Moderna, an American company which developed the mRNA COVID-19 shot, decided in 2020 to not enforce its patent. The move was meant to encourage low- and middle-income countries that couldn’t afford to purchase billions of doses of the vaccine (as the U.S., Canada, and many European countries had done) to develop their own versions of the shot using less expensive resources.
March. 8. Moderna Then, he added that It will This promise is now extended indefinitelyThe 92 low- and medium-income countries receiving vaccines through COVAX are among the most vulnerable. COVAX is a global vaccination distribution project. It procures and distributes vaccines worldwide. However, it could start to require licensing fees from developed countries that are using the company’s technology, the company’s CEO said.
Moderna has also revealed a program which signals its willingness to share technology with developing countries. “Waiving the patents provides that others can create their own capabilities to use the knowledge we created, the intellectual property we created, showing that mRNA vaccines work, and the COVID-19 vaccine specifically, and essentially copy that work the best they can to make their own versions,” Dr. Stephen Hoge, president of Moderna, tells TIME. “It’s about establishing the infrastructure globally and regionally to address needs.”
It is also planning to expand its mRNA-vaccine platform to tackle other diseases which have traditionally affected lower- and middle income countries. Through its new program, called mRNA Access, Moderna identified 15 pathogens also highlighted by public health groups like the World Health Organization (WHO)—including the pathogens responsible for chikungunya, Crimean-Congo hemorrhagic fever, dengue, EbolaPlease see the following: Nipah—and will work with local researchers and manufacturers in these countries to build knowledge about basic mRNA vaccine technology to target these pathogens. “We want to start pushing some of the technology my scientists used and make it available to the world starting with academic institutions,” says Hoge. “It will facilitate familiarity with the technology at the level that we think lays a scientific foundation for a different kind of response five to 10 years from now against the next pandemic.”
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According to Dr. Martin Friede (coordinator of WHO’s Initiative for Vaccine Research), knowledge is equally important as technology. And although it’s certainly welcome now, in the case of the COVID-19 vaccine, it’s coming a bit late, he says.
While Moderna was the first major COVID-19 vaccine manufacturer to announce that it would not enforce its patent on its shot, and now the first to extend that commitment indefinitely for certain countries, Friede says the patent isn’t the only issue, or even the most important one. When Moderna made its initial announcement, “we didn’t suddenly see hundreds of groups rushing to copy the Moderna vaccine,” he says. “It didn’t matter, because there were very few people who actually knew how to make it.”
Moderna, Pfizer BioNTech and other manufacturers of mRNA vaccines were beginning to develop their shot. Wealthy nations lined up in anticipation, hoping that the technology would work. Lower-resource countries couldn’t afford to take that risk, however, and once the shots demonstrated more than 90% efficacy in controlling COVID-19 disease, the immediately available doses had already been claimed by developed nations. “There was a point where over 70% of the populations in industrialized countries were vaccinated, and less than 1% of those in lower income countries were,” says Friede. “That is a criminal inequity. It’s been obvious to us for a long time, but really driven home by COVID-19, that we need to expand our ability and capacity to produce pandemic vaccines in low- and middle-income countries and regions.”
It led to the Creation in July 2021 of an mRNA vaccine technology transfer hub as part of the WHO’s Initiative for Vaccine Research. Researchers Afrigen, a South African biotech company in Cape Town that’s supported by Avacare Healthcare Group and the South African government, were responsible for learning the technology and producing the first doses of the vaccines that could be used for human testing. It was created to allow scientists in low- or middle-income countries to collaborate on mRNA vaccine production.
“It required essentially pulling together people in academics who had [made the vaccines] before, and a few people who had done it in companies,” says Friede. Because Moderna did not agree to transfer its technology for making the vaccine at the time, Afrigen’s team had to start from scratch to learn about preparing the RNA and developing the delivery system for the viral genetic material in lipid nanoparticles. The process was slower and prevented safe and effective local vaccines from being made available to countries in Africa and elsewhere.
“What would have made it all a lot quicker would have been if one of the companies like BioNTech or Moderna had come along and said, ‘We will assist you,’” says Friede. “It would have made the scale up instantaneous rather than laborious…[but]However, this did not happen last year with mRNA technology despite several requests. [from us].”
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It took Afrigen until February 2022, nearly eight months after it had announced its intention to design and develop its own version of Moderna’s mRNA vaccine, to produce its First small batchSouth Africa. Friede believes it is possible, despite all the hurdles. It was also possible because of the efforts made by scientists in Germany, Thailand, China and Thailand to reproduce the mRNA shot. “Our view was that if they can do it, why can’t South Africans do it?” he says. Afrigen’s effort, coordinated through WHO, was funded by European countries through an estimated $100 million deal over five years to supply Africa with COVID-19 vaccines.
In retrospect, designing, developing, and manufacturing the vaccine from scratch, without either BioNTech or Moderna’s help, was “a blessing in disguise,” says Afrigen’s managing director Petro Terblanche. “Now we have actually innovated beyond the technology transfer box. From a sustainable perspective, the platform we now have will allow us to build a new pipeline of products. [against other diseases] that can be developed.” Afrigen is now serving not only as a mRNA COVID-19 vaccine knowledge hub, but also as a model for streamlining production processes for the developing world. It’s looking to take advantage of innovations from European companies like UnivercellsCytiva, and Batavia BiosciencesThese companies are looking for ways to combine equipment, eliminate separate sterilized clean rooms, and allow makers to use more portable containers. This makes them less expensive and more suitable for low-resource environments. Batavia for instance is seeking to lower the cost of vaccines to less than 15 cents per dose under a Bill and Melinda Gates Foundation grant. Cytiva for vaccine manufacturing is creating a plug and play system that allows for local production.
Afrigen’s next move and efforts to expand vaccine production in Africa will be more time-consuming and difficult. Because it developed its own vaccine, Afrigen’s shot will have to go through the same regulatory procedures as Moderna’s did to ensure it is safe and effective in countries hoping to use it. That’s a laborious and expensive process that adds at least a year to the timeline for when the vaccines can get into people’s arms. Afrigen anticipates it won’t have a vaccine available for commercial use until 2024—if all goes well. Terblanche states that Afrigen is in discussion with South African health officials about the best way to organize and manage trials. They hope to start them in November 2022. Moderna might have made the process of a clinical trial faster, she said. “If we had had some of the data from their [animal studies], assays and quality control tests, and detailed process parameters, that would have helped,” she says. “It would have spared resources [for us]. We now have a massive team working on quality control and regulatory issues for how to design the clinical trials.”
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In the future, such help may come through Moderna’s mRNA Access program, says Hoge, if that’s what the academic or government partners wish. “Each agreement will be different by institution,” he says. “We’re entering into agreements with them, and they go and conduct their scientific research. If our tools are useful, and they say, ‘We’d love to talk about how we can advance it into clinical trials,’ we would support them. But if you want to take advantage of the knowledge you gain and do your own version, that’s also your prerogative.”
Hoge acknowledges that mRNA Access won’t be the equivalent of providing turnkey access to the company’s technology, but “it’s an important start. If everybody gets familiar with the platform and has a little bit of experience, then nobody has to start at square one.”
That includes hours of educational and instructional lectures on the ins and outs of manipulating mRNA—“stuff that’s not in textbooks,” says Hoge. “Right now, it’s still so new, it hasn’t been written down and published.”
WHO recognizes, for now at least, that there are still major obstacles to make Afrigen sustainable and an example of how vaccines against pandemics and outbreaks could be made locally. Terblanche points out, for instance, that South Africa isn’t included among the 92 countries in which Moderna won’t enforce its patents. Afrigen might be used as a source of information, but may not make vaccines that can be sold to reduce the cost-prohibitive licensing fees. But facilities in those 92 countries that learn from the hub wouldn’t be subject to the same patent restrictions.
Even with Moderna’s commitment to mRNA Access, and the precedent being set by COVAX and Afrigen, there is still no assurance that low- and middle-income countries will have the desire or capacity to manufacture their own vaccines for the next outbreak. Public health readiness requires that governments invest in building and maintaining infrastructures capable of producing vaccines for an emergency. “To me, the biggest role that governments can play is to create policy reform that allows localization,” says Terblanche. “Lower and middle-income countries can make a concerted effort to say we are going to create a policy environment and an ecosystem that will enable and favor localization, with direct investment and tax incentive systems.” Terblanche argues that such investments in health, which generally take a lower priority in these nations to urgent political and civil needs, will bring a return on investment that countries still aren’t seeing. “We need to change the paradigm to no longer look at these investments as a premium,” she says.
To think this way, one must also forget that in order for vaccine production to be efficient, it is necessary to have huge facilities and produce billions upon trillions of doses. “We don’t believe that paradigm is necessarily correct,” she says. “We believe there is a place for smaller, distributed entities that have well-controlled cost of goods, and well-controlled capital.” Afrigen is hoping to prove that, and the next few years will reveal if the vision of Terblanche and WHO is indeed possible. A good part of the world’s population is certainly depending on it.