Africa's vaccine hubs disrupting the manufacturing landscape
Petro Terblanche still remembers her emotions when she first got an email saying the World Health Organization was looking to build a 'tech-transfer hub' for the new mRNA vaccines against the coronavirus.
At the time, her fledgling Cape Town vaccine venture, called Afrigen, was on a knife edge, struggling to set up labs and get to work in a world that had come to a halt.
The WHO wanted to start making mRNA vaccines in developing countries left without jabs when rich countries hosting the manufacturing hoovered up all the doses.
Under the plan, a big mRNA vaccine manufacturer would share its know-how with the hub, which would replicate the process to train up and help manufacturers around the world open new production lines.
None of Afrigen's 20-odd staff had any experience working with mRNA, but as soon as the email landed, Ms Terblanche, chief executive, thought they could do it.
'I will never forget it. I was sat here at my desk and I saw this and I looked at it and I thought, this is our break. It was something in my tummy which said this is our break,' she told the Telegraph.
Teaming up with Biovac, an established South African vaccine manufacturer, and the country's medical research council, Afrigen was chosen and in June 2021 the WHO's mRNA Technology Transfer programme was launched.
The following four years have seen Afrigen grow in size several-fold and come close to changing the global landscape of mRNA vaccine manufacture.
It has begun transferring mRNA vaccine technology to 14 other partners as far afield as Argentina, Indonesia, Serbia, Vietnam and Senegal.
Yet, the path has not been straightforward and has seen the hub given the cold shoulder by the mRNA pharmaceutical giants who had originally been expected to help.
What had first been envisioned as a joint venture, has instead evolved to see the hub having to forge its own, but more ambitious path.
While no Covid vaccines have been mass produced by the hub in the end, the members are now hoping to take what they learned to make new mRNA jabs for diseases such as Rift Valley Fever, Leishmaniasis and H5N1 flu.
The sovereign expertise they have gained means they will not have to rely on making vaccines developed elsewhere, and can target diseases which are not financially attractive to big European or US pharma giants.
The hub is now a 'a pioneering example of consortia from regions left behind during the Covid pandemic, developing much needed vaccine research and development capabilities,' says Dr Frederik Kristensen, managing director of the Regionalised Vaccine Manufacturing Collaborative (RVMC), which aims to widen out manufacturing.
'This will be a basis for regionalised vaccine manufacturing in the longer term and help move from just manufacturing vaccines developed elsewhere.'
Dr Matthew Downham, manufacturing and supply chain director at the Coalition for Epidemic Preparedness Innovations (CEPI), said the hub could 'fundamentally challenge the disruption and delays seen with the inequitable supply of vaccines during the Covid-19 pandemic'.
He said: 'With mRNA platforms proven to be both fast and flexible, the hub's approach could enable multiple disease vaccines to be produced locally at rapid speed.
'For emerging infectious diseases, it could allow vaccine production to take place closer to the source of an outbreak thereby potentially enabling faster vaccine distribution where it is needed.'
The progress has come despite the hub facing a major blow almost as soon as it was formed.
It had hoped that Moderna, a US mRNA manufacturer, would share the technology for its widely praised Covid-19 jab, but by September 2021 it became clear that a deal could not be done. Pfizer also declined.
'It was scary,' says Ms Terblanche. 'We said, 'shit guys, we are on our own'.
'But it also mobilised an enormous energy in the team. We said look, we can do it. We are a biotech start-up, we are resilient. We know how tough it is when sometimes you don't know where your salary is going to come from.'
The hub decided to go it alone and make their own version of the Moderna jab. The vaccine sequence was already available and much of the process was in the public domain. Moderna had already said it would not enforce Covid-related patents during the pandemic and such reverse engineering is permitted under South African law. Other institutions lent their expertise and equipment manufacturers stepped in with kit.
By February 2022, the hub had already made its own replica of the Moderna shot, without any assistance or approval from the developer. It was also the first mRNA vaccine designed, developed and produced at lab scale on the African continent.
Moderna's response was dismissive, likening what Afrigen had done to making a knock-off designer handbag.
Stéphane Bancel, Moderna's chief executive, said at the time: 'They are claiming it's a copy of Moderna's product. I don't know.'
'It is like when somebody makes a copy of a Louis Vuitton bag. Does it look like a Louis Vuitton bag? Does it last like a Louis Vuitton bag? I don't know.'
Making a version was only the first step. It had to be trialled and tested and validated to ensure it was safe and up to the same manufacturing standards as the original.
Ms Terblanche said: 'We have not reinvented the wheel, we have used publicly available information to forward innovate. But what we have also done is improve the process.'
But as time went on, the hub came up against another obstacle. The pandemic had ended and no one wanted Covid jabs any more.
So the Afrigen Covid mRNA jab is now not being manufactured as a jab, but has become a model used to teach the technology to other partners so they can learn the ropes and meet international benchmarks for quality control.
The aim for each new manufacturer is to show they can make the vaccine on their own, to world class standards.
The technology has already been passed successfully to Biovac in South Africa and the transfer is underway to companies in Argentina, Serbia and India. Others will follow in the coming years.
By the end of 2025, Afrigen and Biovac could between them make 200 million doses of vaccine if another Covid-type pandemic came along. By the end of the decade, the whole network could make 2bn doses a year.
However, with thankfully no sign of such an occurrence, the ambition now is to keep the mRNA labs up and running just in case and that means using them for other mRNA products.
Charles Gore, executive director of the Medicines Patent Pool, said: 'In order to keep this warm for a future pandemic, it's absolutely critical that all the partners continue in the meanwhile to produce mRNA 'something'.
'Clearly if there's no demand for Covid vaccines, it may turn out to be therapeutics, maybe vaccines for other diseases.
'There's a lot to be said for producing vaccines for things that are of particular interest to low and middle income countries.'
Whatever they work on has to bring in enough money to keep them in business.
In January Afrigen announced it was working on an mRNA vaccine for Rift Valley fever, a mosquito-borne infection that affects livestock and people.
Other partners in the network are working with researchers to look at potentially developing mRNA vaccines or drugs for hand foot and mouth disease, HPV, or leishmaniasis.
Ms Terblanche said one day Afrigen hopes to work with the mRNA giants who spurned them at first.
She said: 'In the beginning, there was resentment towards us and we were being accused of stealing intellectual property. All of that has gone calm. Now we find that the interactions are respectful.'
Their progress means Africa has gone a long way in preparing for any new pandemic, or mystery new 'disease X', said Morena Makhoana, chief executive at Biovac.
He said: 'I don't think we will be like 2020 where we say, 'oh my word, where are we going to start'.
'I think we would get into a room, knuckle down and try and understand this disease X.
'We would definitely be able to stand on our own two feet provided that disease X can use mRNA.'
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