Mkhize’s last act — to beg Sahpra and FDA to release the J&J vaccine

Shortly before he was placed on special leave by President Cyril Ramaphosa, health minister Zweli Mkhize called on the South African Health Products Regulatory Authority and the US Food and Drug Administration to sort out their issues so that the Johnson & Johnson vaccination rollout can continue.

“We are very desperate to get those vaccines; we need them yesterday. It will make a big difference because two-thirds of the people that need to be vaccinated are awaiting for the J&J vaccine,” said Mkhize on Tuesday.

The minister, who was placed on special leave pending a Special Investigating Unit probe into the irregular awarding of a R150m Digital Vibes tender, was speaking during a visit to the Northern Cape.

He said: “They (J&J) say, as far as they are concerned, they have no problem. We need our regulator to say you can use it. They must also come back to us to say they have discussed with the FDA, the European Medical Agency, analysed the reports and we are comfortable to go ahead to use it.

“The vaccines are there. They have been waiting for the past month and a half, but it is not the manufacturer that authorises the use, it is the regulator.

“We must allow the regulator to deal with the issue. We had a meeting with Sahpra and J&J and that is when we decided that a meeting must be held with the FDA and Sahpra because they are the regulators.”  

Mkhize said the government made this decision as the J&J was the best vaccine for SA’s needs.

“I have been talking to J&J’s global office twice a week, coming up with solutions, making proposals and it was clear that the matter was out of their hands.”

At this point, said Mkhize, there is still no clarity of when this is going to happen and neither the EMA or Sahpra seem to know, because both rely on the FDA findings before they can make a pronouncement.

The FDA is determining whether substandard manufacturing conditions at the US-based J&J contractor Emergent BioSolutions have been fixed. It is also investigating whether contamination issues identified earlier this year will affect batches of vaccines manufactured by J&J contractors that relied on ingredients supplied by Emergent, including Aspen Pharmacare.

Mkhize said government asked J&J to look outside the affected batches because SA is now in possession of J&J doses in Gqeberha, but they have been halted because of a compliance issue.

“What we have now is that J&J has offered us about 480,000 additional batches and we have said those batches must be used on teachers and some front-line workers, quickly, and then look at the rural provinces including Northern Cape.”

Mkhize said the J&J vaccine was best suited for the Northern Cape, which is now in a third wave.

Hopefully, government will get additional vaccines in the middle of June, he said.

“We have also said they must rearrange the vaccination plan, so that they can be disposed of quickly in a period of about two weeks, so that we can beat the shelf life issues.”

He said the vaccination programme was picking up “quite satisfactorily. However we can expect these numbers to keep doubling. Of the 1.9 million vaccines that we have received, we have got them all out and have already crossed the million mark. On Pfizer, we have got to close to 900,000, so these numbers are increasing.”

He said he was concerned that if one gave a million vaccines doses to a process that has 400 sites, one needed to hold back until there was a higher number of vaccines so they could be spread out more evenly.

“So you don’t end up with a stop-and-start problem.”

Mkhize said in the next month SA will be getting more vaccines and the target of vaccinating 16 million people will be reached.

The first Pfizer dose pushes up the levels of immunity and there are no complications, he said.

“But with this number, we want to have the first vaccine for as many people as possible and then for the months of June/July, we will probably vaccinate 1.2 million who will be getting the second dose. But the bulk of the people must get the first dose of Pfizer,” he said.

After vaccinating those over 60, over-40s will be earmarked.

On the third wave, Mkhize said, if the numbers continue to rise in KwaZulu-Natal, the Eastern Cape and the Western Cape, the entire country will be in a third wave.

 “Our models show that Gauteng is likely to have much more numbers and a higher third wave than the rest of the country. So we are monitoring that situation.”