Immunizant, if approved, will be administered at a single dose, offering a more practical alternative to the currently available vaccine, which requires two doses
The National Health Surveillance Agency (Anvisa) is currently in a continuous analysis process for the approval of a new dengue vaccine developed by the Butantan Institute. This vaccine, if approved, will be administered at a single dose, offering a more practical alternative to the currently available vaccine, which requires two doses. The continuous analysis method, adopted by Anvisa during the pandemic, allows laboratories to send data in steps, which can significantly accelerate the approval process. To date, the Butantan Institute has sent three data packages, but Anvisa has requested complementary information to proceed with the evaluation.
The data packages sent by the Butantan Institute contain a variety of essential information, including administrative documents, details on clinical and non-clinical studies, as well as package insert, labeling, and risk-benefit analysis reports. In response, Anvisa requested additional data, although there is no specific deadline for the Butantan Institute to provide this information due to the continuous nature of the analysis process.
The institute is working quickly to produce the vaccine, with the objective of being prepared for possible deliveries to the Ministry of Health, aiming at a broader protection of the population from 2026. The urgency in approving this new vaccine is intensified by the alarming increase in cases Dengue, especially in the state of São Paulo, which alone concentrates 80% of the 98 deaths in Brazil in 2025. In the previous year, dengue was responsible for 6,000 deaths in the country.
Posted by Luisa Cardoso
