Monopolies Are Getting in the Way of mRNA Vaccines

Two and a half years into the COVID pandemic, the numbers are grim. While 80% of people living in the richest countries on earth have received at least one dose of a COVID vaccine, the corresponding figure for those in the poorest countries is 18%. The loss of life was incalculable, literally: no one is sure how many people have died from COVID. It could be about six million, the formal death toll attributed to the virus, or nearly 15 million, as estimated by World Health Organization’s study of “excess deaths” (unusually high mortality, including deaths likely resulting from COVID but not attributed to it).

Right now, there are two dominant, optimistic narratives. One is that the pandemic was bad, but it’s over. The other suggests that while vaccine inequity in 2021 was inexcusable, poor countries now have enough to last them a while. Both narratives are far from accurate. The pandemic is hardly over: A new Omicron sub-variant is now the dominant global strain, and we should expect further mutations. Additionally, while poor countries may have better access to some Covid vaccines, they have almost no access to mRNA vaccines — the ones most effective against Omicron—COVID their residents vulnerable.

Broad access to mRNA vaccines would change the world, but it won’t happen unless Moderna, Pfizer and BioNTech, the main companies involved relax their monopolies.

mRNA vaccines can be made faster, more easily and by more manufacturers than traditional vaccines. Until the coronavirus pandemic, all our vaccines required cultivation in eggs or yeast, for example, which is time-consuming and complicated. But mRNA technology is something like a hack: even though mRNA vaccines can be synthesized in a test tube, our bodies recognize them as biological. Not only does this simplify and accelerate the process, it also opens up production to many more pharmaceutical companies than the handful who can make traditional biological vaccines. We can produce billions more doses at a rapid pace and in the very locations they are needed. (In a recent analysis, my colleague Alain Alsalhani and I identified over 100 firms across Asia, Africa and Latin America that manufacture a comparable injectable pharmaceutical at high quality standards, and could produce mRNA vaccines if authorized to).

Second, mRNA vaccines have shown better utility as boosters over traditional vaccines, especially against Omicron, making them immediately useful. While the performance of all vaccines fell under Omicron, mRNA vaccines fell the least, which is why they are recommended as boosters over other available options in Europe and the U.S.

Third, the short- and long-term possibilities of mRNA will prove vital. In the short term, the next generation of COVID vaccines—against Omicron variants and others—will be developed with this technology; Moderna just reported encouraging preliminary data and is set to introduce its reformulated vaccine this fall. (There is no indication that COVID vaccine manufacturers using older technology, such as AstraZeneca, Johnson & Johnson and Novavax, are anywhere close to bringing out reformulations). Over the longer term, companies are investigating mRNA technology as a platform for vaccines and treatments for other diseases; Moderna, for instance, has already begun testing an HIV vaccine. As long as this technology is focused on high-income countries, the majority of the world will be excluded from its benefits, now and in the future.

Consider 2021: manufacturers produced plenty of effective vaccine but they didn’t get to everyone who needed them, resulting in viral variants most of those vaccines were less effective against. To date, 93 percent of all mRNA vaccines ordered went to rich countries, according to Airfinity, a health analytics company that tracks vaccine supplies. This year, Moderna expects to make three billion doses, and Pfizer, four billion. But given the pace of booster recommendations in rich countries, as well as the possibility that these manufacturers will have a new vaccine ready soon, it is hard not to see the 2021 story being repeated in 2022, with one half of the world prepared and the other not.

To prevent this we need many more mRNA vaccines, but BioNTech, Pfizer and Moderna have total control over deciding who will make their vaccines, and where. The most obvious way they exercise monopoly control is through patents, which provide a 20-year legal right. While BioNTech and Pfizer have made no patent concessions, Moderna said in March 2021 that it would not enforce patent rights against any company, anywhere in the world, that wanted to make its vaccine during the course of the pandemic. One year later, in March 2022, it shrunk this concession, announcing it would not enforce patent rights only against companies in developing countries.

This is a feeble gesture. Manufacturers like Moderna also exercise monopoly control by keeping their vaccine production process secret and refusing to formally cooperate with other manufacturers. Bereft of the vaccine technology and a formal contract, any manufacturer who wishes to make the Moderna vaccine must reverse engineer the vaccine, run it through clinical trials and then—if it works—figure out how to manufacture it at industrial scale, a process that takes years without Moderna’s help. But it’s up to Moderna to define when the pandemic ends and its concessions cease. And given the time, cost and unpredictability of Moderna’s concession, there has been little interest in the offer, save for a WHO-led, open-source mRNA vaccine effort that is underway in South Africa. Even if those efforts are successful, however, under the terms of Moderna’s most recent announcement, no South African company will be able to produce the resulting vaccine—as South Africa is classified as an upper-middle-income country.

My struggle for mRNA vaccines is personal. I live in India where, until recently, I was ineligible for a COVID vaccine booster, despite having been vaccinated nearly a year ago. My parents, who are in their 80s, received their first booster shot in January—a dose of the AstraZeneca vaccine, which has proven among the least effective at preventing Omicron transmission. Our country, and a majority of the world, await access to the best protection, an mRNA vaccine. While we wait, people in rich countries are getting their second mRNA boosters, which are at least partly necessary because variants continue to emerge in regions of the world where the vulnerable remain unprotected.

We have moved into the Marie Antoinette phase of policymaking, one with a diabolical twist: The solution to poor people not having enough bread is to give the rich more cake.

There is no proposal to make mRNA vaccines equitably available to the world in the immediate future. Moderna intends to build a factory in Kenya. BioNtech plans to build factories in Rwanda and Senegal and to ship modular vaccine plants to developing countries. But each of these efforts will take several years to become operational. And the WHO effort? It will also take at least three years and carries the additional burden of proving it works.

Three years is a long time to wait for protection in a pandemic that has produced a new threat every few months. There is a clear moral case to get vaccines that work to people who live in poor countries. There is also a strategic reason, as doing so will suppress the amount of virus in circulation and help prevent future SARS-CoV-2 variants. The inequity we are living with is not surprising. I’ve seen it play out multiple times over the last 25 years, starting with monopolies on HIV/AIDS drugs in South Africa in the late 1990s. I am surprised, however, that the strategic case has not gotten more traction. I do not expect rich countries to protect people like my parents because it is the right thing to do for others. But I am astonished that they cannot see it is the right thing to do in order to protect themselves.

This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.

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