Official announcement from Anvisa or the Butantan Institute

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

Dec 16, 2024, 02:14 PM

The Butantan Institute has submitted an application to Brazil's National Health Surveillance Agency (Anvisa) for the registration of Butantan-DV, a single-dose dengue vaccine. If approved, this would mark the world's first single-dose vaccine against the disease, potentially simplifying immunization efforts as it eliminates the need for a booster shot. The vaccine, developed entirely by the Brazilian institution, has demonstrated an overall efficacy of 79.6% in preventing symptomatic dengue after one dose and 89% protection against severe dengue and dengue with warning signs. It is quadrivalent, offering protection against all four dengue virus serotypes prevalent in Brazil. Clinical trials, involving over 16,000 participants, concluded in June, with no serious cases of dengue reported among those vaccinated. The results have been published in the New England Journal of Medicine. If Anvisa approves the vaccine, Butantan plans to deliver 100 million doses to the Ministry of Health over the next three years, starting with one million doses in 2025.