11/28/2025 | Camila Neumam | Butantan Institute

https://butantan.gov.br/noticias/vacina-butantan-dv-marca-virada-historica-na-prevencao-da-dengue-no-brasil-e-redesenha-estrategias-de-saude-publica 

Authorities highlight that the world's first single-dose dengue vaccine will transform prevention in the country, expanding coverage, facilitating logistics, and strengthening technological autonomy.

State, federal, and international health authorities classified the approval of the Butantan-DV vaccine by the National Health Surveillance Agency (Anvisa) as a victory for Brazilian science and health sovereignty, marking a historic turning point in the fight against dengue in Brazil.

According to them, its future incorporation into the National Immunization Program (PNI) will be able to change the epidemiological scenario of the country, preventing epidemics and deaths; it should increase coverage as it is a single dose; and it will facilitate the logistics of delivery and distribution of the immunizing agent.

The approval took place this Wednesday (26) at a signing ceremony of the Commitment Term for Studies and Monitoring of the Dengue Vaccine between the Butantan Institute and Anvisa, the last step before the registration of the vaccine. The signing takes place after the conclusion of the evaluation of the immunizing agent by the agency's technical areas and confirms the approval, ensuring that the vaccine is safe and effective for Brazilians, but also defining obligations, deadlines and delivery of complementary information, which guarantees transparency and predictability to the process.

Butantan-DV was approved for people aged 12 to 60 years old, but Butantan will conduct studies with the vaccine in the elderly to expand the age range. The Ministry of Health intends to incorporate the batch of 1 million doses already manufactured by Butantan into the National Immunization Program (PNI), which distributes vaccines to the Unified Health System (SUS), in 2026.

The ceremony was attended by the Minister of Health, Alexandre Padilha; the president of Anvisa (Brazilian Health Regulatory Agency), Leandro Safatle; the Governor of the State of São Paulo, Tarcísio de Freitas; the acting Secretary of State for Health of São Paulo, Priscila Perdicaris; the director of the Butantan Institute, Esper Kallás; and the president of the Pan American Health Organization (PAHO), Jarbas Barbosa.

The Governor of São Paulo, Tarcísio de Freitas, emphasized that single-dose immunization “will greatly help from a logistical point of view, from the point of view of increasing vaccination coverage, and from the point of view of adherence, in addition to allowing a rapid response to outbreaks.” He also highlighted the direct impact on reducing deaths. “Unfortunately, we are still losing lives to dengue fever, but it’s a scenario that we will be able to reverse quickly with immunization,” he emphasized.

The president of Anvisa, Leandro Safatle, stated that it is “a source of pride to have a registered technology developed and manufactured nationally by the Butantan Institute, with very good results.”

“It was a phenomenal effort between the Anvisa and Butantan teams,” he said, highlighting that the process occurred in a continuous flow, without missing any fundamental steps.

The general manager of biological products at Anvisa, Marcelo Moreira, detailed that the technical rigor included a panel of experts to clarify the data presented.

“We estimate that the vaccine has the potential to change the epidemiological landscape in the country, especially with its adoption and inclusion in the National Immunization Program (PNI). The national development and production are also noteworthy. This guarantees the sovereignty and health security of the Brazilian population. It is also estimated that there will be a reduction not only in mortality, but also in hospitalizations and a decrease in pressure on the health service, improving the efficiency of the SUS (Unified Health System),” he highlighted.

The Butantan Institute is already preparing the industrial batches necessary for the final evaluation phase. Director Esper Kallás explained that the current moment demands technical precision and robust documentation. “The clinical study demonstrated the results we were looking for. Now we are committed to ensuring that this quality is maintained on an industrial scale,” he said.

The director of Butantan also stated that the teams are working on delivering the supplementary information requested by Anvisa (Brazilian Health Regulatory Agency). “This is a natural and expected process for innovative vaccines. We are fulfilling each stage with responsibility and total transparency,” he affirmed.

Four vaccines in one
During the presentation, Esper Kallás emphasized that the Butantan-DV tetravalent single-dose formulation solves one of the historical bottlenecks in dengue prevention. “We are not talking about just one vaccine, we are talking about four vaccines in one, and they need to act in a balanced way,” he explained.

He recalled that 2024 saw “an unprecedented increase in cases” [more than 6 million], and highlighted that the five-year follow-up of the phase 3 clinical study, with more than 16,000 people, demonstrated that Butantan-DV has an overall efficacy of 74.7% and 91.6% protection against severe forms. The results were published in renowned scientific journals and validated by Anvisa.

"These data showed that the vaccine presented exceptional efficacy and safety performance for public health," emphasized Esper Kallás. He also guaranteed that the vaccine "protected against all forms of hospitalization in the study conducted."

Incorporation into the National Immunization Program and greater coverage
For the Ministry of Health, the approval represents a decisive step to strengthen the National Immunization Program. Minister Alexandre Padilha celebrated "a day of victory for the vaccine, a victory for science, and a victory for cooperation between the SUS (Unified Health System) and its public institutions."

According to him, the Ministry is already working on a strategy to incorporate Butantan-DV into the National Immunization Program (PNI): “Our expectation is to start at the beginning of the 2026 vaccination schedule.” The minister also highlighted that the single-dose protection brings “great hope for immediate incorporation.”

Alexandre Padilha informed that the Ministry of Health will present the new development to the Tripartite Commission (which brings together state and municipal secretaries) and will convene the PNI's committee of experts to define the best scientific recommendation for incorporation.

He emphasized that this procedure is standard for all health technologies that undergo evaluation. “The expectation is that, once all regulatory and production stages are completed, it will be possible to include the vaccine in the 2026 schedule. The single dose facilitates logistics and expands the potential for coverage, although it is still necessary to complete all formal analyses.”

The final decision on incorporation depends on the evaluation of the National Commission for the Incorporation of Technologies in the SUS (Conitec), which will consider scientific evidence, epidemiological impact, and production capacity.

Technological Autonomy
From an operational perspective, the new vaccine represents an immediate transformation. “The fact that it has a single-dose vaccine completely changes the game. It facilitates logistics, increases adherence, and very quickly accelerates the immunization of the population,” stated the acting Secretary of State for Health of São Paulo, Priscila Perdicaris.

The secretary recalled that the partnership between Butantan and the Chinese company Wuxi will allow for the availability of “more than 30 million doses by mid-2026,” which “expands Brazil's technological autonomy and reduces dependence on imports.” The Butantan Institute's goal is to offer 60 million doses to the National Immunization Program (PNI) by 2027.

The president of PAHO, Jarbas Barbosa, celebrated the fact that Butantan is consolidating itself as a producer not only for the PNI, but also for the entire “Americas region,” classifying the vaccine as “a continental milestone.” He recalled that Latin America recorded 13 million cases of dengue fever and 9,000 deaths last year, and anticipated that neighboring countries are already showing interest in acquiring the vaccine.

“Upon arriving in Washington, I will start receiving calls from ministers wanting to know when Butantan, in addition to supplying Brazil, will be able to supply the region.”

Meeting of Ministers of Mercosur
The announcement of the approval of Butantan-DV by Anvisa occurred during the 57th Meeting of Ministers of Health of Mercosur and Associated States, held at the Butantan Institute, also on Wednesday (26). The meeting was attended by Minister Alexandre Padilha, the president of PAHO, Jarbas Barbosa, and representatives of the Ministers of Health of Argentina, Paraguay, Chile and Uruguay, who discussed the regional production of medicines and vaccines, border health strategies, among other topics.

The event concluded with the transfer of the Pro Tempore Presidency of Health for Mercosur from Alexandre Padilha to the Paraguayan Minister of Health, María Teresa Barán.