Butantan-DV is the 1st single dose in the world; If approved, the institute will make around 100 million doses available over the next 3 years
The institute submitted to (National Health Surveillance Agency) in this Monday (Dec 16, 2024) the request to register your dengue vaccine, Butantan-DV, a 1single dose in the world.
If approved by Anvisa, Butantan could make around 100 million doses available to the (Ministry of Health) over the next 3 years. According to a note from the institute, 1 million doses could be delivered in 2025. The other approximately 100 million doses would be delivered in 2026 and 2027.
The definition of population vaccination criteria must be made by the Ministry of Health, through the (National Immunization Program).
The request could be submitted with the delivery of the last batch of documents necessary for registration. Three packages of information about the vaccine were sent, according to the institute. The data details the manufacturing process of vaccine doses, demonstrating compliance with Anvisa requirements.
The regulatory agency requires the manufacture of 3 consecutive batches of the immunizer made in a consistent and robust manner and meeting all quality requirements.
According to Butantan, the vaccine demonstrated 79,6% of overall efficacy to prevent cases of symptomatic dengue in phase 2 studies. Phase 3 clinical trial results showed 89% protection against severe dengue and dengue with warning signs, as well as prolonged efficacy and safety for up to 5 years.
Clinical trials of the vaccine ended in June 2024, when the last participant completed 5 years of follow-up. According to the director of the Institute, Esper Kallás, Butantan will wait and respect all Anvisa procedures, but said he is confident in the results that will come.
“It is worth investing in research carried out in Brazil and in the internal development of immunobiologicals” he stated.