At least 2-million Johnson & Johnson (J&J) coronavirus vaccines will be delivered to SA within the next fortnight to replace those destroyed in the wake of the contamination scandal at a US plant providing ingredients, Aspen Pharmacare CEO Stephen Saad says.
The development will come as a relief to the government, as pressure is mounting to speed up vaccination of its most vulnerable citizens in the face of surging coronavirus infections.
The vaccine rollout, which began a month ago, has been severely constrained by the delay in access to J&J shots, which were intended to be the backbone of the programme.
SA was initially slow in ordering vaccines, leaving the country a laggard even among similar-size economies. Its inability to get the programme going ahead of the winter wave of infections has left the economy vulnerable to tighter lockdowns.
The set back has left the government with only a limited supply of Pfizer/BioNTech jabs on hand, and seen provincial health departments and private sector players forced to put the brakes on their vaccination plans. Up to Sunday evening, a little less than 1.3-million people had received their first Pfizer shot, and 480,000 healthcare workers had been immunised with J&J’s jab under the Sisonke study.
However, Discovery CEO Adrian Gore said over the weekend the programme was showing “encouraging promise” and those over 60 years of age would be immunised by the end of August.
Saad said he was optimistic the government would quickly regain lost ground and meet its goal of inoculating 40-million people by March 2022. That target has already been pushed back with the government previously saying it aimed to reach that many before the end of 2021.
“I firmly believe the government will meet the commitments it has made,” he said.
Saad said the shots earmarked for SA in the next fortnight would be sourced from Aspen’s Gqeberha factory and J&J’s international network, without specifying the split. A separate consignment of 300,000 doses is due to arrive on Tuesday, according to acting health minister Mmamoloko Kubayi-Ngubane. These doses are expected to go to teachers.
Aspen has a contract to fill and package J&J vaccine vials at its sterile facility in Gqeberha, which has the capacity to produce up to 300-million doses a year. J&J has previously said at least 60% of the doses finished at the Aspen plant would be earmarked for other customers in Africa.
Aspen was not solely reliant on Emergent for active pharmaceutical ingredients (API), said Saad. It has also been provided with vaccine API’s made at J&J’s Netherlands site, he said.
The US Food and Drug Administration (FDA) placed a hold on J&J vaccines worldwide in early May after it identified poor manufacturing conditions at Emergent, which had been forced to throw out 15-million doses of J&J vaccines after staff accidentally contaminated them with components from AstraZeneca vaccines made at the same site. A FDA report on its April inspection of the site found unsanitary conditions, peeling paint and violations of manufacturing standards.
The FDA said on Friday that some batches of J&J vaccine were approved, but others were unfit for use. On Sunday the SA Health Products Regulatory Authority (Sahpra) said none of the 2-million doses awaiting dispatch from Aspen would be released, due to the contamination concerns.
Saad said the issue was not confined to the vaccines that had been set aside for SA, but declined to specify how many more were affected. The issue had no commercial impact on Aspen, which had met all its commitments to J&J, he said.
In a letter to members of medical schemes administered by Discovery Health, Gore said that the daily vaccination rate had 90,000 people a day. A total of 5.7-million doses of Pfizer/BioNtech vaccine were schedule for delivery in May and June, which combined with those due to be delivered in July, would be enough to immunise SA’s over-60s by the end of August. That would only be a few weeks later than the original target of vaccinating this age group by midwinter, he said.
Correction: June 14 2021
An earlier version of this article said the acting minister had said a separate consignment of doses was intended for teachers; she did not say they were for teachers, just that they would arrive on Tuesday.
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