If approved, 100 million doses could be produced within three years
The Butantan Institute, affiliated with the São Paulo government, has completed its application to health regulator ANVISA for the registration of its dengue vaccine candidate, Butantan-DV. On Monday, the institute submitted the final set of required documents, concluding the submission of three comprehensive information packages about the vaccine.
The vaccine candidate is a tetravalent, single-dose immunization. If approved, Butantan-DV would become the world's first single-dose vaccine against dengue fever. Clinical trials concluded in June when the last participant completed five years of monitoring.
Recently, the vaccine's safety and efficacy data were published in the New England Journal of Medicine, revealing an overall efficacy of 79.6% in preventing symptomatic dengue cases. Phase 3 clinical trial results, published in The Lancet Infectious Diseases, also demonstrated 89% protection against severe dengue and dengue with warning signs, with sustained efficacy and safety lasting up to five years.
Upon approval by ANVISA, the Butantan Institute could supply approximately 100 million shots to Brazil's Ministry of Health over the next three years. One million doses could be delivered as early as 2025, with the remaining doses provided between 2026 and 2027. The Ministry of Health will determine the vaccination criteria for the population.