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Ixchiq Vaccine Linked to Fatal Adverse Events in Seniors, FDA and CDC Urge Caution
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Key Takeaways
- The FDA and CDC recommend against Ixchiq vaccination in those 60+ due to severe adverse events, including fatalities.
- Chikungunya is a mosquito-borne viral illness causing severe joint pain, with no treatment beyond symptom management.
FDA and CDC halt Ixchiq chikungunya vaccine for adults 60 years and older due to severe adverse events, including fatalities, urging caution in vaccination practices.
The FDA and CDC made a joint announcement advising against inoculation against chikungunya infection with the Ixchiq vaccine (Valneva) for older adults ages 60 and older. The recommendation comes amid 2 fatalities and 17 adverse effects (AE), mainly neurologic and cardiac events.1
Chikungunya blood test vial | Image Credit: © kitsawet - stock.adobe.com
Chikungunya infection is a viral illness spread through mosquito bites, more commonly found in tropical and subtropical regions of Africa, Southeast Asia, and portions of the Americas. It is characterized by symptoms such as fever and joint pain, which can become severe. The name 'chikungunya,' meaning 'bent over,' reflects the severity of the joint pain associated with the disease. There is no treatment for chikungunya beyond symptom management, and the best form of prevention is through vaccination. The vaccine is given as a single-dose injection comprised of a live, weakened version of the virus.2,3
Ixchiq was the first FDA-approved vaccine for protection against chikungunya infection in 2023 for individuals ages 18 and older, marking a significant milestone in the prevention of the disease. The accelerated approval was granted based on 2 clinical studies where the vaccine showed meaningful protection but did result in chikungunya-related symptoms that limited daily activity (1.6% of patients) or hospitalization (2 patients).2
However, the announcement made on Monday, May 12, 2025, reports severe AEs that warrant the discontinuation of inoculation with Ixchiq. According to postmarketing reports, the AEs are consistent with severe complications of chikungunya disease, resulting in hospitalization. In the official statement, the FDA and CDC wrote:
“As of May 7, 2025, 17 serious adverse events, including 2 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.”3
Of the 2 fatalities, one was a male patient 84 years of age who had encephalitis, and the other was a male patient 77 years of age with Parkinson disease whose swallowing difficulties increased and might have resulted in aspiration pneumonia.4
In light of these findings, the FDA and CDC emphasize the importance of ongoing pharmacovigilance and updated clinical guidance to protect vulnerable populations. Although Ixchiq remains available for use in younger, healthier adults, pharmacists are urged to weigh individual risks and benefits carefully. The agencies also noted that further investigation is underway to determine any underlying mechanisms that may predispose older adults to adverse outcomes and whether additional safeguards or labeling changes may be necessary.
