The Butantan Institute, an organization linked to the State of São Paulo, in Brazil, published the first results of the phase 3 clinical trial of the dengue vaccine, in the New England Journal of Medicine, one of the most prestigious scientific journals in the world. Made with the four types of attenuated dengue virus, the single-dose vaccine prevented the disease in 79.6% of those vaccinated over two years, protecting both those who had already had dengue and those without previous infection.
According to the Brazilian Ministry of Health, from January to mid-February 2024, 1.3 million probable cases of dengue were registered in Brazil, with 343 confirmed deaths and 775 cases under investigation.
An important milestone in this process, according to what we found, occurred in 2017, when the National Bank for Economic and Social Development (BNDES) supported Butantan with R$ 97.2 million (around 18 million euros), to finance clinical trials and construction of a scaling plant to supply the dengue vaccine. Non-refundable resources from the Bank’s Technological Fund (BNDES Funtec) corresponded to 31% of the total investment, worth R$ 305.5 million (around 56 million euros). Composed of parts of the Bank’s profit, BNDES Funtec supports applied research, technological development and innovation projects.
The director of the Industry, Innovation and Foreign Trade Area, José Luis Gordon, recalled the Bank’s history in supporting the health sector, such as “support for generics with Profarma, then for various innovation projects, vaccines, biotechnology. ”
“BNDES has supported the Butantan vaccine since 2008, in a commitment to Brazilian science. At the time, we supported the vaccine freeze-drying process – the transformation of the vaccine into powder to be taken to the most distant places without the need for a cold chain, which makes the process more expensive. It is a source of pride, as a Bank employee, to see such significant support transform into results. We hope that, soon, the vaccine will be in the arms of the Brazilian population as one of the main measures to prevent dengue fever”, said the superintendent of the Industry, Innovation and Foreign Trade Area, João Pieroni.
“There are two differences between the Butantan vaccine and the two vaccines sold in Brazil. The first is that Butantan is a single dose, while the others require two and three doses. Another difference is the age group. In the case of Butantan, participants aged 2 to 59 were studied, which is more comprehensive”, explained the institute’s medical director, Fernanda Boulos.
Developed since the late 1990s, the vaccine provides robust protection against all four dengue serotypes. The single-dose schedule helps “achieve greater vaccination coverage with logistical and economic advantages.”
The vaccine still has to complete clinical trials and go through a regulatory process before being made available by the SUS to the population, which is expected to occur in 2025.
“The phase 3 data is very encouraging. The publication in NEJM, a prestigious journal, reinforces the quality of the clinical trials conducted by Butantan, the capacity of the research centers and scientists involved in the project and the international recognition of the Institute”, highlighted the director of Butantan, Esper Kallás.
The release of the study strengthens the possibility of approval of the vaccine by the National Health Surveillance Agency (Anvisa). The analysis of the vaccine’s effectiveness was carried out over two years of monitoring 16,235 volunteers from all over Brazil, aged 2 to 59 years, in 16 research centers.
Protection was observed in all age groups, with 90% in adults aged 18 to 59, 77.8% in those aged 7 to 17 and 80.1% in children aged 2 to 6 years. Regarding safety, most adverse reactions were classified as mild to moderate, the main ones being pain and redness at the injection site, headache and fatigue. Vaccine-related serious adverse events were recorded in less than 0.1% of those vaccinated, and all recovered fully.
Igor Lopes