The approval was received from the South African Health Products Regulatory Authority on Thursday, said Glenda Gray, who is also the president of the South African Medical Research Council. It will take about six weeks to enrol 12,000 volunteers, she said.
The South African study for the single-shot vaccine is part of a late-stage trial of as many as 60,000 people globally that was initially expected to yield results by year-end, the company said in September. The global study was paused in October after an unexplained illness in one of the participants.
J&J has signed an agreement to have 300 million doses of the vaccine made a year in South Africa by Aspen Pharmacare if it is approved.