The Butantan Institute sent the National Health Surveillance Agency (Anvisa) a registration request for the use of the world's first single-dose dengue vaccine, this Monday (16).
Clinical trials of the vaccine called “Butantan-DV” were completed in June this year, when the last participant completed 5 years of follow-up and found that it was 79.6% effective overall in preventing cases of symptomatic dengue.
According to the Institute, according to the results of the third phase of the clinical trial published in The Lancet Infectious Diseases 89% protection against severe dengue and dengue with warning signs was proven, in addition to prolonged efficacy and safety for up to five years.
If the vaccine is approved by Anvisa, the Butantan Institute will be able to make around 100 million doses available to the Ministry of Health over the next three years.
Furthermore, one million doses of the vaccine could be delivered as early as 2025, if approved.
The other approximately 100 million doses could be delivered in 2026 and 2027.
According to the Institute, after this evaluation, the National Commission for the Incorporation of Technologies into the Unified Health System (CONITEC) will study the possibility of including this vaccine in the SUS.
This technical analysis takes into account a series of criteria, such as long-term benefits and risks for the Brazilian population; in addition to the potential for technological innovation that the incorporation will introduce into the system.
This content was originally published in Butantan requests Anvisa to register the 1st single-dose vaccine against dengue on the CNN Brasil website.
Source: CNN Brasil