Wits University has resumed vaccinating participants in the Oxford Covid-19 vaccine trial after it was given the go-ahead by the South African Health Products Regulatory Authority and two ethics committees.
The trial was temporarily suspended globally about a week ago after an independent data and safety monitoring committee recommendation to review the case of a participant who had fallen ill.
The Ox1Cov-19 Vaccine VIDA-trial is a first for Africa and one of 268 other candidate vaccines researched and tested round the world. Following the trial’s announcement, Shabir Madhi, Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and who leads the trial, said:
“This is a landmark moment for South Africa and Africa at this stage of the Covid-19 pandemic.”
South Africa is the hardest hit in Africa with confirmed 655,572 cases of Covid-19 of which 15,772 were fatal while 585,303 recoveries were recorded.
The SA Health Products Regulatory Authority and two ethics committees have approved the resumption of the Oxford Covid-19 vaccine trial in South Africa.
While the temporary suspension of the program caused a delay in the enrolment of 206 participants and the administration of the vaccine, the research teams are confident this will not affect the integrity of the trial’s findings.
The entire process of temporary suspension and resumption of the trial has been activated by the research teams in the UK and South Africa and overseen by independent safety committees of experts as well as the countries’ relevant medical authorities who assessed whether it was safe to restart.
British drugmaker AstraZeneca paused the global trial on 9 September after a participant fell ill in the UK.