J&J Vaccine Delivery to South Africa in Limbo After U.S. Ruling

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Johnson & Johnson Covid-19 vaccines intended for South Africa remain suspended following a U.S. ruling that ingredients for the country’s doses may have been contaminated during production in a plant in Baltimore.

The U.S. Food and Drug Administration said Friday that some batches of the J&J version were not fit to use, while others are still under review. Two lots have been approved, though it’s not clear where those are headed or how many that covers.

South Africa is heavily reliant on the J&J vaccine to meet a target of inoculating two-thirds of its 60 million population this year, having ordered more than 31 million of the single-dose shot. Aspen Pharmacare Holdings Ltd., Africa’s largest drugmaker, has a contract to fill and package the doses at a factory in the coastal town of Gqebherha, until recently known as Port Elizabeth.

“The vaccines awaiting distribution from the Gqebherha plant need further assessment by the South African Health Products Regulatory Authority,” the country’s ministry of health said in a statement. That will determine “if they are suitable for use in South Africa. There is now a real possibility that they may not be, however this is for the regulator to rule on,” it said.

To compensate, 300,000 J&J doses are cleared to be shipped to South Africa “as a matter of extreme urgency,” the ministry said. Furthermore, the drugmaker has agreed a contract to supply the vaccine to the country and will therefore need to honor that in time.

The news still marks a major setback in South Africa’s vaccine rollout -- just as a third wave of infections is gathering pace. The government has been heavily criticized for delays in ordering doses, and inoculations to the general public only began in mid-May.

The over-60s are receiving doses of the Pfizer Inc. and BioNTech SE version, though just 1.2 million people plus 480,000 health workers have been catered for so far.

©2021 Bloomberg L.P.

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