Brazil Approves Groundbreaking Single-Dose Dengue Vaccine
Brazil's Health Regulatory Agency, known as ANVISA, has granted marketing authorisation for a new dengue fever vaccine developed by the Butantan Institute, making it the first vaccine of its kind requiring only a single dose. This innovative product is targeted at individuals aged between 12 and 59 and promises to provide protection against all four serotypes of the dengue virus.
The announcement was made in light of the recent rise in dengue cases globally, a trend exacerbated by climate change. The vaccine, branded as Butantan-DV, boasts an efficacy rate of 74.4 per cent against symptomatic dengue, with an impressive 91.6 per cent efficacy against severe forms of the disease. Immunity provided by the vaccine is expected to last for up to five years.
Following eight years of rigorous clinical trials involving over 16,000 participants, the Butantan Institute in São Paulo has produced one million doses of the vaccine, according to reports from Brasil de Fato, a partner of TV BRICS. Furthermore, the Institute plans to manufacture an additional 30 million doses set for production in 2026. The Brazilian government anticipates that the vaccine will be included in the national immunisation schedule of the Unified Health System by early 2026.
In 2025, Brazil witnessed a significant decrease in dengue cases, with a reported 75 per cent drop compared to the previous year, as stated on the Brazilian government's official website. This decline comes as a welcomed development amidst increasing disease prevalence worldwide. The Butantan Institute collaborated with the Chinese company WuXi Biologics to facilitate the production and distribution of the vaccine.
Dengue fever, commonly referred to as “breakbone fever,” is transmitted by Aedes mosquitoes and has been a growing concern. In 2024 alone, the World Health Organization recorded approximately 14.6 million dengue cases worldwide, with Brazil accounting for a substantial proportion of fatalities. The introduction of Butantan-DV is seen as a crucial step in addressing the public health crisis posed by the disease.
As global temperatures continue to rise, leading to more favourable conditions for mosquito breeding, health experts urge that vaccination programs like the one introduced in Brazil are vital in controlling and preventing future outbreaks. The Butantan Institute’s single-dose vaccine could significantly ease the burden on healthcare systems and improve access to immunisation in affected regions.
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