No contaminated Johnson & Johnson vaccine doses used in SA, says acting Health Minister

This follows concerns raised by the US Food and Drug Administration last week that Emergent BioSolutions’s Baltimore plant in the US was non-compliant during the manufacture of a substance that is used in the manufacture of the Covid-19 vaccine.

Bottles of the single-dose Johnson & Johnson Covid-19 vaccine. Picture: Frederic J. Brown/AFP

Published Jun 13, 2021

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DURBAN - Acting Health Minister Mmamoloko Kubayi-Ngubane said contaminated Johnson & Johnson (J&J) batches have not been used to vaccinate South Africans.

This follows concerns raised by the US Food and Drug Administration (FDA) last week that Emergent BioSolutions’s Baltimore plant in the US was non-compliant during the manufacture of a substance that is used in the manufacture of the Covid-19 vaccine.

In April, Health Minister Zweli Mkhize temporarily suspended the vaccine because of concerns in the US over a blood clotting disorder. The J&J vaccine roll-out re-commenced weeks later.

Kubayi-Ngubane, who was speaking in an interview with the SABC on Sunday morning, said the J&J batches rejected after quality checks would have some level of impact on South Africa.

Kubayi-Ngubane confirmed that South Africa has received contaminated vaccine batches, but assured the public that they had not been used.

There were two million J&J vaccine doses at the Gqeberha (formerly Port Elizabeth) site, she said.

“I think South African citizens should not panic and worry. What we will receive and use will be approved,” she said.

She said South Africa was able to manage the vaccination roll-out with the available vaccine doses.

“We are expecting some more batches next week from Johnson & Johnson in terms of 300 000, and we are interacting with Johnson & Johnson leadership to secure some more,” said Kubayi-Ngubane

The acting minister said there would be a full review in a week to brief the public about the vaccine roll-out and how South Africa would catch up.

In a statement on Sunday, the South African Health Products Regulatory Authority (Sahpra) confirmed that 300 000 doses of the J&J vaccine have been cleared for shipment to South Africa.

Sahpra chief executive Dr Boitumelo Semete-Makokotlela said doses of the vaccine had been cleared by the FDA.

“There are approximately 300 000 doses (from batches) that have been cleared by the USFDA that meet the requirements and will subsequently be released and shipped to South Africa,” she said.

IOL reported on Saturday that about 60 million doses of the vaccine were contaminated and should be discarded.

“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,” said Semete-Makokotlela.

THE MERCURY

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