The University of Oxford’s partner institution, Wits University, has resumed vaccination on volunteers in the Oxford COVID-19 vaccine trial which is also underway in the UK.
The vaccinations had been paused as part of standard safety review, triggered in the UK, and overseen by an independent Data and Safety Monitoring Committee (DSMC). The DSMC review concluded that the event in the UK was unlikely to be related to the vaccination process.
Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) who is leading the Ox1nCov19 trial in South Africa, said:
“The South African study is overseen by the same independent DSMC as in the UK so all sites in South Africa paused vaccination. The South African Health Products Regulatory Authority and Wits University ethics committees have now approved resuming vaccinations.”
Globally some 18,000 individuals have received study vaccines as part of this trial. In large trials such as this it is expected that some participants will become unwell and every case has to be carefully evaluated to ensure careful assessment of safety.
Madhi continued: “Pausing vaccination to review safety is evidence of the application of sound clinical practice and demonstrates the rigour of the independent oversight process under which this trial is being conducted.”