Brazil: dengue vaccine tested on volunteers

The vaccine against dengue, being developed by Instituto Butantan, will be released to be used on large scale in 2019. The product is being tested. Centers were installed in 13 cities from the country's five regions to immunize volunteers and evaluate the effectiveness of the product. Until now, 4,000 people received a dose, and a total of 17,000 people are expected to participate in the testing phase.

This is the last phase before the vaccine is submitted for approval of the Brazilian Health Surveillance Agency (ANVISA). According to Jorge Kalil, head of the Instituto Butantan, the vaccine may reach the society in 2019.

"I find it difficult to have it available next year. But we're working to make it happen. But maybe for the next summer, it might be available. It depends on many other things," he said.

Investment

São Paulo government signed today (Jan. 3) an agreement with the Brazilian Development Bank (BNDES) to release $29.7 million to build the dengue vaccine factory. The amount covers 31% of the total cost of the Instituto Butantan project, budgeted at $93.6 million.

The resources will allow the construction of a new building that will be able to produce up to 30 million doses per year. The money, invested with no need of return, will also be used to buy the equipment and furniture, and for the training of teams.

São Paulo Governor Geraldo Alckmin, who inspected the works during the ceremony to sign the agreement with the BNDES, said the building should be ready within 60 days. "We are constructing the building while the vaccine is being tested in its last phase. The test will check the effectiveness of producing it on large scale to meet Brazil needs," he said.

The vaccine should protect against the four types of dengue virus. According to the São Paulo state Secretary of Health, David Uip, their expectation is that the immunization power of the product exceeds 80%.

"The vaccine immunogenicity was very good with few adverse effects," he said based on the results observed in the previous phases of the vaccine developed with weakened viruses.

In this last phase of testing, two thirds of the volunteers will receive the vaccine and one third will receive a placebo. From there, the infection rate will be observed in the group that received the vaccine and in the control group, which is the one that received the placebo.

Translated by Amarílis Anchieta