The FDA has officially removed its recommended pause on the use of the Chikungunya vaccine, IXCHIQ®, in individuals aged 60 years and older, following a thorough benefit-risk assessment triggered by post-marketing safety concerns earlier this year. The vaccine, manufactured by Valneva, remains authorized in the United States for adults 18 and older who face significant risk of exposure to Chikungunya virus (CHIKV)—a mosquito-borne pathogen causing fever, severe joint pain, and fatigue, and associated with periodic outbreaks throughout Asia, Africa, the Americas, and beyond.
The temporary pause, instated in May 2025, was prompted by U.S. health officials after reports surfaced of serious adverse reactions, including neurologic and cardiac events among older vaccine recipients; one fatal case of encephalitis was noted. In response, both the FDA and CDC launched investigations, ultimately concluding that—with stricter usage guidelines and updated safety information—the benefits for high-risk older adults outweighed the potential risks. The vaccine’s updated labeling now includes clear warnings regarding risks, especially for seniors with chronic medical conditions, and highlights its contraindication in people with weakened immune systems. Healthcare professionals are urged to perform careful screening and risk-benefit analysis prior to vaccination.
Developed amidst global outbreaks since 2004, IXCHIQ® is a live, attenuated vaccine that primes the immune system against CHIKV. Clinical trials have demonstrated high levels of effectiveness, with nearly all vaccinated individuals developing sustained protective antibodies against the virus. Nevertheless, the FDA notes that routine vaccination is not advised for most U.S. travelers, as the general risk of infection remains low; instead, it targets those traveling to or working in regions with active outbreaks.
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