Durban – Aspen, a global multinational specialty pharmaceutical company, was extremely disappointed to learn over the past weekend that specific batches of the Johnson & Johnson COVID-19 vaccine manufactured at our Gqeberha production site and designated for the South African market have to be destroyed due to the Good Manufacturing Practice risk of isolated material in the drug substance supplied to Aspen by Johnson & Johnson from their contract manufacturing partner in the USA, Emergent. 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.
To mitigate the potential risk to vaccine access, and in substitution of the volumes lost, the following actions have been undertaken:
- Within days, Johnson & Johnson will provide 300 000 doses of the vaccine for South African teachers.
- Within a week, Aspen expects to release Johnson & Johnson vaccines manufactured from drug substance that has not been impacted by the Emergent 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.
- Aspen has further doses of the vaccine in production that will become available in July.
- These Johnson & Johnson vaccines released by Aspen will support the vaccination programmes in South Africa and elsewhere in Africa.
We thank the Aspen teams for their exemplary response in managing this setback and our partner, Johnson & Johnson, who through their actions, have not only assisted in capacitating the African continent, but at this challenging time have stepped up again to ensure that we are able to maintain the momentum needed to give our continent access to lifesaving vaccines.