South Africa, which is struggling to roll out its inoculation programme as it enters a third wave of the coronavirus pandemic, said Sunday it will pull two million doses of the Johnson & Johnson vaccine following contamination concerns at one of the US drugmaker’s sites.
On Friday, the US Food and Drug Administration told J&J that millions of doses produced at the group’s Emergent BioSolutions facility in the city of Baltimore were not suitable for use.
Following a review of the FDA decision, the South African Health Products Regulatory Authority (SAHPRA) said in a statement that it had decided “not to release vaccine produced using the drug substance batches that were not suitable”.
J&J’s Emergent plant was ordered to pause production in April several weeks after it was determined that batches of a substance used to produce the vaccine were cross-contaminated with ingredients from another jab made by Anglo-Swedish pharma giant AstraZeneca.
J&J did not reveal the precise number of doses in each batch, but they are known to correspond to several million jabs.
The FDA is still deciding whether to allow the factory to reopen.
Acknowledging the setback in South Africa’s vaccination programme, Health Minister Mmamoloko Kubayi-Ngubane said Saturday that the country had two batches — representing some two million doses — that were stored in a high-security laboratory in Port Elizabeth belonging to drugmaker 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 a 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 the delivery of 31 million doses of the single-shot J&J vaccine to help inoculate its population of 59 million.