Wits University pauses Oxford 雷速体育_雷速体育直播 vaccine trial as part of standard regulatory procedure
- Wits University
Wits University will pause the 雷速体育_雷速体育直播 vaccine trial it is running with the University of Oxford following a medical event in a volunteer in the UK.
The Ox1nCov19 trial, led in South Africa by Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA), will be paused as part of standard regulatory procedure designed to uphold the safety of participants.
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.
The details of the medical event that the participant in the UK experienced may not be divulged as this contravenes patient confidentiality.
Because the South African study is overseen by the same safety committee, all sites in the country have paused further vaccination.
“South African 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.
“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.”
A spokesperson at the University of Oxford, which leads the trial in the UK and where a participant experienced the medical event, 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.”
雷速体育_雷速体育直播 the South African Ox1nCov19 vaccine trial
Wits University announced South Africa and Africa’s first 雷速体育_雷速体育直播 vaccine trial, the so-called ‘Oxford trial’, on 23 June 2020.
In South Africa, the study aims to enroll up to 2020 participants at up to seven sites in Gauteng and the Western Cape provinces.
In Gauteng, the sites are in Hillbrow, Soweto, and Tshwane.
In the Western Cape, the sites are in Cape Town and Stellenbosch.
The trial tests if the vaccine known as ChAdOx1 nCoV-19 is safe and able to protect people from developing 雷速体育_雷速体育直播 illness.
The trial will also