The Butantan Institute has submitted a request to Brazil's National Health Surveillance Agency (Anvisa) for the registration of its dengue vaccine, Butantan-DV, marking a significant step towards potentially making it the world's first single-dose vaccine against the disease. The institute anticipates being able to produce 100 million doses for the Ministry of Health in the three years following approval.
Esper Kallás, director of the Butantan Institute, hailed the submission as "one of the greatest breakthroughs in health care and science in the history of Brazil and a huge achievement at international level."
Clinical Trial Data
The application is supported by data from extensive clinical trials. The New England Journal of Medicine published data showing 79.6% overall efficacy in preventing symptomatic dengue. Furthermore, The Lancet Infectious Diseases published phase three clinical trial data, demonstrating 89% protection against severe dengue and dengue with alarm signs, with prolonged efficacy and safety observed for up to five years.
The final participant in the clinical trials completed their follow-up in June, marking five years of trials and observation. The data comes from a two-year follow-up of over 16,000 Brazilians who received the vaccine.
Vaccine Details and Production
Butantan-DV is a tetravalent vaccine, designed to protect against all four dengue virus serotypes prevalent in Brazil. The institute has the capacity to supply one million doses in the coming year, with the potential to deliver another 100 million doses in 2026 and 2027.
The submission to Anvisa includes comprehensive details of the vaccine's manufacturing process, demonstrating compliance with the agency's requirements for formulation and packaging. Anvisa has already inspected and approved the vaccine factory located at the Butantan Bioindustrial Center.
Impact and Next Steps
Approval of Butantan-DV is expected to significantly enhance population immunization efforts, particularly addressing the challenge of patients not returning for the second dose in two-dose regimens. Following authorization to manufacture the inoculation, Butantan will submit a price authorization request to the Chamber for the Market Regulation of Medicines.
