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How mountains were moved to get J&J vaccines to South Africa

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How mountains were moved to get J&J vaccines to South Africa
A team including lead investigator in the Johnson & Johnson trial, Professor Glenda Gray, and Dr Zweli Mkhize moved mountains to get the J&J vaccines into the arms of health workers.

Armed with courage, a sense of urgency, an ability to survive on steely determination and

almost no sleep, a team of people including the lead investigator in the Johnson & Johnson (J&J vaccines) trial,

Professor Glenda Gray, and the Minister of Health, Dr Zweli Mkhize, moved heaven, earth,

a whole lot of aeroplanes and trucks and many, many boxes to get the precious

doses of the Johnson & Johnson vaccines to the provinces and into the arms of health workers.

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“‘Our health workers cannot wait’ is what I kept repeating,” said Professor Glenda Gray

as she described what she called the “mad dash” to get the vaccine to South Africa.

“There were huge expectations,” she said. “We had to get to the health workers. The second wave had been torrid.”

According to statistics from the National Department of Health, about 40,000 South

African health workers contracted Covid-19, 6,473 have been hospitalised and 663 have died.

Speaking to SA TIMES early on Friday, an exhausted Gray said that a few weeks ago,

after the arrival of the Oxford/AstraZeneca vaccines in the country,

she received a call from Professor Shabir Madhi, the lead investigator in the AstraZeneca trial to say that the early data he was seeing concerned him.

“We spoke to the minister to say there was a problem.

My results [in the Johnson & Johnson ensemble trial] just came out and I shared them too,” she said.

The AstraZeneca vaccine was found to be only 22% efficacious in preventing

mild and moderate Covid-19 caused by the 501Y.V2 variant that had first been identified in South Africa.

Gray said at the time a million doses of the AstraZeneca vaccine had already landed in South Africa and were under quarantine.

The Johnson & Johnson vaccine had fared better against the 501Y.V2 variant,

showing a 57% efficacy at preventing moderate disease and 85% efficacy in preventing

severe Covid-19, hospitalisation and death.

Gray said: “I started making these phone calls to Johnson & Johnson:

‘Do you perhaps have a spare million doses lying around somewhere in the world?’

“I explained the situation to Dr Paul Stoffels [the chief scientific officer of Johnson &

Johnson and vice chairman of the company’s executive committee].

we told him how our health workers had to endure two waves of infections with inadequate PPE.

He is an infectious disease specialist  worked in the Congo as a young doctor. knew about Ebola,” she said.

“‘Glenda, that is terrible,’ is how he responded, saying: ‘I will see what I can do.’

“In the next 24 hours, Johnson & Johnson was going through their global inventories to

see what they could find. They started bringing vaccines back to Belgium using their own

planes. Dr Stoffels was very moved by our plight. We had meetings every 24 to 48 hours.”

She said when the team then shared their plans with Mkhize, he became very excited.

“He said, ‘Let’s have a discussion and see what we can do.’

“We had the vaccine and we knew it was safe and it worked, but we were not sure yet

how we were going to ensure access to it. After some consultation we had decided that

we would do an early access implementation trial with oversight by the South African

Health Product Regulatory Authority [Sahpra].

She said they had to jump through quite a few logistical hoops.

“We had to move fast and careful,” Gray said. “Our aim was to just get the vaccine here.

We didn’t want to miss a single day, had 14 days,wanted to have our plan in place

before the Oxford/AstraZeneca results came out.

We wanted to avoid our health workers becoming panicky and anxious.”

It was decided that the vaccine would be distributed as part of an implementation study

because this would not delay the process any further.

“We managed to get our study protocol to the South African Health Product Regulating

Authority in 24 hours for review. I kept thinking every day we lose is a day we can’t get

into the field.”

Gray said the protocol was submitted on the Monday. Sahpra returned with queries on the

Wednesday, her team had these answered by the Thursday and they received the green

light the next day.

“Sahpra and the national department moved heaven and earth for us but they didn’t just

give us the green light. It took us 18 hours and no sleep to answer all their queries.”

Next, an urgent meeting was convened for the clinical trial meeting.

“We also submitted our protocol to the ethics committee. They also scrutinised it.

There were no free passes for us. They too came back with a long list of questions we had to answer.”

But eventually the Sahpra permits and permits from the Department of Agriculture were released,

clearing the way for the vaccines to arrive on South African soil.

“Meanwhile they were packing the vaccines in Belgium.

There was a curfew in that country so that made it a bit difficult.

“I just felt that we were moving mountains.”

Late on Tuesday night, Gray was at the OR Tambo International Airport to “welcome” the first batch of 80,000 vaccines.

The plane was about two hours late because of headwinds.

“We then had to pack for the provinces. We managed to convince the warehouse to stay

open all night so we could pack. At 3.42am on Wednesday morning the first shipment

left,” she said.

Vaccines were being transported by road and plane to all the designated vaccination

centres in South Africa. Pictures of the president, doctors, nurses and support personnel

with rolled-up sleeves started appearing on social media. Health workers were using the

hashtag #Covid19Vaccinated.

“We only missed two days,” Gray said, explaining that Monday would have been the

original start date for the use of the AstraZeneca vaccine.

“And we had to move the time of the first vaccine to 1pm. I wanted all the provinces to

start together. It more or less worked but it was a mad dash. Also remember that

scientists are completely OCD,” she said, smiling.

Gray said she was feeling very grateful when the first vaccine was administered. “Our

health workers deserved this vaccine. It was amazing to see the gratitude on their faces.”

President Cyril Ramaphosa was one of the first recipients of the vaccine. He said in a

statement on Wednesday that he decided to have it “to demonstrate our confidence in this

vaccine and help allay any fears that people may have”.

Mkhize was also vaccinated.

“The Department of Health deserved this vaccine. Dr Zweli Mkhize was incredibly brave.

This is his moment as well. We celebrate government working today,” Gray said.

“Minister Mkhize really cares very deeply about the country’s health workers.

“I think we should celebrate the courageous leadership that he has shown.

He had the guts to say that the Oxford/AstraZeneca vaccine was not the right one for us.

The World Health Organisation had said it was good to use, but Mkhize stood up and said we will make another plan.

He could have just remained quiet, like many politicians would have done, but he didn’t. He helped us make a plan.”

In his response to Ramaphosa’s State of the Nation Address, Mkhize called it a miracle.

“I would like to take the opportunity of settling the matter of the Johnson & Johnson

vaccine rollout because it must be understood that our sole purpose is to save lives and

protect our healthcare workers. Firstly, it is without dispute that the Johnson & Johnson

vaccine has a 57% efficacy against the 501Y.V2 variant and is fully protective against

serious illness or death. On this basis, Johnson & Johnson is applying for Emergency Use

Authorisation and it is expected that it will be granted. With this evidence in hand,

we will begin by vaccinating our healthcare workers with the Johnson & Johnson vaccine.

We will be doing this under a protocol which we have dubbed as Sisonke.

This protocol will allow us to survey the vaccination of healthcare workers and will further

add to our understanding of the impact of mass vaccination.

“The immediate rollout of phase one vaccination with Johnson & Johnson through

the Sisonke protocol has been made possible by the fact that the 300,000 doses of the

now proven and efficacious Johnson & Johnson vaccine (J&J vaccines) were already tested and approved

by Sahpra for use under study conditions. It was the quick thinking of the leadership at

MRC [the Medical Research Council] that brought us this solution when we were faced

with this issue.

This was smart thinking which is worthy of celebration and I must thank the team at the

Medical Research Council led by Professor Glenda Gray, the officials at the National

Department of Health led by the Director-General, Dr Sandile Buthelezi, and Johnson & Johnson (J&J vaccines)

for essentially working a miracle to ensure that our plans are not derailed.”

Mkhize said he was very happy that the rollout of vaccines had started,

but added that the target is to reach 80,000 health workers in the next two weeks and

push phase two (the vaccinations of essential workers and older people and those with

comorbidities) forward to begin earlier than in three months’ time.

Manufacturers apply for vaccines to be licensed after trials show them to be safe and

effective, and this is currently under way in the US, Europe and South Africa.

By using an implementation study, the vaccines would become available immediately to

healthcare workers using a research programme while the licensing process takes place.

By Thursday evening, 2,260 health workers had been vaccinated.

More deliveries of the vaccine are expected every two weeks.

 

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