About 2m Johnson & Johnson (J&J) vaccines manufactured in Gqeberha in the Eastern Cape will be destroyed because one batch was regarded as contaminated by authorities in the US.
Briefing media at the Group of Seven rich nations summit in England, President Cyril Ramaphosa last night said: “I’m told they [Aspen] have to dispose of those they have already manufactured. They are going to start all over again with another batch…”
He said in his discussions with US president Joe Biden, he had asked that some of the vaccines that would be donated be sent to SA and other African countries.
“So, we should be able to get some doses from that end but we will be able to get doses also from Europe and we will be able to have, as we have often said, multi-vaccine doses. J&J should be able to get up and going.
"The CEO of Aspen told me that by the middle of the week, they will be able to have started and manufactured quite a number of vaccines which will be made available not only for South Africa but also for the African continent,” Ramaphosa said.
Acting health minister Mamoloko Kubayi-Ngubane yesterday said as the vaccine can’t be used, it would have an impact on the country ’s vaccine rollout programme.
Dr Clare Cutland, a scientific co-ordinator at Wits African Leadership in Vaccinology, said “this is a big setback but the decision wouldn’t have been made lightly by Sahpra [SA Health Products Regulatory Authority]”.
“Not having these doses will probably lead to further delays of the rollout of vaccines, especially to peri-urban and rural areas, which is a big concern,” Cutland said.
The Aspen plant was expected to deliver more than 1m J&J vaccine doses by the end of last month, the department of health had previously announced. SA is currently rolling out a two-dose Pfizer vaccine as the J&J vaccines had been awaiting clearance from the US authorities.
The US Food and Drug Administration (FDA) last week raised concerns over noncompliance with good manufacturing practice at the Emergent plant in Baltimore, US, during the manufacture of a substance used to produce the J&J vaccine.
Kubayi-Ngubane said “in total 300,000 doses have been cleared to be shipped to SA as a matter of extreme urgency”.
The FDA announced that after careful evaluation of these doses, it approved an extension of the expiry date after determining that the vaccine can be stored at 2-8°C, under normal bar fridge temperatures, for up to five months instead of three months, Kubayi-Ngubane said .
“Work is being undertaken to identify more safe doses for the rest of the mass vaccination programme. We further note that the FDA is still evaluating some batches and we will await those outcomes, in the hope that this will make more doses of Johnson & Johnson available to the international community, including SA,” she said.
Sahpra CEO Dr Boitumelo Semete Makokotlela said in a statement yesterday: “Sahpra focuses on the quality, safety and efficacy of all health products, including Covid-19 vaccines, and will ensure that the safety and well-being of South Africans will not be compromised in any way.”
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