“Today’s approval addresses an unmet medical need and is an important step forward in preventing a potentially debilitating disease with limited treatment options,” said Peter Marks, director of the Center for Evaluation and of research on biologics of the FDA, in a press release.
Chikungunya is a viral disease transmitted to humans through the bites of infected people. Aedes mosquitoes, especially Aedes aegypti And Aedes albopictus. Its symptoms include high fever, severe joint and muscle pain, headache and skin rashes. Chikungunya cases have been identified in more than 110 countries in Asia, Africa, Europe and the Americas. According to the World Health Organization, more than 2 million cases have been reported worldwide since 2005.
Before 2006, the virus was rarely identified in U.S. travelers, according to the Centers for Disease Control and Prevention. But since then, an average of 28 people per year have tested positive for the disease. In 2022, the CDC reported 81 travel-related cases.
Public health experts fear the number of cases will continue to rise because warmer temperatures are optimal for mosquitoes carrying the virus to multiply and thrive.
“This is really a vaccine for the future, because chikungunya is not very present yet, but it looks like it will be in the coming decades,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development.
Hotez says climate change and urbanization are the main culprits behind the increasing prevalence of vector-borne diseases such as chikungunya. He added that Ixchiq’s approval lays the groundwork for other vaccines to treat mosquito-related diseases.
The FDA approved Ixchiq, made by biotechnology company Valneva Austria GmbH, as a single dose for people 18 and older at increased risk of exposure to the disease.
Approval was granted under the FDA’s accelerated approval process, designed to expedite “reasonably likely” treatments for serious or life-threatening illnesses. As part of this process, the FDA evaluated the safety of the vaccine in two clinical studies and tested its effectiveness based on antibody levels present in 266 participants who received the vaccine. The FDA reported that almost all participants had the same levels of antibodies that have been shown to be protective in non-human primates.
More data on the vaccine is needed to confirm its effectiveness and the severity of its side effects, including headache, muscle pain, fever and tenderness at the injection site. As part of the approval process, the FDA requires the manufacturer to conduct additional studies after the injections are administered.
“As this vaccine is rolled out, it will be important to know that this vaccine prevents disease, and these are the kinds of steps that need to be taken to confirm that this will be a public health success” , said Albert Ko., an infectious disease physician and epidemiologist at the Yale School of Public Health.
There are no specific antiviral treatments or other preventive interventions for chikungunya. Most acute symptoms disappear within a few days, but some people may develop long-term arthritis pain. Those most at risk of developing serious illness are newborns who were infected at the time of birth. and people over 65 years old.