NATIONAL NEWS - This after University of Oxford gave Wits the green light to continue working on the Ox1nCov19 vaccine.
The trials were brought to a halt last week when one trial participant in the United Kingdom experienced a medical event. As part of standard regulatory procedure designed to uphold the safety of participants, the trials were suspended globally but as of 12 September, studies being conducted in the UK, USA, Brazil and South Africa have resumed.
According to a Wits University statement, the South African Health Products Regulatory Authority and local ethics committees had this week approved resuming vaccination in the country.
Professor Shabir Madhi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit who leads the Ox1nCov19 trials in South Africa, confirmed that the country’s vaccination trials resumed on 15 September once local regulatory and ethics committees had given the go-ahead.
He said, “The South African study is overseen by the same independent Data and Safety Monitoring Committee [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 vaccination and we have done so.”
Globally, some 18 000 individuals have received study vaccines as part of these trials. Wits stated that in large trials such as these, it was expected that some participants would become unwell and every case had to be carefully evaluated to ensure careful assessment of safety.
The details of the medical event that the participant in the UK experienced may not be divulged as this contravened patient confidentiality. According to University of Oxford, the pausing of the study and trials was to allow for a better review and understanding of the safety data.
The UK’s DSMC review concluded that the event in the UK was unlikely to be related to the vaccination process.
Madhi said the suspension of the trials to review the safety of the potential vaccine was proof of sound clinical practice and showed the rigour of the independent oversight process under which the trials were being conducted.