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September 17, 2020

University of Oxford Resumes Vaccine Trial

Oxford University

Oxford, September 16, 2020 —The University of Oxford has announced that the ongoing randomized controlled clinical trials of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 have resumed across all UK clinical trial sites.

“Globally, some 18,000 individuals have received study vaccines as part of the trial. In large trials such as this, it is expected that some participants will become unwell, and every case must be carefully evaluated to ensure careful assessment of safety,” the university said.

“On Sunday [06/09/2020], our standard review process triggered a study-pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee and the national regulators. All routine follow-up appointments continued as usual during this period.

“The independent review process has concluded, and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK.

“We cannot disclose medical information about the illness for reasons of participant confidentiality.

We are committed to our participants’ safety and the highest standards of conduct in our studies and will continue to monitor safety closely,” Oxford University stated.

Brazilian trial of Oxford vaccine resumes.

On Saturday [September 12], the Brazilian National Health Surveillance Agency (Anvisa) and the National Council for Research Ethics (Conep) informed the Federal University of São Paulo that all centers participating in the study in Brazil could resume vaccination of volunteers from Monday [September 14]. The Federal University of São Paulo coordinates the clinical research of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 in partnership with Oxford University.

In Brazil, 4,600 volunteers have already been recruited from São Paulo, Rio de Janeiro, and Salvador.

Serum Institute of India to Resume Clinical Trial Of Oxford Covid-19 Vaccine.

The Serum Institute of India has received approval from the Drugs Controller General of India (DCGI) to resume the clinical trial of the Oxford COVID-19 vaccine candidate, officials from the drug manufacturing company confirmed on Wednesday.

The Serum Institute of India is the manufacturing partner of the vaccine candidate named Covishield, developed jointly by the University of Oxford’s Jenner Institute and AstraZeneca.

The Pune-based firm has selected 17 sites in India to conduct the trial. A total of 1,600 candidates will take part in the study.

The selected sites include —

Sources: The University of Oxford. Serum Institute of India.

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Edited & Posted by the Editor | 3:31 AM | Link to this Post

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