Ixchiq has been approved by the US Food and Drug Administration, making it the first chikungunya vaccine to be approved.?This vaccine is intended for people over the age of 18 who are at high risk of contracting the chikungunya virus.
Mosquito bites primarily transmit chikungunya and are a global health threat, with over 5,000,000 cases reported in the last 15 years.?While the virus is most common in tropical and subtropical areas, it has spread to new areas, increasing its global impact.
Last Thursday, the US Food and Drug Administration approved the world's first vaccine for chikungunya, a virus spread by infected mosquitos that the FDA described as "an emerging global health threat."
The vaccine, developed by Europe's Valneva and marketed as Ixchiq, has been approved for people aged 18 and up who are at high risk of exposure, according to the FDA.?
Ixchiq's approval by the US Food and Drug Administration is expected to accelerate the vaccine's rollout in countries where the virus is most prevalent.?
Ixchiq is given as a single injection into the muscle and contains a weakened form of the chikungunya virus. The vaccine may cause symptoms similar to the disease itself.
Around 3,500 people in North America took part in the safety evaluations, with common side effects including headache, fatigue, and joint pain. In 1.6% of Ixchiq recipients, severe chikungunya-like reactions occurred, resulting in hospitalization in two cases.
The FDA has ordered a postmarketing study to evaluate the possibility of severe adverse reactions to Ixchiq.
There is a warning about the potential transmission of the vaccine virus from pregnant women to newborns, emphasizing the importance of careful consideration by healthcare providers.
Ixchiq's efficacy is based on immune response data, and the FDA granted accelerated approval. Confirmatory clinical trials are needed to prove its clinical benefit.
On Thursday, November 9, 2023.
Chikungunya, which causes fever and severe joint pain, is most commonly seen in Africa, Southeast Asia, and parts of the Americas.
"However, the chikungunya virus has spread to new geographical areas, causing a rise in global prevalence of the disease," the FDA said, noting that more than five million cases have been reported in the last 15 years.
"Infection with the Chikungunya virus can cause severe disease and long-term health problems, especially in older adults and people with underlying medical conditions," said senior FDA official Peter Marks in a statement.
"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."
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