FDA approves first vaccine against chikungunya
The United States Food and Drug Administration (FDA) announced on Thursday the approval of Ixchiq, the first vaccine against the chikungunya virus. This disease, transmitted mainly by infected mosquitoes, has been recognized as an emerging threat to global health, with more than 5 million cases reported in the last 15 years.
The approval focuses on individuals over 18 years of age with a higher risk of exposure to the virus, especially in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas, where carrier mosquitoes are endemic.
The Ixchiq vaccine, developed by French biotechnology company Valneva, received “accelerated approval” from the FDA due to the severity and life-threatening conditions associated with the chikungunya virus.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighted the importance of addressing an unmet medical need and praised the approval as a crucial advance in preventing this debilitating disease, especially in individuals of advanced age or with underlying medical conditions.
Few side effects
Chikungunya virus infection can lead to serious illness and long-term health problems, underscoring the urgency of preventative measures. The approval of Ixchiq offers an additional option in the fight against this disease, which has seen an increase in incidence worldwide.
FDA officials revealed that the vaccine was evaluated in two clinical studies in North America, involving about 3,500 people ages 18 and older who received the dose and about 1,000 participants who received a placebo.
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Among the most commonly reported side effects are headache, fatigue, muscle pain, joint pain, fever, nausea, and injection site tenderness. Although some chikungunya-like adverse reactions affecting daily activity were reported, they represent a minority, with only 1.6% of vaccine recipients requiring medical intervention, compared to none in the placebo group.
The safety of the vaccine was also evaluated in relation to pregnant people, as it was determined that the chikungunya virus can be serious and life-threatening for newborns of mothers infected during childbirth. The precautions include a warning about the possibility of transmission of the virus from mothers to newborns, underscoring the importance of additional considerations in this particular group.
Currently, treatment of the disease involves a single-dose injection into the muscle, containing a live, weakened version of the virus. Studies revealed that most people had the virus in their bloodstream one week after vaccination, but no vaccine virus was detected two weeks after inoculation, according to the FDA.
Although the Ixchiq vaccine marks a significant advance in the prevention of chikungunya, the FDA emphasizes the importance of continuing to research and monitor its long-term effectiveness. The approval represents a vital step toward controlling this disease, providing hope to at-risk communities and highlighting the continued importance of research and development in the field of public health.
