South Africa's pharmaceutical regulator SAHPRA said on Monday it has received its first application to register a Covid-19 vaccine from Johnson & Johnson.
"As of today we have received one application, this was received on Thursday evening from J&J, and we started the review process," said Boitumelo Semete, chief executive of the South African Health Products Regulatory Authority.
J&J did not immediately respond to an emailed request for comment.
The US firm's vaccine candidate is one of at least four Covid vaccines being trialled in South Africa, along with candidates being developed by Novavax, AstraZeneca and Pfizer.
Semete told a news conference the regulator would focus on "safety, quality and efficacy" of any coronavirus vaccine used in the country of around 58-million as it fast-tracks vaccine approvals.
South Africa, which officially entered a second wave of infections last week, has more than 860 000 infections and 23 000 deaths, and is the worst-hit country in the continent.