Clinical trials for AstraZeneca-Oxford’s COVID-19 vaccine ‘AZD1222’ resume in UK after MHRA nod
AstraZeneca has resumed British clinical trials of its COVID-19 vaccine AZD1222, one of the most advanced in development in collaboration with the Oxford University, after receiving the green light from the Medicines Health Regulatory Authority (MHRA) safety watchdog, the company said on Saturday.
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.
“On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees, and international regulators,” AstraZeneca said.
It added that safety reviewers had recommended to Britain`s Medicines Health Regulatory Authority (MHRA) that it was safe to resume the UK trials.
“AstraZeneca and the University of Oxford as the trial sponsor cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards,” it added.
The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
AstraZeneca, based in Cambridge, said it could not disclose further medical information. However, AstraZeneca said that it is committed to the safety of the trial participants and the highest standards of conduct in clinical trials.
“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 company said.
Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca as the most promising.