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RIO DE JANEIRO: A volunteer participating in clinical trials of the COVID-19 vaccine developed by the University of Oxford and AstraZeneca has died in Brazil, authorities announced on Wednesday (October 21), although the media said he had received a placebo, not the test vaccine. .
It is the first death reported in the various coronavirus vaccine trials being carried out around the world.
However, the study organizers said an independent review had concluded that there were no safety concerns and that testing of the vaccine would continue.
AstraZeneca declined to comment immediately.
Media reports said the volunteer was a 28-year-old doctor working on the front lines of the pandemic who died from complications from COVID-19.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said an independent review committee also recommended that the trial continue. The university previously confirmed that the volunteer was Brazilian, but did not provide further personal details.
“Everything is progressing as expected, with no record of serious vaccine-related complications involving any of the participating volunteers,” the Brazilian university said in a statement.
So far, 8,000 of the 10,000 volunteers expected in the trial have been recruited and given the first dose in six cities in Brazil, and many have already received the second injection, a university spokesman said.
The Brazilian newspaper Globo and the international news agency Bloomberg said the man was in the control group and had received a placebo instead of the test vaccine, citing sources close to the trials.
“After careful evaluation of this case in Brazil, there have been no concerns about the safety of the clinical trial, and the independent review, in addition to the Brazilian regulator, has recommended that the trial continue,” Oxford said in a statement.
AstraZeneca said medical confidentiality meant that it could not provide details on any individual volunteers, but that the independent review “did not raise concerns about the continuation of the ongoing study.”
Brazil’s national health regulator Anvisa confirmed that it had been notified of the case on October 19.
The D’Or Teaching and Research Institute (IDOR), which is helping organize the trials in Brazil, said the independent review “raised no doubts about the safety of the study and recommended that it continue.”
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
The trials were resumed after British regulators and an independent review concluded that the disease was not a side effect of the vaccine.
Half of the volunteers in the end-stage clinical trial, a double-blind, randomized, controlled study, receive a placebo, IDOR said.
So far, around 8,000 volunteers have been vaccinated in Brazil and more than 20,000 worldwide, he said.
Study participants must be doctors, nurses, or other healthcare workers who come in regular contact with the virus.
The deceased volunteer was a young doctor who had been treating COVID-19 patients since March in the emergency rooms and intensive care units of two Rio de Janeiro hospitals, Globo said.
He graduated from medical school last year and was in good health before contracting the disease, family and friends told the newspaper.
Brazil’s federal government has plans to buy the vaccine from the United Kingdom and produce it at the FioCruz biomedical research center in Rio de Janeiro, while the Butantan Institute research center at the São Paulo state research center is testing a competing vaccine. from China Sinovac Biotech.
Brazilian President Jair Bolsonaro said Wednesday that the federal government will not buy the Sinovac vaccine.
Brazil has the second deadliest outbreak of the coronavirus, after the United States, with more than 154,000 deaths. It has the third highest number of cases, with more than 5.2 million infected, after the United States and India.
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