- The SA Health Products Regulatory Authority (SAHPRA) says it will not release the J&J vaccine doses stored in Gqeberha, Eastern Cape, due to contamination.
- Acting Health Minister Mmamoloko Kubayi-Ngubane told media on Saturday that the two million doses would not be used.
- Some provinces in South Africa are in the third wave of Covid-19, with Gauteng being the worst hit.
The SA Health Products Regulatory Authority (SAHPRA) on Sunday said it would not release the Johnson & Johnson vaccine which has been deemed unfit to use by US authorities.
"SAHPRA reviewed the data provided by the USFDA [US Food and Drug Administration] and has made a decision not to release vaccine produced using the drug substance batches that were not suitable," it said in a statement.
The body said there were at least 300 000 doses from batches that had been cleared by the FDA and that met the requirements, and that these would be released and shipped to South Africa.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela said: "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."
Acting Health Minister Mmamoloko Kubayi-Ngubane confirmed on Saturday that the J&J doses awaiting distribution from the Aspen Pharma plant in Gqeberha, Eastern Cape, would not be used due to suspicions that they had been contaminated at a US factory.
Speaking at Soweto's Baragwanath Hospital, Kubayi-Ngubane said at least two million doses had been affected.
A month long probe found that safety protocols were not followed at the manufacturing facility at Emergent BioSolutions in Baltimore. Only J&J and Pfizer vaccines are authorised in South Africa.
As the Covid-19 third wave hit most parts of the country, government had expected to utilise the two million doses to inoculate healthcare workers and those aged over 60.
Gauteng is the worst hit province, with 9 300 new cases reported in the past 24 hours.
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