Butantan-DV will be applied to people aged 12 to 59 years and has proven effective
November 26
2025
– 12:57 pm
(Updated at 12:59 p.m.)
summary
Anvisa has approved the single-dose Butantan-DV dengue vaccine for people aged 12 to 59 years, with proven efficacy and expected to enter the vaccination calendar in 2026.
On Wednesday, January 26, the National Health Surveillance Agency (Anvisa) approved the registration of Butantan-DV, a single-dose vaccine against dengue produced by the Butantan Institute. The vaccine is the first in the world to contain a single dose.
The vaccinating agent must be included in the National Immunization Program (PNI), but the application start date will still be determined by the Ministry of Health. Butantan-DV will be used to vaccinate residents aged 12 to 59 years.
Without specifying dates, Health Minister Alexandre Padilha stated, during a press conference, that the vaccine will be available in the vaccination calendar at the beginning of 2026. “It is a day of hope for Brazilian health. We expect that we will be able to start using this vaccine at the beginning of 2026.”
The Ministry of Health will be responsible for distributing doses to the states.
-ubu6ndm3875k.jpeg "The press conference was attended by Health Minister Alexandre Padilha, São Paulo State Governor Tarcisio de Freitas, Anvisa CEO Leandro Savatelli, as well as representatives of the São Paulo State Ministry of Health and the Butantan Institute.")
Even before Anvisa’s approval, Butantan had already started producing the vaccine at its industrial complex. There are already more than 1 million doses ready to be made available to the National Cancer Institute.
Butantan also has a partnership with Chinese company WuXi to increase production of doses. The agreement allows for greater supply capacity to deliver about 30 million doses in the second half of 2026.
Clinical trials
The vaccine was approved after five years of observational studies with volunteers from a phase III clinical trial sent to Anvisa.
The population, ages 12 to 59 years, showed an overall effectiveness of 74.7%, 91.6% effectiveness against severe dengue and warning signs, and 100% effectiveness against dengue hospitalization. The study was conducted between 2016 and 2024, and Butantan-DV was evaluated in more than 16,000 volunteers living in 14 Brazilian states.
The vaccine consists of four serotypes of the virus that causes dengue fever, and the vaccine has proven to be safe and effective in people who have already had the disease and those who have not previously had contact with the virus that causes it.
Reactions to the vaccine were mild to moderate, with the main symptoms being pain and redness at the injection site, headache and fatigue. Serious adverse effects associated with the vaccine were rare, and all subjects recovered.
Age group
The vaccine is the first in the world that can be administered with a single dose, and has the ability to facilitate public commitment, in addition to campaign logistics. The findings were described in a report published by British researchers in the scientific journal Human Vaccines & Immunotherapeutics in 2018.
According to the study, lower-dose immunization programs are synonymous with increased vaccination coverage and improvements in disease control. Now, the idea is to expand the age range to include children and people over 60 years old.
Anvisa has also allowed the vaccine to be evaluated in populations aged 60 to 79 years. Other studies evaluating the inclusion of children aged 2 to 11 years will also be collected.
In 2024, Brazil had 6.5 million registered cases of dengue fever, four times more than in 2023, according to the Ministry of Health. In 2025, through mid-November, 1.6 million possible cases of the disease have been reported. Since 2000, more than 20 million Brazilians have been infected with dengue fever.