The delayed update by the US Food & Drug Administration (FDA) on the manufacturing conditions at a US factory, which halted the release of millions of doses of the coronavirus vaccine of Johnson & Johnson (J&J) worldwide, may come as early as Monday, says a senior health official.
J&J’s vaccines are central to the SA government’s rollout plans as they require only a single shot and are easier to store than the Pfizer/BioNTech double-shot vaccine that is now being provided.
The global hold on the shots has slowed SA’s vaccination drive, which by Saturday evening had reached just 1.3-million people — barely 2% of the population.
The government had hoped to hear by Friday that Emergent BioSolutions had been given the green light by the FDA, clearing the way for SA to begin administering J&J’s shot as part of its mass vaccination programme, which began three weeks ago. But the FDA rescheduled its planned inspection of the site last week, delaying the finalisation of a report that will have far-reaching implications for vaccination programmes worldwide that are depending on J&J’s jab.
At the heart of the issue is manufacturing conditions at Emergent, which makes vaccine ingredients used by J&J contractors, including SA’s Aspen Pharmacare. The FDA shut down Emergent BioSolutions’ Baltimore plant in April after it contaminated and ruined 15-million doses of J&J vaccines made at the site.
The FDA is expected to clarify the extent to which other batches containing ingredients supplied by Emergent were contaminated, said health department deputy director-general Nicholas Crisp.
SA ordered 31-million doses of J&J’s single shot vaccine, with the expectation that they would be supplied through Aspen. About 2-million doses earmarked for SA are ready for dispatch from Aspen’s Gqeberha factory, but until the FDA finalises its report the health department will not know whether all, some or none of these vaccines are contaminated, said Crisp.
“They are keeping their cards very close to their chest. We have no idea what they are going to rule. We are just holding our breath,” he said.
J&J had offered SA a separate consignment of 480,000 doses, which the government is considering giving to teachers and other school staff provided the shots are given the green light by the FDA, said Crisp.
Already thawed
“We will take every dose we can,” he said.
As these shots have already been thawed and must be used by June 28, any further delays in the FDA’s report on Emergent could scupper plans to give them to teachers, he warned.
The intention is to vaccinate people working in basic education and in public as well as private schools, he said. This will include teachers, administrative and support staff.
“We have done all the preparatory work and have an interface for the entire basic education system with the electronic vaccine data system. Each province has its own plans, and how they will do it school by school,” he said.
SA has been receiving a steady supply of Pfizer/BioNTech doses, in line with the delivery schedule previously announced by health minister Zweli Mkhize.
By June 1, 1.3-million doses had been delivered to provinces, with 636,000 more awaiting final clearance by the national control laboratory. A further 2.5-million doses are expected in several tranches by June 21.
A question mark still hangs over the timing of the delivery of the 1.4-million Pfizer doses set aside for SA by international vaccine financing mechanism Covax.
Crisp said the government does not yet know when it will receive delivery of these shots.
Documents published by Covax detailing its distribution plans indicate SA is in line for the shots in the first half of the year. However, Covax, its delivery partner Unicef, and Pfizer could not provide Business Day with a delivery date.
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