Brazilian volunteer in AstraZeneca Covid-19 vaccine trial has died in the placebo arm — reports
A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.
The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a source familiar with the matter saying that the trial would have been suspended had the volunteer been given the experimental Covid-19 vaccine, implying that they were part of the placebo arm.
Oxford University, which is developing the vaccine in tandem with AstraZeneca, told Reuters that after assessing the situation, “there have been no concerns about safety of the clinical trial.” Anvisa added that the vaccine trials will continue in the wake of the death. The agency gave no further details into the circumstances.
AstraZeneca $AZN share prices dipped about 2% as the news broke, but since leveled off and closed Wednesday down 1.19%.
A company spokesperson gave the following comment to Endpoints News:
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.
Reports earlier Wednesday noted that AstraZeneca was scheduled to restart its Phase III study in the US sometime this week. Dosing came to a halt worldwide in early September after a British volunteer developed a condition thought to be transverse myelitis, a rare spinal inflammation disorder.
Trials have already resumed in the UK, India, Japan and South Africa in addition to Brazil, and the EMA has since initiated a rolling review of the vaccine candidate.
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