How to Vaccinate the World, Part 1

PUBLISHED

Amy Kapczynski (@akapczynski) is a Professor of Law at Yale Law School. 

PUBLISHED

Amy Kapczynski (@akapczynski) is a Professor of Law at Yale Law School. 

Over the last few days, anyone with a loved one in India–or who has simply been following the news–has heard unforgettable stories of the horrors unfolding there. Hospitals are overflowing. People are taking to Twitter pleading for help, posting their plummeting oxygen levels until their accounts go silent. Vaccines and oxygen are in short supply, and upwards of 3000 people are now dying each day. COVID maps show that many countries around the world are now bleeding deep red–not only India but also Brazil, Argentina, Uruguay, Colombia, Turkey. Suddenly, our attention is focused again where it should have been months ago: on the vaccine apartheid that is rapidly cleaving the world into two.  

More than 80% of the world’s vaccines have gone to people in high income countries, and just 0.3% to people in low income countries. There is no plan for global vaccine access that is anywhere close to addressing this calamity. The Biden Administration has been largely silent on the matter. A drama similar to the crisis in HIV/AIDS medicines (where millions died, because patents and high prices limited antiretrovirals to the global North–until activists challenged patents and prices plummeted) is unfolding, but on a vastly greater scale. This time there is also real and immediate risk to health in the US given the continued evolution of viral variants.

As was true in the anti-retroviral fights, the key to solving this problem is in seeing it for what it is.  It is manmade, and it is a problem of private power and monopoly. All of the companies making COVID vaccines are protected by patents and secrecy rights–which are in turn protected by international law and governments in the North. Aiming to maximize their profits, these companies are controlling supplies rather than sharing knowledge to enable more production around the world. The problem is even worse than that. Our global R&D system layers privatized control and profits atop a vast regime of open science and public subsidy. Transnational scientific networks enabled the first COVID virus sequences from China to be freely shared around the world, for example, and the US poured billions in R&D funds and made critical scientific contributions to the COVID vaccines. The rules of global markets are not just unequal but extractive. They reproduce colonial dynamics in new forms.

The rules of global markets are not just unequal but extractive. They reproduce colonial dynamics in new forms.

The solution is public power exercised in the name of our collective health–one that emphasizes the creation of new supply chains, that prioritizes health over the profit motive, and that is self-aware about the need to embed democratic values in our production processes. In this post, I’ll describe what needs to be done. A follow-on post with Jishian Ravinthiran will describe how the US government, using existing legal authorities, can do it.

First, what needs to be done? Most obviously, we need to massively scale up vaccine production to meet the demand for vaccines in low- and middle-income countries. COVAX, the major international initiative in this vein, only aims to meet around 20% of the need in the 92 poorest countries by the end of 2021. And it’s far behind even this catastrophically modest goal, beset by manufacturing shortfalls and vaccine hoarding. (In fact much of that delay can be located in India–and it is hard to expect countries in crisis to do otherwise.)

Assuming mostly two-dose vaccines, we need more than 8 billion doses to meet the need in low- and middle-income countries–and we need them in months, not years. (Vaccine donations have garnered a lot of attention, but get us only a fraction of the way there. The recent promise of 60 million AstraZeneca doses would meet just 2% of need in India alone.) To get there, we need a rapid and dramatic scaleup in manufacturing capacity. We also need to build supply chains spread across multiple regions with some intentional redundancies, because manufacturing mistakes and hoarding are likely to stay with us. Finally, we need to include all effective vaccine types to get to the goal, including the one-shot adenovirus vaccine made by Johnson & Johnson (J&J) and the mRNA vaccines that currently are being effectively reserved for rich countries alone. Both received massive US government subsidy (directly in the case of J&J and Moderna and for Pfizer in the form of guaranteed purchase contracts that de-risked the enterprise). The mRNA vaccines are critically important because they are the easiest vaccines to modify, and likely the most effective against emerging variants. The one produced by Moderna, in particular, is key, because its cold storage requirements are not much different from adenovirus vaccines (like the one made by J&J), making it more suitable for worldwide use.  

Can we in fact scale up production so dramatically, and quickly? Many commentators assume not, relying either on breezy free market assumptions (“if it could be done, it would be already be done”), or on the claims of the multinational companies that control production. Those companies–supported by Bill Gates, who has enormous influence on global public health policy, and so far by the US government–say that they are doing all that they can via their proprietary supply chains, and that teaching others to make these vaccines is too hard. They also argue that raw materials, like the lipid nanoparticles that are used to encapsulate the mRNA vaccines, are in inevitably short supply, making efforts to scale up futile.

For months, advocates experienced in access to medicines debates have been refuting these claims point by point. Groups like Public Citizen, PrEP4All, and the People’s Vaccine campaign have pointed out that we went from a global capacity of zero doses of COVID vaccines to several billion doses in just a few short months. Analysis of deals made between companies and their contract manufacturers shows that partners achieved commercial scale production just 2 months after deals were announced for the adenovirus (J&J and AstraZeneca) vaccines, and in 2 to 7 months for mRNA vaccines. Some adenovirus vaccines are already successfully being made by Indian companies. The mRNA vaccines are newer, but their manufacturing is even easier to scale, because it relies on chemical and not biological processes. It took just six months for BioNTech to turn a cancer antibody factory into an mRNA vaccine factory, complete with regulatory approval. Recently these manufacturers have been exceeding their original production forecasts.

Why shouldn’t we assume that the status quo is the best we can do–that the limit on global supply is a kind of law of nature, born of the difficulties transmitting information quickly or getting enough raw materials? Doesn’t the law of supply and demand suggest that, as long as countries are willing to pay at least the cost of making these vaccines, that these companies would be making them if it were possible?  Long experience with the pharmaceutical industry suggests not. Companies made the same arguments about anti-retroviral HIV/AIDS medicines years ago, asserting that these drugs were too complex to make in poor countries and that they were doing all that they could to generate affordable supplies. It wasn’t true then; it’s unlikely to be true now.

Monopolists have perfectly rational reasons to restrict supply, even in a pandemic.

Monopolists have perfectly rational reasons to restrict supply, even in a pandemic. Building new production lines would require incurring major fixed costs, and the next 10 billion doses may well involve far less profit than the first billion. Low- and middle-income countries themselves (or rich countries on their behalf) may not be able to pay much more than the cost of production. It can be a profit maximizing strategy to focus on rich country markets and to keep the know-how secret to control the market for vaccines in the long run. Pfizer’s CFO said that quiet part out loud recently. “As this shifts from pandemic to endemic, we think there’s an opportunity here for us,” he noted. In the midst of this global calamity, his attention was on this “significant opportunity . . . from a pricing perspective.”

Some argue that rich countries could solve this problem if they threw more money at pharma, assuming that at some price point they will figure it out. It’s a standard law and economics move–internalize externalities and watch “the market” work. But governments and the public are rightfully reluctant to empty the treasury into the coffers of companies who could not have made a cent without the billions of dollars invested by governments. Doing so is giving into a sort of extortion. And it fails to serve the only kind of “efficiency” that really makes sense–the common-sense notion that we should invest our resources wisely, to get more from less and avoid waste where we can.

Moderna’s clinical development, for example, was entirely funded by the US government. Paying hundreds of billions on top of that, rather than simply asserting government rights and stepping in to ensure production, would be wasteful, because the government can instead use the tools it has to make Moderna cooperate. Innovation incentives are less of a concern than windfalls here. Yes, Moderna and other companies contributed important research to the mRNA platform, but they’ve been handsomely compensated so far, and no serious observer of US political economy can argue that there is a real political risk that this will not continue.

Using the Defense Production Act, the US has already dramatically increased production of ventilators and has brokered a deal to scale up one-shot COVID vaccines by pressing J&J to collaborate with Merck to bring new production online. There is no reason to think that it cannot be used to address other bottlenecks as they emerge.

What about the supply chain? There will surely be bottlenecks, but these are the kinds of problems that companies need governments to help them solve, and we should be moving mountains to do that. The US Defense Production Act–more about this in the next post–is designed precisely for these kinds of situations. Using it, the US has already dramatically increased production of ventilators and has brokered a deal to scale up one-shot COVID vaccines by pressing J&J to collaborate with Merck to bring new production online. There is no reason to think that it cannot be used to address other bottlenecks as they emerge.

But does the US in fact have the power to mandate the kind of sharing and scaleup of production that would be needed, given the reluctance of the companies that currently control the vaccines? And what about patent barriers, here and around the world? I’ll address that in a post to follow.

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