SAO PAULO / FRANFURT: Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the Covid-19 vaccine developed by AstraZeneca and the University of Oxford had passed away, but added that the trial would continue.
Oxford confirmed the plan to continue testing, saying in a statement that after careful evaluation “there have been no concerns about the safety of the clinical trial.”
A source familiar with the matter told Reuters that the trial would have been suspended if the volunteer who died had received the Covid-19 vaccine, suggesting that the person was part of the control group that received the meningitis vaccine.
CNN Brazil reported that the volunteer was a 28-year-old man who lived in Rio de Janeiro and died of complications from Covid-19.
Anvisa did not provide further details, citing the medical confidentiality of those involved in the trials.
AstraZeneca declined to comment immediately.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said separately that the volunteer was Brazilian without revealing where the person lived.
It is up to an independent review board to decide whether the trials will continue, a university spokesman said. The board is made up of experts who are not from AstraZeneca, nor from universities, nor from the Brazilian center for biomedical research FioCruz that plans to produce the vaccine in Brazil.
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, he said.
AstraZeneca shares fell 1.8%.
Brazil’s federal government has plans to buy the vaccine from the United Kingdom and produce it at FioCruz in Rio de Janeiro, while the Butantan Institute research center at the São Paulo state research center is testing a rival vaccine from China’s Sinovac Biotech. Ltd.
Brazil has the second deadliest outbreak of the coronavirus, with more than 154,000 deaths from Covid-19, after the United States. It has the third highest number of cases, with more than 5.2 million infected, after the United States and India.
Oxford confirmed the plan to continue testing, saying in a statement that after careful evaluation “there have been no concerns about the safety of the clinical trial.”
A source familiar with the matter told Reuters that the trial would have been suspended if the volunteer who died had received the Covid-19 vaccine, suggesting that the person was part of the control group that received the meningitis vaccine.
CNN Brazil reported that the volunteer was a 28-year-old man who lived in Rio de Janeiro and died of complications from Covid-19.
Anvisa did not provide further details, citing the medical confidentiality of those involved in the trials.
AstraZeneca declined to comment immediately.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said separately that the volunteer was Brazilian without revealing where the person lived.
It is up to an independent review board to decide whether the trials will continue, a university spokesman said. The board is made up of experts who are not from AstraZeneca, nor from universities, nor from the Brazilian center for biomedical research FioCruz that plans to produce the vaccine in Brazil.
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, he said.
AstraZeneca shares fell 1.8%.
Brazil’s federal government has plans to buy the vaccine from the United Kingdom and produce it at FioCruz in Rio de Janeiro, while the Butantan Institute research center at the São Paulo state research center is testing a rival vaccine from China’s Sinovac Biotech. Ltd.
Brazil has the second deadliest outbreak of the coronavirus, with more than 154,000 deaths from Covid-19, after the United States. 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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