FDA

FDA, CDC recommend pause in use of Ixchiq vaccine in older patients amid safety review

May 12, 2025

FDA and CDC are recommending a pause in the use of Ixchiq (chikungunya vaccine, live) in individuals 60 years and older while the agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events. As of May 7, 2025, 17 serious adverse events, including two deaths, have been reported globally in individuals 62 through 89 years of age who received Ixchiq, with six reports from the U.S. Most adverse events were in individuals with underlying chronic medical conditions. Adverse events reported to the the Vaccine Adverse Event Reporting System may not be causally related to vaccination. Approximately 80,000 doses of Ixchiq have been distributed globally.

Ixchiq, approved in November 2023, contains a live, weakened chikungunya virus and may cause symptoms similar to chikungunya disease. Severe or prolonged chikungunya-like adverse reactions occurred in 1.6% of recipients during clinical studies. FDA and CDC will continue to evaluate the safety of Ixchiq and update the public upon completing their assessment.

Source:

FDA. (2025, May 9). FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While Postmarketing Safety Reports are Investigated. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-and-cdc-recommend-pause-use-ixchiq-chikungunya-vaccine-live-individuals-60-years-age-and-older