At least two million doses of the Johnson & Johnson (J&J) vaccination that were produced at the Aspen Pharma plant in Gqeberha will not be used, as it has been contaminated.
On Saturday, 12 June Acting Health Minister Mmamoloko Kubayi-Ngubane said these doses would not be used because they had reason to believe it had been contaminated at a factory in the United States.
Earlier today President Cyril Ramaphosa confirmed that the J&J vaccine has been deemed unfit to use by US authorities.
“We’ve had some challenges with relation to J&J, which seem to be contaminated. Aspen has produced two million doses of the J&J vaccine, but they were told it is contaminated and they have to dispose of those they have already manufactured.
“I spoke to the CEO of Aspen and he said they will start all over again with another batch. They should be able to gear up their manufacturing capacity,” Ramaphosa said.
The SA Health Products Regulatory Authority (SAHPRA) today issued a statement saying that “a concern was identified by the USFDA (US Food and Drug Administration), relating to non-compliance with Good Manufacturing Practices (GMP) at the Emergent plant in Baltimore, USA, during the manufacturing of drug substance which is used in the manufacture of the COVID-19 vaccine”.
“Subsequently, on 11 June 2021, the USFDA authorised two batches of drug substance produced from the Emergent site and further determined that several other batches are not suitable for use. SAHPRA reviewed the data provided by the FDA and has made a decision not to release vaccine produced using the drug substance batches that were not suitable,” SAHPRA said.
News24 reported that a month long probe found that safety protocols were not followed at the manufacturing facility at Emergent BioSolutions in Baltimore. Only J&J and Pfizer vaccines are authorised in South Africa.
Ramaphosa said that the government has stored a lot of their vaccination programme’s hope on the J&J vaccine, “because it is a one jab vaccine”.
“In the meantime we’ve been using other vaccines, particulartly Pfizer. In my discussions with (American) president Joe Biden we did say to him that we would like the doses he is going to donate to be channelled to Africa and South Africa and he agreed he is going to do that as soon as possible. We will also be getting doses from Europe,” Ramaphosa said.
As far as the J&J vaccine is concerned, Ramaphosa said Aspen should be able to start with the production of new batches of the vaccine soon. “The CEO told me that by the middle of next week they will be able to have started and manufactured quite a number of vaccines that will be made available not only for South Africa, but for Africa as well.”
2. Mamoloko Kubayi-Ngubane (sent to me 17:45):
“I can confirm that 2 mil doses at Gqeberha have been affected + will not be used. Only 1 batch was regarded contaminated from USA + the other 1 was not but because they were stored together, it’s difficult to isolate one batch.”— Mia Malan (@miamalan) June 13, 2021
