FDA lifts pause on Chikungunya vaccine for older adults, with some caveats

FDA has removed its May 2025 recommendation to pause use of Ixchiq, the live chikungunya vaccine, in adults aged ≥60 years. This decision follows a completed benefit-risk reassessment prompted by postmarketing reports of serious adverse events, including cardiac and neurologic complications.

Ixchiq remains approved for individuals ≥18 years at high risk of chikungunya virus exposure. However, new labeling emphasizes that most U.S. travelers are not advised to receive the vaccine, given their low exposure risk. The updated warnings detail rare but severe vaccine-related reactions—some mimicking complications of natural infection—including encephalitis and hospitalization, particularly in older adults with chronic conditions.

Clinicians should weigh individual risk factors for both chikungunya infection and vaccine-related adverse events. FDA continues to monitor safety through VAERS and has mandated a postmarketing study, set to begin by October 2025.

Source:

(2025, August 6). FDA. FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Removes Recommended Pause in Use and Approves Required Updated Labeling. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live