On Monday (Dec. 8), Brazil’s national drug authority Anvisa published the registration of the dengue vaccine developed by the Butantan Institute in the country’s federal gazette.

The Ministry of Health intends to begin administering doses in 2026, free of charge, through the SUS, the country’s national heal care network.

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In a statement, Anvisa reported that the publication makes official the conclusion of the regulatory process and enables the production and sale of the vaccine, which will be offered exclusively through the public health system.

“The registration is a milestone in the fight against dengue in Brazil. The vaccine has undergone all the technical and regulatory stages required by health legislation, ensuring its safety, quality, and efficacy,” the text reads.

The statement also mentions that the vaccine is tetravalent and combats the four serotypes of dengue, in addition to being administered in a single dose. “This is the first dengue vaccine to be produced by a Brazilian laboratory,” the watchdog added.

The note stresses that, despite the registration, the Butantan Institute must continue additional studies on the vaccine and actively monitor its use by the general population.

The dose approved by Anvisa is indicated for people aged 12 to 59 – a profile that, according to the note, may be expanded in the future, depending on new studies.

In November, the institute reported that 1 million doses of the vaccine were ready for distribution. It estimates that more than 30 million doses will be available by mid-2026.

Partnership

The inoculation, named Butantan-DV, was developed by the Butantan Institute through a partnership coordinated by the Ministry of Health with the Chinese company WuXi Vaccines.

The new dose uses live attenuated virus technology, already used in other vaccines in use in Brazil and worldwide – such as the MMR vaccine, the yellow fever vaccine, the polio vaccine, and some flu vaccines.

Butantan-DV is reported as showing an overall efficacy of 74.7 percent against symptomatic dengue in people aged 12 to 59. This means that in 74 percent of cases, the disease was prevented by the vaccine. The dose also demonstrated 89 percent protection against severe forms of the disease.

Brazil’s Minister of Health, Alexandre Padilha, announced this Wednesday (Nov. 26) that the country’s national drug regulator Anvisa has approved the registration of the dengue vaccine (Butantan-DV), produced by the Butantan Institute.

This is the world’s first single-dose dengue vaccine, and it is expected to be offered free of charge through the Brazilian public health network, the SUS, in 2026.

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The Butantan Institute notes that 1 million units of the dengue vaccine are ready for distribution and estimates having more than 30 million doses available by mid-2026.

“Today is a day of joy - a victory for the vaccine, a victory for science, a victory for the cooperation between the Brazilian SUS and its public institutions spread throughout the country, including the Butantan Institute,” said Padilha.

The approved indication covers people aged 12 to 59. This range may be expanded in the future, depending on new studies to be submitted by the manufacturer.

Dengue worldwide

The vaccine could benefit not only Brazilians but also populations in other countries, according to Renato Kfouri, vice-president of the Brazilian Society of Immunizations (SBIm).

He warns that the disease is rapidly expanding worldwide, especially in tropical countries.

“Today, more than half of the world’s population lives in areas at risk for the disease.”

The disease vector, the mosquito, expands as temperatures rise. Climate change and shifting rainfall patterns favor its proliferation.

“Dengue and other arboviruses are expanding diseases, and vaccines are essential for controlling them, especially in tropical countries,” the doctor emphasizes.

Butantan-DV

The vaccine, called Butantan-DV, was developed through a partnership between the Ministry of Health and the Chinese company WuXi Vaccines.

The new vaccine uses live attenuated virus technology, which is safe and already applied in other immunizations used in Brazil and worldwide, such as the MMR, yellow fever, polio, and some influenza vaccines.

According to the technical evaluation by Anvisa, Butantan-DV showed an overall efficacy of 74.7 percent against symptomatic dengue in the population aged 12 to 59 years. This means that in 74 percent of cases the disease was prevented thanks to the vaccine.

It also demonstrated 89 percent protection against severe forms and those with warning signs, as published in The Lancet Infectious Diseases.