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It is unclear whether the volunteer took the vaccine dose or was in a placebo group. AstraZeneca has not provided much information but said they followed all required review processes.
Soon after resuming the COVID-19 vaccine trial at almost all sites, AstraZeneca plc (NASDAQ: AZN) has faced another challenge. On Wednesday, Brazilian health authority Anvisa announced a volunteer involved in AstraZeneca and Oxford University’s vaccine trial died. The investigation into the accident is being conducted, but the trial will continue.
The Incident Details
According to local Brazilian press reports, the volunteer was a 28-year-old physician. He himself treated COVID-19 patients in Rio de Janeiro. But it is unclear whether he took the vaccine dose or was in a placebo group.
Oxford University commented:
“All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed. 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.”
AstraZeneca spokesperson has not provided much information but said they followed all required review processes:
“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.”
AstraZeneca and Oxford have already faced pressure to disclose more information about the incident. Japan’s Ministry of Health was the first to request details from AstraZeneca on death. As the ministry has explained, they want to ensure proper vaccine trials are taking place in Japan.
In Brazil, there are more than 5 million confirmed coronavirus cases. The country has seen a rapid augmentation in the number of COVID-19 patients in October and is eagerly awaiting for the vaccine. Earlier, Brazil’s health authority Anvisa pledged it would conduct its vaccination analysis “without any outside influence or pressure”.
AstraZeneca and Oxford’s Progress in COVID-19 Vaccine Trial
AstraZeneca is working on the COVID-19 vaccine with the University of Oxford. The vaccine candidate is a combination of two monoclonal antibodies (mAbs) that may be effective in treating the novel coronavirus. AstraZeneca and Oxford have significantly progressed in developing the vaccine, reaching the late-stage Phase 3 trial. However, in September, AstraZeneca announced trial suspension following a serious suspected adverse reaction found in a participant. The British-Swedish pharma giant had to conduct a safety review and investigate whether the vaccine caused the illness.
At the beginning of October, AstraZeneca resumed clinical trials of its vaccine candidate in Japan, Brazil, India, and South Africa. The company has also started talks with United States authorities to recommence the vaccine trial process.
The recent volunteer’s death has not yet affected the COVID-19 vaccine trial process. However, it affected the performance of AstraZeneca stock. AZN shares closed 1.19% down on Wednesday, at $51.57 per share.