The UK committee has resolved its investigations and recommended the MHRA that Covid-19 vaccine trials in the UK are safe to resume
AstraZeneca has resumed the clinical trial programme of its Covid-19 vaccine AZD1222 in the UK, after the vaccine’s safety being confirmed by the Medicines Health Regulatory Authority (MHRA).
The British drugmaker has voluntarily halted the vaccination across all global trials on 6 September 2020, following an unexplained illness observed in a UK clinical trial participant.
The voluntary pause in clinical trials was aimed at facilitating review of safety data by independent committees, and international regulators, said the company.
Also, the UK committee has resolved its investigations, recommending the MHRA that Covid-19 clinical trials in the UK are safe to resume.
AstraZeneca to partner with global health authorities to resume other AZD1222 trials
AstraZeneca and its clinical trial sponsor the University of Oxford have not disclosed any additional medical information regarding the voluntary pause of the trial and its release.
The pharmaceutical company said that all the investigators and participants in the trial will be informed of the latest updates and the relevant details in the trial will be recorded on global clinical registries, as per the clinical trial and regulatory standards.
Previously called ChAdOx1, AZD1222 was developed by the University of Oxford and its spin-out company Vaccitech, and licenced by the company.
The vaccine leverages a replication-deficient chimpanzee viral vector to deliver the genetic material of the SARS-CoV-2 virus spike protein, and induce an immune response against the coronavirus.
The company claimed that it is committed to the safety of trial participants and the high standards of conduct in clinical trials, and will work together with the global health authorities to receive guidance on resuming other clinical trials.