Brazilian Covid vaccine could be tested in humans in 2023

The Covid-19 vaccine developed by researchers at UFMG (Federal University of Minas Gerais) and Fiocruz (Oswaldo Cruz Foundation) could be tested in humans in early 2023, according to scientists involved in the project.

The immunizing SpiN-TEC has performed well in laboratory and animal studies.

However, the volunteer trial depends on meeting Anvisa’s (National Health Authority) requirements.

Development of the vaccine began in March 2020 by UFMG’s CT Vaccines in partnership with Fiocruz Minas and with support from the Ministry of Science, Technology, and Innovation.

At the end of July 2021, the researchers began applying for authorization to conduct human testing.

Since then, they have been discussing with Anvisa what the testing protocol should look like and what requirements must be met.

“Anvisa has held technical meetings to help guide the researchers through the process and fill in the missing and necessary requirements for evaluating the clinical research proposal,” the health agency told Agência Brasil.

It also said it “expects the submission of the missing documents and information by the developers to complete the clinical research approval process.

The current status of the process is ‘in technical need,'” it added.

Testing with the vaccine has already been approved: by the UFMG Human Experimentation Ethics Board and by the CEP/Conep system formed by the National Commission on Ethics in Research and the Research Ethics Committee.

Conep is the highest authority on the ethical evaluation of research protocols involving human subjects. Their approval is essential for the study to proceed.

The tests have confirmed that the vaccine protects against exacerbations of Covid-19 in mice and nonhuman primates without causing relevant side effects.

In an article published Aug. 17 in the journal Nature Communications, the researchers presented data suggesting that SpiN-TEC elicits a robust T-lymphocyte response against traditional and Omicron variants of the new coronavirus.

Researcher at CT Vaccines of UFMG and coordinator of the study, Ricardo Gazzinelli, says that although much of the population is already vaccinated, the vaccine may help control the epidemiological scenario in Brazil.

In an interview with Fiocruz news agency, the researcher added that the vaccine could be used in booster doses, which may also be needed in coming years. “We have asked Anvisa to test the response to this booster against Covid-19.”

SpiN-TEC has different technology than the four Covid-19 vaccines used in Brazil: CoronaVac, AstraZeneca/Fiocruz, Pfizer, and Janssen. It fuses two SARS-CoV-2 proteins, S and N, to form a “chimera” protein.

According to the developers, this association gives SpiN-TEC an advantage over other immunization agents that target only the S protein because it is the one the virus uses to enter human cells.

The problem with targeting only the S protein is that it is also the one that has had the most mutations during the evolution of the new coronavirus, which gave the new variants greater efficacy against neutralizing antibodies.

On the other hand, the N protein is less susceptible to the mutations that led to the new variants.

In addition to demonstrating the vaccine’s safety, the human study aims to prove that SpiN-TEC protects coronavirus through the chimera with the two proteins without giving its variants a chance to escape.