UFMG hopes to cross ‘death valley’ and start tests of its own vaccine against Covid

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One of the researchers leading the Covid-19 vaccine being developed by UFMG (Federal University of Minas Gerais), Professor Ana Paula Fernandes says that the project can help unlock the development of other immunizations in Brazil.

The group is close to crossing the so-called valley of death, a phase in which most research projects fail. In October, Anvisa (National Health Surveillance Agency) authorized human trials, and the first stage is expected to begin later this year.

“It is a great frontier of science, technology and innovation in Brazil to develop, design and carry out the entire process for regulatory approval of a vaccine, meeting the requirements and reaching the stage of being able to carry out the clinical study in humans”, he says.

“It is a completely innovative process in the context of the development of vaccines and immunobiologicals in Brazil. Our expectation is that all this learning, the breaking of this barrier and the transposition of this valley of death can be replicated in other vaccines for which the Brazilian population is still extremely lacking.”

Named SpiN-Tec MCTI UFMG, the immunizing agent began to be developed in 2020 by the Vaccine Technology Center at the university in Minas Gerais.

Since then, the project has had the support of USP (University of São Paulo), Fiocruz (Fundação Oswaldo Cruz), and has received funds from the Municipality of Belo Horizonte, the Ministry of Science, Technology and Innovation and research support foundations. of Minas and São Paulo.

The clinical trial will include healthy participants of both sexes, aged between 18 and 85 years, who have completed the primary vaccination course with Coronavac or AstraZeneca, and received one or two booster doses with AstraZeneca or Pfizer for at least six months.

With most Brazilians vaccinated against Covid-19, SpiN-Tec will be applied as a booster dose, but the researchers believe that the immunizer could also be used as a first dose, if safety and efficacy are proven.

“First, we are going to test in this condition. There is nothing to prevent us from evaluating other formats throughout this process and, in the future, it can be used in children and, mainly, as a dose for primary vaccination [primeira dose]”, says Fernandes.

In the first and second phases —already approved by Anvisa—, safety, the ideal dose to be applied and efficacy will be evaluated. Once these two phases are completed, the group must ask for authorization for the third phase, in which about 4,000 volunteers will be tested. Only after that can the vaccine be registered and produced.

Despite the high vaccine coverage against Covid-19, Fernandes says that a 100% national immunizer can make the country technologically independent, reduce vaccination costs and be able to unlock other vaccines, such as monkeypox and live malaria. and leishmaniasis.

On another front, the Butantan Institute, responsible for the production of CoronaVac, has been working on the development of another national vaccine, ButanVac. The results of the first phase, which ended in June, indicated that the immunizing agent is safe and induces the production of antibodies.

“Covid has not disappeared. Certainly, we will need to offer booster doses and, at some point, replace imported vaccines with a vaccine developed in the national territory to vaccinate the population independently. vaccine”, defends Fernandes.

“Obviously, as you create a highly skilled team, and you complete the entire vaccine development process, this learning will be very important for the generation of new vaccines”, he says.

Even before the coronavirus pandemic, the technology used in SpiN-Tec was already being developed by UFMG for vaccines against leishmaniasis and Chagas disease.

The purpose of the immunizer is to induce the so-called cellular immune response in the body, that is, the production of defense cells (T lymphocytes) specialized in recognizing and killing the virus.

Therefore, unlike ButanVac, manufactured with the same technique used in the flu vaccine, SpiN-Tec intends to test the effectiveness of a new technology against Covid-19 developed in Brazilian territory.

Anvisa analyzed the previous stages of the research, including animal tests, and concluded that the data “demonstrated an acceptable safety profile of the candidate vaccine”. The results of the animal studies were published in August in the journal Nature Communications.

“We can say that it is 100% conceived and developed in the national territory. Which is a difference, for example, from CoronaVac, ButanVac and AstraZeneca because the technology of these vaccines was not developed by Brazilian researchers”, says the researcher from UFMG.

“It is an unprecedented aspect in the development of vaccines in Brazil because all the vaccines used in our national immunization plan had the technology imported. So this is the big difference.”

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