Aspen says it will release 300 000 Johnson & Johnson (J&J) doses earmarked for teachers soon.
In a statement released this week, Aspen said it was “extremely disappointed” to learn that specific batches of the J&J manufactured at its Gqeberha production site have to be destroyed.
This is due to the good manufacturing practice risk of isolated material in the drug substance supplied to Aspen by J&J from their contract-manufacturing partner in the United States.
“The batches manufactured had been retained in storage awaiting the outcome of the US FDA assessment,” Aspen said.
On Sunday, the South African Health Products Regulatory Authority (SAHPRA) said it has decided not to release the long-awaited Johnson & Johnson (J&J) vaccines for use in the country.
However, SAHPRA said about 300 000 doses from batches that have been cleared by the US Food & Drug Administration (FDA) meet the requirements and will subsequently be released and shipped to South Africa.
According to the pharmaceutical company, this is not only a setback to both the Aspen and J&J teams, who worked tirelessly to produced these shots, but it has the potential to negatively affect vaccine rollout across South Africa and Africa.
However, the company has since come out with ways to mitigate the potential risk to vaccine access.
“Within days, Johnson & Johnson will provide 300 000 doses of the vaccine for South African teachers,” the company announced.
In the next week, Aspen said it expects to release J&J vaccines manufactured from the 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, thereby ensuring the momentum in the South African vaccine initiative is maintained.”
The multinational said further doses of the lifesaving vaccines will become available in July.
“These Johnson & Johnson vaccines released by Aspen will support the vaccination programmes in South Africa and elsewhere in Africa.”
Aspen has thanked its team and J&J for their exemplary response in managing this setback.
“Through their actions, they have not only assisted incapacitating the African continent but at this challenging time, they have stepped up again to ensure that we are able to maintain the momentum needed to give our continent access to lifesaving vaccines.” – SAnews.gov.za