President Cyril Ramaphosa says Aspen Pharmaceuticals has beefed up production capacity to start work on new batches of the Johnson and Johnson (J&J) COVID-19 vaccines.
This after US drug authority the FDA ruled that J&J batches were contaminated and not fit for human use. South Africa’s Health Ministry has confirmed that the doses will be discarded, jeopardising the country’s vaccination goals. Answering questions on the sidelines of the G7 Summit in the United Kingdom, President Ramaphosa says other vaccines such as Pfizer will assist in the meantime.
President Ramaphosa’s media briefing at the G7 summit:
Assurances that contaminated vaccines will not be released
The South African Health Products Regulatory Authority (SAHPRA) and acting Health Minister Mmamoloko Kubayi-Ngubane assured South Africans that the contaminated COVID-19 vaccine doses will not be released in the country.
This comes after it emerged that some batches awaiting to be distributed from the Gqeberha Aspen plant in the Eastern Cape had been contaminated.
SAHPRA has pleaded with South Africans not to panic as there are emergency plans in place to deal with any crisis, that emerges in the country.
SAHPRA and Acting Health Minister on contaminated vaccines:
SAHPRA has confirmed that 300 000 doses that have been approved by the US Food & Drug Administration, will be released for shipment to SA. The product regulator says it’s unclear when the doses will be shipped to the country. They have also indicated that they are unsure whether Aspen will be reimbursed for the millions they have spent on the manufacturing of the doses, that will go unused.
The Johnson & Johnson vaccine will now be stored for four and half months instead of three months, at a temperature of 2 to 8 degrees Celsius.
Kubayi-Ngubane has assured that quality and safety of all COVID-19 vaccines will not be compromised.
“Based on what has been announced by the FDA we are affected in terms of those batches there at Gqeberha site and what we have there on site is 2 million. I think some people were almost thinking that these are the batches that would have vaccinated South African citizens with these batches that are contaminated. I need to reiterate that is not correct. These batches have not been used. So I think South Africans citizens should not panic and what we will receive and use, would be approved.”
SAHPRA CEO, Dr Boitumelo Semete says the batches in question will not be released.
“The batches that at the Aspen sites that have been finished. The ones that were in question, those will not be released. They cannot be made available to the public. However, these are doses from the factory that have been cleared that will be made available. We will make sure that the country gets the correct batches of vaccine.”
Dr Semete continued to say that the contaminated doses will have a negative impact on government’s vaccination roll out plan.
“It has impacted the vaccine rollout and plans of the country. These are doses expected to be made available. The public must have confidence as regulator. We will ensure that any product that is not of the right quality, it’s not made available in the country. There is level of confidence for the public to have but it does affect our roll out strategy.”
Vaccine commitment by G7 countries
President Ramaphosa also said he’s pleased with the commitments made at the G7 Summit around COVID-19 vaccines and global economic recovery. He says the G7 leaders have pledged more vaccine support as well as boosting manufacturing capacity in the less developed world.
The “most advanced” countries committed to share one billion doses of vaccines through COVAX. However, the pledge doesn’t represent entirely new resources.
President Ramaphosa says the Global South needs manufacturing capabilities since it doesn’t want to depend on donations.
