The SA Health Products Regulatory Authority (Sahpra) said on Tuesday it had approved a “section 21” emergency use application for the Covid-19 vaccine developed by Pfizer and BioNTech.
The country’s drugs regulator said the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including against the dominant local coronavirus variant.
South Africa is the hardest-hit country on the African continent in terms of recorded coronavirus cases and deaths, and suffered a severe second wave of infections driven by the more infectious 501Y.V2 variant, first identified late last year.
It kick-started its vaccination campaign with Johnson & Johnson's one-dose vaccine last month in a research study targeting up to 500,000 health workers.