A Brazilian volunteer in a coronavirus vaccine trial of AstraZeneca died last week, the country’s health ministry disclosed on Wednesday, Reuters reported. Brazil, however, said that the trial of the vaccine – developed by the pharmaceutical firm and Oxford University – would continue.
The country’s health agency Anvisa said that an international safety board monitoring the vaccine study gave notice of the death earlier this week, but the International Evaluation and Security Committee recommended that the trial continue, according to CNN.
It was unclear whether the volunteer received the experimental vaccine or a placebo, but experts said that if a volunteer had died after receiving the experimental vaccine, the company would have halted the trial over safety concerns. A Brazilian newspaper, O Globo, reported that the man had died of the coronavirus.
But Gustavo Mendes, a manager at Anvisa, told The New York Times that an assessment by the independent safety board showed the volunteer’s death was not related to the vaccine. “The death outcome in a Covid-19 clinical study is what we call an expected outcome because Covid can cause death,” he said. Mendes said the decision to not halt the study was taken by Anvisa along with its United Kingdom counterpart.
Oxford, too, confirmed the plan to keep testing, saying that after careful assessment there were no concerns about safety of the clinical trial.
“All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed,” Oxford University told CNN. “Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue.”
AstraZeneca declined to comment immediately. A company spokesperson, Brendan McEvoy, refused to comment citing medical confidentiality, but added that all required review procedures had been followed. “These assessments have not led to any concerns about continuation of the ongoing study,” he told The New York Times.
The Federal University of Sao Paulo, which is helping coordinate phase three clinical trials in Brazil, said an independent review committee had also recommended the trial should continue. “Everything is proceeding as expected, without any record of serious vaccine-related complications involving any of the participating volunteers,” the Brazilian university said in a statement.
Instituto D’Or, a Brazilian medical research facility that served as a local partner for the study, said in a statement that approximately 8,000 Brazilians have participated in the trial. No safety issues have been reported, the institute said.
The death comes just weeks after AstraZeneca halted its global trials after a participant who had received its experimental vaccine fell sick with an unexplained illness . But within days, AstraZeneca had resumed its trials in the United Kingdom, concluding there was not enough evidence to link the event to their product. American study sites, however, have yet to restart the trials.
Earlier this month, Johnson and Johnson, also paused its trials because of an illness in one of its volunteers. The Phase 3 trial of its vaccine began last month, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the United States and around the world. The company has so far not disclosed any details of the illness.
Over 100 vaccines are being developed around the world to tackle the coronavirus pandemic. The global coronavirus count has crossed 4.11 crore and the toll rose to 11,30,405, according to Johns Hopkins University. The number of recoveries is over 2.80 crore.
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