After a participant fell ill earlier this month, the Oxford Covid-19 vaccine trial was voluntarily put on hold. The trial – which is a collaboration between AstraZeneca and researchers from Oxford University – has been widely regarded as one of the leading candidates in the race to finding an effective vaccine. Even though the medical event took place in the United Kingdom, the trial was stopped worldwide. Countries hosting the trial include Brazil, the US, UK and South Africa. Professor Shabir Madhi – who leads the trials in South Africa – has confirmed that vaccine trials have recommenced locally, with the South African Health Products Regulatory Authority [SAHPRA] and Wits University ethics committees giving the go ahead. – Jarryd Neves
Wits media statement:
Wits University has resumed vaccinating in the Oxford Covid-19 vaccine trial currently also underway in the UK, Brazil and the US. The South African Health Products Regulatory Authority and local ethics committees this week approved resuming vaccination in South Africa.
Vaccination in the Ox1nCov19 vaccine trial in the UK paused last week following a medical event in one trial participant in the UK.
A spokesperson for the University of Oxford said on Saturday, 12 September that the UK’s independent review process had concluded and, following the recommendations of both the independent safety review committee and the UK’s Medicines and Healthcare products Regulatory Agency, the trials will recommence in the UK.
Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) who leads the Ox1nCov19 trial in South Africa confirmed today that vaccination resumed in South Africa on Tuesday 15 September, once local regulatory and ethics committees had given the go-ahead.
“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 [SAHPRA] and Wits University ethics committees have now approved resuming vaccination, and we have done so,” says Madhi.
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.
The University of Oxford spokesperson said, “We cannot disclose medical information about the illness for reasons of participant confidentiality.”
However, the DSMC review concluded that the event in the UK was unlikely to be related to the vaccination process.
“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,” says Madhi. “Assessing the safety of the vaccine is the reason why studies such as these are essential in South Africa, before there is widespread use of the vaccine.