Ixchiq, the first chikungunya vaccine, has been approved by the US Food and Drug Administration (FDA) for individuals 18 years of age and older who are at increased risk of exposure to mosquito-borne virus.
Containing a live, weakened version of the chikungunya-causing virus, Ixchiq is administered as a single dose by injection into the muscle and may cause symptoms in the recipient similar to those experienced by people having the viral disease, the FDA said in a statement.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options,” said Marks.
The effectiveness of the vaccine was determined through a clinical study in individuals 18 years of age and older in the US, the agency’s statement said. The level of antibody generated in the 266 vaccinated participants was “based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated”, it said.
The study had compared the immune response of these individuals with that of 96 participants receiving placebo, it said.
The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo, the FDA said.