Valneva Austria has received approval from the US Food and Drug Administration (FDA) for Ixchiq, the first chikungunya vaccine.
Ixchiq is approved to be used for individuals aged 18 years and above at increased risk of exposure to the virus.
Administered as a single dose by injection into the muscle, the vaccine has a live, weakened version of the chikungunya virus.
It is expected to cause symptoms in individuals who receive the vaccine similar to those experienced by people with the disease.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.
“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.”
Ixchiq’s safety was assessed in two trials that were carried out in North America.
In these trials, nearly 3,500 subjects aged 18 years and above took part and were given a dose of the vaccine with one study including around 1,000 participants who received a placebo.
Headache, muscle pain, fatigue, joint pain, nausea, fever and tenderness at the injection site were the most commonly reported side effects by recipients of the vaccine.
As per the FDA’s requirement, the company needs to conduct a postmarketing study for evaluating the serious risk of severe chikungunya-like adverse reactions after Ixchiq administration.
The regulator approved Ixchiq using the accelerated approval pathway.
Initially, the vaccine received fast track and breakthrough therapy designations.