Oxford vaccine trial: The University of Oxford and AstraZeneca Plc have restarted a U.K. trial of an experimental Covid-19 vaccine after the study was halted over concerns about a participant who fell ill. Oxford said in a statement that the U.K. regulator, the Medicines Health Regulatory Authority (MHRA), had recommended that the trials resume after an independent review of the safety data triggered a pause on Sept. 6. It declined to disclose any details about the participant’s illness.
Here’s the full statement by the University of Oxford
The ongoing randomized controlled clinical Oxford vaccine trial 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 studied 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 is a clear example of why we should not bias the process and should respect the process till the end. Good news, @UniofOxford.
Mean-while, A historic 18-day session of Parliament in India begins on Monday with the Covid-19 pandemic forcing the implementation of a range of first-time measures and the exclusion of several significant conventions. The customary all-party meeting of the government was not held this time and the session will be curtailed to four-hour sessions for each house for seven days a week.
The coronavirus tally in India crossed the 47 lakh-mark with 94,732 new cases reported in the last 24 hours. As many as 1,114 deaths were reported on Saturday, taking the toll to 78,586. Of the 47,54,357 infections, 9,73,175 are active cases, while 37,02,596 patients have been discharged.
Union Health Minister Dr. Harsh Vardhan Sunday said that a COVID-19 vaccine is likely to be available in India by early next year and the government is considering its emergency authorization for high-risk settings. While answering the questions sent to him by people across the country on social