Pharmaceutical company Aspen says it will have 300 000 doses of the Johnson & Johnson vaccine ready for South African teachers within days.
In a statement on Monday, Aspen said that it is “extremely disappointed” that a batch of two million J&J vaccines will have to be destroyed. These vaccines, which were filled and packaged in Aspen’s Gqeberha factory, used substances from a US factory that may have seen contamination, according to US authorities.
However, within the next week, Aspen expects to release Johnson & Johnson vaccines manufactured from a drug substance that has not been impacted by the contamination. Over the next few weeks, Johnson & Johnson will be “delivering substantial quantities of compliant finished vaccines” to South Africa to replace the lost stock, Aspen said.
On Sunday, the SA Health Products Regulatory Authority (SAHPRA) said it would not release the Johnson & Johnson vaccine which has been deemed unfit to use by US authorities.
A month-long probe found that safety protocols were not followed at the manufacturing facility at Emergent BioSolutions in Baltimore.
“The batches manufactured had been retained in storage awaiting the outcome of the US FDA assessment of Emergent. This is not only a setback to both the Aspen and Johnson & Johnson teams who have worked tirelessly to ensure the manufacture of these batches, but more importantly, has the potential to negatively impact the vaccine rollout across South Africa and Africa,” Aspen said in a statement.
SAHPRA said there were at least 300 000 doses from batches that had been cleared by the FDA, and that these would be released and shipped to South Africa.
“Within days, Johnson & Johnson will provide 300 000 doses of the vaccine for South African teachers,” Aspen added. Earlier this month, government said a vaccination plan for teachers is still in the planning phase.
Further doses of the vaccine is currently in production and will become available in July, Aspen said.