Brazil’s health agency has approved Butantan-DV, a first-of-its-kind dengue vaccine developed domestically, offering a potential turning point in teh fight against the mosquito-borne illness that reached record levels in the country and across Latin America in 2024. The single-dose vaccine promises streamlined protection against all four dengue serotypes, and is prioritized for distribution in remote and underserved regions-including within the Amazon rainforest-where healthcare access remains a meaningful challenge. With over 1.2 million doses already produced and plans for expanded manufacturing underway, Butantan-DV represents a major advancement in both regional public health and vaccine production capacity.
Brazil Approves First-of-its-Kind Dengue Vaccine, Prioritizing Access for Remote Populations
Brazil’s health agency has approved Butantan-DV, a groundbreaking dengue vaccine developed in Brazil, offering a single-dose protection against all four serotypes of the virus. The vaccine is expected to significantly benefit individuals living in remote and underserved regions of the country, including those in the Amazon rainforest, where access to healthcare is often limited.
“Indigenous and riverine communities will no longer need to make multiple trips to health posts, or can receive vaccination during a single visit from community health workers,” explained epidemiologist Jesem Orellana of the Fundação Oswaldo Cruz (Fiocruz) in Manaus, who was not involved in the vaccine’s development. Dengue fever remains a significant public health concern in many tropical and subtropical regions, and this new vaccine represents a major step forward in prevention efforts.
The Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s national health regulatory agency, granted approval for Butantan-DV on November 26, 2023, for use in individuals aged 12 to 59 years. The Instituto Butantan, the vaccine’s developer, has already produced 1.2 million doses, with potential for immediate deployment. Official integration into Brazil’s National Immunization Program (PNI) is slated for early 2026.
To further expand production capacity, Butantan has partnered with Chinese vaccine manufacturer WuXi Vaccines to produce an additional 60 million doses over the next two years. Approximately half of this volume is expected to be available before the end of 2026.
“Brazil is now becoming a strategic player in the international vaccine production landscape, and will soon be able to supply other Latin American countries also affected by the disease, such as Argentina, Peru and Colombia.”
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Renato Kfouri, vice president of the Brazilian Society of Immunizations
A committee of PNI specialists will determine the specific vaccination strategy and priority age groups in the coming weeks.
Currently, the vaccine is not authorized for use in pregnant women, individuals with compromised immune systems, or older adults. Anvisa is continuing to analyze efficacy data for these populations.
“Brazil is now becoming a strategic player in the international vaccine production landscape, and will soon be able to supply other Latin American countries also affected by the disease, such as Argentina, Peru and Colombia,” stated Renato Kfouri, vice president of the Brazilian Society of Immunizations, to SciDev.Net.
The Instituto Butantan has confirmed its ability to offer the vaccine to other countries in the region, though a specific timeline has not yet been established.
“Our priority at this time is supplying the public health system through the Ministry of Health, our primary client,” explained Fernanda Boulos, medical director of Butantan, to SciDev.Net.
The Instituto Butantan has already produced over one million doses of the dengue vaccine. Credit: Andre Rico/Instituto Butantan for SciDev.Net.
Attenuated Virus Vaccine
Butantan-DV is an attenuated virus vaccine, meaning it uses a weakened form of the virus that can replicate but does not cause illness. The vaccine was evaluated over nearly a decade in 10,259 volunteers from various regions of Brazil, with an additional 5,976 participants receiving a placebo.
Previous results, following two and 3.7 years of monitoring, were published in The New England Journal of Medicine and The Lancet Infectious Diseases, respectively.
The most recent data indicates an overall efficacy of 74.7%, and 91.6% against severe dengue, as well as 100% efficacy against hospitalizations. This means that none of the vaccinated individuals who became infected and developed symptoms required hospitalization. These findings could significantly reduce the burden on healthcare systems in dengue-endemic areas.
According to Butantan representatives, these results will soon be published in the journal Nature Medicine.
Broad Protection
Comprising all four serotypes of the dengue virus, Butantan-DV can be administered to individuals with prior dengue infection as well as those who have never been exposed to the pathogen.
Maurício Lacerda Nogueira, a physician and virologist at the Faculty of Medicine of São José do Rio Preto in São Paulo, highlighted key advancements over other dengue vaccines previously approved by Anvisa: Dengvaxia, from French laboratory Sanofi Pasteur, and Qdenga, from Japanese pharmaceutical Takeda.
“The first could only be given to people who had already had dengue, which prevented its incorporation into the public health network,” Lacerda explained to SciDev.Net. “It’s no coincidence that Sanofi decided to suspend its production without ever having used it on a large scale,” noted the researcher, who was involved in the development of Butantan-DV.
Takeda’s vaccine can be administered to individuals with prior dengue infection, but its efficacy against the serotype responsible for severe dengue – characterized by intense abdominal pain, vomiting, difficulty breathing, and fluid accumulation – has not been proven.
“Qdenga also hasn’t been widely available because the company responsible for its production has a limited supply of doses,” Kfouri added.
Furthermore, it requires two doses, which can hinder adherence. “Many people who receive the first dose do not return for the second and end up only partially protected,” Lacerda explained. “Both doses are essential to ensure complete protection against the pathogen.”
Jesem Orellana added: “Similarly, administering a two-dose vaccine in remote and hard-to-reach regions, such as the Amazon, crossed by rivers and with still very precarious land connections, is much more difficult and costly.”
Record Cases
Brazil recorded a record number of dengue cases and deaths in 2024: 6.4 million infections and 5,972 deaths, according to the Ministry of Health. In Latin America and the Caribbean, more than 12.6 million dengue cases and nearly 8,000 deaths were documented, according to data from the Pan American Health Organization (PAHO). Argentina, Brazil, Colombia, and Mexico account for 90% of the cases and 88% of the deaths.
Experts believe Butantan-DV will drastically reduce these numbers, helping to alleviate dengue as a major public health problem.
However, the new vaccine will not eradicate the disease, particularly in the context of climate change and expanding environmental and social conditions increasingly favorable to the proliferation of the Aedes aegypti mosquito, the main vector of the disease.
“The vaccine is important, but it doesn’t mean abandoning mosquito control, which, in addition to dengue, continues to transmit other diseases, such as chikungunya and yellow fever. These can occupy the space left by dengue, so control remains essential, surveillance is fundamental, and investment in measures to reduce the vector’s reproductive capacity is crucial,” Orellana concluded.
This article was produced by SciDev.Net’s Latin America and Caribbean edition.
