Some experts see reverse engineering – recreating vaccines from fragments of publicly available information – as one of the few remaining ways to redress the power imbalances of the pandemic. So far, only 0.7% of vaccines went to low-income countries, while nearly half went to wealthy countries, according to an analysis by the People’s Vaccine Alliance.
The fact that the WHO, whose survival depends on the goodwill of rich countries and the pharmaceutical industry, is leading the attempt to reproduce a proprietary vaccine shows the depth of the differences in supply.
The United Nations-backed effort to balance the global distribution of vaccines, known as COVAX, has failed to alleviate the dire scarcity in poor countries. Donated cans arrive at a fraction of the need to fill the void. Meanwhile, pressures on drug companies, including the Biden government’s demands on Moderna, have nowhere to go.
Until now, WHO has never been directly involved in replicating a novel vaccine for current worldwide use against the objections of the original developers. The hub in Cape Town is intended to expand access to the novel messenger RNA technology that Moderna, Pfizer and German partner BioNTech use in their vaccines.
“This is the first time we’re doing it at this level because of the urgency and also because of the novelty of this technology,” said Martin Friede, a WHO vaccine research coordinator who helps run the hub.
Dr. Tom Frieden, former head of the US Centers for Disease Control and Prevention, has described the world as a “hostage-taking” by Moderna and Pfizer, whose vaccines are believed to be the most effective against COVID-19. The novel mRNA method uses the genetic code of the spike protein of the coronavirus and is said to trigger a better immune response than conventional vaccines.
The Biden administration argued that American taxpayers were largely funding Moderna’s vaccine development and insisted that the company should expand production to help supply developing countries. The global shortage by 2022 is estimated at 500 million and 4 billion doses, depending on how many other vaccines hit the market.
“The United States government has played a very important role in making Moderna the company it is,” said David Kessler, director of Operation Warp Speed, the US program to accelerate COVID-19 vaccine development.
Kessler didn’t want to say how far the administration would go to harass the company. “You understand what we’re expecting,” he said.
Moderna has promised to build a vaccine factory in Africa at some point. But after asking drug makers to share their recipes, raw materials and technological know-how, some poorer countries are fed up with the wait.
Petro Terblanche, managing director of Afrigen, said the Cape Town company’s goal is to have a version of the Moderna vaccine ready within a year that will be tested in humans and scaled up for commercial production shortly afterwards.
“We have a lot of competition from Big Pharma. They don’t want us to be successful,” said Terblanche. “They are already starting to say that we do not have the opportunity. We will show them.”
If the team in South Africa manages to manufacture a version of Moderna’s vaccine, the information will be released publicly for use by others, Terblanche said. Such an exchange comes closer to an approach advocated by US President Joe Biden in the spring and which the pharmaceutical industry vehemently rejects.
Commercial production is where intellectual property could become an issue. Moderna has announced that it will not take legal action against a company for violating its vaccine rights, but it has also not offered to help companies that have volunteered to get its mRNA uptake.
Chairman Noubar Afeyan said Moderna has decided it is better to expand production itself than share technology and plans to ship billions of additional cans over the next year.
“Within the next six to nine months, the most reliable and efficient way to make high quality vaccines is if we make them,” said Afeyan.
Zoltan Kis, an expert on messenger RNA vaccines at the University of Sheffield, UK, said reproducing Moderna’s vaccine was “doable” but the task would be a lot easier if the company shared its expertise. Kis estimated that there were fewer than a dozen key steps in the process. But certain processes are tricky, such as sealing the fragile messenger RNA in lipid nanoparticles, he said.
“It’s like a very complicated recipe,” he said. “Having the recipe would be very, very helpful, and it would also be helpful if someone could show you how to do it.”
A United Nations-backed public health organization is still hoping to convince Moderna that its approach to delivering vaccines to poorer countries is wrong. The Medicines Patent Pool, founded in 2010, initially focused on convincing pharmaceutical companies to share patents for AIDS drugs.
“It’s not about outsiders helping Africa,” said executive director Charles Gore of the South African vaccine center. “Africa wants to be strengthened, and that is what this is about.”
It will ultimately be up to Gore to try to resolve the intellectual property issue. The work to restore Moderna’s COVID-19 vaccine is protected as research, so a potential dispute over steps to commercially sell a replicated version would result, he said.
“It’s about convincing Moderna to work with us instead of using other methods,” said Gore.
He said the drug patent pool had repeatedly tried to convince Pfizer and BioNTech – the first companies with an effective vaccine – to even discuss sharing their formulas.
Rep. Raja Krishnamoorthi, who is a member of Congress supporting a bill calling on the United States to invest more in the manufacture and distribution of COVID-19 vaccines in low- and middle-income countries, said Reverse Engineering won’t happen fast enough to keep the virus from mutating and spreading further.
“We have to show some rush. We have to show a sense of urgency and I don’t see that urgency,” he said. “Either we end this pandemic or we muddle through.”
Activists argue that the meager amount of vaccines available to poorer countries through donations, COVAX, and purchases suggests that the western-dominated pharmaceutical industry has collapsed.
“The enemy of these companies is the loss of their potential profit across the board,” said Joia Mukherjee, chief medical officer for global nonprofit, Partners in Health. “The enemy is not the virus, the enemy does not suffer.”
Back in Cape Town, the promise to use mRNA technology against other diseases motivates the young scientists.
“The excitement is to see how we are using mRNA technology to develop a COVID-19 vaccine,” said Caryn Fenner, Afrigen technical director. But more importantly, said Fenner, “uses the mRNA platform not just for COVID, but for beyond COVID.”
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Cheng reported from London; Hinnant reports from Paris.
