. No such reactions occurred in the placebo group. Due to these findings, the FDA and CDC are recommending a pause in the vaccine’s use for individuals aged 60 and older while they conduct a further safety review.