Brazil Approves Butantan’s Single-Dose Dengue Vaccine for Ages 12–59

Overview

• Anvisa signed a Termo de Compromisso and granted registration for Butantan‑DV, with official publication in the government register still pending.
• The single‑dose, tetravalent live‑attenuated vaccine is authorized for 12–59‑year‑olds and showed 74.7% overall efficacy, 91.6% against severe dengue or warning signs, and 100% against hospitalization over five years.
• Butantan says more than 1 million doses are ready and a manufacturing partnership with WuXi targets roughly 30 million doses available by mid‑2026.
• The Health Ministry intends to add the vaccine to the National Immunization Program and start public vaccinations in early 2026, with CMED pricing and CONITEC evaluations next and a Dec. 1 meeting to propose priority groups.
• Active safety monitoring is mandated under the commitment terms, and further studies will assess use in adults 60–79 and gather additional data for children 2–11.