The news is reported in the magazine ‘Nature’: “‘Companies go on without help”
A copy of the mRna Moderna covid vaccine, researchers from a South African biotech company said they almost created it without the US firm’s involvement. The news is reported in the journal ‘Nature’. Cape Town-based Afrigen Biologics and Vaccines produced only microlitres of the vaccine, based on data that Moderna used to make its shield product. But – reads the website of the scientific magazine – the result is an important milestone for a broader initiative launched by the World Health Organization (WHO), a technology transfer hub that aims to build a production capacity for these vaccines in countries low and middle income.
“Moderna and Pfizer-BioNTech’s vaccines are still primarily targeted at wealthier nations,” says Martin Friede, the WHO official who coordinates the hub. “Our goal is to allow other countries to create their own.” Many steps remain before the Afrigen-signed mRNA imitation vaccine can be distributed to people in Africa. But the one carried out by South African researchers is the first phase of the plan. The next phase of the project involves several companies in the global south to learn from Afrigen how to create batches of vaccines themselves, to test them in rodents. By the end of November, WHO expects an imitation of the Moderna vaccine to be ready for phase 1 trials in humans to test its safety. WHO hopes the creation process will lay the foundation for a more globally distributed mRNA vaccine industry in the future.
Gerhardt Boukes, chief researcher of Afrigen, the heart company of the WHO hub, said he was proud of the work done. The experts started with the mRna that encodes a modified portion of the Sars-CoV-2 coronavirus and went on to encapsulate it in a lipid nanoparticle that carries the vaccine to the cells. “We didn’t have the help of the major vaccine manufacturers,” he says, “so we did it ourselves to show the world that it can be done, and it can be done here on the African continent,” he explained. When WHO launched its hub in South Africa last June, it asked Moderna, Pfizer and BioNTech to help teach researchers how to make Covid vaccines. But the companies have not responded, according to ‘Nature’ and the WHO has decided to go ahead anyway without their help.
The choice of the vaccine to replicate fell on Moderna’s because more information on its development is publicly available and because Moderna promised not to enforce its patents during the pandemic. However, the American company did not respond to ‘Nature’ which asked for a comment on WHO’s decision to copy the vaccine. With funds from countries including France, Germany and Belgium, South African researchers began work on the project at the end of September. A team from the University of Witwaterstrand in Johannesburg took the initiative to take the first step: to create a DNA molecule that would serve as a model for synthesizing the mRna needed for the vaccine.
Although this sequence was patented by Moderna, researchers from Stanford University in California had filed it in the online database ‘Virological.org’ in March last year. Despite delays in the shipment of raw materials, the South African team completed the process in 10 weeks and sent vials of mRna to Afrigen in early December. Several scientists from around the world, learning of the ongoing initiative, have offered their assistance to the researchers, reports the service published in ‘Nature’.
“Some of them – it says – were researchers from the National Institutes of Health in the United States who had conducted fundamental work on mRna vaccines”. A gesture defined as “extraordinary” by Petro Terblanche, managing director of Afrigen: “I think many scientists were disappointed with what had happened with the distribution of the vaccine and wanted to help get the world out of this dilemma.”
On January 5 it was the turn of encapsulation. Boukes says he has not yet used Moderna’s specific lipid blend, but another one that is readily made available by the manufacturer of the machine the lab uses to create the lipid nanoparticles. The plan is to use Moderna’s in the next few days as soon as a last necessary tool arrives. Next, the team will analyze the formulation to make sure it is truly a similar copy of Moderna’s vaccine.
What will happen next year remains uncertain. Charles Gore, director of the Medicines Patent Pool, an international organization working with the hub, says the initiative has no intention of infringing Moderna’s patents. Laboratory research is generally not subject to patent rules, he explains. And once the vaccine is ready for use, the hope, he adds, is that Moderna can then license its patents or that by then there will be alternatives these companies could produce without fear of facing a lawsuit.