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The COVID-19 vaccine developed by Russian scientists will begin to be tested on about 10,000 people in Brazil at the end of October, after the health authorities approve its use in the country, official sources reported this Friday.
The forecast was disclosed by the government of the southern state of Paraná, which signed a technology transfer agreement with the Gamaleya Institute, responsible for the vaccine known as Sputnik V, to be experienced and later produced in Brazil.
“The Government of Paraná will submit the validation protocol for phase 3 clinical studies of the Russian vaccine to the National Health Surveillance Agency (Anvisa) until the end of September. Once approved by the regulatory body, the forecast is that testing can start at the end of October“, according to a statement from the government.
Read here: Preliminary study on Russian vaccine shows encouraging results, according to the Lancet
If approved, Sputnik V will be the fifth COVID-19 vaccine candidate to be tested in Brazil in phase three clinical studies, that is, with thousands of people.
The multinational Johnson & Johnson received clearance to test its vaccine in mid-August, which is already done in Brazil with those developed by AstraZeneca and University of Oxford, the China Sinovac Biotech, and by the consortium BioNTech and Wyeth / Pfizer.
Brazil, where the coronavirus already leaves about 125,000 dead and four million infected, which makes it the second country most affected by the pandemic in the world after the United States, has become a benchmark for clinical trials of vaccines and medicines against the disease.
With about 210 million inhabitants of great genetic diversity and the high number of cases, the South American giant is the ideal laboratory for testing various potential vaccines, who are now looking to verify its efficacy and safety.
The announcement that Brazil is ready to test the Russian vaccine was made shortly after the British medical magazine The Lancet will publish an article detailing the successful results of clinical trials with Sputnik V, which generated mistrust due to the fact that until now there was no scientific evidence of its effectiveness.
According to The Lancet, the Russian vaccine was able to generate antibodies in people in which it was experienced in the first phase of clinical trials and did not generate any adverse effect.
The published study details the first findings from two clinical trials in their first two phases, in which 76 people participated.
According to the director of the Paraná Institute of Technology (Tecpar), Jorge Callado, the publication showed that the vaccine generates a “good immune response” within 28 days.
“The previous material that the Russians gave us already showed promising results, but We had not announced them because we signed a confidentiality term with Russia. Today its effectiveness is already evident. It is an important day for the continuity of the works, “Callado said at a press conference.
The official added that, once the authorization from Anvisa is received, about 10,000 people in the state of Paraná, with priority for health professionals and people from risk groups, will receive the vaccine in two doses, with an interval of 21 days.
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“Once the efficacy has been verified, which must occur 60 days after the start of the immunization of the volunteers, Anvisa will be asked for authorization to carry out effective vaccination in Brazilian territory“, said.
According to Callado, the first doses to be applied will be imported from Russia but those produced in Brazil thanks to technology transfer will be available in the second half of 2021.
