CAPE TOWN, South Africa — In an industrial area of this seaside city, a little-known biotech company is entering a pivotal phase of making Africa’s first coronavirus vaccine by attempting to replicate Moderna’s highly effective mRNA-based shot.
Getting Africa — and other parts of the world — vaccinated has gained new urgency with the emergence of a new variant, dubbed omicron, that was first detected by South African scientists. Health officials have warned since the start of the pandemic almost two years ago that the coronavirus will continue to evolve and spread as long as significant populations remained unvaccinated.
With help from the World Health Organization (WHO) and international consultants, including from the U.S. National Institutes of Health, Afrigen has become part of the African continent’s first training and technology transfer hub for mRNA vaccines, a step toward answering calls from global health officials for Africa to develop its own vaccine-manufacturing capability to avoid supply shortages during a crisis.
What’s missing is the vaccine formula. Moderna refuses to share its recipe, citing intellectual property, so Afrigen has used publicly available information and help from outside advisers to begin making the vaccine.
If Moderna were to share information, Afrigen Managing Director Petro Terblanche said, the company could produce a replica within a year. Without it, the time estimate balloons to three years.
“It will be an interesting debate when we get to Phase 3, and we have a vaccine ready for low-income countries,” she said, “and Moderna says, ‘No, you can’t proceed.’”
Moderna, for its part, announced last month that it would spend up to $500 million to build its own vaccine plant in Africa — with Senegal, Rwanda and South Africa as possible sites — to make up to 500 million doses of mRNA vaccines each year. Moderna spokeswoman Colleen Hussey did not respond to a request for comment.
Afrigen’s team of scientists hopes, ultimately, to transfer the technology to other manufacturers in developing regions, in an effort to avoid a repeat of the global coronavirus vaccine inequity that has left poorer countries scrambling for supplies during the worst pandemic in a century.
Now, with the genetic sequence for the vaccine in hand, the Afrigen team is preparing to develop the first complete lab sample, which they will then compare to Moderna’s version.
The challenge for Afrigen is to ensure the vaccine can be developed at scale and that its quality is always the same, said Martin Friede, coordinator of the WHO’s Initiative for Vaccine Research, which is leading the technology transfer effort in Africa.
“It’s like saying you know how to make a loaf of bread but you are now asked to set up a process to make 100,000 loaves per day,” Friede said.
Afrigen is working toward creating a vaccine that is less expensive than Moderna’s and will not require freezing in storage — both essential for widespread distribution in poorer countries.
“All eyes are on us,” said Caryn Fenner, Afrigen’s technical director. “If one really thinks about the bigness of it and its significance, it almost cripples you.”
At the World Trade Organization (WTO), trade ministers had been scheduled to begin meetings Tuesday over a contentious proposal by South Africa and India to temporarily waive intellectual property rights on coronavirus vaccines and therapies or find a way to allow developing countries to access the technologies. The meeting has been postponed because of the omicron variant. No new date has been set.
The novel mRNA process uses the genetic code for the spike protein of the coronavirus and is thought to trigger a better immune response than other vaccines. Scientists believe the technology could be used to make drugs that tackle other ailments, such as cancer or malaria.
African countries have historically depended on Western donors and United Nations-backed programs such as the vaccine alliance known as Gavi, a partnership of donors and pharmaceutical companies that buys vaccines at lower prices and makes them available to countries that need them. Covax, a vaccine marketplace that was meant to secure coronavirus inoculations for developing countries, has struggled to access enough supplies during the pandemic.
The solution, said Friede of the WHO, is for African countries to make the vaccines themselves.
“Our objective is to make something as close as possible to Moderna’s without pretending it is a 100 percent carbon copy,” he said. “Unless Moderna tells us and shares all of their procedures — which probably they won’t — we can’t make a pure copy. Even without Moderna telling us how to make their vaccine, we will be able to make something which is close to their vaccine.”
The head of the WTO, Ngozi Okonjo-Iweala, speaking before the meeting was postponed, said reaching an agreement that gave poorer countries access to drugmakers’ technology would be difficult. It would require a “reasonable compromise” by all sides, she said, not just to agree on sharing intellectual property rights but also on lowering trade restrictions on vaccine supply chains, and improving transparency of vaccine production, distribution and contracts.
“Right now the process isn’t moving,” Okonjo-Iweala said in an interview. “This is a pandemic. If we can’t come to a meeting of minds now, then we will miss the timing.”
Moderna has said it will not prosecute those found to be infringing on its covid-related patents during the pandemic, which amounts to an informal waiver, said Marie-Paule Kieny, a French virologist who chairs the U.N.-backed Medicine Patent Pool, which is part of the WHO’s efforts in Africa.
The concern with a waiver, Kieny said, is what happens once the pandemic ends. Any broader waiver agreed on at the WTO talks would likely have a time limit, she said, without a commitment from the drugmakers to enter into licensing agreements.
She said companies should negotiate now with drugmakers such as Moderna to reach formal licensing agreements before the pandemic is over.
Friede acknowledged that any company that takes the Afrigen vaccine to commercial production may need a license from Moderna once the U.S. drugmaker’s waiver expires.
“It would depend on whether the production occurred during the pandemic and the Moderna waiver was still applicable, and whether Moderna has granted patents in countries of manufacture,” he said. “If this indeed happens during the pandemic, we assume the Moderna waiver would still be valid. In this case, there will be no clear role for the WTO unless it is for a mechanism that goes beyond the pandemic.”
Even if there is a deal at the WTO meeting, Okonjo-Iweala said it would take several years for manufacturers in Africa and elsewhere to build capacity to make their own vaccines.
“When we are talking about manufacturing in Africa, we are really thinking of the medium to longer term — for the next pandemic, that is,” she said.
South Africa argues that a temporary waiver would allow vaccine manufacturing to start sooner than waiting for licensing agreements and open the way for further collaboration, including technology transfers. Large Western manufacturers, however, argue that a waiver would stifle innovation when it is needed the most. They also say there will be enough vaccines on the world market by mid-2022 to meet supply demands.
Fatima Hassan, a human rights lawyer who heads the Health Justice Initiative in South Africa, accused Moderna of “deliberate divide and rule strategies” by not supporting the technology hub that Afrigen is part of and then announcing it would build its own vaccine plant in Africa.
“It’s quite incredible that given the public funding and the public investment that there isn’t a single manufacturing license for the global South. It’s all fill and finish,” she said, referring to an existing contract with Johnson & Johnson in which South African facilities put the final touches on vaccines but don’t have access to their recipe. “These companies are playing God.”
Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations that is managing the supply of vaccines to poor countries through Covax, acknowledged that the concentration of vaccine manufacturing in just a handful of countries — the United States, Europe, India and China — has led to global supply inequities.
“The pandemic has revealed that the system we had and the way we had vaccine manufacturing configured was unable to produce an equitable outcome for the world or even an efficient outcome for the world,” Hatchett said. “It is a debate that the world needs to have.”
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