Wits stops Covid-19 vaccine trial after UK participant experiences 'medical event'
Wits University on Wednesday announced that it has paused the Oxford Covid-19 (OX1nCoc19) vaccine trial in SA after a UK participant experienced what they called a medical event.
Professor of Vaccinology at the university and director of the SA Medical Research Council Shabir Madhi, who leads the South African OX1nCov19 trial, said the standard procedure was designed to uphold the safety of participants.
The trial was launched in June as Wits collaborated with University of Oxford and the Oxford Jenner Institute.
This trial was aimed at finding a vaccine that will prevent infection by SARS-CoV-2, a virus that causes Covid-19.
Madhi said following the UK incident, the Independent data and safety monitoring committee (DSMC) has recommended that all studies which they are overseeing pause to allow the committee to undertake a thorough review of the case in the UK.
“Because the South African study is overseen by the same safety committee, 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,” Madhi said.
Madhi said the details of the medical event that the participant in the UK experienced may not be divulged as this contravenes patient confidentiality.
He said pausing vaccination to review safety was evidence of the application of sound clinical practice and demonstrates the rigor 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.
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