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Dengue vaccine from Instituto Butantan will be tested throughout Brazil

Dengue vaccine from Instituto Butantan will be tested throughout Brazil

The Butantan Institute, considered one of the largest producers of immunobiological in Brazil, announced that the vaccine against dengue that are developing will enter phase 3 of testing. At this stage of the process, 17,000 volunteers will be recruited for the double-blind randomized study. "That is, two thirds of the volunteers will receive the vaccine, while the others will only receive the vehicle without the virus," explains David Uip, Secretary of Health of the State of São Paulo, at a press conference with the governor of São Paulo Geraldo Alckmin and the director of the Butantan Institute Jorge Kalil.

The Butantan Institute vaccine will be given in a single dose and intends to immunize against the four types of virus. Therefore, in this stage the tests will be done in 12 states, since it is necessary that the volunteers are exposed to the four types of dengue, and in the state of São Paulo there is a greater incidence of type 1 and 4.

The plan is that this phase of the study lasts for about 5 years, but before that, if the vaccine already has sufficient evidence pointing to its effectiveness, it will begin to be produced on a large scale throughout the country, and later on a worldwide scale, as the study proceeds. To this end, Secretary David Uip intends to meet with national and international companies to negotiate aid in production. The doses that will be used in phase 3 of the tests have already been produced by the Butantan Institute. "We will also participate in large-scale production when it occurs," says Jorge Kalil, director of the Institute. The idea is that the vaccine is distributed free of charge by the Unified Health System (SUS). It will all depend, however, on the time it will take to get these 17,000 volunteers, though there is a lot of interest, according to those responsible for the vaccine.

In the early stages of testing, the vaccine had only minor adverse reddening effects. body (the technically called skin rash) and headaches. "We believe that redness is another indication that the application has been successfully done as a side effect," said David Uip. However, he points out that this large-scale test also aims to check for side effects in a larger sample of people.

People who have had the disease can take this vaccine. "In fact, in phase two of the test these patients had better vaccine results," says Kalil. In addition, when a person gets a type of dengue, it only develops antibodies to this specific virus, which does not make it immune to other types.

Dengue vaccine in Mexico

Meanwhile Mexico was the first country to approve the registration of the dengue vaccine from Sanofi Pasteur, which is also requesting registration in Brazil. The Mexican regulatory agency indicates the product only for the age group between nine and 45 years. Immunization should be done in three doses at six-month intervals.

The laboratory responsible for the vaccine states that the immunizer has 60.8% efficacy against the four serotypes of the disease, a hospitalization reduction rate of 80.3 % and 95.5% decrease in severe cases of dengue.

The development of this product took about 20 years and, by the end of December, the application for registration has been made in at least 20 countries. As reported, vaccine trials were conducted in people between nine months and 60 years, but the regulatory agency, based on the studies, decides what will be the target age range in the country.

When asked about this vaccine at a press conference, the Secretary of Health of the State of São Paulo David Uip said that the vaccine developed by the Butantan Institute is more effective because it is made with the virus attenuated and not with a part of the virus, such as that produced by Sanofi Pasteur. In addition, they point out restrictions on this vaccine that have been imposed on the country, which will only administer it in places where 60% of the population has the virus.Battle against Aedes aegypti

David Uip stressed that the existence of a vaccine against dengue does not exempt the state and country from measures to reduce mosquito outbreaks. "It is important to remember that Aedes aegypti is a vector of three other diseases: zika fever, chikungunya fever and yellow fever, and the current vaccine only immunizes against the dengue virus," the secretary warned. development of a vaccine for zika virus, David Uip and Jorge Kalil stated that Butantan has started this project, but there is still nothing produced. However, the production of the dengue vaccine already brings valuable insights into the creation of this other immunization.


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