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2h ago

Anvisa Approves Butantan’s Single‑Dose Dengue Vaccine for Ages 12–59

Officials target an early‑2026 rollout through the public immunization program following price review and incorporation steps.

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Overview

  • Regulators signed a Termo de Compromisso with Instituto Butantan, completing the final step for formal registration of the Butantan‑DV vaccine.
  • Phase‑3 data in Brazil showed 74.7% overall efficacy, about 91.6% protection against severe disease, and 100% protection against hospitalization over up to five years of follow‑up.
  • More than 16,000 volunteers across 14 states participated in trials, and reported side effects were mostly mild to moderate, with rare serious events and full recovery.
  • Butantan has over 1 million doses ready, with a WuXi partnership expected to add roughly 30 million doses in the second half of 2026; São Paulo’s governor projected up to 60 million doses over two years.
  • The Health Ministry will define prioritization after CMED pricing and CONITEC review, with a technical committee set to recommend the initial target groups for vaccination.