Brazil Approves Butantan’s Single‑Dose Dengue Vaccine, With SUS Rollout Set for January

Overview

• Anvisa published the vaccine’s registration in the Diário Oficial, completing approval and authorizing production and exclusive distribution through Brazil’s public health system.
• The Health Ministry plans to begin vaccinations by late January 2026 with about 1.3 million doses, prioritizing primary care workers and then adults aged 50 to 59 as supply expands.
• Botucatu (SP) will serve as a real‑world impact site, aiming to vaccinate roughly 40%–50% of residents aged 15 to 59 to track reductions in dengue, with other DENV‑3–affected cities under evaluation.
• Anvisa’s review cites 74.7% efficacy against symptomatic dengue and about 89% protection against severe forms in the studied 12–59 age group; the vaccine is tetravalent, live‑attenuated and given in a single dose, with post‑market monitoring and a study in people 60+ planned.
• Butantan reports an initial stock near 1–1.3 million doses and will scale output through a partnership with WuXi Vaccines, while the Takeda Qdenga vaccine remains in use for adolescents under existing SUS contracts.