A Brazilian volunteer in the coronavirus vaccine trial of AstraZeneca died last week, the Ministry of Health announced Wednesday, Reuters said. Brazil, however, said that the vaccine trial – developed by the pharmaceutical industry and Oxford University – will proceed.
Anvisa, the country’s health department, said that earlier this week the International Protection Board overseeing the vaccine research notified the death, but the International Assessment and Protection Committee recommended that the experiment proceed, according to CNN.
It was uncertain whether the volunteer administered the experimental vaccine or placebo, but experts said that if the volunteer died after receiving the experimental vaccine, the organization would have abandoned the trial due to safety issues. O Globo, a Brazilian daily, announced that the man had died of coronavirus.
But Gustavo Mendes, the boss at Anvisa, told the New York Times that the review by the Independent Safety Board revealed that the death of the volunteer was not linked to the vaccine. “The death result of the Covid-19 clinical trial is what we call the predicted outcome because Covid will cause death,” he said. Mendes said that the decision not to interrupt the analysis was made by Anvisa and his counterpart in the United Kingdom.
Oxford has reiterated the plan to begin research, adding that there were no questions regarding the efficacy of the clinical trial following a thorough evaluation.
“All major medical events, whether in the control group or in the Covid-19 vaccination group, are independently reviewed,” Oxford University said to CNN. “Following careful assessment of this case in Brazil, there was no doubt about the safety of the clinical trial and the independent review, in addition to the advice of the Brazilian regulator, that the trial should proceed.”
AstraZeneca refused to comment immediately. The company’s spokesman, Brendan McEvoy, declined to comment on patient secrecy but added that all the appropriate examination protocols had been followed. “These evaluations did not give rise to any questions regarding the continuation of the ongoing research,” the New York Times reported.
The Federal University of Sao Paulo, which is helping to organize phase three clinical trials in Brazil, reported that the independent evaluation committee had recommended that the trial be continued. “All is progressing as planned, without any record of significant vaccine-related problems affecting any of the volunteers involved,” the Brazilian university said in a statement.
Instituto D’Or, a Brazilian medical research laboratory that acted as a local research affiliate, said in a statement that about 8,000 Brazilians had participated in the trial. No safety concerns have been identified, said the institute.
Death occurs only weeks after AstraZeneca suspended its global trials after a researcher who had obtained an experimental vaccine became sick with an unknown illness. But within days, AstraZeneca reopened its trials in the United Kingdom, concluding that there was not enough data to link the case to its product. However, the American study sites are yet to restart the experiments.
Johnson and Johnson have suspended their trials earlier this month because of sickness in one of their participants. The Phase 3 vaccine trial started last month with the intention of enrolling up to 60,000 volunteers across more than 200 locations in the United States and around the world. To date, the company has not released any specifics about the disease.
About 100 vaccines are being developed around the world to combat the coronavirus pandemic. The global coronavirus count has crossed 4.11 crores and the toll has increased to 11.30.405 crores, according to Johns Hopkins University. The number of recoveries is more than 2.80 crore.