Oxford University resumed testing the coronavirus vaccine in the United States on Saturday following confirmation by the Medicines Health Regulatory Authority (MHRA). The advanced COVID-19 vaccine trial developed by the University of Oxford and Astrazeneca was suspended this week after illness in a study subject in Britain.
Here is the full statement from the University of Oxford
Ongoing randomized controlled clinical trials of the Oxford ChAdOx1 nCoV-19 coronavirus vaccine will resume at all UK clinical trial sites.
Worldwide, about 18,000 people have received the study vaccines as part of the trial. In large trials like this one, some participants are expected to feel unwell and each case must be carefully evaluated to ensure a careful assessment of safety.
On Sunday [06/09/2020] Our standard review process caused a pause in the study of vaccination in all our global trials to allow for review of safety data by an independent safety review committee and national regulators. All routine follow-up appointments continued normally during this period.
The independent review process has been concluded and, following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, trials will resume in the UK.
We cannot disclose medical information about the disease for reasons of participant confidentiality.
We are committed to the safety of our participants and to the highest standards of conduct in our studies and will continue to monitor safety closely.
Adar Poonawalla, Executive Director of the Serum Institute of India, said: “As I mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we should not skew the process and should respect the process to the end Good news @UniofOxford.
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