The South African Health Products Authority (SAHPRA) has voiced cautious optimism over the efficacy of the Pfizer/BioNTech vaccine against new variants of the coronavirus.
South Africa has secured 20 million doses of the vaccine, a batch of which are expected in the country from the end of next month.
The health product regulator says the approval of the jab is subject to further efficacy and safety surveillance. It has also approved a Section-21 emergency use application of the Pfizer/BioNTech shot.
SAHPRA’s Chairperson is Professor Helen Rees explains: “Our feeling is because this is such an effective vaccine that we are pretty confident that it is going to work, if not as well against the original, that it is going to work. Having said that, however, we are working with Pfizer and the other vaccine manufacturers and they are producing from the lab, data that shows the effectiveness. So we are very optimistic that it is going to work, particularly against severe disease.”
SAHPRA approves Section 21 emergency use application for the Pfizer-BioNTech vaccine
Rollout
SAHPRA has suggested that the national rollout of the Pfizer/BioNTech vaccine should begin as soon as the doses arrive in the country.
Rees adds, “I think the aim would be, as soon as we get these vaccines, the Department of Health and all the provinces are geared up to roll this out and as soon as we can get them in, into the airport and ship them out, we should start this rollout…”
“We want to go as fast we can but to be fair as well, even countries like Rwanda didn’t go fast to begin with. They had to get everything into gear and once you have done that then rollouts become much more straightforward,” says Rees.
She added saying the SAHPRA hoped that the vaccines would be rolled out in the country in April.
In the Explainer below, we breakdown the South African government’s COVID-19 vaccine rollout strategy as the country gets ready to receive 1 million doses of the vaccine:
SAHPRA has approved the Section 21 application for Pfizer/Biontech Comirnaty Vaccine. This approval is subject to conducting a post Section 21 authorisation efficacy and safety surveillance of Comirnaty vaccine in South Africa
— SAHPRA (@SAHPRA1) March 16, 2021
Sale of AstraZeneca vaccine
Meanwhile, SAHPRA says the Health Department is in the process of ensuring the AstraZeneca vaccine is sold and transferred to other countries. South Africa halted the use of the AstraZeneca jab earlier this year due to concerns over its efficacy against the dominant 501Y.V2 variant.
Several other countries have halted the rollout of the jab, following reports of clots developing in a small number of recipients.
The European Medicines Agency has reiterated that there is no indication that the AstraZeneca vaccine causes blood clots.
Professor Helen Rees says, “The Department of Health is negotiating on the sale, but that is quite far advanced and I think there will be a transfer fairly soon to other countries. In terms of the blood clots, what you have to do when you get these sorts of reports is, is the benefit of the vaccine exceed any potential risks because the risks are so so small that the benefit of the vaccine is so huge. So that is the process that is on-going and it hasn’t been finalised yet. The suspensions are temporary.”
11 EU countries pause use of AstraZeneca:
