Anvisa (National Health Surveillance Agency) authorized this Monday (3) the start of human trials of the Covid-19 vaccine being developed by UFMG (Federal University of Minas Gerais), SpiN-Tec MCTI UFMG.
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.
To verify the safety and effectiveness of the Brazilian immunizer, a part of the group will receive the booster dose of SpiN-Tec and the other, the booster of AstraZeneca. The researchers’ expectation is that people vaccinated with the new formulation will produce an equal or even greater number of antibodies.
The study will be funded by UFMG, the Ministry of Science, Technology and Innovation, Fiocruz (Fundação Oswaldo Cruz) and the city of Belo Horizonte (MG). The scientists had already received authorization from Conep (National Research Ethics Commission).
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.
“For the approval of the clinical trial, Anvisa held meetings with the UFMG team in order to align all the technical requirements necessary for the tests and evaluated all the evidence presented, as a priority”, the agency said on Monday.
“Clinical trials are studies of a new drug carried out in human beings. The clinical phase serves to validate the relationship of efficacy and safety of the drug and also to validate new therapeutic indications.”
To develop the immunizer, the researchers fused two different coronavirus proteins: the N (from the nucleocapsid), a structure that houses the virus’s genetic material, and a portion of the S (spike or spike) used by the pathogen to bind and invade the cell. human. The resulting molecule was named SpiN.
The clinical trial start date will be defined by the study sponsors. In August, the coordinator of the Center for Vaccine Technology at UFMG and senior researcher Fiocruz Ricardo Tostes Gazzinelli stated that the group was ready to begin testing immediately after authorization from Anvisa.
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