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FDA Grants World's First Vaccine Approval for Chikungunya Virus

FDA Grants World’s First Vaccine Approval for Chikungunya Virus

In a significant milestone, the United States Food and Drug Administration (FDA) has given the green light to the Ixchiq® vaccine developed by Valneva, marking a global first in the prevention of Chikungunya virus-related diseases.

Understanding the Chikungunya Virus

Chikungunya Virus (CHIKV), classified under the Togaviridae family, is transmitted through Aedes mosquitoes. Its global spread, encompassing over 110 countries, has raised concerns, with climate change potentially exacerbating the issue. As Earth’s temperature continues to rise, the habitats of these mosquitoes are likely to expand.

Between 2013 and 2023, over 3.7 million cases were reported in North and South America alone. While CHIKV’s mortality rate is low, its morbidity is high, manifesting as symptomatic illness approximately four to seven days post-infection. Clinical symptoms include sudden onset fever, debilitating joint and muscle pain, headaches, nausea, rash, and chronic arthralgia.

Travelers face a heightened infection risk in regions where CHIKV-transmitting mosquitoes are endemic, including North and South America, parts of Africa, and Southeast Asia.

The Ixchiq Vaccine: A Game-Changer

The newly FDA-approved Ixchiq vaccine is a live attenuated vaccine administered intramuscularly, designed to prevent CHIKV-related diseases in individuals aged 18 and above at an elevated risk of CHIKV exposure. Valneva reports that this indication was granted under accelerated approval based on anti-CHIKV neutralizing antibody titers.

The continuation of this indication depends on demonstrating clinical benefit in confirmatory studies.

Data from a Phase-III trial reveals an impressive 98.9% sero-response rate 28 days post-vaccination. The vaccine-induced immune response persisted at a rate of 96.3% six months post-vaccination. Valneva commits to investigating antibody persistence for at least five years.

Next Steps: US Rollout and European Approval

The plan is to commence the vaccine’s US market launch early next year. As for Europe, approval may take a bit longer. Valneva informs that initial safety data from a clinical study in Brazil, supporting European approval, was submitted to the European Medicines Agency (EMA) in October 2023.

Stay tuned for further developments as the world takes a significant step in combating Chikungunya virus infections.


Original source: This information was Initially covered by PZ.de and has been translated for our readers.

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