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 chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. (Credit: Steven Cornfield on Unsplash)
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
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 most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.
In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that lasted for at least 30 days. The Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.
The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq.
The effectiveness of Ixchiq is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level.
Ixchiq was approved using the Accelerated Approval pathway. Accelerated approval allows the FDA to approve certain products for serious or life-threatening conditions based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit. In the FDA’s evaluation of Ixchiq for accelerated approval, evidence of effectiveness is based on immune response data in clinical trial participants. As a condition for approval for Ixchiq, the FDA is requiring confirmatory clinical studies to be conducted to verify clinical benefit.
Ixchiq was granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. In addition, the FDA awarded the manufacturer of Ixchiq a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
The FDA granted approval for Ixchiq to Valneva Austria GmbH.
Source: Company Press Release