Researchers say that immunizer is more efficient against variants and can be used for booster doses
The vaccine against covid-19 developed by researchers from UFMG (Federal University of Minas Gerais) and Fiocruz (Fundação Oswaldo Cruz) could be tested in humans in early 2023, according to the expectation of the scientists involved in the project. The SpiN-TEC immunizer has been obtaining good results in the laboratory and in animal tests. However, the study in volunteers depends on meeting the requirements of Anvisa (National Health Surveillance Agency).
The vaccine began to be developed in March 2020 by the CT Vaccines from UFMG, in partnership with Fiocruz Minas and with the support of the Ministry of Science, Technology and Innovation. At the end of July 2021, the researchers started the request for authorization to carry out tests on humans, and since then they have been discussing with Anvisa how the testing protocol should be and the requirements that need to be met.
“Anvisa has held technical meetings to guide researchers in the instruction of the process and for full compliance with the missing and necessary requirements for the evaluation of the clinical research proposal”, the health agency told Brazil Agency.
It also reported that “awaits the submission of missing documents and information by the developers so that the clinical research authorization process can be completed. The current status of the process is ‘under technical requirement’”, he added.
The UFMG Human Experimentation Ethics Council and the CEP/Conep system, formed by the National Research Ethics Commission and the Research Ethics Committee, have already approved the tests with the vaccine. Conep is the highest instance of ethical evaluation in research protocols with human beings. Its approval is essential for the study to proceed.
The tests carried out to date have confirmed that the vaccine offers protection against the worsening of cases of covid-19 without causing relevant side effects in mice and non-human primates. In an article published on August 17 in the journal Nature Communicationsthe researchers presented data indicating that SpiN-TEC induces a robust T-lymphocyte response against both the traditional and the micron variants of the novel coronavirus.
The researcher at CT Vaccines at UFMG and coordinator of the study, Ricardo Gazzinelli, says that, despite the fact that a large part of the population is already vaccinated, the immunizer can contribute to the control of the epidemiological scenario in Brazil.
“There are already studies showing that the response of current vaccines against the ômicron variant is ineffective, hence the importance of developing new solutions that attack this and other variants.”, says in the article. “In addition, SpiN-TEC has low cost and high stability. Vaccines that use RNA need to be frozen at low temperatures, which makes transport difficult. The UFMG immunizer can be kept at room temperature, which facilitates distribution to distant places.”
The researcher added in an interview with the Fiocruz News Agency that the vaccine can be used in booster doses, which may continue to be needed in the coming years. “Our request to Anvisa is to test the response capacity in relation to this reinforcement against covid-19”.
SpiN-TEC has a different technology from the 4 vaccines against covid-19 used in Brazil: CoronaVac, AstraZeneca/Fiocruz, Pfizer and Janssen. Uses the fusion of two SARS-CoV-2 proteins, S and N, to form a protein “chimera”.
According to the developers, this association gives SpiN-TEC a differential in relation to other immunizers, which target only the S protein, as it is the one that the virus uses to invade human cells.
The problem with attacking only the S protein is that it is also the one that most accumulated mutations throughout the evolution of the new coronavirus, which gave the new variants more efficiency against neutralizing antibodies. The N protein, on the other hand, is less subject to the mutations that gave rise to the new variants.
In addition to the vaccine’s safety, the human study wants to prove that, by containing the chimera with the two proteins, SpiN-TEC will be able to offer protection against the coronavirus without giving its variants a chance to escape.
With information from Brazil Agency.
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