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JOHANNESBURG — South Africa’s drugs regulator SAHPRA said on Tuesday that it had approved a “section 21” emergency use application for the COVID-19 vaccine developed by Pfizer and BioNTech.

SAHPRA added in a statement that the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including monitoring its efficacy 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.

But it has so far administered only 150,000 doses of the Johnson & Johnson vaccine, lagging wealthier nations on other continents that have already vaccinated millions of their citizens.

The government says it has secured 20 million doses of the two-dose Pfizer-BioNTech vaccine in bilateral negotiations, with deliveries ramping up from the second quarter of the year.

It also hopes to receive 117,000 doses of the Pfizer-BioNTech vaccine before the end of the month from the COVAX Facility, the global vaccine distribution scheme co-led by the World Health Organization and partners including the Gavi vaccines alliance.

(Reporting by Alexander Winning and Wendell Roelf; Editing by Steve Orlofsky)

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