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Wits University announced Wednesday that has stopped the Oxford Covid-19 (OX1nCoc19) vaccine trial in South Africa after a participant from the United Kingdom experienced what they called a medical event.
Professor of Vaccination at University and South African Medical Research Council director Shabir Madhi, who leads the South African trial OX1nCov19, said the standard procedure was designed to keep participants safe.
The proof launched in June as Wits He collaborated with the University of Oxford and the Oxford Jenner Institute.
This trial aimed to find a vaccine that prevents infection by SARS-CoV-2, a virus that causes Covid-19.
Madhi said that after the incident in the UK, the independent data and security monitoring committee (DSMC) recommended that all studies they are monitoring be stopped to allow the committee to carry out a comprehensive 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 stopped vaccination. Trial volunteers who are scheduled to receive a first or second dose of the vaccine have been notified and we are in regular communication with them about when vaccination will resume.
“This decision will be based on the recommendation of the DSMC. Ensuring the safety of all participants in our study is our highest priority,” Madhi said.
Madhi said details of the medical event the participant experienced in the UK may not be disclosed as this violates patient confidentiality.
He said stopping vaccination to review safety was evidence of sound clinical practice and demonstrates the rigor of the independent monitoring process under which this trial is being conducted.
“Evaluating the safety of the vaccine is why studies like these are essential in South Africa, before the vaccine becomes widespread,” Madhi said.
