Set on redressing vaccine inequality between rich and poor nations, a South African consortium is taking on pharmaceutical giants in its quest to produce Africa's first homegrown mRNA Covid-19 vaccine and share it with the global south.
It was sheer determination that kept South African biotech company Afrigen Biologics Vaccines, a small fish in the world of big pharma, fighting to produce homegrown African vaccines against Covid-19.
Managing Director Petro Terblanche recalls the day they received word that Moderna, the pharmaceutical giant responsible for one of the world's first Covid-19 mRNA vaccines, would not be manufacturing shots in Cape Town.
“They underestimated the absolute ‘can-do’ attitude of people in this country,” she says.
Within two months, Afrigen had used publicly available information about Moderna's mRNA vaccine to develop its own.
“Even Moderna underestimated the science space in this country,” Terblanche says.
Researchers at the Antiviral Gene Therapy Research Unit based at the University of Witwatersrand had already been working on mRNA technology. Together with Afrigen, they were able to crack the code that could put South Africa on the map for producing the first mRNA vaccine for Covid-19 to be designed and manufactured in Africa.
“I think we’ve surprised many people … we were afraid that people would be saying, ‘those guys, they’re just bullshitting.’ So, we really had to be fundamentally solid and secure. But once we had the result, we proudly announced it,” says Terblanche.
Their determination to create a vaccine was fuelled by the disparity between access to Covid-19 vaccines in lower-income countries and in the wealthier world. More than 72 percent of people in high-income countries have received at least one dose, according to the latest World Health Organization (WHO) figures, compared to less than 25 percent in low-income countries.
Vaccine equity
After the pandemic was declared in 2019, pharma companies rushed to create vaccines that were bought up by wealthy nations, leaving developing countries in Africa and elsewhere in the lurch. As of today, only 20 percent of the African population is vaccinated against the coronavirus.
The People’s Vaccine Alliance, a global coalition of civil society organisations, described the scramble for vaccines and lack of equitable access as “evidence of systematic racism in the global coronavirus response”.
To prevent this from happening again, WHO worked on commitments to produce vaccines by and for low- and middle-income countries in the global south.
South Africa, where Afrigen works in partnership with Biovac Laboratory in Cape Town and South Africa’s Medical Research Council, was selected by WHO as the international hub to produce homegrown mRNA vaccines. The WHO programme includes 15 ‘spokes’, other country participants who will receive three-part training from Afrigen, which includes transfer of the technology.
Tunisia, Senegal, Nigeria, Egypt, and Kenya make up the African spokes, while India, Brazil, and Serbia are among the other nations involved.
Scientists from six partipicating countries have already completed the first round of training at Afrigen’s facilities. The next step involves the transfer of technology in an open and collaborative manner. And the third step will focus on producing vaccines in commercial quantities.
An African solution for worldwide problems
This spoke system flies in the face of the economic model which drives the global pharmaceutical companies. “Sustainability for us is not 200 percent profits; it’s not our mindset, it’s not our desire,” says Terblanche.
She says that a long-term solution is needed not only for Covid-19, but for a raft of other diseases on the African continent, such as Lassa Fever, Marburg disease, Ebola and Tuberculosis – diseases that the West is less likely to invest in.
“Our batch sizes are so small, it gives us flexibility that is unique; this is a model that says you don’t have to be big to be sustainable and relevant,” she insists.
While Afrigen is creating the batches, the other part of the equation – the scaling-up of vaccine production, manufacturing and distribution – will be delivered by Biovac Institute, which has nearly 20 years of vaccine expertise.
Chief executive Morena Makhoana is used to hearing naysayers question whether an African company is capable of manufacturing vaccines.
“Why are you trying to do things that are too complex for you down in South Africa?” is a typical refrain, he says.
His vaccine manufacture company is currently fulfilling contracts with a number of international pharma companies, including French giant Sanofi.
Biovac has already started to prepare to adopt Afrigen’s technology so that they will be ready to scale up and manufacture its mRNA Covid-19 vaccines, the company's head of science and innovation, Patrick Tippoo, tells RFI.
They are waiting for Afrigen’s clinical trial results. The initial clinical trials on mice proved successful and it is hoped that clinical trials on humans will begin in May 2023.
“While they’re working on that, we’re making sure that we’re getting our facilities organised, critical equipment is being ordered, that will be installed, commissioned and qualified,” says Tippoo.
The preparations include readying BioVac’s state-of-the-art ‘freezer farm’ – a new facility filled with specialised freezers that will hold the vaccines at -80°C.
“Biotechnology can exist in South Africa, and all people of all colours can participate meaningfully, even in hi-tech environments, and that for us is important,” says Makhoana.
He gives some impressive statistics on the scientists and staff who work at Biovac: 92 percent of their 584-strong workforce are Black, 55 percent are women, and 51 percent are Black women.
“And that for us is important because it essentially represents the South African demographic,” he says.
Filling a vaccine gap
Afrigen's mRNA vaccines still need to be cleared by the South African Health Products Regulatory Authority (SAHPRA), which regulates clinical trials.
In order to get the green light from WHO to distribute the vaccines, South Africa will need to be registered at least at maturity level 3 on the organisation's global classification system for national medical products regulatory authorities. The ranking means that a country’s regulatory system is stable and can ensure the quality, safety, and effectiveness of vaccines that are manufactured, imported or distributed there.
Of all countries on the African continent, only Egypt is certified at maturity level 3 for vaccines, though some countries have the rating for other processes.
SAHPRA is hoping to present the mRNA project to WHO as its test case to seek the certification.
“This will be the first vaccine that’s taken through the product development process in South Africa,” says Tippoo.
South Africa has gaps in its vaccine ecosystem, and the hub-and-spokes project is the perfect example to show both the regulatory side and the drug product manufacturing side, he adds.
This gap can only be filled when a manufacturer begins to manufacture drug substance, like the South Africa consortium. Until now, product has always been developed and made elsewhere.
“There’s a lot more road to cover into the future, but I believe that we’re on a trajectory,” says Tippoo.
“In terms of the capability, there’s no doubt in my mind that it can be done.”
