The University of Oxford and AstraZeneca have resumed British clinical trials of its Covid-19 vaccine, after getting the green light from safety watchdogs. The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.
AstraZeneca said, “On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators.” It added that safety reviewers had recommended to Britain's Medicines Health Regulatory Authority (MHRA) that it was safe to resume the British trials. A patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
AstraZeneca said it could not disclose further medical information. It said, “The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic.”
The Serum Institute of India said it would restart its trials once it had permission from the Drugs Controller General of India. Brazil health regulator ANVISA said it was awaiting notice from the British MHRA confirming that resumption of trials has been authorised before resuming in Brazil. The Federal University of Sao Paulo, which is conducting the paused trials, said in a statement that 4,600 of the planned 5,000 volunteers have been recruited and vaccinated without any of them reporting any serious health issues.
AstraZeneca has already agreed to supply close to three billion doses to governments across the globe, more than any other vaccine project.
