The recent approval by the United States Food and Drug Administration (FDA) for Valneva’s Ixchiq vaccine stands as an advancement in the ongoing battle against the chikungunya virus, a mosquito-borne illness rapidly expanding its reach across the globe. For individuals 18 and above who are at a greater risk of exposure to the disease, Ixchiq has now been introduced as a vaccine.
Valneva’s Ixchiq is the world’s premier licensed vaccine targeting chikungunya, validated by the FDA through an accelerated approval process. This endorsement is rooted in the vaccine’s demonstrated ability to produce anti-CHIKV neutralizing antibody titers, marking a significant step forward in disease prevention strategies. However, its continued approval is contingent upon the confirmation of its clinical benefits through subsequent studies.
Chikungunya, primarily transmitted through mosquito bites, is rapidly spreading to new geographical areas, leading to a surge in global prevalence. According to the USFDA, parts of the Americas that have mosquitoes carrying chikungunya and tropical and subtropical areas within Southeast Asia and Africa are regions at the highest risk for the disease.
The need for safe and effective vaccines in light of the escalating threat posed by chikungunya, intensified by climate change has been highlighted by the CEO of Coalition for Epidemic Preparedness Innovations (CEPI), Richard Hatchett. The partnership between Valneva, Instituto Butantan, CEPI, and the support from the EU aims to make this vaccine accessible to the populations most affected in low- and middle-income countries. However, detailed plans regarding vaccine accessibility in these regions are yet to be outlined.
The severity of chikungunya infections, especially among older adults and individuals with underlying medical conditions, can result in prolonged health issues and debilitating joint pain. Symptoms typically include fever, joint pain, and, in some cases, persisting joint pain lasting for months or years. Current treatment involves rest, adequate fluids, and over-the-counter medications to manage pain and fever.
The vaccine contains a weakened version of the virus and when is injected into the muscle as a single dose injection, one administered it side effects manifest as the symptoms of the chikungunya virus. The safety and efficacy of the drug were evaluated through clinical studies involving over 3,000 participants aged 18 years and older, with one study encompassing approximately 1,000 individuals who received a placebo. Muscle and joint pain, fever, headache, fatigue, nausea, and tenderness at the injection site are among the commonly reported side effects listed by vaccine recipients.
While the FDA has granted approval, the company is mandated to conduct a post-marketing study to comprehensively assess the potential risk of severe chikungunya-like adverse reactions post-administration of Ixchiq. Following the approval Valneva intends to commercialize the vaccine by next year in the U.S.
