Globally about 18,000 individuals have received study vaccines as part of the trial.
“In large trials such as this, it is expected some participants will become unwell, and every case has to be carefully evaluated to ensure careful assessment of safety,” said Wits University.
Oxford University said it could not disclose medical information about the individual's illness for reasons of participant confidentiality. However, it said, the review process had concluded that the event in the UK was “unlikely to be related to the vaccination process”.
Madhi said: “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.
“Assessing the safety of the vaccine is the reason studies such as these are essential in SA before there is widespread use of the vaccine.”
TimesLIVE
Wits University resumes vaccinating in Oxford Covid-19 trial after scare
Image: Supplied/Wits
Wits University has resumed vaccinating in the Oxford Covid-19 vaccine trial also under way in the UK, Brazil and the US.
The trial was recently paused after a British participant fell ill with a suspected adverse reaction. The participant was expected to recover, according to Stat News, which first reported the suspension.
On Wednesday, Wits University said the SA Health Products Regulatory Authority (SAHPRA) and local ethics committees this week approved resuming vaccinations in SA.
The university quoted a spokesperson for the University of Oxford as saying on Saturday that the trials could also resume in Britain. This after the UK’s independent review process had concluded.
Prof Shabir Madhi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA), who leads the Ox1nCov19 trial in SA, confirmed on Wednesday that vaccination resumed in SA on Tuesday after local regulatory and ethics committees had given the go-ahead.
“The SA study is overseen by the same independent Data and Safety Monitoring Committee [DSMC] as in the UK, so all sites in SA paused vaccination,” said Madhi.
Oxford puts leading Covid-19 vaccine trial on hold over safety concern
Globally about 18,000 individuals have received study vaccines as part of the trial.
“In large trials such as this, it is expected some participants will become unwell, and every case has to be carefully evaluated to ensure careful assessment of safety,” said Wits University.
Oxford University said it could not disclose medical information about the individual's illness for reasons of participant confidentiality. However, it said, the review process had concluded that the event in the UK was “unlikely to be related to the vaccination process”.
Madhi said: “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.
“Assessing the safety of the vaccine is the reason studies such as these are essential in SA before there is widespread use of the vaccine.”
TimesLIVE
Wits stops Covid-19 vaccine trial after UK participant experiences 'medical event'
South African volunteers on AstraZeneca vaccine trial say not alarmed by pause
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