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The clinical trials of the Brazilian vaccine announced on Friday 26 by the Ministry of Science and Technology should take between 9 and 12 months, indicating that the immunize it should be available to the public only next year. Helena Faccioli, president of Farmacore, a biotechnology company that developed the product in partnership with scientists from Ribeirão Preto Faculty of Medicine, University of São Paulo (USP). “Phases 1 and 2 will have 360 volunteers and should last 3 to 4 months. If we add up the time required for phase 3, we predict that the entire clinical trial will take 9 to 12 months. ”
Helena says that she received the MCTI transfer guarantee of R $ 30 million to enable phases 1 and 2. “They have been with us since the beginning of the project, in April of last year. But the signing of the contract will only be done after Anvisa approves the tests ”, he explains.
preclinical phase received R $ 4 million from the federal government. “The vaccine demonstrated 98% protection in animal antibody tests. It also induced the production of T cells (defending) and did not generate any side effects ”, he reports.
The president of Farmacore explains that the vaccine uses two components: a nanolipid particle and an antigen, which is the S1 protein in the coronavirus. The first awakens our immune system and the second causes the body to produce specific antibodies to COVID-19. The antigen was developed by Farmacore and USP. The nanolipid particle was created by the American company PDS, a partner in the project.
According to Helena, the particle will have to be imported for clinical tests, but if the vaccine is approved, the production of all the components will be done in Brazil, according to an agreement with the US company. “We are already in an advanced stage of negotiation with a large national industry to make production viable,” said the president.
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