This Wednesday it was known from the voice of the local health authorities that a volunteer participating in the clinical trials of the covid-19 vaccine developed by the pharmaceutical group AstraZeneca and the University of Oxford died in Brazil.
It’s about the first death reported in the various vaccine trials against the coronavirus that are carried out throughout the world and for now it has not officially transpired whether the man received the vaccine or the placebo that is used in this type of research.
However, study organizers said an independent review concluded that there are no safety concerns and that testing of the vaccine would continue.
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“All major medical incidents, whether the participants are in the control group or the covid-19 vaccine group, are reviewed independently. After careful evaluation of this case in Brazil, there have been no concerns about the safety of the clinical trial and the independent review coupled with the Brazilian regulatory agency recommended that the study should continue, ”said the University of Oxford in a statement.
According to the local press, the volunteer was a 28-year-old doctor who worked on the front lines of the pandemic and who died of complications from covid-19. The Brazilian health surveillance agency, Anvisa, confirmed that it was “formally notified of the case on October 19.”
Following an evaluation of this case, there have been no concerns about the safety of the clinical trial.
He D’Or Institute for Teaching and Research (IDOR), which is helping organize the trials in Brazil, said the independent review process “raised no doubts about the safety of the study and recommended that it continue.”
Oxford Y AstraZeneca they had to suspend trials of the vaccine in September, when a volunteer in the UK developed a “potentially unexplained illness”. The trials were resumed after British regulators and an independent safety review concluded that the disease was not a side effect of the vaccine.
Half of the 8,000 volunteers who have so far participated in the clinical trial in Brazil received placebo, IDOR said.
Study participants must be doctors, nurses, or other healthcare workers who are in regular contact with the virus.
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The Brazilian newspaper O Globo said that the deceased volunteer was a young doctor who had been treating covid-19 patients since March in emergency rooms and the intensive care units of two hospitals in Rio de Janeiro. He graduated from medical school last year and was in good health before contracting the disease, family and friends told the newspaper.