CAPE TOWN — The little machine that produced the first batch of what’s hoped will be a copy of Moderna’s coronavirus vaccine for the developing world is small and inconspicuous, much like the facility that it’s housed in.
Located in an industrial suburb of Cape Town, the building looks no different from the outside to the plumbing and lighting warehouses nearby. But inside, there is a maze of high-tech “clean” rooms that will house the start of what the World Health Organization (WHO) hopes will be the central hub for the development of an mRNA coronavirus vaccine. The idea is for the technology behind the vaccine to be shared openly with companies around the world.
The ultimate goal is even more ambitious — to propagate knowledge on how to produce mRNA vaccines to target some of the most pressing diseases affecting low- and middle-income countries, such as tuberculosis (TB), malaria and even HIV.
Sitting in her office, Petro Terblanche, the woman at the helm of Afrigen, which houses the mRNA hub, said that since the launch of the project seven months ago it’s been “an absolute new world.”
It’s not been smooth sailing as the initiative failed in its original ambition to team up with Moderna or BioNTech.
However, led by the WHO, and with help from experts around the globe, a small team came up with a backup plan and produced in January the first drug product formulation based on Moderna’s mRNA coronavirus vaccine.
“We did not get the tech transfer from Moderna. We did it ourselves,” Terblanche told POLITICO. Moderna might not be on board but the pharma company had already handed the hub what was needed — a declaration that it will not enforce its patents during the pandemic. Of the €92 million needed to fund the initiative over the next five years, 59 percent has been raised, said Terblanche, with money coming in from sources including the EU and individual member countries such as France, Germany and Belgium.
Without a waiver on intellectual property rights that South Africa and India are pushing for at the World Trade Organization, and without the help from Big Pharma, a group of experts is striving to make it possible to produce mRNA vaccines independently and distribute them equitably.
The vision is big but so too are the obstacles. In addition to the science, the hub is negotiating complicated intellectual property rights regimes, trying to sign deals with biotechs and still holding on to its vision of teaming up with Big Pharma. “This whole project is complex, and probably one of the most complex ones I’ve ever put my nose into,” said Terblanche.
The long road to jab in arm
The Cape Town hub is set for its official launch either in February or March and it’s already got something to show for its efforts — the first batch of vaccine based on Moderna’s jab.
Together with academics at the University of the Witwatersrand, the team at Afrigen — whose team has nearly doubled to 40 people with the hiring of engineers, regulatory experts and manufacturing scientists — designed the sequence, produced the vaccine and is now doing analytics on the trial run with a view to further optimizing it. The hope is for “comparable efficacy and safety” to Moderna’s jab, said Terblanche.
The hub produced the vaccine using information that is available in the public domain. For Moderna’s vaccine that includes the sequence of the messenger RNA that instructs cells in the human body to produce the spike protein of the SARS-CoV-2 virus, training the immune system to recognize and attack it in the case of infection, as well as the exact formula for the lipid nanoparticle that carries the mRNA into cells.
But to prove it’s the same as Moderna’s vaccine, Afrigen will likely need to repeat the trials already carried out by Moderna — that’s unless regulators allow a fast-track process. While Terblanche hopes for a speedier route, a 36-month timeline may be realistic.
However, there is still a possibility that Moderna comes on board.
The WHO’s Martin Friede, coordinating the project from Geneva, said discussions were still on with Moderna. “I can’t say more than that. The communication lines are open,” he said. If Moderna does back the venture, the timeline would be cut down to around 12 months. Asked to comment for this article, Moderna referred to its previous statements on not enforcing its patents during the pandemic, as well as its own plans to build an mRNA vaccine facility in Africa. The company has not yet announced where it would build that plant.
The question of intellectual property looms large over the project. However, Friede is adamant about one thing: “There’s no infringement taking place here whatsoever.”
Moderna’s own assertions about not enforcing patents during the pandemic mean “that the hub can produce a Moderna vaccine based on the Moderna technology without worrying about intellectual property issues anywhere on earth,” explained Friede. In addition, South African law also provides for a company to undertake trials on a product with a view to applying for regulatory approval without infringing on a patent.
However, it’s the bigger picture that the hub is looking at.
“We need to have a license to utilize the components of the IP that is relevant for our vaccine eternally,” said Terblanche. “And we need to be assured that, for the pipeline of access to TB, HIV, malaria and others, we are not restricted through an IP perspective.”
“We have a careful strategy that we’re designing … And we will have to make key decisions, I think, within eight months from now — key decisions on which way they’re going to go.”
Reshaping the landscape
As for the debate at the WTO over a waiver of intellectual property rights, those running the hub say that a waiver wouldn’t work for it in the long term.
“It is not in our interest and the interest of goals of this project just to have a waiver. We need to have long-term freedom to operate,” said Terblanche.
That’s because part of the strategy is to develop future vaccines, such as a second-generation coronavirus vaccine that’s better suited to low- and middle-income countries, which the hub could license from willing biotechs rather than relying on Moderna. The aim is for a vaccine that can be stored at higher temperatures and is cheaper to make.
Discussions are underway with several biotech companies that are offering their technologies to the hub. The idea would be that the South African hub would then be able to license this technology to other low- and middle-income countries.
Therein lies the big picture: Dozens of companies around the world, learning how to produce an mRNA vaccine, whether that be Moderna’s or a completely different one.
So far, three companies have been selected as the “spokes” of the South African hub — local company Biovac, Brazil’s Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation (Fiocruz), and Argentina’s Sinergium Biotech. About 10 more companies will be named as spokes in the coming weeks, Friede revealed, as well as a new workforce training hub.
At the site chosen in Brazil, Fiocruz is also developing its own coronavirus vaccine that it hopes to use. If the vaccine produced by the hub in South Africa proves more successful, it would switch to that one. In the meantime, the Brazilian spoke plans to use the Moderna jab produced in South Africa as a control in their studies. Sotiris Missailidis, the research and development director at Fiocruz, puts the timetable for its own vaccine at October 2023.
Preparing for the future
The long timescales lead to the big question looming over the project — is it even going to be needed when the vaccines are ready?
Missailidis says it will. “We’re still going to live with the coronavirus as an endemic disease for the next years to come,” he said. Pointing to discussions on the potential need for annual vaccination against coronavirus, Missailidis said it’s important for low- and middle-income countries to be independent with their production.
The other aim is for the work on coronavirus vaccines to help establish a platform that can be used for other endemic diseases, said Missailidis. “The idea is that we can be independent to develop and produce whatever [vaccines] each region needs. It doesn’t matter if it’s Ebola or chikungunya in Latin America, the broader thing is … establishing the know-how to produce the vaccine from end to end,” he said.
Back in Geneva, it hasn’t been an easy process to manage a project of this scale during an ongoing pandemic.
“The challenge has been to get people to stop running,” said Friede. Rigor over speed is his mantra, with the failure of other would-be mRNA coronavirus vaccine producers such as Sanofi and CureVac serving as lessons to the hub.
“I prefer that we do this rigorously,” said Friede. “The priority is to ensure that the capacity is built so that every region has got capacity to respond to the next pandemic, because the one thing we are certain of is there will be another pandemic. It might be flu, it might be coronavirus, it might be something else.”
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.