A single-dose dengue vaccine that’s the first of its kind to be produced and approved in Brazil is poised to particularly benefit people in Brazil’s hardest-to-reach regions, including the Amazon, according to disease experts. The Butantan-DV vaccine represents a pioneering approach by targeting all four dengue serotypes with a single shot. It received approval from Brazil’s regulatory body last week (November 26) for individuals aged 12 to 59.
This development comes in the wake of Brazil’s largest dengue outbreak to date, which the Ministry of Health reported as 6.4 million cases and 5,972 deaths in 2024. Butantan-DV is a live, attenuated vaccine, meaning it uses weakened viruses to stimulate immunity without triggering disease. It underwent nearly a decade of testing, involving about 16,000 volunteers across Brazil.
In late-stage trials, the vaccine demonstrated an overall efficacy of 74.7% and a notably stronger 91.6% efficacy against the more severe forms of dengue, according to the Butantan Institute, the public research center that developed it.
Brazil plans to integrate Butantan-DV into its national immunization program in early 2026, with more than 1 million doses ready for distribution, the institute stated.
Esper Kallas, Butantan’s director, described the vaccine as a powerful tool in the fight against a mosquito-borne illness that has plagued the country for decades.
Experts emphasize that a one-dose vaccine will improve access for remote communities. The only dengue vaccine currently available globally, TAK-003 (Qdenga), requires two doses spaced three months apart.
Indigenous communities, in particular, stand to gain because they would no longer need to repeatedly travel to health clinics; instead, vaccination could be completed during a single community health visit, according to epidemiologist Jesem Orellana of Fiocruz, a prominent public health research institution in Brazil. Orellana, who was not involved in the vaccine’s development, told SciDev.Net that administering two doses in remote regions—often defined by river networks and limited land access—is far more challenging and expensive.
Butantan has partnered with Chinese firm WuXi Vaccines to manufacture 60 million doses over the next two years, with about half of that total expected to be delivered before the end of 2026. The exact vaccination strategy and priority groups will be determined soon by specialists from Brazil’s National Immunization Program.
The new vaccine has not yet been authorized for pregnant women, individuals who are immunocompromised, or older adults. Anvisa, Brazil’s health regulator, is evaluating evidence of its efficacy in these populations.
Renato Kfouri, vice president of the Brazilian Society of Immunizations, commented to SciDev.Net that this development positions Brazil as a strategic participant in international vaccine production and could enable it to supply neighboring Latin American countries affected by dengue, such as Argentina, Peru, and Colombia.
Globally, the World Health Organization reported more than 14 million dengue cases in 2024, with 12.6 million occurring in Latin America alone and more than 8,000 deaths in the region.
Butantan indicated it could offer the new vaccine to other regional countries, though it did not specify a timetable. Fernanda Boulos, Butantan’s chief scientific officer, noted that the immediate priority is supplying Brazil’s public health system through the Ministry of Health.
A decade of research underpins Butantan-DV, which is composed of all four dengue serotypes and can be administered to both people who have previously been infected and those who have never encountered the virus. Mauricio Nogueira, a physician and virologist at São José do Rio Preto’s Faculty of Medicine, highlighted that this characteristic differentiates Butantan-DV from the two previously approved dengue vaccines, Dengvaxia and Qdenga. Dengvaxia could be given only to those previously infected, complicating its integration into public health programs, while Qdenga’s two-dose schedule poses adherence challenges that can leave people only partially protected if they fail to complete the series.
The emphasis on one-dose vaccination does not mean mosquito control efforts should be abandoned. Experts warn that elimination of dengue requires a combination of approaches, including ongoing mosquito control, robust surveillance, and investments aimed at reducing the vector’s breeding capacity, especially in the face of climate change and rapid urbanization that favor Aedes aegypti, the primary dengue vector. Orellana stressed that vaccines complement, rather than replace, traditional public health measures.
This report is produced by SciDev.Net’s Latin America and Caribbean desk.
