UK volunteers ‘medical event’ pauses Wits vaccine trial
JOBURG – Pausing of the study and trials will allow for a better review and understanding of the safety data.
Wits University has halted the Covid-19 vaccine trial they are running with University of Oxford.
According to a statement released by Wits, a volunteer in the United Kingdom was experiencing a ‘medical event’, forcing trials to pause as part of standard regulatory procedure designed to uphold the safety of participants.
The statement read, ‘Following a medical event experienced by a participant involved in the study of the ChAdOx1-CoV19 vaccine in the UK, 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.’
Due to the South African study being overseen by the same safety committee, all sites in the country have paused further vaccination. The South African trial was announced by Wits University on 23 June and it aimed to enroll up to 2 020 participants at seven sites in Gauteng and the Western Cape. The trial would provide valuable information on whether the body generated good immune responses against the virus.
Professor Shabir Madhi who leads the trial in South Africa said, “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.”
Madhi added that this act to review the safety of the potential vaccine was proof of sound clinical practice and showed the rigour of the independent oversight process under which the trial was being conducted.
The details of the medical event that the participant in the UK experienced may not be divulged as this contravened patient confidentiality.
According to the University of Oxford, the pausing of the study and trials will allow for a better review and understanding of the safety data. A statement from Oxford read, ‘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.’
