The US Food and Drug Administration (FDA) yesterday announced that it 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.
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Chikungunya is considered an emerging health threat worldwide, with at least 5 million cases reported in the past 15 years, mainly in areas where the mosquito that carries the virus is endemic. The most affected regions include Africa, Southeast Asia, and some parts of the Americas. The FDA says chikungunya is spreading to new areas, leading to an increase in global prevalence.
The disease is not 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 aches. Transmission to infants 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 advance in preventing a potential which is a debilitating disease with limited treatment options.”
The live attenuated vaccine is given as a single dose, and the effects of the vaccine can be similar to the symptoms of chikungunya disease. The FDA is requiring the company to do a postmarketing study to evaluate the risk of severe reactions following vaccination with Ixchinq. The prescribing information contains a warning that it is not known whether the vaccine virus can transmit or cause any adverse effects in newborns.
Valneva, in a statement now, it says that accelerated approval is based on neutralizing antibody titers and that continued approval depends on studies proving a clinical benefit. Its phase 3 study found a 98.9% seroresponse rate at 28 days that was maintained at 96.3% 6 months after vaccination. It said it plans to commercialize the vaccine in early 2024 and is pushing for a vote by the Centers for Disease Control and Prevention’s vaccine advisory group in February 2024.
