With the country officially having entered the third wave, South Africa is looking to accessing the Chinese and Russian vaccines and Aspen is moving to replace the 2m J&J doses that have to be dumped, writes MedicalBrief.
TimesLIVE reports that acting Health minister Mmamoloko Kubayi-Ngubane, speaking at Chris Hani Baragwanath Hospital in Soweto, said: “We cannot ignore the fact that [the FDA ruling] has taken our vaccine rollout a bit backwards.”
The South African Health Products Regulatory Authority has been asked to fast-track assessment of the Sinovac (Chinese) and Sputnik (Russian) vaccines. Kubayi-Ngubane said her department was preparing recommendations to the government.
In a statement, Aspen Pharmacare Holdings has promised delivery, within days, of 300,000 doses of the Johnson & Johnson (J&J) vaccine for South African teachers. Further doses of the vaccine in production will become available in July.
Aspen said it was “extremely disappointed to learn that specific batches of the J&J 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 had been in storage awaiting the outcome of the US Food & Drug Administration (FDA) assessment of Emergent.
Aspen described this as not only a setback to itself and J&J teams, which had “worked tirelessly to ensure the manufacture of these batches”, but more importantly, this had the potential to negatively affect the entire 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, J&J will provide 300 000 doses of the vaccine for South African 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 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 J&J vaccines released by Aspen will support the vaccination programmes in South Africa and elsewhere in Africa.
Full TimesLIVE report (Open access)