Johannesburg – The race to get a Covid-19 vaccine in the country has hit a snag after it was forced to stop after a participant fell ill.
One participant in the third phase of the vaccine trial for the Oxford University based study in the United Kingdom showed signs of an “unexplained illness”, forcing the research to be stopped.
Details of the illness are not being divulged because of confidentiality issues. The Independent Data and Safety Monitoring Committee (DSMC) recommended all trials be paused.
The vaccine trial, known as Ox1nCov19, and which was one of the forerunners in the race, is being run in the United Kingdom, the United States, South Africa and Brazil with 18 000 participants.
Locally, nearly 1 814 people are part of the trials; with the aim of enrolling 2020 in Gauteng and the Western Cape, that are being run at Wits University. It is being led by Shabir Madhi, professor of vaccinology at Wits University and executive director of the SA Medical Research Council’s vaccines and infectious diseases analytics (VIDA) research unit.
“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.
“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 why studies such as these are essential in South Africa before there is widespread use of the vaccine,” Madhi said.
Launching the trials in June, Madhi warned that if the trials posed a danger to participants, it would be stopped immediately.
“If there is a concern by the data safety monitoring committee or there is any suggestion that the vaccine is doing any harm irrespective of how many people have been enrolled in the study, it will be terminated immediately,” Mahdi said at the time.
Announcing the halting of trials while investigating the issue, an Oxford University spokesperson said: “As part of the ongoing randomised controlled global trials of the coronavirus vaccine, our standard review process triggered a study pause to vaccination to allow review of safety data.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials. In large trials, illnesses will happen by chance, but must be independently reviewed to check this carefully. We are committed to the safety of our participants and the highest standards of conduct in our studies.”
The Star