Anvisa (Brazil's Health Regulatory Agency) approved on Tuesday (26) the registration of Butantan-DV, the world's first single-dose dengue vaccine, developed by the Butantan Institute in partnership with the Ministry of Health and Chinese laboratory WuXi Biologics. The vaccine has been cleared for people aged 12 to 59, and it is expected to begin being administered through the public health system (SUS) in 2026.
With safety and efficacy confirmed, the Ministry of Health will take the matter next week to SUS's expert committee, which will define the vaccination strategy —the trend is for a gradual rollout. Although 1 million doses have already been produced since early 2025, the ministry has not yet defined which age group will be prioritized.
Butantan-DV provides an estimated five years of protection and is 79.6% effective against symptomatic cases and 89% effective against severe cases. Being tetravalent, it protects against all four virus serotypes. The institute plans to deliver 30 million doses annually starting in the second half of 2026, with the possibility of increasing production.
Currently, SUS offers only Qdenga, from pharmaceutical company Takeda, administered in two doses and indicated for children and adolescents aged 10 to 14, the group with the highest hospitalization rates from dengue.
The expansion of the disease-control arsenal comes after the historic record of 2024, which saw more than 5.9 million cases and 6,297 deaths —a number higher than the sum of the previous eight years.