Covid-19: Oxford vaccine trial volunteer dies

22 Oct 2020 10:38, Somoy English Desk
Covid-19: Oxford vaccine trial volunteer dies
Covid-19: Oxford vaccine trial volunteer dies

A Brazilian citizen who participated in the clinical trial of an experimental coronavirus vaccine has died, officials here said Wednesday.

Brazil’s National Health Surveillance Agency, which is overseeing multiple vaccine trials in a country suffering one of the world’s worst outbreaks, said the individual volunteered to receive the vaccine candidate developed by Oxford University and produced by AstraZeneca.

The Brazilian newspaper O Globo, citing unnamed sources, reported that the volunteer was in a control group that did not receive the experimental vaccine and died of Covid-19. The news service G1 said the volunteer was a 28-year-old physician who treated coronavirus patients in Rio de Janeiro.

The National Health Surveillance Agency said it was informed of the volunteer’s death Monday. The agency said AstraZeneca’s international safety committee had recommended the trial continue, reports The Washington Post.

Under the trial’s protocol, half the participants receive the experimental vaccine, and half receive an established meningitis vaccine that has been proved safe. The trial, like others, is overseen by an independent board that reviews all adverse events. 

Any severe event that might have been caused by the vaccine would trigger a pause in the study for an investigation. The trial is not paused due to the death.

A spokesman for AstraZeneca said he could not comment on individual cases in an ongoing trial, citing confidentiality requirements and clinical trial rules. But he said there were no concerns that would lead the study to pause.

“We can confirm that all required review processes have been followed,” spokesman Brendan McEvoy 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.”

Oxford confirmed that the volunteer’s death was reviewed by an independent committee.

“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,” the university said in a statement.

The trial was suspended last month after a participant developed an unexplained illness. AstraZeneca has since resumed trials in Brazil, India, South Africa, Japan and Britain. It remains on hold in the United States.


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