The South African Health Products Regulatory Authority (Sahpra) as well as the Acting Minister of Health Mmamoloko Kubayi-Ngubane have assured South Africans that the contaminated COVID-19 vaccine doses will not be released in South Africa.
This after it emerged that some batches waiting to be distributed from the Gqeberha Aspen plant in the Eastern Cape had been contaminated.
Sahpra CEO, Dr Boitumelo Semete-Makokotlela is pleading with South Africans not to panic as there are emergency plans in place.
“The batches at the Aspen sites that have been finished, the ones that were in question, those will not be released, they can not be made available to the public. However, these are doses from the factory that have been cleared that will be made available. We will make sure that the country gets the correct batches of vaccine.”
Dr Semete-Makokotlela says the contaminated doses have had a negative impact on the government’s vaccination rollout plan.
“It has impacted the vaccine roll-out and plans of the country. These are doses expected to be made available. The public must have confidence … as [the] regulator we will ensure that any product that is not of the right quality, is not made available in the country. It does affect our rollout strategy,” explains Semete-Makokotlela.
Sahpra CEO, Dr Boitumelo Semete-Makokotlela speaking about contaminated J&J vaccines:
‘Vaccines will not be compromised’
Sahpra has confirmed that 300 000 doses that have been approved by the US Food & Drug Administration will be released for shipment to SA. The product regulator says it’s unclear when the doses will be shipped to the country. They have also indicated that they are unsure whether Aspen will be reimbursed for the millions they have spent on the manufacturing of the doses, that will go unused.
The Johnson & Johnson vaccine will now be stored for four-and-half months instead of three months — at a temperature of 2.8 degrees Celsius.
Acting Health Minister, Mamoloko Kubayi-Ngubane has assured that the quality and safety of all COVID-19 vaccines will not be compromised.
“Based on what has been announced by the FDA we are affected in terms of those batches there at Gqeberha site and what we have there on site is 2 million. I think some people were almost thinking that these are the batches that would have vaccinated South African citizens with these batches that are contaminated. I need to reiterate that is not correct. These batches have not been used. So I think South African citizens should not panic and what we will receive and use, would be approved.”
In a statement last week, the regulator confirmed that the vaccines were affected by contamination issues at a US vaccine plant in Baltimore. The US Food and Drug Authority (FDA) halted the release of all J&J vaccines from the plant pending an investigation. On Friday the FDA cleared some of the batches at the plant but confirmed that it had to destroy 60 million doses that were contaminated.
Vaccinologist Professor Shabir Mahdi on South Africa’s latest coronavirus cases and vaccine challenges:
