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COVID-19: Oxford Vaccine Trials Delayed Due to Safety Approvals  

The delay has been encountered due to a pending safety approval from Data Safety and Monitoring Board.

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The clinical trials for the COVID-19 vaccine candidate being jointly developed by AstraZeneca and the University of Oxford have been delayed by at least a week. According to a Times of India report, the trials were earlier expected to begin by the first week of September at PGIMER (The Post Graduate Institute of Medical Education and Research) in Chandigarh.

The delay has been encountered due to a pending safety approval from Data Safety and Monitoring Board (DSMB) for the first hundred candidates selected to undergo the trials, the institute told IANS.

For the time being, the further recruitment of the candidates for the trials for the Oxford vaccine is on hold because we are waiting for the approval for safety of the first hundred participants recruited till now from the Data Safety and Monitoring Board.
Dr Madhu Gupta, Principal Investigator of the vaccine trial at PGIMER
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Gupta had earlier revealed that a 16-member staff, including herself, would be responsible for supervising the clinical trials.

The PGIMER is among the 17 sites selected for the human clinical trials of the adenovirus-based vaccine candidate being developed by Oxford, and will partake in the second and third phases of the trials. The institute said that it received 400 volunteers for participation in the trials. The first dose of the vaccine will be administered to 253 of these participants.

Serum Institute of India (SII) will be responsible for the production and marketing of this vaccine candidate. SII is one of the largest vaccine producers in the country. Adar Poonawalla, CEO of SII, has said that the the COVID-19 vaccine might be ready by the end of this year.

(With inputs from Times of India)

(The article was first published in FIT and has been republished with permission)

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