Oxford University restarts COVID-19 vaccine trial in UK. Full statement1 min read . Updated: 12 Sep 2020, 11:11 PM IST
- Globally some 18,000 individuals have received study vaccines as part of the trial, Oxford University said
- We cannot disclose medical information about the illness for reasons of participant confidentiality, the Oxford said
The Oxford University on Saturday resumed the coronavirus vaccine trial in the United Sates following the confirmation by the Medicines Health Regulatory Authority (MHRA). The advanced trial of COVID-19 vaccine developed by Oxford University and Astrazeneca were suspended this week after an illness in a study subject in Britain.
Here's the full statement by University of Oxford
The ongoing randomised controlled clinical trials of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 will resume 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.
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 normal 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 the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.
Adar Poonawalla, the chief executive officer of Serum Institute of India, said "As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford.