Pharmaceutical giant Aspen says Johnson and Johnson will be providing 300 000 doses of its vaccine within days for South African teachers.
This follows the Good Manufacturing Practice determination at the weekend of the risk of isolated material in the drug substance supplied to Aspen by Johnson & Johnson from their contract manufacturing partner in America.
It means that a batch of two million J & J vaccines, which were filled and packaged at Aspen’s Gqeberha production site, will now have to be destroyed.
The batches manufactured had been retained in storage awaiting the outcome of the US FDA assessment of Aspen’s USA partner, Emergent.
Aspen says its extremely disappointed at the setback which has the potential to negatively impact the vaccine rollout across South Africa and Africa.
It says in a statement that to mitigate the potential risk to vaccine access, and in substitution of the volumes lost, J & J will be providing 300 000 doses of the vaccine for South African teachers within the next few days.
It added that 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 it also has further doses of the vaccine in production that will become available in July.
Aspen has invested in excess of R3 billion at its sterile manufacturing site in Nelson Mandela Bay, the single largest investment in the pharmaceutical industry in South Africa.
