What Moderna Reveals About the Cruel Absurdity of "Innovation" Under Pharmaceutical Monopolies
South African scientists spent 8 months reinventing the wheel while Moderna withheld patent information.
Last Thursday, the South African company Afrigen Biologics announced a significant achievement: In collaboration with researchers from University of the Witwatersrand, it has nearly completed the process of reverse engineering the Moderna Covid vaccine. This milestone was met after Moderna had refused to provide the recipe and know-how to a South African technology transfer hub established by the World Health Organization (WHO). The development marks an important scientific breakthrough that could eventually increase access to the mRNA vaccine, which is the premium treatment for the Omicron variant. But it also illustrates the cruel absurdity of a global system in which scientists are forced to spend precious time and resources re-creating something that already exists, but is hoarded to protect industry profits, in a context where every moment of delay means more lives lost.
The Cambridge, Mass.-based Moderna is making tremendous profits by selling its life-saving vaccine. It announced on January 10 that it expects 2022 sales to reach $18.5 billion, just from contracts for its Covid vaccines. This enormous revenue is due, in part, to the fact that the company produces one of the only two mRNA vaccines in circulation: The mRNA vaccines are the most effective against Omicron, and the simplest to adapt to new variants. The other company producing an mRNA vaccine is Pfizer. The two corporations have collectively shipped more than 70% of all of their vaccine doses to wealthy countries, while pledges to middle- and low-income countries have faced significant delays. A report from the People’s Vaccine Alliance, a global health coalition, determined that, as of October 2021, Moderna had only shipped 0.2% of its total vaccine stock to low-income countries. According to the Centers for Disease Control and Prevention, 641.6 million doses of mRNA vaccines have been delivered within the United States, which has a population of 332.5 million, while WHO data shows just 114 million doses have been received by the entire continent of Africa, which has a much larger population of 1.39 billion.
South Africa has relied on the mRNA vaccine from Pfizer, as well as the Johnson & Johnson vaccine, but Moderna has been largely absent. Candice Sehoma, a Johannesburg-based Access Campaign advocacy officer for the medical humanitarian organization Doctors Without Borders, tells In These Times over the phone, “It is important to acknowledge that companies have prioritized high-income countries. Only late last year did Moderna commit to giving Africa about 110 million vaccines.” And in Botswana, for example, Moderna has been extremely late in delivering Botswana its vaccines, for which Sehoma says the country was overcharged.
Poorer countries are not only more likely to receive lower-quality vaccines, but fewer vaccines overall: Just 1 in 8 people have been vaccinated, compared to 2 in 3 in wealthy countries.
Moderna could share critical information to facilitate international production of its vaccine, but it has consistently refused, even as it has carefully cultivated an image as a company with a different, and more moral, approach to patents. In October of 2020, Moderna garnered significant positive press coverage when it announced that, “while the pandemic continues, Moderna will not enforce our Covid-19 related patents against those making vaccines intended to combat the pandemic.” The stories and headlines made it seem as though the company was opening the door to widespread production of the vaccine, potentially at the cost of profits. Forbes reported on October 8 that the decision “would allow other vaccine-makers to make use of the company’s technology.” The statement issued by the company itself on October 8 seemed to encourage this public perception. “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible,” the company said.
The announcement contained a few red flags. The company didn’t specify when, exactly, the pandemic would be declared “over” and its patent enforcement reinstated, but gave itself broad discretion to determine an end date, and even implied that the crisis could end within the year (though the company has not yet made such a declaration). Public health groups, furthermore, warned at the time that mere non-enforcement of patents is not enough.
“To truly make an impact and help curb the spread of Covid-19, pharmaceutical companies must agree to not enforce any intellectual property (IP) on Covid-19 tools at any point — not just patents — since know-how, technology, and other components of vaccine development and manufacturing can still be protected under IP rules,” Doctors Without Borders (Médecins Sans Frontières) wrote. Moderna did specify in its statement that it would license its Covid vaccine intellectual property “upon request,” but only during the “post pandemic period,” when, ostensibly, there would be far less dire need.
Yet, in reality, Moderna has repeatedly rejected calls from global health activists and public officials to share its vaccine recipe and technological know-how, so that the world can scale up vaccine manufacturing. Last June, when the WHO launched its technology transfer hub, it requested that Pfizer and Moderna help researchers in Global South countries figure out how to make their vaccines. The hub was created in partnership with COVAX, the largely failed, Gates Foundation-backed initiative to distribute vaccines around the world. As the WHO explained at the time, the hub was meant to be a training facility “where the technology is established at industrial scale and clinical development performed” and where “interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology.” Ideally, such a hub, once established, could also be used to share information about how to produce treatments for malaria, HIV, and other diseases, its founders said.
Neither company deigned to give a response, leaving those researchers on their own to spend eight months reverse engineering the vaccines. Meanwhile, more than 100,000 people in Africa have died just since the WHO hub was announced in June, according to Our World in Data, an online scientific publication.
Instead of providing this vital information to the South African hub, the company has taken the step of actually pursuing patents in South Africa, leaving researchers and public health advocates worried that Moderna does, in fact, plan to enforce intellectual property rules, either now or the moment the company determines the pandemic to be “over.” At least three patents related to the Covid vaccines have been granted to the company so far, according to a brief from Doctors Without Borders.
Activists say these patents pose a direct threat to the technology transfer hub, where the new research breakthrough will remain in the public domain. The patents “create uncertainties for any outputs of the Covid-19 mRNA Vaccine Technology Transfer Hub in South Africa, Doctors Without Borders said in the brief. The organization added, “Although the Hub continues working on research and development (R&D) for the time being, the patents granted to Moderna could create a chilling effect and legal risks of potential patent disputes for entities that acquire technologies from the Hub and intend to take the products to market.”
Because of this, activists are calling on the South African government to revoke Moderna’s patents.
Even if Moderna does not enforce its patents, South African researchers are looking at a long timeline without the company’s active cooperation. As Politico explains, “to prove it’s the same as Moderna’s vaccine, Afrigen will likely need to repeat the trials already carried out by Moderna — that’s unless regulators allow a fast-track process.” While Afrigen executives are hoping this moves quickly, “a 36-month timeline may be realistic,” reports Politico. In other words, it would be far more efficient and life-saving for the company to just hand over the information scientists need to recreate the vaccine.
According to Sehoma from Doctors Without Borders, “It’s going to take the hub three years to get the vaccine to market. They still have to do clinical trials to qualify the vaccine. They still need to do that whole process, when there have been trials for the Moderna vaccine already. But they still have to go through the process of showing it’s efficacious.”
The timeline would be much quicker with Moderna’s cooperation, says Sehoma. “It’s a bit of an absurd thing to think about,” she underscores, “that you have to wait all this time to do something that is already tried and tested.”
Instead, Moderna declared in October 2021 that it will build a manufacturing facility somewhere in Africa, an announcement that appeared aimed at bolstering the company’s public image. But Moderna has given no time frame for when exactly that facility will start producing the 500 million doses a year the company has promised. Facilities in the continent that are strong candidates for producing the vaccine remain unable to do so, because Moderna will not show them how. It’s the equivalent of allowing large swaths of arable land to lie fallow in the middle of a terrible famine. Again: glowing headlines, dubious follow through.
Moderna, meanwhile, has de facto supported intellectual property rules in other venues. After India and South Africa introduced a proposal that the World Trade Organization (WTO) suspend key patent rules to enable widespread access to cheaper generic versions of Covid vaccines and treatments, Moderna made public statements undermining the key justifications for the effort. The proposal is stalled in the World Trade Organization, thanks to fervent opposition from the European Union, the intransigence of the Biden administration, and opposition from the pharmaceutical industry. (Even if Moderna follows through on its pledge not to enforce patents during the pandemic, an assertion that has not yet been tested, such a proposal would set precedent that could, potentially, threaten the company’s future profits.)
In May, after the Biden administration said it would support the WTO patent waiver (although its ensuing support has been tepid), Moderna CEO Stéphane Bancel made the dubious claim that such a waiver would not help increase vaccine supply.
“This is a new technology,” Bancel said. “You cannot go hire people who know how to make mRNA. Those people don’t exist.” The subtext of this assertion, which is a key pharmaceutical industry talking point, is that the Global South lacks the ability to make mRNA vaccines, so freeing up the patents won’t boost global supply. It’s a claim that can be empirically disproven: Healthcare researchers recently identified 120 facilities in Asia, Latin America, and Africa that are strong candidates for producing mRNA vaccines if companies would only show them how. Yet, the false assertion by the pharmaceutical industry has had legs, likely because it plays into racist notions that Global South countries lack the sophistication of their former colonizers. It’s proven a potent argument against the patent waiver, one that has been repeated by heads of state around the world.
The Biden administration, meanwhile, has refused to compel the company to share its recipe with the WHO hub in South Africa, or with governments and manufacturers around the world, even though the U.S. used public funds to bankroll research and development, and the U.S. “owns a patent that covers methods of stabilizing coronavirus spike proteins, a technology that Moderna and other manufacturers rely on to make their Covid-19 vaccines,” the advocacy group Public Citizen explains. (Despite its claims of taking a new approach to patents, Moderna initially vociferously opposed giving National Institutes of Health researchers joint credit for the vaccine discovery, though it paused this dispute in December.)
There is no reason to have any faith in the company’s will to deliver its vaccine to Global South countries that are in desperate need: It is, after all, legally bound to protect only the interests of its shareholders. Yet, the U.S. system of distributing vaccines globally is predicated on the assumption that Moderna and other companies will act benevolently. The Biden administration’s strategy for making the United States an “arsenal of vaccines,” for example, consists of devoting billions of dollars toward production of Moderna and Pfizer vaccines, in a plan that hands broad latitude to the companies, and does not require that they actively work to share recipes and know-how so that facilities around the world can make the vaccines themselves. This is despite calls from around the world for the U.S. government to force Moderna and Pfizer to share this vital information, not only with the WHO hub, but with companies, governments, and scientists — anyone who can help increase supply.
In other parts of the world, people are simply instructed by the Biden administration to wait for the U.S. to hand an mRNA vaccine to them, even as the U.S. has only delivered on a third of its vaccine donation pledges (though it has pledged significantly more than other rich nations). In rich nations’ policy discussions, the concept that people in Indonesia or Argentina or India or South Africa should have the right to make the vaccine themselves has, from the offset, been largely dismissed. “We don’t want to be at the whim of the U.S.,” the India-based coordinator of the Accessibsa project, which aims to expand access to medicines, told me on a Zoom call. “May I please,” he poses, “have a voice in your decision about how to save me?”
Joshua Mei contributed research to this article.
Sarah Lazare is the editor of Workday Magazine and a contributing editor for In These Times. She tweets at @sarahlazare.