The National Health Surveillance Agency (Anvisa) approved, on Monday (14), the vaccine against chikungunya of the Butantan Institute and the Franco-Austrian biotechnology company Valneva. With this, the immunizer is authorized to be applied to the population over 18 years.
This is the first vaccine produced against chikungunya, a mosquito disease Aedes aegyptisame as dengue. The immunizer has already been approved by Food and Drug Administration (FDA), the United States Regulatory Agency, and the European Union’s European Medicines Agency (EMA).
Anvisa’s favorable opinion represents an important step in approving the butantan version of the immunizer, which is already under review by the regulatory agency. Both vaccines have practically the same composition. The version of the Butantan Institute will be appropriate to the possible incorporation in facing the disease at the public health level.
Then see what is already known about the Butantan and Valneva chikungunya vaccine.
Who can get the vaccine?
The vaccine can be applied to people, 18 and over, who are at increased exposure to the chikungunya virus, according to Anvisa. The immunizer is contraindicated for pregnant women, immunodeficient or immunosuppressed people.
What is the effectiveness of the immunizer?
In a study conducted in the United States with 4,000 volunteers from 18 to 65 years old, the vaccine presented a good safety profile, with 98.9% of participants producing antibodies against chikungunya. The levels of these antibodies remained robust for at least six months.
The results of the study were published in the scientific journal The Lancetof great prestige in the scientific area, in June 2023.
In the clinical study of phase 3, done with Brazilian adolescents, after a dose of the vaccine, was observed presence of neutralizing antibodies in 100% of volunteers with previous infection and 98.8% of those without previous contact with the virus. The protection was maintained in 99.1% of young people after six months. The results were published in The Lancet Infectious Diseases.
Most adverse events recorded after vaccination were light or moderate, the most reported headache, body pain, fatigue and fever.
How does the vaccine work?
Butantan and Valneva’s chikungunya vaccine is an attenuated living virus vaccine developed by the Austrian pharmacist. This means that the immunizer uses the weakened chikungunya virus, capable of stimulating the immune system without causing the disease. Thus, the body develops an immune response that protects the individual from future infections.
The manufacture of the vaccine will be made in Germany by the company IDT Biologika Gmbh. Butantan predicts manufacturing in Brazil in the future.
How was the vaccine approval?
To approve the vaccine, Anvisa evaluated the documentation submitted in the immunizer registration dossier, which included production and quality data, and clinical studies to demonstrate effectiveness and safety. This is the case of the study published at The Lancet in 2023 and at The Lancet Infectious Diseases in 2024.
Anvisa also participated as a guest of the IXCHIQ Vaccine Evaluation by EMA, under the Open (Opening Our Proceeds at EMA to Non-Eu Authorories). The project allows different agencies to simultaneously evaluate vaccines and medicines of interest in public health.
The agency also had the independent assessment of the working group for discussion of non -clinical and clinical development of vaccines intended for protection against arboviruses, instituted within the Technical Chamber of Medicines (Cateme), composed of arbovirus specialists and vaccine development.
When will the vaccine be available to the population?
There is still no forecast of when the vaccine will be available to the population. According to Butantan, the institute is working in a version of the vaccine with part of the production process carried out in Brazil.
The version uses national components and will be better suitable for incorporation by the Unified Health System (SUS), pending analysis by the National Commission for Incorporation of Technologies in the Unified Health System (Conitec), National Immunization Program and other health authorities.
“From the approval by Conitec, the vaccine can be supplied strategically. In the case of Chikungunya, it is possible that the plan of the ministry is first vaccinated from residents of endemic regions, that is, that concentrate more cases,” says the director of the Butantan Institute, Esper Kalllas, in a statement.
What is the importance of the vaccine?
The chikungunya virus accesses the bloodstream and affects the joint membrane, causing intense pain, and high fever, headache, muscle pain and red spots on the body. Among the main complications of the disease is chronic joint pain, which can last years and impact patients’ quality of life.
In 2024, by the end of August, 254,651 probable cases were recorded in Brazil, an increase of 45.5% over the same period of 2023, according to the Ministry of Health’s Arbovirus panel.
This is the world’s first vaccine against the disease, which affects more than 110 countries, according to the World Health Organization (WHO). The countries with the most records of the disease are Brazil, Paraguay, Argentina and Bolivia.
The disease has no specific treatment and, therefore, its prevention is of fundamental importance, and can be done, in addition to vaccination, with actions such as emptying and often cleaning containers with stopped water, such as plant vessels, buckets, tires, plastic bottles, unused and without maintenance, and properly dispose of waste.
Chikungunya vaccine maintains immunity in teenagers after a year
This content was originally published in Chikungunya vaccine: See what is already known about immunizer on the CNN Brazil website.
Source: CNN Brasil

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