Aspen Pharmacare reacts to FDAs directive for a batch of Johnson & Johnson COVID-19 vaccines to be destroyed

SOUTH AFRICA – Aspen, a global multinational specialty pharmaceutical company, has sqaid in a statement released to the press that they are disappointed to learn specific batches of the Johnson & Johnson COVID-19 vaccine manufactured at  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 company will undertake to see to it that Johnson & Johnson provides 300,000 doses of the vaccine for South African teachers with a few days.

Also, Aspen projects 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 also 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 noted that they have more doses of the vaccine in production that will become available in July.

These Johnson & Johnson vaccines released by Aspen will support the vaccination programs in South Africa and elsewhere in Africa.

South Africa is the most affected nation in the continent and has recorded 5, 552 new confirmed cases of Covid-19 as of yesterday and 114 deaths, bringing the official death toll to 57 879.

According to a statement by the National Institute for Communicable Diseases (NICD), as of Monday, the country recorded 1 752 630 laboratory-confirmed cases.

“The majority of new cases are from the Gauteng province (67%), followed by the Western Cape (8%) and North West (5%),” NICD spokesperson Sinenhlanhla Jimoh said.

The country has managed to vaccinate 1,777,288 people with 1,797 doses having been administered in the last 24-hour cycle. Of the total number of people vaccinated, 1,297,520 were done using the Pfizer vaccine.