The South African Health Products Regulatory Authority (Sahpra) has approved the Section 21 application for the Pfizer/BioNTech Covid-19 vaccine.
It means the sought-after vaccine has been approved for distribution, but the approval is subject to monitoring the vaccine's efficacy and safety, Sahpra said in a statement on Tuesday.
"This approval is subject to conducting a post Section 21 authorisation efficacy and safety surveillance of Comirnaty vaccine in South Africa (including efficacy against the SARS-CoV2 B.1.351 lineage)."
South Africa ordered 20 million doses of the Pfizer vaccine, but it is still unclear when it will arrive.
While studies have shown the variant identified in South Africa could pose challenges to the Pfizer vaccine, the chair of the Ministerial Advisory Committee, Professor Barry Schoub, said the vaccine was still a good option.
South Africa has yet to properly start its vaccine rollout, with the Johnson and Johnson vaccine being administered to healthcare workers under trial conditions.