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Volunteer in AstraZeneca Covid-19 vaccine trial dies in Brazil

Clinical trials for the drugmaker's vaccine remain on hold in the United States.
Image: FILE PHOTO: Outbreak of the coronavirus disease (COVID-19), in Sao Paulo
An employee is seen at the Reference Center for Special Immunobiologicals of the Federal University of Sao Paulo where the trials of the Oxford/AstraZeneca coronavirus vaccine are conducted, in Sao Paulo on June 24, 2020.Amanda Perobelli / Reuters file

A volunteer in AstraZeneca's Covid-19 vaccine trial has died in Brazil, the country's National Health Surveillance Agency said Wednesday.

The agency, Anvisa, said in a statement that it was formally notified of the death on Monday.

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The vaccine candidate is being developed with the University of Oxford.

In a statement to NBC News, AstraZeneca said that the trial would continue.

"We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed," the statement said. "All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study."

"All relevant critical events observed among participants in the control group or any group receiving a vaccine against COVID-19 are reviewed by an independent safety committee," the University of Oxford said in a statement. "Careful analysis of this case in Brazil, raised no doubt as to the safety of the ongoing clinical study. A review by the independent committee and Brazilian regulatory agencies recommend that the study should continue.”

Ian Jones, a professor of virology at the University of Reading in the United Kingdom said that it was likely the death was not vaccine-related.

"Without details it’s impossible to know what has happened in this case but as the trial is continuing, I think we can assume the circumstances of the death were such that it was clearly not vaccine related," Jones said in a statement.

AstraZeneca's phase 3 clinical trial was put on hold in early September after a study participant in the U.K. developed a spinal cord injury. The trials have since resumed in the U.K. as well as in Brazil, though they remain on hold in the U.S.

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Laura Saravia contributed.