FDA Approves First Vaccine for Mosquito-Borne Chikungunya Virus

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Nov. 10, 2023 -- The FDA on Thursday approved the first vaccine for the chikungunya virus, which is transmitted to humans through mosquito bites.

The vaccine, called Ixchiq and produced by Valneva Austria GmbH, is given in a single dose to people over 18 who are at increased risk of exposure to the virus. The safety of the vaccine was determined through two clinical studies involving about 3,500 adults. Common side effects included headache, fatigue, muscle pain, joint pain, fever, nausea, and tenderness where the needle went in the skin.

Severe reactions that prevented daily activity or required medical intervention occurred in 1.6% of vaccine recipients, the FDA said in a statement announcing the approval. Two people who received the vaccine had to be hospitalized. 

Chikungunya is “an emerging global health threat” and at least 5 million cases have been reported in the last 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, a rash, headache, and muscle pain. Some people will experience joint pain for months or years. The World Health Organization says deaths and severe illnesses are rare. 

The CDC says chikungunya cases in the U.S were rare before 2006. From 2006 to 2013, an average of 28 people per year tested positive, all of them travelers returning from affected areas in Asia, Africa, or the Indian Ocean. Beginning in 2014, chikungunya cases were reported among U.S. travelers returning from affected areas in the Americas. Local transmission was identified in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands, according to the federal agency. 

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals 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 is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”