SA’s drug regulator says it still can’t approve the J&J vaccine without word from the US
- South Africa is due to receive 31 million doses of Johnson & Johnson’s Covid-19 vaccine, with almost 10% of those shots initially expected to arrive before the end of June.
- But cross contamination at a US manufacturing plant, and a protracted investigation by the Food and Drug Administration, has halted supply.
- Millions of doses held at Aspen’s production facility in Gqeberha can’t be released until the FDA finalises its report.
- On Monday South Africa’s own regulator says its hands are still tied.
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Batches of Johnson & Johnson’s (J&J) Janssen vaccine, currently held at Aspen’s production facility in Gqeberha, cannot be approved for use by the South African Health Products Regulatory Authority (Sahpra) without a report from the United States’ Food and Drug Administration (FDA).
Such a report had been confidently expected by Friday past, in the latest missed deadline.
South Africa has ordered 31 million doses of the J&J vaccine. Almost 3 million of these jabs – additional to those used to vaccinate healthcare workers within the Sisonke Project – were due to be delivered by the end of June.
This vaccine was set to underpin South Africa’s rollout. Being completed locally reduces logistical costs, while its ability to be transported and stored in normal fridges makes the J&J jab especially valuable to the country’s rural communities.
But South Africa has not administered a single locally produced J&J shot in more than a month.
The first brief pause on the J&J rollout occurred in April, when the FDA reported rare blood clots in patients who had received the vaccine. South Africa followed suit and briefly suspended the Sisonke Project.
Fears were after allayed after two weeks, with both Sahpra and the FDA announcing the resumption of J&J jabs.
This restart didn’t last long. Around the same time South Africa was looking to resume its use of the shot, the FDA revealed that a production facility in Baltimore – Emergent BioSolutions – had cross contaminated batches of the vaccine.
The facility, tasked with producing ingredients for the production of the Covid-19 vaccine, was shut down and its recent shipments placed under quarantine. This confinement applies to the doses produced at Aspen’s facility in Gqeberha, which cannot be released until the FDA finalises its report into spread of the cross contamination.
South Africa was hopeful that this report would be finalised, and the J&J doses released, by mid-May. But with no word from the FDA or J&J by the end of May, the department of health’s director general, Sandile Buthelezi, said he expected to hear from the regulator on Friday 4 June. By late Monday afternoon, the FDA had still not issued any correspondence concerning the tainted J&J jabs.
With South Africa’s demand for vaccines exceeding supply – and the country currently relying solely on the two-dose Pfizer shot – concerns around the J&J jabs in limbo continue to mount. But Sahpra, which is tasked with approving or disallowing the use of vaccines in South Africa, says that its hands are tied without the FDA’s report.
“Sahpra is in continuous discussion with the US FDA to ensure that this matter is resolved speedily,” said CEO Boitumelo Semete-Makokotlela in a statement which explained that the regulator had insufficient information to approve specific batches of the Janssen vaccine.
“Sahpra will take all the necessary steps to ensure that the vaccines that are administered to South Africans meet all the requisite stringent standards so that the health and well being of all who live in South Africa are not compromised in any way.”
Sahpra added that the embargo on J&J jabs – which were initially approved by the regulator for use in South Africa at the end of March – relates to Emergent BioSolutions’ non-compliance with the Good Manufacturing Practices (GMP).
While the initial contaminated batch uncovered by the FDA has been rejected, four more batches, which form part of South Africa’s supply via Aspen in Gqeberha, are still being examined.
Sahpra did not indicate when South Africa could expect word from the FDA regarding the release or rejections of vaccine doses stored in Gqeberha. The cross contamination has also impacted vaccine supplies in Europe and other parts of the world.
The J&J vaccine is due to be used in the vaccination of teachers, as soon as it is available.
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