With a forecast of 1 million doses in 2025, Butantan will produce a dengue vaccine

If approved, the vaccine will be the world’s first single-dose vaccine against the disease. “It is one of the greatest advances in health and science in the country’s history and a huge achievement at an international level”, said Esper Kallás, director of the Butantan Institute, when the documents were sent to the agency. “We will wait and respect all Anvisa procedures, a body of very high competence. But we are confident in the results that will come”, Kallás added at the time.

Next steps

Butantan-DV will not be available to Brazilians immediately after registration is approved. If approved, Anvisa must send a request for price authorization to the Medicines Market Regulation Chamber (CMED).

After this stage, the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) will study the possible incorporation of the vaccine into the Unified Health System (SUS). If the position is favorable, the procedures for distribution by the Ministry of Health could be initiated – but the ministry has already signaled that it does not plan for mass vaccination this year.

Butantan-DV is a tetravalent immunizer, formulated to protect against the four serotypes of the dengue virus. The clinical trials concluded in June last year, with the latest results published in the scientific journal The Lancet Infectious Diseases. The data reflects the monitoring of 16,235 participants and indicates that the Butantan vaccine demonstrated efficacy and safety in people aged 2 to 59 years.

Brazil has a vaccine available against the disease, the Japanese Qdenga, which needs to be imported and requires two doses for immunization.