Ixchiq, the first chikungunya vaccine, received US FDA approval

 Ixchiq, the first chikungunya vaccine, received US FDA approval

According to the FDA, two clinical trials were carried out in North America to assess the safety of Ixchiq. Approximately 3,500 individuals who were 18 years of age or older got a dose of the vaccine, while approximately 1,000 participants in one study received a placebo.

The FDA said that confirmatory clinical trials to confirm clinical benefit must be carried out before approving Ixchiq.

The US Food and Drug Administration (FDA) has authorized Ixchiq, the first vaccination against chikungunya, for those 18 years of age and older who are more likely to be exposed to a virus carried by mosquitoes. Ixchiq is injected into the muscle as a single dosage and contains a live, attenuated strain of the virus that causes chikungunya. According to a statement from the FDA, the drug may elicit symptoms in the recipient that are similar to those of patients who have the viral illness.

According to Peter Marks, director of the FDA's Center for Biologics Development and Research, "infection have the chikungunya virus can lead to severe disease as well as prolonged health problems, particularly among older adults or those with underlying medical conditions." "Today’s acceptance addresses an unmet medical need therefore is an important advancement in preventing the development of a potentially debilitating disease alongside limited treatment options," Marks added.

According to the agency's announcement, a clinical research involving US adults 18 years of age and older established the vaccine's efficacy. It was said that the amount of antibodies produced in the 266 vaccinated individuals was "based on a level proved to be protective in non-human primates that had been given blood from human beings who had been vaccinated". According to the research, these subjects' immunological responses were compared to those of 96 people who received a placebo. According to the FDA, two clinical trials were carried out in North America to assess the safety of Ixchiq. Approximately 3,500 individuals who were 18 years of age or older got a dose of the vaccine, while approximately 1,000 participants in one study received a placebo.

According to the federal authorities, headache, exhaustion, joint and muscle discomfort, fever, nausea, and injection site sensitivity were the most often reported adverse effects. Two recipients were admitted to the hospital and 1.6% of the recipients had serious adverse responses akin to chikungunya that interfered with daily activities and/or required medical attention. According to the organization, the negative effects persisted in some people for at least 30 days. Valneva Austria GmbH, a Vienna, Austria-based biotechnology business, received permission from the FDA for Ixchiq, the statement said.

Additionally, the government said that Ixchiq was authorized under the Accelerated Approval process on the basis of efficacy data gathered from clinical trials. The FDA said that confirmatory clinical trials to confirm clinical benefit must be carried out before approving Ixchiq. In addition, the government mandates that the biotechnology business carry out a postmarketing research to evaluate the potential substantial risk of severe adverse events similar to chikungunya after Ixchiq is administered, according to the statement.