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It is not yet clear whether this volunteer received a vaccine or a placebo.
This is the first known case of the death of a volunteer in a clinical trial of a coronavirus vaccine. Currently, a series of clinical trials of potential COVID-19 vaccines are underway around the world.
However, the study organizers said that an independent evaluation had concluded that there were no safety concerns and that the vaccine being developed with British pharmaceutical giant AstraZeneca would continue to be tested.
Media reported that the volunteer was a 28-year-old doctor working on the front lines of the anti-coronavirus front line. He died of complications from COVID-19.
“Whether participants are in the control group or the COVID-19 vaccine group, all major medical incidents are subject to independent evaluation,” said a statement issued by the University of Oxford.
“A comprehensive evaluation of this case in Brazil has not revealed any safety issues with this clinical trial. Following an evaluation by the Brazilian authorities, a further independent evaluation recommended that testing be continued,” the statement read.
Anvisa, the national health regulator, confirmed that it had been “officially informed of the case on October 19” and had received an independent review report from the Safety and Evaluation Committee that oversees the trials.
The D’Or Institute for Research and Education (IDOR), which is helping organize the tests in Brazil, said the independent review “did not raise any concerns about the safety of the tests and recommended that they continue.”
In September, the University of Oxford and AstraZeneca had to suspend clinical trials of their COVID-19 vaccine because a volunteer in the UK was diagnosed with inflammation affecting the spine.
Testing was resumed when UK supervisory authorities agreed with the independent evaluation findings that the disease was not a side effect of the vaccine.
IDOR reported that half of the volunteers in the final phase of clinical trials, a double-blind, double-blind, randomized, placebo-controlled study, received placebo.
In Brazil, around 8,000 have already been vaccinated. volunteers, more than 20,000 worldwide, IDOR said.
Study participants must be doctors, nurses, or other health professionals who are regularly exposed to the virus.
The Brazilian newspaper Globo reported that the deceased volunteer was a young doctor who had been treating patients with COVID-19 in the emergency and intensive care units of two hospitals in Rio de Janeiro since March.
He completed his medical studies last year, and before becoming infected with the coronavirus, his health was excellent, relatives and friends of the deceased told the newspaper.
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