Brazil's health regulatory agency, Anvisa, announced the definitive approval of the chikungunya vaccine IXCHIQ®. The decision marks the world's first approval of a chikungunya vaccine in an endemic country, signaling an advancement in the fight against the mosquito-borne disease. According to Benzinga, the approval is a milestone not only for Brazil but also for regions struggling with chikungunya outbreaks.
Chikungunya is a viral disease transmitted through the bite of infected female Aedes aegypti mosquitoes, the same vector responsible for spreading dengue and Zika viruses. The disease presents with symptoms such as sudden onset fever exceeding 38.5°C and intense joint pain in the feet and hands. These symptoms can be debilitating, with joint pain potentially persisting for weeks to years, severely affecting patients' quality of life.
Brazil has been grappling with chikungunya since the virus was introduced in 2013. The country is considered the epicenter of the disease in the Americas, with epidemics reported over the years. As of April 14 of this year, Brazil recorded a total of 68,100 registered cases of chikungunya, resulting in 56 deaths.
Developed through a collaboration between the Butantan Institute of Brazil and the Franco-Austrian pharmaceutical company Valneva, IXCHIQ® is the first vaccine authorized against chikungunya disease in Brazil. It is indicated for individuals aged 18 years and older who are at increased risk of exposure to the chikungunya virus. The vaccine also received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the prevention of chikungunya.
"From the approval by Conitec, the vaccine can be provided strategically. In the case of chikungunya, it is possible that the Ministry's plan is to vaccinate first the residents of endemic regions, that is, those that concentrate more cases," said Esper Kallás, director of the Butantan Institute, according to G1.
The Brazilian Ministry of Health plans to request the incorporation of the chikungunya vaccine into the Unified Health System (SUS) for evaluation by Conitec. This move aims to ensure that the vaccine becomes accessible to populations most affected by the disease, particularly in regions with high transmission rates.
Clinical studies demonstrated the vaccine's efficacy. In a Phase 3 clinical study conducted in the United States with 4,000 volunteers aged 18 to 65 years, 98.9% produced neutralizing antibodies, which prevent the virus from entering cells. These protective levels were maintained for at least six months after vaccination. Additionally, the protection was sustained in 99.1% of younger participants after six months.
"The vaccine demonstrated robust production of neutralizing antibodies against the chikungunya virus in clinical studies that evaluated adults and adolescents who received a dose," Anvisa noted, as reported by SAPO. The most commonly reported adverse events were mild to moderate, including headache, body pain, fatigue, and fever.
The Butantan Institute is also working on a version of the vaccine with national components, which would allow for faster daily production of the immunizer in Brazil. This endeavor aims to make the vaccine more accessible and reduce costs associated with importing doses.
"Chikungunya is a disease that has been growing in Brazil over the years. The fact that there is a vaccine that is safe and effective brings relief to society. From the registration by Anvisa, the Ministry of Health begins the steps for the incorporation of the vaccine into the SUS," said Mariângela Simão, the Secretary of Health Surveillance and Environment of the Ministry of Health, according to O Estado de S. Paulo.
Despite the vaccine's approval, health officials stress the continued importance of vector control measures. Since there is currently no specific treatment for chikungunya, preventing mosquito bites remains crucial. Precautions include emptying and frequently cleaning containers with stagnant water, such as plant pots, buckets, and tires, and properly discarding garbage to eliminate mosquito breeding sites.
The collaboration between Valneva SE and the Butantan Institute aims to ensure fast access to the chikungunya vaccine for Brazil and other countries in the region. Supported by the European Union and the Coalition for Epidemic Preparedness Innovations (CEPI), this partnership seeks to address the public health challenge posed by chikungunya in affected areas.
Residents of Brazil now have access to an effective vaccine that prevents chikungunya, marking a step forward in combating the disease. With over 1 million total cases reported between January 2019 and July 2024, according to Terra, the availability of IXCHIQ® offers hope for reducing the incidence and impact of chikungunya in Brazil and beyond.
The article was written with the assistance of a news analysis system.