Brazilian volunteer from AstraZeneca COVID-19 vaccine trial in Brazil dies, trial continues

SAO PAULO / FRANKFURT (Reuters) – Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University had died, 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.”

AstraZeneca declined to comment immediately.

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 a meningitis injection.

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.

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 shares fell 1.8%.

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 a competing vaccine from China’s Sinovac Biotech Ltd It is being tested by the Instituto Butantan research center in the state of Sao Paulo.

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.

(Information from Eduardo Simoes in Sao Paulo and Ludwig Burger in Frankfurt; additional information from Ricardo Brito and Anthony Boadle in Brasilia and Alistair Smout in London; written by Jake Spring; edited by Jonathan Oatis and Rosalba O’Brien)