On November 9, the United States granted approval for Ixchiq, the world’s first chikungunya vaccine, developed by the European company Valneva. Chikungunya is an illness caused by a virus transmitted through infected mosquitoes, deemed an “emerging global health threat” by the US Food and Drug Administration (FDA). The vaccine has been authorized for individuals aged 18 and above who are at risk of exposure to the disease.
The FDA’s approval is expected to accelerate the vaccine’s deployment in regions where chikungunya poses a public health concern. Chikungunya typically manifests with fever and severe joint pain and is more prevalent in tropical and subtropical climates, particularly in Africa, Asia, and the Americas.
While historically more confined geographically, the chikungunya virus has spread to new areas, contributing to an increase in global disease prevalence, with over 5 million cases reported in the last 15 years, according to the FDA.
The vaccine, administered in a single dose, incorporates a weakened but live chikungunya virus. FDA senior official Peter Marks highlighted the importance of this approval in addressing an unmet medical need, particularly for older adults and individuals with underlying health conditions, emphasizing the vaccine’s role in preventing a potentially debilitating disease with limited treatment options.
Before receiving approval, the vaccine underwent two clinical trials involving 3,500 participants. Commonly reported side effects included fatigue, headache, muscle and joint pain, fever, and nausea. Serious reactions were observed in 1.6% of Ixchiq recipients, with two patients requiring hospitalization. The FDA has requested the company to conduct a post-marketing study to assess whether severe reactions similar to chikungunya occur after vaccine administration.
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