published : 2023-11-11
First Chikungunya Vaccine, 'Emerging Global Health Threat,' Approved by FDA
Vaccine Receives FDA Approval for Individuals 18 and Older at Risk of Exposure
The U.S. Food and Drug Administration (FDA) has announced the approval of Ixchiq, the very first chikungunya vaccine. Developed by Valneva, this vaccine is now authorized for use in individuals aged 18 and older who are at risk of being exposed to the chikungunya virus.
Chikungunya is a virus transmitted through mosquito bites, similar to dengue or Zika. As an 'emerging global health threat,' the virus has been responsible for over five million reported cases in the past 15 years.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a medical contributor at Fox News, stated, 'This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes.'
The FDA warns that chikungunya infection can lead to severe disease and prolonged health problems, especially among older adults and individuals with underlying medical conditions. Therefore, the approval of the Ixchiq vaccine addresses an unmet medical need and marks a significant advancement in preventing this potentially debilitating disease.
Before obtaining FDA approval, the Ixchiq vaccine underwent extensive safety testing in clinical trials involving 3,500 adults. The vaccine is administered as a single-dose injection and contains a weakened form of the virus. Side effects reported by participants included headache, muscle pain, fatigue, joint pain, nausea, fever, and tenderness at the injection site.
Out of all recipients, only a small share (1.6%) experienced adverse reactions, with two requiring hospitalization. Furthermore, a separate study demonstrated the efficacy of the vaccine, as nearly all of the 266 adult participants showed protective antibody levels after vaccination.
The most common symptoms of chikungunya include fever, joint pain, headache, muscle pain, joint swelling, and rash. The Centers for Disease Control and Prevention (CDC) recommends rest, hydration, and over-the-counter medications to relieve fever for infected individuals experiencing symptoms.
Chikungunya is primarily transmitted by mosquitoes prevalent in Africa, Southeast Asia, and parts of the Americas. While deaths from the virus are rare, older adults, newborns infected at birth, and individuals with heart disease, diabetes, or high blood pressure face the highest risk of adverse health effects.
Since late 2013, the virus has spread throughout the Americas after initially being documented in Caribbean countries. Those planning to travel to countries with widespread chikungunya should take precautions such as using insect repellent, wearing protective clothing, and staying in screened areas to minimize the risk of infection.
Dr. Siegel affirms that the Ixchiq vaccine is 'safe and effective' and contains a live weakened version of the virus. However, it is not intended for immunocompromised individuals. The vaccine's fast-track approval prioritizes those most at risk of severe cases of chikungunya.
In conclusion, the approval of the first chikungunya vaccine by the FDA is a significant step in combating this emerging global health threat. With millions of reported cases in recent years, finding an effective preventive measure is crucial to protect those most vulnerable to the virus. While the vaccine's safety and efficacy have been confirmed through rigorous testing, ongoing post-marketing studies will continue to provide valuable insights. As we move forward, the Ixchiq vaccine offers hope for a future with reduced chikungunya-related illness and a healthier global population.