South Africa will not release unsuitable J&J vaccine doses after US ruling

South Africa will not allow some Johnson & Johnson COVID-19 vaccines to be used following a US ruling that ingredients for the country’s doses may have been contaminated during production in a plant in Baltimore.

The 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. South African authorities have reviewed data provided by the FDA and “made a decision not to release vaccine produced using the drug substance batches that were not suitable, The South African Health Products Regulatory Authority said Sunday in a statement.

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.

“However, there are approximately 300,000 doses from batches that have been cleared by the US FDA that meet the requirements and will subsequently be released and shipped to South Africa, the regulator said.

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’s version, though just 1.2 million people plus 480,000 health workers have been catered to so far.

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