“Today’s approval addresses an unmet medical need to prevent a potentially debilitating disease for which treatment options are limited,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “This is an important advance in the field.”
Chikungunya is a viral disease that is spread to humans through the bite of an infected person. Aedes Mosquitoes, especially Aedes aegypti and Aedes albopictus. Symptoms include high fever, severe joint and muscle pain, headache, and rash. Chikungunya cases have been confirmed in the following areas: Over 110 countries in Asia, Africa, Europe and the Americas.was there More than 2 million cases have been reported worldwide since 2005according to the World Health Organization.
Prior to 2006, The virus was rarely detected in U.S. travelers., according to the Centers for Disease Control and Prevention. But since then, an average of 28 people have tested positive for the disease each year. In 2022, CDC reported 81 Travel-related matters.
Public health experts fear the number of cases will continue to rise because warmer temperatures are ideal for the mosquitoes that carry the virus to reproduce and thrive.
“This is really a vaccine of the future because chikungunya hasn’t yet caused a large-scale outbreak, but it’s likely to happen within the next few decades,” said Peter Hotez, dean of Baylor University’s National School of Tropical Medicine. Told. He is an M.D. and co-director of the Vaccine Development Center at Texas Children’s Hospital.
Hotez said climate change and urbanization are the main causes of the spread of vector-borne diseases such as chikungunya. He added that the approval of Ixic lays the foundation for other vaccines to treat mosquito-related diseases.
The FDA has approved Ixchiq, manufactured by biotechnology company Valneva Austria GmbH, as a single dose for people 18 and older who are at high risk of exposure to the disease.
The approval was granted through the FDA’s expedited approval process, which aims to expedite “reasonably possible” treatments for serious or life-threatening diseases. Under this process, the FDA evaluated the vaccine’s safety in two clinical studies and tested its effectiveness based on antibody levels present in 266 participants who received the vaccine. The FDA reported that nearly all participants had antibody levels similar to those shown to be protective in non-human primates.
More data on the vaccine is needed to confirm its effectiveness and the severity of side effects such as headache, muscle pain, fever, and tenderness at the injection site. As part of the approval process, the FDA requires manufacturers to conduct additional studies after vaccination.
“As this vaccine is rolled out, it will be important to know that this vaccine prevents disease. We need to take these steps to ensure this is a public health success.” Albert Coe said. , an infectious disease physician and epidemiologist at the Yale School of Public Health.
There are no specific antiviral treatments or other preventive measures for chikungunya. Most acute symptoms resolve within a few days, but some people may experience long-term arthritis pain.Newborns who are infected at birth are at highest risk of developing severe disease. and people over 65 years old.
