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A Brazilian national who participated in the clinical trial of an experimental Covid-19 vaccine developed by Oxford University and AstraZeneca has died. Brazil's National Health Surveillance Agency said that the volunteer was reported dead on Monday, but it didn't provide any further details about the death, citing medical confidentiality of those involved in trials. The testing of the vaccine would continue, it informed the media.
However, citing unnamed sources, the country's local newspapers reported that the volunteer was in a control group that did not receive the experimental vaccine, and died from Covid-19 complications. The deceased was a 28-year-old physician who treated coronavirus patients in Rio de Janeiro, as per the reports. A spokesman for AstraZeneca told media persons that there were no concerns that would lead the study to pause.
Oxford University also confirmed that an independent committee had reviewed the volunteer's death and there have been no concerns about the safety of the clinical trial.
"Following careful assessment of this case in Brazil, there have been no concerns about the 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 that Reuters quoted in its report.
The Federal University of Sao Paulo, which is helping coordinate the clinical trials of the Oxford vaccine in Brazil, confirmed that the volunteer was a Brazilian.
The trials of the Oxford/AstraZeneca coronavirus vaccine, called AZD1222, was suspended last month after a participant developed an unexplained illness. A woman who participated in the vaccine trial in the US developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord. While the trail remains on hold in the U.S. as officials examine whether the poses a safety risk, AstraZeneca had resumed the final-stage testing of the vaccine trials in Brazil, India, South Africa, Japan and Britain.
The Brazilian government had earlier shared its plans of purchasing the vaccine and producing it at its biomedical research centre Fiocruz in Rio de Janeiro. Quoting a source, Reuters recently reported that the US trial could resume as early as this week, following the completion of the FDA review. So far, the FDA has not said anything on whether or not the death of the Brazilian volunteer would affect the resumption of the trial in the US.
Pune-based vaccine maker Serum Institute of India has tied up with AstraZeneca to manufacture the University of Oxford's vaccine candidate for Covid-19. The institute also halted the trails in the country for a brief period and resumed after getting permission from the Drugs Controller General of India (DCGI) last month.
Serum Institute, which is considered as the world's largest vaccine manufacturer by volume, aims to supply 400 million doses of the Oxford vaccine by December. It also has plans to manufacture and deliver up to 100 million doses of the AstraZeneca-Oxford and Novavax Covid-19 vaccines for India and 92 other low- and middle-income countries. The said vaccines are expected to be available as early as the first half of 2021.
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