Brazil's COVID-19 vaccine volunteer dies, authorities say trial to continue

An employee is seen at the Federal University of Sao Paulo where the trials of the Oxford  AstraZeneca coronavirus vaccine are being conducted

Brazil's National Health Surveillance Agency (ANVISA) said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.

"None of the trials now under way are created to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths".

He explained that all ongoing phase three trials for which details have been released are evaluating mild, not severe, disease - and they will be able to report final results once around 150 participants develop symptoms. "Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus".

AstraZeneca announced in early September that its coronavirus vaccine candidate AZD1222 was moving into phase three clinical trials in the USA, with about 30,000 participants. The same is true of its ability to save lives or prevent transmission: "the trials are not created to find out".

The U.K.'s Medicines and Healthcare products Regulatory Agency determined that the evidence was insufficient to link AstraZeneca's U.K trial program setback with the vaccine, as per Reuters. They're "event-driven" trials, meaning that the goal is to keep them going until a certain number of volunteers become infected.

It's not clear yet whether the late participant was receiving the vaccine or placebo.

Yet Doshi argues that vaccine makers "have done little to dispel the notion" that severe COVID-19 was what was being assessed.

An anonymous source told Reuters that if the victim had received the vaccine, the trial would have been stopped. The brazilian regulator said that the trial is bound to coninue regardless of this.

"People expect that the most severe part of the Covid iceberg - the ICU admissions and hospitalizations and deaths - that's what a vaccine would put an end to", he said.

"None of the trials now underway are created to detect a reduction in any serious outcome such as hospitalizations, intensive care use, or deaths".

"The trials are ongoing", he told CNN.



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