Conep approved third phase of vaccine testing of Chinese drugmaker Sinovac

Governor João Doria (PSDB) said on the morning of Thursday (9) that the National Commission of Ethics in Research (Conep) approved the realization of the third phase of the vaccine tests against the new coronavirus developed by chinese biotech drugmaker Sinovac in partnership with the Butantan Institute.
"Good morning, guys. Excellent news: the National Commission of Ethics in Research (Conep) approved the conduct of the third phase of clinical trials of the coronavirus vaccine developed by the Butantan Institute with the laboratory Sinovac Biotech", posted on a social network.
The Butantan Institute confirmed that it received on Wednesday (8) the approval of Conep. Conep evaluates the standards, type of study and biosafety. The Conep evaluation was the last requirement needed to validate the study that will prove the safety and efficacy of the vaccine. Last Friday (3), Butantan had already received the authorization of the National Health Surveillance Agency (Anvisa).
After the recruitment of volunteers, the vaccine should begin to be applied on July 20. Only health professionals who are active will be able to participate in the study. Other prerequisites are that volunteers have not previously become infected with Covid-19, women are not pregnant or plan to become pregnant within the next three months, and that volunteers live near one of the 12 research centers that will conduct the project.
According to the state government, the Butantan Institute is adapting a factory for vaccine production. The production capacity is up to 100 million doses. The agreement with the Chinese laboratory provides that if the vaccine is effective, Brazil will have 60 million doses for distribution.
The partnership had been announced on June 11. At the time, Doria said that if proven the efficacy and safety of the vaccine, it will be made available in the SUS from June 2021.
These new phase 3 tests of CoronaVac, the name of the vaccine, will be done on a large scale and need to provide a definitive assessment of efficacy and safety, that is, the vaccine needs to be able to create antibodies to immunize against Covid-19.
Twelve research centers from six units in the country will be responsible for recruiting and monitoring participants. The first center to start the tests will be the Hospital das Clínicas of the School of Medicine of USP. The other centers will start when they have obtained local approvals.
In são Paulo, the Emílio Ribas Institute of Infectious Diseases and the Hospital Israelita Albert Einstein were also selected as research centers. Also in the State of São Paulo, the Municipal University of São Caetano do Sul, the Hospital das Clínicas da Unicamp (Campinas), the Faculty of Medicine of São José do Rio Preto and the Hospital das Clínicas of the School of Medicine of the USP of Ribeirão Preto will participate.
The research will also be carried out at the University of Brasilia (UnB); at the National Institute of Infectious Diseases Evandro Chagas, in Rio de Janeiro; at the Drug Research and Development Center of the Federal University of Minas Gerais; at the São Lucas Hospital of PUC do Rio Grande do Sul and at the Hospital das Clínicas of the Federal University of Paraná.
In a statement, Anvisa said that phases 1 and 2, made in healthy humans and animals, showed good results with the two-dose scheme of the vaccine.
This is the second vaccine test against covid-19 released by Anvisa in the country. On 2 June, the Agency authorised the clinical trial of the vaccine developed by the University of Oxford in the United Kingdom.
The Sinovac vaccine has already been approved for clinical trials in China. It uses a version of the inactivated virus. This means that there is no presence of the coronavirus Sars-Cov-2 alive in the solution, which reduces the risks of this type of immunization.
Inactivated vaccines are composed of the dead virus or parts of it. This ensures that it cannot duplicate itself in the system. It is the same principle as hepatitis and influenza (influenza) vaccines.
It implants a kind of cellular memory responsible for activating the immunity of those who are vaccinated. When it comes into contact with the active coronavirus, the body is already prepared to induce an immune response.
Chinese scientists have reached the clinical stage of testing – human trials – on three other vaccines. One produced by military personnel in collaboration with CanSino Biologics, and two more developed by state-owned China National Biotec.