Oxford vaccine trials, halted last week, resume after regulators give a go-ahead

The clinical trials of the Oxford vaccine, in partnership with AstraZeneca, will resume across all UK clinical trial sites, stated a press release from the University of Oxford. The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the trials will recommence in the UK.

They have stated that they would not 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,” added the University of Oxford.

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. Several experts stated that the pause was not surprising as unexplained illnesses can happen by chance in large clinical trials.

A week ago, on September 6, AstraZeneca triggered a pause in the trials so that an independent committee could investigate an unexplained illness in a UK participant. They had paused vaccination across all of their global trials to allow the review of safety data by an independent safety review committee.

The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers. This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus, stated the release.

The Oxford vaccine ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans