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.