Anvisa approves the first single-dose dengue vaccine, developed by Butantan.

A Anvisa approved the Butantan-DV, the world's first single-dose dengue vaccine, developed by Butantan InstituteWith an overall efficacy of 74,7% and 100% protection against hospitalizations, the vaccine has already begun national production and will be incorporated into the SUS (Brazilian public health system), representing an advance in the fight against dengue in Brazil. See all the details:

How Butantan-DV works

A Butantan-DV It works using an attenuated virus platform developed by Butantan Institute In partnership with international researchers, this technology weakens the dengue virus in the laboratory so that it cannot cause the disease, but retains enough structure to train the immune system. The formulation includes all four serotypes of the virus, which is essential in countries like Brazil, where all of them circulate simultaneously and increase the risk of more severe reinfections. Upon receiving the single dose, the body produces antibodies and immunological memory for all types of dengue, generating broad and lasting protection.

The development of the vaccine went through a meticulous process within the Butantan, which already had established experience with live attenuated virus vaccines — such as the flu vaccine produced annually by the institute. A Butantan-DV It was born from an initial lineage created by National Institutes of Health (NIH)in the United States, but it was improved and completely nationalized by Butantan over more than ten years. The refinement stages included preclinical testing, adjustments to formulation stability, control of viral replication, and validation in different age groups.

A Anvisa closely followed the entire development process, from the submission of research protocols to the continuous monitoring of phase 3 studies. To technically approve the Butantan-DVThe agency reviewed thousands of pages of clinical data, laboratory reports, pharmacovigilance reports, and quality inspections at Butantan's production facilities. This rigor included auditing studies conducted in 14 Brazilian states, with more than 16 volunteers followed for five years. The vaccine's performance—with protection above 90% against severe forms of the disease and maintenance of efficacy over time—was decisive in the positive conclusion of the technical evaluation.

Another central point of the process was the productive capacity of Butantan Institute, a factor that also weighed in the analysis of AnvisaThe institute's manufacturing plant had already begun production even before final approval, which ensured more than 1 million doses were ready for immediate distribution to... National Immunization Program (PNI)The structure of Butantan It underwent specific inspections to validate quality controls, biosafety, vaccine purity, and batch traceability. With the signing of the Commitment Agreement between Anvisa and Butantan — the final step before definitive registration — formalized the commitment to continuous monitoring and complementary studies for expanding vaccination to other age groups, including the elderly and children.

Results of clinical trials

Clinical trials of Butantan-DV The study involved more than 16 volunteers in 14 Brazilian states and followed participants for five years, allowing for the evaluation not only of immediate efficacy but also the durability of protection. The results demonstrated that the vaccine offers significant protection against symptomatic infections and, especially, against the most severe forms of the disease—precisely those that overwhelm hospitals and increase the risk of death. This consistent performance over time was one of the determining factors for the vaccine's technical approval. Anvisa.

In addition to efficacy, studies have shown a favorable safety profile, with adverse events being mostly mild and transient. The protection against hospitalizations was noteworthy, reaching 100%, reinforcing the vaccine's potential impact on reducing hospitalizations and preventing the collapse of healthcare systems during periods of high transmission.

Who can get the vaccine?

A Butantan-DV was initially approved for people between 12 and 59 yearsThis is the age range in which clinical studies have already presented complete efficacy and safety results. This population includes both individuals who have never had dengue fever and those who have been previously infected, as the vaccine has demonstrated a good immune response in both cases.

Additional age groups — such as children aged 2 to 11 years e adults over 60 — still depend on further analyses authorized by Anvisa, which is evaluating new data to, in the future, expand the vaccine's indication with complete safety.

Where to get the single vaccine against dengue fever.

The single-dose dengue vaccine will be available exclusively through Unified Health System (SUS), as defined by Ministry of HealthThis means that the vaccination will take place in public vaccination units, following the national schedule and campaign strategies defined for each state and municipality. The distribution of the first doses will be directed to priority regions, considering Aedes aegypti infestation rates, outbreak history, and epidemiological indicators.

Before starting the campaign, the Ministry of Health The government will announce the participating cities, the vaccination schedule, and specific guidelines for each authorized age group. The public can find nearby vaccination sites through official government channels, such as... Connect SUS and the state health departments. As Butantan's production increases and new shipments are delivered, more locations will be included in the schedule, expanding access throughout the country.

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Source: Agency Brazil.

reviewed by Gabriel Princessval in 26 / 11 / 2025