The South African Health Products Regulatory Authority (Sahpra) has approved a section 21 emergency-use application for the Covid-19 vaccine developed by Pfizer and BioNTech.
Sahpra said in a statement that the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including against the dominant local coronavirus variant.
The regulator said it has three pillars to ensure that medicines, medical devices and meet the requisite standards to protect the health and well-being of all who reside in South Africa:
Government has secured a total of 43 million doses through deals with pharmaceutical companies Johnson & Johnson, Pfizer and the Covax group.
However, just a fraction of these vaccines has been sent to the country, with the manufacturers operating on a quarterly basis for deliveries.
For the first quarter, which ends on 31 March, government has anticipated 500,000 doses of Johnson & Johnson and 600,000 doses from Pfizer. This makes it difficult to track annual targets, Health minister Dr Zweli Mkhize said in a briefing last week.
“In other words, at the moment, all we can tell is that by this quarter, this is likely to be how much we will get,” said Mkhize.
“Once we have got the matter refined, we will be in a position to know month by month or even week by week supplies of what they will give us. That helps us with the planning of the vaccination programme.”
He said that government is expecting a further eight million doses between April and June, which will be used to complete vaccination for healthcare workers and start phase two of the programme which will focus on at-risk groups.
This means that phase 3 of the programme – which focuses on the bulk of the population – will only start sometime between July and September, with a further 11.6 million doses expected.
As of Tuesday (16 March), the total number of vaccines administered to healthcare workers in South Africa stands at 147,753.
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