Butantan Seeks Approval for World's First Single-Dose, Quadrivalent Dengue Vaccine with 79.6% Efficacy

Dec 16, 2024, 02:14 PM

The Butantan Institute has submitted a request to Brazil's National Health Surveillance Agency (Anvisa) for the registration of its dengue vaccine, Butantan-DV, which would be the world's first single-dose vaccine against the disease. The vaccine, developed entirely by the Brazilian institution, has shown an overall efficacy of 79.6% in preventing dengue after a single dose, according to clinical trials involving over 16,235 participants. The trials, published in the New England Journal of Medicine and The Lancet Infectious Diseases, also demonstrated 89% protection against severe dengue and dengue with warning signs, with efficacy and safety lasting up to five years. If approved, Butantan expects to deliver around 100 million doses to the Ministry of Health over the next three years, with one million doses potentially available in 2025 and the remaining doses in 2026 and 2027. The vaccine is quadrivalent, offering protection against all four dengue serotypes prevalent in Brazil. This development is seen as a significant advancement in both national and global public health efforts against dengue, which is transmitted by the Aedes aegypti mosquito.