The South African Health Products Regulatory Authority (SAHPRA) has decided that the 2 million doses of the Johnson & Johnson (J&J) COVID-19 vaccines at the Aspen plant in Gqerberha will not be released for distribution in South Africa.
In a statement, 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) last month 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. The batches that were approved now have to carry a warning.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela confirmed an earlier statement by the Department of Health that 300 000 doses of the FDA approved doses will be released for shipment to South Africa. She reiterated that SAHPRA is committed to the quality and safety of all health products and that it will ensure that the safety and well-being of South Africans will not be compromised in any way.
In an interview with the SABC News, Acting Health Minister, Mamoloko Kubayi-Ngubane urged South Africans not to panic as they won’t be vaccinated with the contaminated doses.
“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 Africans citizens should not panic and what we will receive and use, would be approved.”
EXPLAINER | FDA’s decision to order J&J to discard its vaccines: Sherwin Bryce-Pease