Overview
- Publication in the Diário Oficial on December 8 concludes the regulatory review and authorizes production and commercialization exclusively through Brazil’s public health system.
- The vaccine is tetravalent, live-attenuated, and given in a single dose, the first dengue shot produced by a Brazilian laboratory, with trials showing 74.7% overall efficacy and strong protection against severe disease and hospitalization.
- Reports differ on the authorized age range, with outlets citing either 12–59 or 2–59 years, and a SUS/PNI committee will set target groups with inclusion expected to be decided in January 2026.
- Butantan reports about 1 million doses ready and projects large-scale output, with 25 million more by the second half of 2026 and 35 million in 2027, supported by a manufacturing partnership with WuXi.
- Anvisa requires continued studies and active post-market monitoring of the vaccine’s use in the population.