The University of the Witwatersrand (Wits) has announced that it will pause its coronavirus vaccine trial owing to a medical event in a volunteer in the UK.

The trial will be paused as part of standard regulatory procedure for the safety of participants.

The details of the medical event that the participant in the UK experienced may not be divulged as this contravenes patient confidentiality.

Wits announced South Africa and Africa’s first Covid-19 vaccine trial, the so-called ‘Oxford trial’, in June.

Vaccines and Infectious Diseases Analytics Research Unit executive director Professor Shabir Madhi, who is leading the Ox1nCov19 trial in South Africa, 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 are the reasons why studies such as these are essential in South Africa before there is widespread use of the vaccine,” said Madhi.  

The Independent Data and Safety Monitoring Committee (DSMC) has recommended that all studies which they are overseeing pause further vaccination. This will allow the DSMC to undertake a thorough review of the case in the UK.

Madhi said all sites in the country have paused further vaccination.

“Trial volunteers who are scheduled to receive either a first or second dose of the vaccine have been notified and we are in regular communication with them as to when vaccination will resume. This decision will be based on the DSMC’s recommendation. Ensuring the safety of all our study participants is our highest priority,” says Madhi.