On the 6th September, a standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by an independent committee. The FDA has now reached the same conclusion as other international regulators, who have deemed that the trials are safe to resume.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University said: ‘We are very pleased the FDA has reached the same conclusion as the other regulators of the clinical trial sites around the world, declaring the trial safe to proceed in the USA. This will enable our partners AstraZeneca to begin trialling the vaccine in another 30,000 volunteers, taking our combined large scale, phase 3 clinical trials to 50,000 globally. We will continue to adhere to our rigorous safety processes while moving as quickly as possible so we can start protecting people around the world against this terrible virus as soon as possible.’
Globally over 20,000 individuals have been recruited into the clinical trials. It is commonplace that in large-scale trials, some participants will become unwell and every case has to be carefully evaluated to ensure careful assessment of safety. All routine follow-up appointments continued as normal during this period.
The University of Oxford has worked with partners AstraZeneca to provide information as required by international guidelines and regulators, and all trial investigators and participants will continue to be updated with the relevant information and this will be disclosed according to the clinical trial and regulatory standards.
Oxford University is committed to the safety of trial participants and the highest standards of conduct in clinical trials and will continue to monitor safety closely.