11/26/2025 | Instituto Butantan

https://butantan.gov.br/noticias/vacina-da-dengue-do-instituto-butantan-primeira-do-mundo-em-dose-unica-e-aprovada-pela-anvisa 

Butantan Institute has already produced more than one million doses to make available to the Ministry of Health

The Butantan-DV dengue vaccine from the Butantan Institute, an agency linked to the São Paulo State Health Secretariat, was approved this Wednesday (November 26) by the National Health Surveillance Agency (Anvisa) for use in the Brazilian population aged 12 to 59 years. With the favorable opinion, the immunizing agent, which is the world's first single-dose dengue vaccine, should be included in the National Immunization Program (PNI). The start of vaccination and the age range for application will still be defined by the Ministry of Health.

Even before approval, the Butantan Institute had already begun producing the immunizing agent in its industrial park, having more than one million doses ready to be made available to the National Immunization Program (PNI). In addition, Butantan has entered into an international partnership with the Chinese company WuXi to increase production. The agreement will allow for an expansion of supply capacity to deliver approximately 30 million doses in the second half of 2026.

“It is a historic achievement for science and health in Brazil. A disease that has afflicted us for decades can now be faced with a very powerful weapon: the single-dose vaccine from the Butantan Institute. A development made by Brazilian scientists, workers, and volunteers that could save lives throughout the country,” says the director of the Butantan Institute, Esper Kallás.

For the Secretary of State for Health of São Paulo, Eleuses Paiva, the immunizing agent is one of the greatest scientific advances of recent decades. “The production of the dengue vaccine in São Paulo demonstrates our capacity to lead the development of strategic biotechnologies for the country, reducing dependence on imports and ensuring autonomy in protecting our population,” he states.

In 2024, Brazil registered 6.5 million probable cases of dengue – four times more than in 2023, according to the Ministry of Health. In 2025, up to mid-November, 1.6 million probable cases were reported. Since the beginning of the 2000s, more than 20 million Brazilians have already been affected by the disease.

The vaccine's approval is supported by the results of five years of follow-up of volunteers in the phase 3 clinical trial submitted to Anvisa (Brazilian Health Regulatory Agency). In the 12-59 age group, the immunizing agent showed 74.7% overall efficacy, 91.6% efficacy against severe dengue and dengue with warning signs, and 100% efficacy against hospitalizations due to dengue. The study, conducted between 2016 and 2024, evaluated the Butantan-DV vaccine in over 16,000 volunteers residing in 14 Brazilian states. Previous results from two- and 3.7-year follow-up periods were published in The New England Journal of Medicine and The Lancet Infectious Diseases, respectively.

Composed of the four serotypes of the dengue virus, the immunizing agent proved safe and effective in both people with previous infection and those who had never been exposed to the pathogen. Most reactions were mild to moderate, the main ones being pain and redness at the injection site, headache, and fatigue. Serious adverse events related to the vaccine were rare, and all participants recovered.

The Butantan Institute's dengue vaccine is the first in the world that can be administered in just one dose, which has the potential to facilitate public adherence and campaign logistics. The benefits of a single dose were described in a report published by UK researchers in Human Vaccines & Immunotherapeutics in 2018. The study indicated that immunization programs with fewer doses are associated with better vaccine coverage and disease control.

Other target groups
The Butantan Institute intends to expand the vaccination age range to include both the pediatric population and those over 60 years of age. To this end, it has already received approval from Anvisa (Brazilian Health Regulatory Agency) to evaluate the dengue vaccine in the population aged 60 to 79 years. If the research results are satisfactory, it will be possible to request the inclusion of this group in the vaccine recommendations from the regulatory agency. Furthermore, more data will need to be collected to assess the possible inclusion of children aged 2 to 11 years in the vaccine recommendations. Clinical studies have already proven that the vaccine is safe in this age group.