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Image posted, REUTERS
The Brazilian Health Authority has no details of the volunteer’s death and confirmed that there are no concerns about the safety of the vaccine.
It was decided to resume trials of a possible coronavirus vaccine developed by the University of Oxford in cooperation with AstraZeneca, after reviewing the causes of death of a volunteer in Brazil.
The Brazilian Health Authority has not provided any details of the volunteer’s death due to confidentiality protocols for patient information.
Oxford University said “careful evaluation” did not reveal any safety concerns.
The BBC learned that the volunteer did not receive the Oxford vaccine.
Half of the volunteers who participated in the trial received the potential vaccine. The other half of the volunteers received a licensed meningitis vaccine.
Neither the volunteer nor his family know what vaccine they are receiving. This allows researchers to compare the results of the two groups to assess the efficacy of a possible vaccine.
AstraZeneca said in a statement that it could not “comment on individual cases” but stated that “all required reviews have been followed.”
“All important medical indicators are carefully evaluated by test monitors, the Independent Safety Oversight Committee and regulatory authorities,” the company added. “These evaluations did not reveal any concerns about the continuity of the trials.”
There are high hopes that this potential vaccine will be one of the first vaccines to enter the market.
The vaccine has passed the first and second stage tests, while the third stage tests are being carried out on participants in countries such as Great Britain, Brazil and India.
Trials of the Oxford vaccine were halted last month after a patient reported side effects in Britain, but were resumed days later.
Phase III trials in the United States are still pending, while regulators are conducting their own evaluation there.
The Brazilian Health Authority said it had received information about the death of the Brazilian volunteer on October 19.
“All major medical incidents … are reviewed independently,” Oxford University said in a statement.
He added: “The independent review and recommendations from the Brazilian body emphasized the need for the experiment to continue.”
Brazil has recorded around 5.3 million confirmed cases of the coronavirus, the third highest in the world after the United States and India, in addition to 155,000 deaths so far, according to data compiled by Johns Hopkins University.
