The Brazilian medical association Anvisa reported on Wednesday that a volunteer in the Brazilian trial of AstraZeneca's novel coronavirus vaccine had passed away. An implication that tragedy is not related to the vaccine is when the administrators stated there was no need to suspend the trial.
In addition to this, Anvisa had claimed that it was informed of the passing on Monday. Still, they preferred to proceed with the trial under monitoring of the International Evaluation and Security Committee. It was not known if, as a phase of the experiment, the volunteer got the vaccine or a placebo injection. Anvisa also claimed no further details had been disclosed on medical privacy grounds.
Trial should continue
As of now, 8,000 volunteers have obtained either the vaccine or perhaps a placebo throughout the trial according to the D'Or Institute, which has been conducting the clinical study in Rio.
The Institute had said that: "The rigorous analysis of data collected up to now did not raise any doubts about the safety of the study, and thus recommended that it continue."
A spokesperson for vaccine manufacturer AstraZeneca refused to comment immediately on headlines that a volunteer in Brazil had died in a coronavirus vaccine trial and said nothing had transpired to warrant the trial being postponed or suspended.
The spokesperson said in a news outlet: "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."
"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," he continued.
Vaccine specialists note how, with various factors, volunteers in human trials could become sick or die, but they may not have been linked to the vaccine.
AstraZeneca previously on hold
The AstraZeneca vaccine proceeds to be evaluated through tens of thousands of volunteers worldwide, but the latest death report is now the third catastrophic trial warning.
A death in a trial demands an evaluation to determine whether the vaccine or placebo was administered to the volunteer - or if the tragedy was due to involvement in the trial or for varying causes.
AstraZeneca brought its trial on a "brief pause" in July when a health examination occurred to assess the illness of a volunteer. The volunteer's diagnosis had not been revealed much later when AstraZeneca wrote in a statement to a news outlet that the volunteer was determined to have "an undiagnosed case of multiple sclerosis," as well as the diagnosis was "unrelated to the vaccine" by an expert panel.
Then AstraZeneca revealed in September that it had suspended worldwide trials of its coronavirus vaccine due to a similar volunteer medical condition. The Phase 3 US trial of AstraZeneca began on August 31, and afterward, the trial break was declared on September 8.
The trial has resumed in the UK but remains on pause in the US.
The human trials stay on hold in the US while the trial has already continued in the UK.
