This Wednesday (26), Agência Nacional of Desenvolvida by Instituto Butantan, the vaccine will initially be indicated for citizens aged 12 to 59 years. Ministério of Saúde will define the incorporation schedule for Programa Nacional of Imunizações (PNI) in the short term.
The decision comes after analyzing five years of data from the phase 3 clinical trial, in which more than 16 thousand volunteers participated in 14 Brazilian states. The vaccine demonstrated an overall efficacy of 74.7% against the disease and 91.6% protection against severe forms.
More than 1 million doses are already ready at the Butantan factory, in São Paulo, and national production guarantees autonomy in future supply.
Proven effectiveness in different scenarios
The results of the studies showed consistent performance both in citizens who have never had dengue fever and in those with previous infection. Protection against hospitalization reached 100% in monitored volunteers.
The vaccine includes all four serotypes of the virus (DENV-1, DENV-2, DENV-3 and DENV-4) in an attenuated version. The Esse format allows for a broad immunological response with a single application.
National production and international collaboration.
The Butantan began production even before regulatory approval. Atualmente, unit São Paulo operates with installed capacity to meet emergency demands.
More than 1 million doses already packaged and ready for distribution
The partnership with the Chinese company WuXi foresees the delivery of 30 million doses in 2026
Technology transfer ensures rapid expansion of production
National production reduces dependence on imports and logistics costs.
Advantages of the single dose regimen
Experts highlight that the single-dose regimen facilitates the campaign's logistics. Países with high circulation of the virus, they achieve greater vaccination coverage in less time.
Published studies show that single-dose vaccines show up to 30% greater adherence compared to two-dose regimens. Simplification also reduces turnover losses between applications.
Adverse reactions and safety profile.
The most frequent reactions were mild or moderate. Dor at the application site, redness, headache and tiredness appeared in some volunteers.
Serious adverse events occurred in less than 0.1% of cases and all progressed to complete recovery. The five-year follow-up identified no long-term risks.
Next steps and expansion of the age range
Anvisa authorized additional studies for citizens aged 60 to 79. Preliminary Os Dados already indicate safety in children aged 2 to 11 years, however they require additional analysis.
Ministry of Saúde evaluates priority distribution strategies for regions with the highest incidence. Incorporation into the PNI also depends on defining the initial target audience and the delivery schedule.
Brazil registered 6.5 million probable cases of dengue in 2024 and has already accumulated 1.6 million notifications in 2025. The new vaccine appears as an additional tool in the fight against the disease transmitted by Aedes aegypti.
Comparison with the immunizer already available
Butantan-DV presents similar results to the Qdenga vaccine, from Takeda, currently offered on the private network. The main difference is in the application scheme.
While the Qdenga requires two doses three months apart, the Butantan vaccine protects with a single application. The Essa feature can significantly increase coverage in public campaigns.