November 10, 2023 – The FDA on Thursday approved the primary vaccine against the chikungunya virus, which is transmitted to humans through mosquito bites.
The vaccine, called Ixchiq, manufactured by Valneva Austria GmbH, is given in a single dose to people over 18 who're at increased risk of contracting the virus. The safety of the vaccine was determined through two clinical trials involving roughly 3,500 adults. Common unintended effects included headache, fatigue, muscle pain, joint pain, fever, nausea, and tenderness where the needle entered the skin.
Severe reactions that prevented day by day activity or required medical intervention occurred in 1.6% of vaccine recipients, the FDA said in a report opinion Announcement of approval. Two individuals who received the vaccine required hospitalization.
Chikungunya is “an emerging global health threat” and at the least 5 million cases have been reported previously 15 years, the FDA said. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas.
Common symptoms of the virus include fever, joint pain, rash, headache and muscle pain. Some people suffer from joint pain for months or years. The World Health Organization says Deaths and serious illnesses are rare.
The CDC says Chikungunya cases within the United States were rare before 2006. From 2006 to 2013, a median of 28 people tested positive per 12 months, all travelers coming back from affected areas in Asia, Africa or the Indian Ocean. As of 2014, cases of chikungunya were reported in U.S. travelers coming back from affected areas in America. According to the federal agency, local transmission has been detected in Florida, Texas, Puerto Rico and the U.S. Virgin Islands.
“Chikungunya virus infection can cause serious illness and ongoing health problems, particularly in older adults and people with underlying medical conditions,” said Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research. “Today’s approval addresses an unmet medical need and represents an important advance in the prevention of a potentially debilitating disease with limited treatment options.”