Aspen Pharmacare expressed its disappointment on Monday after it was announced that the Johnson & Johnson Covid-19 vaccine manufactured in Gqeberha had to be destroyed.
The vaccines will be destroyed due to the Good Manufacturing Practice risk of isolated material in the drug substance supplied to Aspen by Johnson & Johnson from its contract manufacturing partner in the US, Emergent.
The SA Health Products Regulatory Authority said on Sunday that 300,000 doses of the J&J vaccine would be safe to use and would be shipped to SA.
These are from batches that have been cleared by the US Food and Drug Administration (FDA).
This was after the discovery in April that ingredients from AstraZeneca’s Covid-19 vaccine, also being produced at the plant at the time, had contaminated a batch of J&J’s vaccine.
Aspen Group chief executive Stephen Saad said it was not only a setback for both the Aspen and J&J teams, but would potentially negatively affect the vaccine rollout across SA and Africa.
“Aspen has invested in excess of R3bn at this sterile manufacturing site, the single largest investment in the pharmaceutical industry in SA , which contained high-technology, state-of-the-art pharmaceutical equipment and systems that would be used to manufacture advanced sterile medicines, including vaccines,” he said.
Saad said to mitigate the potential risk to vaccine access, and in substitution of the volumes lost, these actions have been undertaken:
- Within days, J&J will provide 300,000 doses of the vaccine for SA teachers;
- Within a week, Aspen expects to release J&J vaccines manufactured from drug substance that has not been affected by the Emergent contamination;
- Over the next few weeks, J&J will be delivering substantial quantities of compliant finished vaccines to SA to replace the lost stock, thereby ensuring the momentum in the SA vaccine initiative is maintained;
- Aspen has further doses of the vaccine in production that will become available in July; and
- These J&J vaccines released by Aspen will support the vaccination programmes in SA and elsewhere in Africa.
Saad thanked the Aspen teams and partner J&J for their exemplary response in managing the setback.
HeraldLIVE