Brazil’s health regulatory agency ANVISA has approved the world’s first single-dose dengue vaccine, Butantan‑DV, developed by the Butantan Institute in São Paulo. The vaccine is authorised for use in people aged 12 to 59 years.
Unlike existing dengue vaccines, for example TAK-003, which requires two doses given at least three months apart, Butantan-DV requires just one dose, which could significantly streamline vaccination campaigns.
Dengue is a mosquito-borne viral infection transmitted primarily by the Aedes aegypti mosquito, which is most active during the early morning and late afternoon.
The illness typically causes high fever, severe body pain, headache, and fatigue, earning it the nickname “breakbone fever.”
While most cases are mild, dengue can sometimes progress to severe forms, leading to bleeding, plasma leakage, organ impairment, and even death if not managed promptly.
With rising global temperatures and rapid urbanization, dengue has become a growing public health concern in many tropical and subtropical regions. Prevention largely depends on controlling mosquito populations, avoiding bites, and enhancing community awareness.
In phase-3 clinical trials conducted across Brazil, involving more than 16,000 volunteers, Butantan-DV demonstrated 91.6% efficacy against severe dengue.
The vaccine employs a live, attenuated (weakened) dengue virus approach, designed to protect against multiple dengue serotypes, the four known variants of dengue virus.
According to officials at Butantan Institute, the vaccine’s single-dose schedule could make mass immunization faster and more feasible, especially in regions with high dengue burden.
Dengue has surged worldwide in recent years; 2024 saw record high numbers globally.
Public health experts link part of this rise to climate change, which expands the favorable habitat of the primary dengue vector, the Aedes aegypti mosquito and increases mosquito-borne transmission in more regions.
In high-burden settings such as Brazil, and other tropical or subtropical countries, a safe, effective, single-dose vaccine could greatly reduce hospitalizations, severe disease, and deaths, provided it is deployed widely and equitably.
While Butantan-DV’s approval marks a major milestone, important questions remain under scientific and public-health scrutiny:
Broad protection across all four dengue serotypes in real-world conditions, though initial data show strong efficacy against severe dengue.
Long-term safety, durability of immune response, and population-level impact once vaccination is rolled out at scale.
Integration of the vaccine into existing dengue-control strategies, including mosquito-control measures, public awareness, and environmental interventions.
If the vaccine proves effective outside Brazil, it could be a game changer for dengue-endemic countries, including India, which sees regular dengue outbreaks. A low-dose, easy-to-administer dengue vaccine would ease logistical hurdles, improve vaccination coverage, and reduce the burden on healthcare systems.
However, experts stress vaccination is only one part of dengue prevention, mosquito control, environmental hygiene, public awareness, and prompt medical care will remain essential.
(Rh/TL)