Brazil’s National Health Surveillance Agency (Anvisa) has granted technical approval to Butantan-DV, the world’s first single-dose dengue vaccine, which has demonstrated 75 percent efficacy against the disease and over 90 percent efficacy in preventing severe cases and hospitalizations.
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Anvisa completed the technical evaluation of the immunogen, formalized the administrative process for its final registration, and signed the Commitment Agreement with the Butantan Institute on Wednesday, November 26, paving the way for the release of the registration in the coming days. The vaccine met all safety, efficacy, and quality criteria.
Butantan-DV will initially be administered to people aged 12 to 59. Renato Kfouri, Vice President of the Brazilian Society of Immunization (SBIm), highlighted its efficacy against the disease and its effectiveness in preventing severe forms and hospitalizations.
Kfouri emphasized the strategic advantage of domestic production, which facilitates access and distribution scale. Despite technical approval, the Ministry of Health has not yet announced a timeline for incorporating the vaccine into the national immunization schedule.
The measure comes in response to the serious dengue fever health crisis facing Brazil, which in 2024 alone registered 6.5 million probable cases—four times more than the previous year—and has accumulated 1.6 million reported cases so far in 2025.
To expand supply, the Butantan Institute signed an international partnership with the Chinese company WuXi, which will allow for the delivery of approximately 30 million doses in the second half of 2026.
