FDA approves first chikungunya vaccine

The US Food and Drug Administration (FDA) yesterday announced that it has approved Valneva’s chikungunya vaccine, the first vaccine of its kind against the mosquito-borne disease. Called Ixchiq, the vaccine is approved for those ages 18 and older at increased risk for the disease.

Chikungunya is considered an emerging global health threat, with at least 5 million cases reported over the last 15 years, mainly in areas where the mosquito that carries the virus is endemic. The most-affected regions include Africa, Southeast Asia, and parts of the Americas. The FDA said chikungunya is spreading to new areas, which has led to a rise in global prevalence.

The disease isn’t usually fatal but is known to cause fever and sometimes debilitating joint pain that can last months to years. Other symptoms include rash, headache, and muscle pain. Transmission to babies from mothers during pregnancy can cause potentially fatal infections.

Peter Marks, MD, PhD, who directs the FDA’s Center for Biologics Evaluation and Research, said 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.”

The live attenuated vaccine is given as a single dose, and the vaccine effects can be similar to chikungunya illness symptoms. The FDA is requiring the company to do a postmarketing study to evaluate the risk of severe reactions following Ixchinq immunization. The prescribing information contains a warning that it’s not known if the vaccine virus can transmit or cause any adverse effects in newborns.

Valneva, in a statement today, said the accelerated approval is based on neutralizing antibody titers and that continued approval hinges on studies that confirm a clinical benefit. Its phase 3 study found a 98.9% seroresponse rate at 28 days that was sustained at 96.3% 6 months after vaccination. It said it plans to commercialize the vaccine in early 2024 and is working toward a vote by the Centers for Disease Control and Prevention’s vaccine advisory group in February 2024.

 

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