- The US medicines regulator has postponed its announcement on whether SA can release its Johnson & Johnson vaccine doses from Aspen's Gqeberha plant.
- The announcement has been postponed from Friday, 4 June to the week of 7 June.
- South Africa may receive an additional 480 000 Johnson & Johnson doses, but only if the US regulator finds it to be uncontaminated.
- The 480 000 doses will expire on 28 June and will be used to vaccinate staff at schools, instead of healthcare workers and people over 60.
Education staff will not receive Johnson & Johnson (J&J) Covid-19 vaccinations in the week of 7 June – even if 480 000 doses, which J&J offered South Africa as a replacement for some of the country's potentially contaminated jabs, arrive in the country next week.
Whether – and when – the shipment arrives, depends on the outcome of an investigation by the United States medicines regulator, the Food and Drug Administration (FDA). The FDA needs to determine whether this batch, too, was contaminated with ingredients of AstraZeneca's Covid-19 shot, says Nicholas Crisp, the deputy director general in the health department who is managing the distribution of Covid-19 vaccines.
Some of J&J and AstraZeneca's key ingredients are manufactured in the same factory belonging to a company that the FDA is investigating for substandard pharmaceutical practices and potential cross-contamination of ingredients.
If the consignment of nearly half a million J&J doses is cleared by the FDA, it will only arrive in South Africa by mid to late next week – with an expiry date of 28 June, because it was the only stock available. The shots would therefore have to be used within a couple of weeks.
At this stage, Covid-19 vaccines have an average lifespan of about six months.
Why have South Africa's J&J doses not been released?
South Africa has procured 31 million doses of the J&J vaccine, of which at least the first two batches of 1.1 million and 900 000 cannot be released before the FDA has concluded its investigation.
The vaccine vials in these batches were filled in South Africa at the drug company Aspen's Gqeberha plant – but with key ingredients, also known as active pharmaceutical ingredients (APIs), manufactured at the Baltimore factory of Emergent BioSolutions, a company that J&J has contracted to produce the API for its vaccine.
In March, the FDA inspected Emergent BioSolutions' production facility and found the conditions to be unsanitary and pharmaceutical practices to be of an unsatisfactory standard. The regulator established that a batch of 15 million doses of APIs for J&J's vaccine had been contaminated with some of the ingredients of AstraZeneca's vaccine, that was manufactured at the same factory, and therefore ruled that Emergent BioSolutions had to discard the doses.
As a precautionary measure, the FDA stopped all J&J production at Emergent BioSolutions, pending the outcome of its investigation and an evaluation of measures taken by the company to improve its pharmaceutical practices. The FDA also decided to analyse all batches of the J&J APIs which were manufactured during the same period as the March batch that Emergent BioSolutions had to do away with.
Crisp says the regulator is examining four batches – South Africa's J&J vaccine at Aspen were made with APIs from all of these batches.
The FDA was expected to make an announcement on Friday about whether it found any of the four batches of APIs to have been contaminated, and whether doses made with them could therefore be released or not. The regulator, however, sent a memo to the affected countries on Thursday that it would now only make an announcement in the week of 7 June. The delay is due to a final inspection of Emergent BioSolutions that was supposed to have been conducted on Wednesday, but was then postponed to Friday.
The affected countries include South Africa, Canada and several countries in Europe. None of them can currently release any vaccines manufactured with APIs from the batches being investigated.
Why are there now an additional 480 000 jabs – and why will teachers instead of people of 60 and older get them?
The additional 480 000 J&J doses, which were scheduled to arrive in South Africa over the weekend (if the APIs it was manufactured with had been cleared by the FDA in time), was a "bridging consignment", says Crisp, in case some of the already manufactured doses at Aspen couldn't be released because the FDA found them to be contaminated.
"We wanted to ensure that we look at all possible scenarios and plan around them so that we have a plan for each potential scenario," he says. "If our vaccines at Aspen had been cleared, we would still have had the consignment shipped to us and paid for the vaccines as an add-on to our current 31 million doses."
Crisp says because this consignment of the vaccine will soon expire, and because, when they started making plans for the shipment the health department didn't yet know the FDA's decision about whether our doses at Aspen could be released or not, they had to consider a route other than "community distribution" (vaccinations at national rollout sites) – a route that addressed "scale" and "turnaround time".
Currently, only healthcare workers and people 60 years and older qualify to be vaccinated as part of South Africa's national rollout (other groups will only qualify once most of the current group has received jabs).
"If we set up J&J vaccination sites as part of our normal rollout and then didn't have more jabs after the 480 000 had been consumed [if it turned out that the FDA ruled South Africa couldn't use the J&J jabs at Aspen], we would have to stop and start – and that could potentially lead to a lack of trust in our ability to provide a constant supply of vaccines," Crisp says.
The department would also have had 500 000 doses that it would have to use within less than three weeks. "The education department provided us with numbers of staff, around 500 000, that needed to be vaccinated, so the numbers matched up with the supply. But most importantly, they came up with a fast-moving mass vaccination plan for staff at schools that involved them driving employees to central points in districts," Crisp explains.
He says the health department has also taken into consideration that the education department has gazetted that pupils in public primary schools have to return to school daily (as opposed to grades attending school in shifts) on 26 July. He said that would put teachers and other school staff at an increased risk of infection in the midst of a third Covid-19 wave that the country would have reached by then.
"Vaccinations would protect staff and make the daily return of learners considerably safer," Crisp says.
The doses haven't yet been cleared by the FDA. So what now?
On Thursday, a memo of the KwaZulu-Natal health department, which said the national health department had confirmed that J&J jabs would arrive in time to vaccinate teachers from 9 June, started to circulate on social media. The memo was signed by the head of the department Sandile Tshabalala.
On Friday, the Sunday Times reported that the Professional Teachers' Union (PEU) confirmed that teachers' unions were told on Friday that 500 000 J&J shots would be made available to teachers and support staff.
But Crisp says if the FDA makes its announcement early in the week of 7 June, and if they rule that the additional consignment of 480 000 J&J doses had not been contaminated, the doses will only arrive later in the week of 7 June, as a chartered flight would first need to be secured.
Once the vaccine doses arrive, they would have to be sent for quality testing at the National Control Lab at the University of the Free State in Bloemfontein, which means the vaccines will only be ready for distribution in the week of 14 June.
That would leave the country with exactly 14 days to use the shots before they expire.
Crisp says it's by no means a done deal that the 480 000 jabs will be cleared by the FDA, but if they are, they'll be used for all schools, not just public schools. "The vaccines will go to staff paid for by the education department, those funded by school governing boards and also to staff at private primary and high schools," he says.
The rest of the country's current vaccine supply, in other words, the Pfizer consignments that we'll receive each Sunday night in June, as well as our J&J jabs at Aspen (if the FDA says we can release them), will continue to be used at national rollout vaccination sites and be prioritised for healthcare workers and people 60 and older until the bulk of that group has been vaccinated.
Crisp explains: "Once we've vaccinated enough people in the current groups, we will move onto our next priority group – people of 40 and older".