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’
JOHANNESBURG – 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 millions of 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 batches concerned 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 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.
It 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.
SAHPRA said that a new delivery of around 300,000 doses of the J&J jab “that have been cleared by the US FDA that meet the requirements and will subsequently be released and shipped to South Africa.”
The government already temporarily suspended vaccination in April after rare cases of blood clots were reported in the US.
And in February, South Africa turned down more than 1.5 million doses of AstraZeneca’s vaccine because of doubts about its efficacy on the local coronavirus variant.
Lagging behind many other countries, South Africa has only vaccinated just over 1% of its population. It is the African country hardest hit by the pandemic, with more than 1.7 million infections and nearly 58,000 deaths.
More than 9,300 new cases were registered in the past 24 hours.