CNN
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The US Food and Drug Administration announced on Thursday that it has given approval to the first vaccine aimed at preventing the disease caused by the chikungunya virus.
The single-dose vaccine, Ixchiq, produced by Valneva Austria GmbH, has been approved for use in adults at an increased risk of contracting the virus. The vaccine received both fast track and breakthrough therapy designations.
Chikungunya, a mosquito-borne disease, has no specific treatment and can be debilitating and potentially deadly for newborns. The virus has been considered an emerging threat to global health, exacerbated by climate change. In the past 15 years, there have been at least 5 million cases, as reported by the World Health Organization.
People at the highest risk of infection reside in Africa, Southeast Asia, and parts of the Americas, where mosquitoes carrying the chikungunya virus are endemic. However, the virus has now spread to new regions of the world due to the climate crisis.
Prior to 2006, the virus was rarely identified in US travelers, as reported by the US Centers for Disease Control and Prevention. However, local transmission cases were reported in warmer parts of the US in late 2014, including Florida, Texas, Puerto Rico, and the US Virgin Islands.
Individuals who contract chikungunya typically experience fever and joint pain, along with headaches, muscle pain, and a rash. Joint pain can be severe and long-lasting, affecting approximately 20% to 30% of cases. For newborns, the virus poses a potentially life-threatening danger.
Ixchiq contains a live, weakened version of the virus, which may cause symptoms similar to an actual infection.
In a study, the vaccine virus was detected in the blood of vaccinated individuals in the first few weeks post-vaccination. The prescribing information for the vaccine includes a warning about potential transmission of the vaccine virus from a pregnant person to their newborn, and the possibility of harm to the newborn. Providers are advised to carefully evaluate the risks and benefits for their patients with regard to the virus, gestational age, and potential harm to the fetus or newborn.
Without a specific treatment for chikungunya, the best option for vulnerable individuals is vaccination, according to scientists.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated that “infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.” The approval of the vaccine addresses an unmet medical need and represents a significant advancement in the prevention of this potentially debilitating disease with limited treatment options.
The FDA is requiring Valneva to conduct a postmarket study to ensure the safety of the vaccine.
Common side effects reported in studies for the vaccine’s approval included headache, muscle and joint pain, fever, tenderness at the injection site, and fatigue. A small percentage of individuals experienced severe chikungunya-like adverse reactions, with a few requiring hospitalization. Some also had reactions that lasted at least 30 days. Providers are advised to discuss potential reactions with patients.
