Thu, 29 Oct 2020

Covid-19: Mkhize finally makes MAC recommendations public

"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," Wits spokesperson Deborah Minors said.

Madhi said the South African study was overseen by the same independent Data and Safety Monitoring Committee [DSMC] as in the UK, so all sites in South Africa had also paused vaccination when the UK did.

"The South African Health Products Regulatory Authority (SAHPRA) and Wits University ethics committees have now approved resuming vaccination, and we have done so," added Madhi.

The university said that globally, some 18 000 individuals received study vaccines as part of this trial.

Trials

However, in large trials such as this, it was expected that some participants would become unwell and every case had to be carefully evaluated to ensure careful assessment of safety.

"We cannot disclose medical information about the illness for reasons of participant confidentiality," the University of Oxford spokesperson said.

However, Wits assured that 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," said 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."

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