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Afrigen’s Cape Town bid to reverse engineer Moderna’s vaccine

In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer Modernaʼs COVID-19 shot, a vaccine that has yet to reach South Africa and most of the worldʼs poorest people, reports Associated Press.

By working to replicate Modernaʼs COVID-19 shot, the scientists are effectively making an end run around an industry that has vastly prioritised rich countries over poor in both sales and manufacturing, writes AP. And they are doing it with unusual backing from the World Health Organization, which is coordinating a vaccine research, training and production hub in South Africa along with a related supply chain for critical raw materials. Itʼs a last-resort effort to make doses for people going without, and the intellectual property implications are still murky.

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. Only 0.7% of vaccines have gone to low-income countries so far, while nearly half have gone to wealthy countries, according to an analysis by the Peopleʼs Vaccine Alliance.

That WHO, which relies upon the goodwill of wealthy countries and the
pharmaceutical industry for its continued existence, is leading the attempt to reproduce a proprietary vaccine demonstrates the depths of the supply disparities.

The UN-backed effort to even out global vaccine distribution, known as COVAX, has failed to alleviate dire shortages in poor countries. Donated doses are coming in at a fraction of what is needed to fill the gap. Meanwhile, reports AP, pressure for drug companies to share, including Biden administration demands on Moderna, has led nowhere.

Until now, WHO has never directly taken part in replicating a novel vaccine for current global use over the objections of the original developers. The Cape Town hub is intended to expand access to the novel messenger RNA technology that Moderna, as well as Pfizer and German partner BioNTech, used in their vaccines.

Dr Tom Frieden, the former head of the US Centers for Disease Control and Prevention, has described the world as “being held hostage” by Moderna and Pfizer, whose vaccines are considered the most effective against COVID-19. 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 traditional vaccines.

Arguing that American taxpayers largely funded Modernaʼs vaccine development, the Biden administration has insisted the company must expand production to help supply developing nations. The global shortfall through 2022 is estimated at 500m and 4m doses, depending on how many other vaccines come on the market.

“The United States government has played a very substantial role in making Moderna the company it is,” said David Kessler, the head of Operation Warp Speed, the US programme to accelerate COVID-19 vaccine development.

Kessler would not say how far the administration would go in pressing the company. “They understand what we expect to happen,” he said. Moderna has pledged to build a vaccine factory in Africa at some point in the future. But after pleading with drugmakers to share their recipes, raw materials and technological know-how, some poorer countries are fed up with waiting.

Afrigen Managing Director Petro Terblanche said the Cape Town company is aiming to have a version of the Moderna vaccine ready for testing in people within a year and scaled up for commercial production not long after.

“We have a lot of competition coming from Big Pharma. They donʼt want to see us succeed,” Terblanche said. “They are already starting to say that we donʼt have the capability to do this. We are going to show them.”

If the team in South Africa succeeds in making a version of Modernaʼs vaccine, the information will be publicly released for use by others, Terblanche said. Such sharing is closer to an approach US President Joe Biden championed in the spring and which the pharmaceutical industry strongly opposes.

Commercial production is the point at which intellectual property could become an issue. Moderna has said it would not pursue legal action against a company for infringing on its vaccine rights, but neither has it offered to help companies that have volunteered to make its mRNA shot.

Chairman Noubar Afeyan said Moderna had determined it would be better to expand production itself than to share technology and plans to deliver billions of additional doses next year.

“Within the next six to nine months, the most reliable way to make high- quality vaccines and in an efficient way is for us to make them,” Afeyan said.

Zoltan Kis, an expert in messenger RNA vaccines at Britainʼs University of Sheffield, said reproducing Modernaʼs vaccine is “doable” but the task would be far easier if the company shared its expertise. Kis estimated the process involves fewer than a dozen major steps. But certain procedures are tricky, such as sealing the fragile messenger RNA in lipid nanoparticles, he said.

A UN-backed public health organisation still hopes to persuade Moderna that its approach to providing vaccines for poorer countries misses the mark. Formed in 2010, the Medicines Patent Pool initially focused on convincing pharmaceutical companies to share patents for Aids drugs.

“Itʼs not about outsiders helping Africa,” Executive Director Charles Gore said of the South Africa vaccine hub. “Africa wants to be empowered, and thatʼs what this is about.”

According to AP, it will eventually fall to Gore to try to resolve the intellectual property question. Work to recreate Modernaʼs COVID-19 vaccine is protected as research, so a potential dispute would surround steps to sell a replicated version commercially, he said.

“Itʼs about persuading Moderna to work with us rather than using other methods,” Gore said. He said the Medicines Patent Pool repeatedly tried but failed to convince Pfizer and BioNTech to even discuss sharing their formulas.

Campaigners argue the meagre amount of vaccines available to poorer countries through donations, COVAX and purchases suggests the Western-dominated pharmaceutical industry is broken.


Associated Press article – Africa tries to end vaccine inequity by replicating its own (Open access)


See more from MedicalBrief archives:


As COVAX disappoints, developing countries turn to home-grown jabs


Cyril Ramaphosa: Global distribution of vaccines 'unjust and immoral'


SA case study sheds light on how to develop pharma manufacturing



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