Saturday, December 4, 2021

African efforts to replicate mRNA vaccine target mismatches

In a pair of warehouses in Cape Town, transformed into a maze of sterile air-locked rooms, young scientists assemble and calibrate the equipment needed to reengineer a coronavirus vaccine that has yet to reach South Africa and most of the world’s poorest people.

The energy of the brilliant labs matches the urgency of their mission to reduce vaccine imbalances. By working to replicate the Moderna COVID-19 vaccine, scientists are effectively trying to end an industry that puts rich countries over poor countries in both sales and production.

And they are doing so with the extraordinary support of the World Health Organization, which coordinates South Africa’s vaccine research, training and manufacturing center and the associated supply chain for critical raw materials. The last resort is to make doses for people who do without them, and the implications for intellectual property are still unclear.

“We’re doing this for Africa right now, and that’s driving us,” said Emil Hendricks, a 22-year-old biotechnologist at Afrigen Biologics and Vaccines, a company trying to replicate the Moderna injection. “We can no longer rely on these big superpowers to come and rescue us.”

Some experts see reverse engineering – recreating vaccines from pieces of publicly available information – as one of the few remaining ways to correct the imbalance of forces in the pandemic. According to the People’s Vaccine Alliance analysis, only 0.7% of vaccines were sent to low-income countries, and almost half to rich countries.

The fact that WHO, which relies on the goodwill of wealthy countries and the pharmaceutical industry to stay alive, is spearheading the effort to replicate a patented vaccine demonstrates the depth of the inequality in supply.

UN-backed efforts to equalize the global distribution of vaccines, known as COVAX, have failed to alleviate acute vaccine shortages in poor countries. Donated doses represent only a small fraction of what is needed to fill the gap. Meanwhile, pressure on pharmaceutical companies, including the Biden administration’s demands on Moderna, has come to nothing.

Until now, WHO has never been directly involved in the replication of a new vaccine for current global use, despite objections from the original developers. The Cape Town center is designed to expand access to the new RNA messenger technology that Moderna, as well as Pfizer and German partner BioNTech, have used in their vaccines.

“This is the first time we are doing this at this level because of the urgency and also because of the novelty of this technology,” said Martin Fride, WHO vaccine research coordinator who helps run the center.

Dr. Tom Frieden, former head of the US Centers for Disease Control and Prevention, called the world a hostage of Moderna and Pfizer, whose vaccines are considered the most effective against COVID-19. The new mRNA process uses the genetic code of the coronavirus spike protein and is thought to trigger a better immune response than traditional vaccines.

Claiming that American taxpayers were heavily funding the development of the Moderna vaccine, the Biden administration insisted that the company should expand production to help supply developing countries. The global shortage until 2022 is estimated at 500 million and 4 billion doses, depending on how many other vaccines are on the market.

“The United States government has been very instrumental in transforming Moderna into the company it is,” said David Kessler, head of Operation Warp Speed, a US program to accelerate the development of the COVID-19 vaccine.

Kessler did not say how far the administration would go in putting pressure on the company. “They understand what we expect,” he said.

Moderna has pledged to build a vaccine plant in Africa in the future. But after drug manufacturers begged for their recipes, raw materials and technological know-how, some of the poorer countries stopped waiting.

Afrigen Managing Director Petro Terblanche said the Cape Town-based company is aiming to have a version of the Moderna vaccine ready for human testing within a year, and begin commercial production shortly thereafter.

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“We have a lot of competition from Big Pharma. They don’t want us to succeed, ”Terblanche said. “They are already starting to say that we have no way to do this. We’re going to show them. “

If a team in South Africa manages to create a version of the Moderna vaccine, the information will be published for use by others, Terblanche said. Such an exchange is closer to the approach that US President Joe Biden advocated in the spring, and the pharmaceutical industry is vehemently opposed.

Commercial production is when intellectual property can be a problem. Moderna said it would not pursue legal action against the company for infringing its vaccine rights, but it also did not offer assistance to companies that volunteered to inject its mRNA.

Chairman Noubar Afeyan said Moderna has decided that it would be better to expand its own production than share technology, and plans to deliver billions of additional doses next year.

“Over the next six to nine months, the most reliable and efficient way to produce high quality vaccines will be their production,” Afeyan said.

Zoltan Keys, an RNA messenger vaccine expert at the University of Sheffield in the UK, said replicating the Moderna vaccine was “doable,” but the task would be much easier if the company shared its expertise. Kees estimates that this process includes less than a dozen main stages. But some of the procedures are complex, such as encapsulating fragile messenger RNA in lipid nanoparticles, he said.

“It looks like a very complicated recipe,” he said. “The recipe would be very, very helpful, and it would also be helpful if someone could show you how to do it.”

The UN-backed public health organization still hopes to convince Moderna that its approach to providing vaccines to poorer countries is not true. The Medicines Patent Pool, created in 2010, was originally intended to persuade pharmaceutical companies to share patents for AIDS medicines.

“This is not about outsiders helping Africa,” said CEO Charles Gore of the South African Vaccine Center. “Africa wants to be empowered, and that’s the point.”

Ultimately, Gore will be forced to try to resolve the issue of intellectual property. The work to recreate the Moderna COVID-19 vaccine is protected as research, he said, so potential controversy will revolve around steps to commercialize the replicated version.

“It’s about convincing Moderna to work with us and not use other methods,” Gore said.

He said the Medicines Patent Fund has tried repeatedly but failed to convince Pfizer and BioNTech – the first companies to release an effective vaccine – to even discuss the possibility of sharing their formulas.

Rep. Raja Krishnamurti, who is one of the congressional members who supported a bill urging the United States to invest more in the production and distribution of COVID-19 vaccines in low- and middle-income countries, said reverse engineering would not happen. fast enough that the virus does not mutate and spread further.

“We need to be active. We must show a sense of urgency, and I do not see this urgency, ”he said. “Either we end this pandemic or we get out of it.”

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

“The enemy of these corporations is losing their potential profit in the future,” said Joya Mukherjee, chief medical officer of global health nonprofit Partners in Health.

“The enemy is not a virus, the enemy does not suffer.”

Back in Cape Town, young scientists are motivated by the promise of using mRNA technology against other diseases.

“It is interesting to know how we are using mRNA technology to develop a vaccine against COVID-19,” said Karin Fenner, CTO at Afrigen. But more importantly, Fenner said, “not only uses the mRNA platform for COVID, but not only for COVID.”

Nation World News Desk
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