Two million doses of the Johnson & Johnson (J&J) vaccine awaiting distribution from the Aspen Pharma plant in Gqeberha, Eastern Cape, will not be used due to suspicions that a core component of the vaccine was contaminated in a US factory.
Acting Health Minister Mmamoloko Kubayi-Ngubane confirmed yesterday that the vaccines would not be used. She was speaking during the first leg of her national tour at Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg.
"Two million doses that are affected [are] currently in a warehouse in Gqeberha," she was quoted as saying by EWN. As a result, South Africa's vaccination programme, which is already the slowest vaccine roll-out of all middle-income countries in the world and one of the slowest in Africa, could be plunged into a crisis.
They are part of the consignment that is contaminated.Source
The shocking news comes after the US Food and Drug Administration (FDA) said on Friday night that it could give no guarantee that the South African consignment of vaccines was not contaminated.
A component of the vaccine was manufactured at Emergent BioSolutions in Baltimore, where a months-long investigation found that safety protocols had not been strictly adhered to.
Active pharmaceutical ingredients for Johnson & Johnson and AstraZeneca vaccines are made at the Baltimore plant.
According to The New York Times, FDA inspectors found that workers at the plant did not shower or change their clothing after first working with AstraZeneca ingredients and then with J&J ingredients.
This means J&J vaccines could be contaminated with AstraZeneca ingredients.
The FDA has been investigating 100 million doses manufactured at the Emergent plant since April, The New York Times reported.
Up to 60 million of these doses could be infected.
The SA Health Products Regulatory Authority (SAHPRA), which is known for taking no risks, is still to decide whether the vaccine may be used or not.
The Emergent plant is still closed and there is uncertainty about when J&J will be able to deliver the other 29 million doses that South Africa ordered.
South African health authorities had been relying on the 2 million doses to vaccinate health workers and people older than 60 in rural areas.
There is a real possibility that the vaccines may not be suitable [for use in South Africa], but the regulator must decide on this.Health department
The J&J vaccine requires only one dose and, unlike the Pfizer-BioNTech vaccine, does not need to be stored at ultralow temperatures.
The vaccination programme in rural areas is already far behind schedule because government had to wait for an FDA ruling.
To make matters worse, members of the ministerial advisory committee are also concerned that the delivery of Pfizer-BioNTech doses could be delayed in the third quarter.
Only J&J and Pfizer-BioNTech vaccines have been approved for use in South Africa.
All this as a third wave of infections sweeps across the country.
The National Institute for Communicable Diseases said on Thursday night that the country was officially experiencing a third wave.
By Friday, more than 8 000 new cases had been recorded a day nationwide - levels last seen with the flattening of the second wave in January.
By Friday night, 16.5% of Covid-19 tests were positive, compared with 13.1% a week earlier and 11.5% on May 28.
This time, the mess with the vaccines is not our government's fault.Source
The worst-hit province is Gauteng, where 60% of new cases were reported on Friday (4 809 out of 8 021). A total 748 new cases were reported in the Western Cape, 508 in North West and 394 in KwaZulu-Natal.
According to experts, South Africa's only counter to the third wave will be stricter lockdown measures.
The only good news on Friday night was that 300 000 J&J doses would be sent to the country for a vaccination programme for teachers.
The SAHPRA will have to approve this.
"There is a real possibility that the vaccines may not be suitable [for use in South Africa], but the regulator must decide on this," said the health department in a statement on Friday night.
A source close to government told City Press' sister publication Rapport that the likelihood of the SAHPRA approving the vaccines at Aspen "are almost zero".
"They are part of the consignment that is contaminated," the source said.
"This time, the mess with the vaccines is not our government's fault."
We believe that we will get enough Johnson & Johnson vaccines by mid-July to continue our mass [vaccination] programme.Source
SAHPRA spokesperson Yuven Gounden said they had received documentation from the FDA yesterday morning and would release further information tomorrow.
The regulatory authority is strict when it comes to decisions on drugs, tests and vaccines against Covid-19.
In February, it rejected the use of the AstraZeneca vaccine due to questions about its efficacy against the Beta variant, which is responsible for scores of infections in South Africa.
Apart from the possible loss of the 2 million doses in Gqeberha, it is also not clear when South Africa will receive the 29 million J&J doses.
The Emergent plant has been closed since April and it is unclear when production will resume.
The FDA has indicated that some of the J&J doses from Baltimore may be used in the US or be exported.
"President Cyril Ramaphosa will negotiate with US President Joe Biden at the G7 summit to try to get some of these doses," said a source involved in working with the vaccine programmes.
"We believe that we will get enough Johnson & Johnson vaccines by mid-July to continue our mass [vaccination] programme."
Government plans to vaccinate 5.5 million people - health workers and people older than 60 - by the end of the month.
To meet this target, 220 000 people will have to be vaccinated per day. The current average is 40 000 per day.
At the time of going to print, 1.6 million South Africans had been vaccinated.
A total of 1.1 million South Africans have already received their first injection of the double-dose Pfizer-BioNTech vaccine.
The pharmaceutical company has so far sent 2.5 million doses to South Africa. Another 1.9 million will arrive between tomorrow and next Monday, and a further 8.5 million doses are on order.
However, Pfizer has warned of global vaccine shortages, an informed source said.
Due to expected shortages, the South African government has already decided to administer the first dose of the Pfizer-BioNTech vaccine to more people before those who have already been vaccinated receive their second dose.
The waiting time between doses in South Africa has been extended to six weeks. In the UK, it was 12 weeks.
"We can learn from other countries, seeing that our vaccine programme started late," said Dr Benjamin Kagina, a vaccine specialist at the University of Cape Town.
"It makes sense to prolong the time course, but a second dose is essential to achieve maximum effectiveness, especially in view of variants that dilute the impact of the vaccines."
Dr Nicholas Crisp, deputy director-general of health, told Rapport on Friday that the uncertainty surrounding the Johnson & Johnson doses was causing him sleepless nights.
According to Crisp, the doses are critical because no announcements about new agreements with other providers are expected soon.
Government is now negotiating with "everyone, even the [manufacturers of] vaccines that have not yet been approved by the SAHPRA".
news you need