The department of health says it has finally signed a crucial contract with US pharmaceutical giant Pfizer for the supply of 20-million vaccines with delivery beginning mid-April.
Together with the Johnson & Johnson (J&J) agreement for 30-million vaccines, the scene is finally set for SA to begin the rollout of its vaccine programme. Pfizer is a double-dose vaccine, while J&J is a single dose. So far the government has vaccinated 269,102 health workers under a J&J implementation trial.
The signing comes as a new but small study showed that the Pfizer BioNTech vaccine was 100% effective against cases of the B.1.351 variant first identified in SA. In larger global trials it has been found to be 91% effective in preventing disease.
The signing follows a long and difficult negotiation with Pfizer. The Treasury is believed to have balked at some of the contractual obligations, particularly about liability provisions. The contracts are not for public dissemination as governments are required to sign non-disclosure agreements.
Deputy director-general of the department Anban Pillay, who confirmed the deal, said that the negotiation process had slowed the final signing.
"Contracts have to be negotiated with the company and this is with their headquarters not local office and this takes time. Second, we have to get a mandate for certain contractual provisions that are not supported by current policies."
The delay was one of several issues that prompted Business for SA to request a high-level meeting with President Cyril Ramaphosa, minister of finance Tito Mboweni and minister of health Zweli Mkhize last Wednesday. Business leaders are believed to have urged the government to sign, arguing that though the provisions strongly favour the company, "beggars cannot be choosers".
The power of pharmaceutical companies in negotiating vaccine supply contracts is a growing cause of concern globally as smaller and poorer countries get left out. Pharmaceutical companies typically do not provide exact delivery dates to which they can be held.
"Vaccine manufacturers are unable to give an exact date but rather a period for delivery," said Pillay. "Our agreements are based on volumes that will be delivered in each quarter of the year, April to June and so on.
"The first doses of Pfizer are expected in mid-April."
Conditions precedent in supply contracts also mean that supply can be interrupted should the conditions not be met within the required timeframe.
One example is the establishment of a no-fault compensation fund for adverse events caused by the vaccine, which several pharmaceutical companies require be in place by a certain date.
SA has agreed to establish such a fund but there is still a long way to go because the Treasury and the department of health are still determining where the fund will be housed.
The Pfizer study in SA, results of which were announced last Thursday, included 800 participants. There were nine cases of Covid-19 in the group that received the placebo vaccine and zero cases were observed in the group that received the vaccine, the company said.
Six of the nine people who became ill were infected with the B.1.351 variant (also known as 501.Y.V2), which showed it was circulating. But no-one who was vaccinated became ill, which suggests that the vaccine worked to provide protection against the variant.
The vaccine has emergency approval in the US and has been licensed in SA under a section 21 permit by the SA Health Products Regulatory Authority (Sahpra). The J&J vaccine received conditional approval for use in SA last Thursday.
J&J has signed agreements to provide 31-million doses of the vaccine to SA. The release last week detailed that it will provide 2.8-million doses between April and June, with the "first delivery scheduled for the second half of April".
Sahpra granted the vaccine a "conditional approval".
In the global Ensemble trial, the vaccine showed people were 67% less likely to develop Covid-19 than those who received a placebo shot and 85% less likely to develop serious illness. In the SA trial, the vaccine reduced the chance of serious Covid-19 by 57%, even as the B.1.351 variant first identified in SA was circulating.
With Katharine Child
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