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The initial chikungunya vaccine, Ixchiq, has received approval from the U.S. Food and Drug Administration. This vaccine is intended for individuals aged 18 and above who face an elevated risk of exposure to the chikungunya virus.
Chikungunya, primarily transmitted through mosquito bites, poses a global health threat, with over 5 million reported cases in the past 15 years. While the highest infection risk exists in tropical regions, the virus has extended its reach, contributing to a heightened global prevalence. Common symptoms include fever, joint pain, rash, headache, and muscle pain, with some cases resulting in prolonged joint discomfort.
Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, highlights the significance of Ixchiq’s approval in addressing an unmet medical need, particularly for older adults and those with underlying health conditions.
Ixchiq, administered as a single muscle injection, contains a weakened form of the chikungunya virus, potentially causing symptoms resembling the disease. Safety assessments involved two North American clinical studies with around 3,500 participants, revealing commonly reported side effects such as headache, fatigue, and muscle and joint pain.
Although severe chikungunya-like reactions occurred in 1.6% of Ixchiq recipients, the FDA requires postmarketing studies to evaluate these risks further. The transmission of the virus from pregnant individuals to newborns is noted, emphasizing caution in administering the vaccine to pregnant individuals based on exposure risk, gestational age, and potential fetal or neonatal risks.
Ixchiq’s effectiveness is substantiated by immune response data from a U.S. clinical study. It obtained Accelerated Approval, signifying the FDA’s endorsement for serious conditions based on evidence predicting clinical benefit. Confirmatory clinical studies are mandated for verification.
Fast Track, Breakthrough Therapy, and Priority Review designations were granted, and the manufacturer, Valneva Austria GmbH, received a tropical disease priority review voucher, aligning with the FDA’s encouragement for tropical disease treatment development, as outlined in the Food and Drug Administration Amendments Act of 2007.
