South Africa rolls back on FDA unwholesome-termed Johnson&Johnson COVID vaccines

SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has announced it will not release Johnson& Johnson(J&J) vaccines produced using the drug substance batches that were not suitable.

South Africa, which is struggling to roll out its inoculation program as it enters a third wave of the pandemic, said it will pull two million of doses of the Johnson & Johnson vaccine following contamination concerns at one of the US drug maker’s sites.

This follows an announcement made by the US Food and Drug Administration that millions of doses of Johnson & Johnson’s coronavirus vaccine produced at a troubled Baltimore factory could not be used.

The agency directed that at least 60 million doses of Johnson & Johnson’s coronavirus vaccine made at a problem-plagued Emergent BioSolutions plant must be discarded. These 60 million doses are in addition to 15 million doses already thrown out, due to contamination by the AstraZeneca vaccine at the plant earlier this year.

J&J’s Emergent plant has been ordered to pause production as the FDA is still deciding whether to allow the factory to reopen.

Acknowledging the setback in South Africa’s vaccination program, acting Health Minister, Mmamoloko Kubayi-Ngubane, said that the country had two batches, representing some two million doses, that were stored in a high-security laboratory in Port Elizabeth belonging to drug maker Aspen.

South Africa is one of the countries campaigning for a waiver of patents on Covid-19 vaccines in order to allow every nation to produce generic versions at low cost.

If we are to save lives and end the pandemic, we need to expand and diversify manufacturing and get medical products to treat, combat and prevent the pandemic to as many people as quickly as possible,” President Cyril Ramaphosa told the G7 group of wealthy nations meeting in Britain on Sunday.

South Africa is counting on a delivery of 31 million doses of the single-shot J&J vaccine to help inoculate its population of 59 million, as cases continue surging by day. The country recorded 9,300 new cases in the past 24 hours.

The country that has vaccinated just over One percent of its population has also secured 30 million doses of the Pfizer-BioNTech vaccine, but that jab must be stored at extremely low temperatures and requires two shots.

Germany, which also withdrew the contaminated batch from circulation has demanded that Johnson& Johnson replace the spoilt vaccines.

Speaking through press, the German Health Ministry demanded that J&J supplies 6.5 million doses in July to offset a definite vaccine shortfall. The ministry termed the situation as regrettable, as every vaccine dose counts.

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