Peer-reviewed publication or official report on clinical trial results

Butantan Institute Submits Quadrivalent Dengue Vaccine for Approval, Aims for 100 Million Doses

Dec 16, 2024, 03:59 PM

The Butantan Institute has submitted an application to Brazil's National Health Surveillance Agency (Anvisa) for the registration of its dengue vaccine, Butantan-DV. This quadrivalent vaccine, if approved, would be the world's first single-dose dengue vaccine. Clinical trials involving over 16,000 participants have demonstrated an overall efficacy of 79.6% in preventing symptomatic dengue cases and 89% protection against severe dengue. The trials also showed prolonged efficacy and safety for up to five years. If approved, Butantan could provide approximately 100 million doses to Brazil's Ministry of Health over the next three years, with the potential to deliver one million doses as early as 2025. The vaccine is designed to protect against all four serotypes of the dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4).