South Africa has suffered the latest in a series of setbacks to its Covid-19 vaccination program, with the country’s medical-products regulator saying on Sunday that doses of the Johnson & Johnson vaccine that were manufactured at a plant in Baltimore, Maryland and awaiting distribution in South Africa cannot be used because of possible contamination.
The decision by the South African Health Products Regulatory Authority (SAHPRA) could render two million doses of the J&J jab being held at a finishing plant in South Africa’s Eastern Cape province unavailable for use in the country. The move follows a determination by the US Food and Drug Administration that as many as 60 million doses of J&J vaccine manufactured at the plant are unsuitable for use because of contamination.
“SAHPRA reviewed the data provided by the FDA and has made a decision not to release vaccine produced using the drug substance batches that were not suitable,” the regulator said in a statement. As part of its process, SAPHRA requires documentation of the quality of vaccines from the regulatory authority in the country where a vaccine is manufactured; in this instance, the FDA.
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