Voices of the Virus

‘The U.S. Government Has to Take Back Control’

Public Citizen’s Zain Rizvi tells Democracy how we let a handful of pharmaceutical companies turn the people’s vaccine into the rich people’s vaccine during a once-in-a-century public health crisis—and how we can turn things around.

By Zain Rizvi

Tagged access to medicinesbig pharmaCOVID-19equalityInequalityintellectual propertyPharmaceutical Industryvaccine

While many Americans are receiving their booster shots, much of the world has yet to receive even a first dose of COVID-19 vaccine. Only nine countries in Africa, for example, have reached a 10 percent vaccination rate. American drug companies Pfizer and Moderna, despite unprecedented public contribution to the development of their vaccines, have maintained their duopoly on vital mRNA technology, which they have refused to share with developing country manufacturers.

Drug policy expert and Public Citizen Research Director Zain Rizvi has been at the forefront of exposing these companies’ bad practices, including the bullying carried out by Pfizer through its contracts with national governments. He was also an instrumental part of the team at Public Citizen that pushed the NIH to clarify its role in the development of the Moderna vaccine, leading to explosive recent revelations in The New York Times about the ongoing battle between the NIH and Moderna over ownership of key elements of the latter’s vaccine, a battle that could have far-reaching consequences for global access.

Associate Editor Sophia Crabbe-Field spoke to Zain Rizvi about why charity isn’t enough, about building local manufacturing capacity around the world and breaking the Pfizer-Moderna duopoly, about why Americans should care about the rest of the world, and how to turn the “rich people’s vaccine” back into the “people’s vaccine.” They spoke on Tuesday, November 9.

Sophia Crabbe-Field: Biden was widely applauded back in May when he supported the TRIPS patent waiver, but since then he’s received a lot more flack from both inside and outside the access to medicines community. Can you speak briefly to the main criticisms toward the Biden Administration at this moment in terms of leadership on this issue?

Zain Rizvi: The Biden Administration said it wanted to be arsenal of vaccines for the world. It wanted to take a wartime footing to the response. While the Biden Administration has taken important steps,  there just remains so much more to be done.

The initial support by the Biden Administration of the WTO TRIPS waiver was an important moment, but the TRIPS waiver discussions are still ongoing, that’s one thing, and then, fundamentally, the U.S. government still has not deployed all its existing authority to scale up vaccine production around the world.

And so there’s three big buckets of action. One is about dose reallocation and getting doses that are already existing out to the world as quickly as possible. There is technology transfer and using things like the Defense Production Act and getting intellectual property out of the way through the TRIPS waiver.

And then, third, there are investments in building capacity all around the world. And so we needed bold action then and we need bold action now because there are still huge, huge gaps in vaccine access and given all the uncertainty with the pandemic, nobody really knows what the next six months look like, nobody really knows what the next year looks like. We have hopes, but we have seen how our hopes have been shattered before in terms of the virus spreading and the virus mutating.

SC-F: In September, the Biden Administration promised another 500 million doses of the Pfizer vaccine to be delivered to developing countries. How far along are they on delivering on that promise? And do you think they will deliver on it in a timely manner?

ZR: My understanding is that there are, in total, including Pfizer and including some of the other existing doses they had, more than 200 million doses that have so far been donated. Additional donations are welcome. But the Biden Administration has to, at the same time, really address the monopoly power that these pharmaceutical corporations have, because the most powerful government in the history of the world cannot simply just place an order and get added to the line for deliveries. It’s about expanding supply as quickly as possible.

One thing I’ve said previously and I think it’s really important is that doses are charity, but knowledge is justice. And that’s the idea that donations are important and can help in the short term, but only distributed global vaccine manufacturing enabled by the sharing of knowledge can help with with the medium and long-term challenges here.

No matter how many times I speak about this, I never failed to get outraged about it. We are in a once-in-a-century crisis, and yet a handful of corporations are allowed to keep the knowledge that can help end the pandemic secret. And, for months, not only were the corporations allowed to keep this knowledge secret, but they were also shouting from the rooftops that the monopolies they have are not contributing to shortages. It’s so ridiculous that it’s almost hard to believe it. It’s hard to imagine how this argument was taken seriously, but the idea that monopolies are not causing this situation was indeed taken seriously for many, many months.

So, as a whole, the global community’s response has been breathtakingly inadequate. We have governments like the South African government decrying what it calls “vaccine apartheid.” Think about what that really means, for a government like South Africa, given its history, given its very recent history and given the very fresh wounds in that country, to use that kind of language. The scale and magnitude of vaccine and inequality is something I don’t think folks have fully appreciated and not just that but also what it does to a country whether it’s about economic recovery, whether it’s about public health consequences, whether it’s about national security, to not have access to vaccines.

SC-F: You mentioned that in the first few months of the pandemic people believed the pharma narrative about monopolies. But have you since seen any kind of switch in public perception recently?

ZR: More and more evidence has emerged  that shows there are vaccine manufacturers around the world who want to be able to make COVID-19 vaccines, but who are not able to make COVID-19 vaccines at this moment, partly because a handful of corporations control the lifesaving technology. And the more evidence that emerges, the more outrageous the fact that governments did so little to require companies to share technology from the very beginning becomes.

One thing I always go back to is that the Pfizer vaccine was authorized by the FDA on December 11. Since then, more than 3 million people have died, largely because they had not been able to get access to vaccines. And so, December 12 could have been the moment for the U.S. government to say: “We are launching a WARP Speed for the world. We are going to help ramp up production for everyone around the planet as quickly as possible. We will make the vaccines a global public good.” And that has not happened.

And so we are, in some sense, still facing the consequences of the decisions that were made many, many months ago. And so there was a great New York Times story recently that profiled many vaccine manufacturers who want to be able to manufacture mRNA vaccines. And yet the two companies that have a duopoly on approved mRNA vaccines refuse to share the technology widely. And so you have a situation in which many countries in Africa have not been able to access vaccines. You have African scientists who are trying to reproduce the Moderna COVID-19 vaccine, working with the World Health Organization. And yet Moderna refuses to provide help. And so a company that has shown very little interest until recently in supplying vaccines to low-income countries is failing to provide  help to scientists in those countries to be able to make their own vaccine. And that is deeply unacceptable.

SC-F: When you talk about the missed potential of a WARP Speed for the world, what would have been the concrete steps that the Administration could have taken at that time but didn’t?

ZR: The Trump Administration and the Biden Administration both had a chance to launch an ambitious global vaccine manufacturing program. They could have delivered a real plan on how to vaccinate the world. They could have lined up all the qualified vaccine producers in the world, and asked what they needed in terms of technical know-how and financial investment to surge production.

For example, we worked with engineers at Imperial College to model out what it would take to produce 8 billion doses of mRNA vaccine in one year. And for the NIH Moderna vaccine, for example, it would have taken about $25 billion to produce 8 billion doses in one year. It would have required setting up 55 production lines to make 10,000 batches. We estimated production lines, we estimated number of employees, we estimated number of ingredients, we estimated volume of ingredients. We offered a model. Others, like PrEP4All, offered additional ambitious proposals. People knew what bold action looked like, but it was simply not done.

Yet there have been champions in the House. For example, in Congress, Representative [Raja] Krishnamoorthi was advocating for the NOVID Act, which would have pushed the U.S. government to spend $34 billion on global vaccine manufacturing and delivery. So we could have made the requisite investments, shared the technology, and ramped up production all around the world. Instead, production is largely still controlled by a handful of manufacturers at a handful of locations, which are largely concentrated in the Global North, particularly for the mRNA vaccines. And so that is part of the story, but the story is not over yet because the pandemic is not over yet and there are still meaningful steps that the global community, and particularly the Biden Administration, can still take.

mRNA vaccine production is very different. It’s a whole new world. It requires far less physical space, it is far less capital intensive, the processes are shorter and simpler than traditional vaccine manufacturing. A lot more manufacturers can do it. You can setup a new production line for only around $60 million. That potential has not been fully realized because a few corporations have dictated who can make mRNA vaccines, how they can make them, where they can make them, and at what price.

The Biden Administration can still help ramp up mRNA vaccine manufacturing around the world. They can still use the Defense Production Act to require companies like Moderna to share the technology. Yet the Biden Administration has publicly been downplaying the authority that it has. But, if you look at the text of the act, it’s pretty clear just how much power the Biden Administration has to act in this once-in-a-century crisis.

SC-F: I wanted to ask you more specifically about that. I know that [Biden’s COVID-19 Response Leader] David Kessler recently said that “the companies understand our authorities and they understand we not be afraid to use them.” But I also know the White House has stated recently that it doesn’t have the authority to share Moderna’s vaccine recipe. What do you make of these contradictory messages?

ZR: So there are two sources of authority here. One is the Defense Production Act. And then the other is the contractual rights that we identified in the BARDA contract with Moderna.

Based on the War Powers Acts of World War II, the Defense Production Act provides the President with broad authority to support the nation’s defense. The Defense Production Act authority for technology transfer is clear. The text even explicitly refers to allocating “technical information.” The DPA is an in-case-of-emergency-break-glass kind of tool. But even with a pandemic raging around the world that has killed millions of people and the heightened risk of new variants to Americans, the U.S. government is still not maximizing the use of this tool. mRNA  technology transfer is not happening. The glass is still there.

Let me put it another way: If the United States faced the threat of an armed attack, and the one manufacturer that could deliver the right weapons refused to share its know-how with others to quickly expand production, do we think the executive could require action? Is that even a question?

And so it is not entirely clear to me on what basis the Biden Administration is saying that it does not have the authority to require companies to enter into technology transfer contracts. In fact, the Biden Administration previously said that it was willing to use DPA to secure a technology transfer partnership with Johnson & Johnson and Merck—if the companies had failed to play ball.

In addition to DPA, the Biomedical Advanced Research and Development Authority (BARDA) [a department of HHS that works on the development of medical countermeasures including for pandemics] gave these companies billions of dollars and secured some rights in return via contracts. And so Moderna as a company relied heavily on U.S. government investment, in U.S. government assistance, starting from the invention of the vaccine, all the way to its development, all the way to its manufacturing. And so in one of the contracts we found with BARDA, the U.S. government obtained unlimited rights to data funded under the contract with Moderna. And so the contract was heavily redacted.

But from the public provisions, it appeared that there was some information the U.S. government had unlimited rights to share. Since then, however, the Biden Administration has disputed this. They have said that they had reviewed the contract, dozens of lawyers have reviewed the contract and the unredacted portions, and they do not believe that they have enough information that would be sufficient for vaccine manufacturing.

In terms of the contract, the Biden Administration is saying, similarly again, without really providing any legal analysis or providing sufficient evidence, that they also do not hold unlimited rights and information that would be sufficient for vaccine manufacturing. But what’s revealing about this claim in particular is that even if you don’t have information that is sufficient for vaccine manufacturing, you can still have information that is helpful for vaccine manufacturing that you might have unlimited rights to. And so the Biden Administration has still not made the unredacted Moderna contract public, they have not made any legal analysis public.

My sense of the situation is that the Biden Administration is turning a political question into a legal question, and then saying the lawyers are tying their hands. But so far they have not provided evidence as to how the laws or the contracts actually tie their hands. My own read is that these are fundamentally political questions. There’s no escaping that political choice.

SC-F: How optimistic do you feel that the Biden Administration could use the Defense Production Act or another tactic to more broadly distribute the vaccine recipe?

ZR: If you look at the statutory provisions in the Defense Production Act, it’s hard for me to see how it could be clearer that it gives the President authority to share technical information. It literally says the President has authority to allocate materials and materials is defined as including technical information.

SC-F: It was just revealed by The New York Times that the NIH and Moderna have been locked in a dispute over ownership of key elements of the Moderna vaccine for the past year. How did this revelation come about and what does it mean?

ZR: A few weeks ago, we were digging through Moderna patent filings and found that the National Institutes of Health even asked Moderna to be named on a key patent application. Moderna said no. The NIH confirmed the dispute to The New York Times, and a NIH official later called it a “serious mistake” by Moderna.

The dispute got a lot of attention I think in part because people felt the injustice in their bones, and because it is part of a larger story about the public sector’s often neglected role in medicine development. Moderna worked with federal scientists, like Tony Fauci’s team at the NIH, to invent the vaccine, run clinical trials, and scale manufacturing. Taxpayers provided $1.4 billion in R&D money alone, along with an additional $8 billion in purchase commitments.

It is not just the Moderna vaccine. It is the NIH-Moderna vaccine. And yet, because the U.S. government has refused to exercise control, Moderna has been able to turn the people’s vaccine into a rich people’s vaccine. Moderna has overwhelmingly sold the vaccine to rich countries, and overcharged others. What U.S. government official can justify the fact that Botswana is reportedly buying the Moderna vaccine for $29 per dose? That’s more than what many high-income countries are paying for the vaccine. Moderna is cashing in on a crisis. It is appalling.

The question that needs to be asked is: Why is a company that was essentially a startup a couple of years ago in Massachusetts allowed to call the shots and, in some ways, dictate the response to a global pandemic, even after receiving so much public support?

On one side, you have the U.S. government that clearly wants Moderna to allocate more doses to low- and middle-income countries and to share technology with other developing country manufacturers. And, on the other side, you have this startup that has hugely benefited from public investment and now is the company that it is because of government support.

The U.S. government has to take back control.

SC-F: You spoke to the fact that there was some support in the Senate and the House for pushing the Biden Administration to take stronger steps and show stronger leadership. I know there was Senator Angus King who put out something asking that manufacturers license to the Medicines Patent Pool. And there was also the group of 14 Senators who were pushing Biden for more leadership. How useful would the steps that they’re suggesting be, and how much sway do you think these members could have on the White House?

ZR: What the members are calling for are enormously useful and practical steps that the Biden Administration could take if it wanted to tomorrow to put the world on a better path to producing much more COVID-19 vaccine and also equipping the world to deal with future pandemics.

One way to think about this is that distributed mRNA vaccine manufacturing might be the world’s insurance policy against future pandemics. If you had distributed mRNA vaccines around the world when this pandemic hit, imagine how many lives we could have saved. And so it really is a public health, economic, a national security imperative. Members of Congress have been really instrumental in stepping up and pointing to all the ways the Biden Administration can strengthen its COVID-19 response.

In the Build Back Better Act, there is approximately $1.3 billion for several priorities, including for a global and domestic vaccine manufacturing. And so ensuring that that money gets retained and, ideally, augmented in the Senate version of Build Back Better is really important. Spending a few hundred million dollars here and spending a few hundred million dollars there might not seem like a ton of money in the trillion-dollar debates that we’re talking about, but it could be hugely influential in setting up mRNA vaccine production capacity around the world.

SC-F: I just wanted to briefly talk about the report that you authored on Pfizer. If I’m not mistaken, it was also building on some of the work by the Bureau of Investigative Journalism that had reported on some of the abusive ways in which Pfizer had carried out negotiations with various countries. And you were looking at the results of these contract negotiations and what were some of the onerous terms that Pfizer was imposing on these countries. Can you speak briefly to what these terms look like?

ZR: The Bureau did an amazing job tracking down these governments around the world that were deeply unhappy with the demands placed on them by Pfizer. And, several months later, we reviewed many vaccine contracts that Pfizer had entered into with governments around the world. And what they reveal is technical in some sense, but it’s simple in another, which is that they reveal the vast power imbalance in vaccine negotiations. You had this one vaccine corporation, which has a monopoly on a life-saving vaccine that is going to countries and saying, essentially, “If you want this vaccine, then you have to agree to some of these conditions.”

And so the conditions range in every contract, but some of the conditions we found include: Pfizer has the ability to restrict what governments can say about the contract; Pfizer has the ability to restrict and control the donations; in some contracts, Pfizer can require governments to put up state assets as collateral if there was a legal dispute; Pfizer can require governments to bypass domestic legal processes and instead go through international arbitration mechanisms. So they really paint a picture of a company that has used its monopoly power in a once-in-a-century public health crisis to extract some seriously concerning concessions from desperate governments.

SC-F: And what is the precedent for these kinds of contracts, including the level of secrecy that’s surrounded them?

ZR: There’s a question about what is commercially standard and then there’s a question about what is standard and appropriate in a public health crisis. And so, on both counts, from the kind of outrage that some of these demands generated from governments, my perspective is that it was unusual.

SC-F: What could countries, like the United States, like Germany, when they’re in this situation, as they were, where there’s a pandemic and there’s these few companies that have these drugs and the governments have already provided the funds to help create the drug and have then given the rights for the vaccine recipes to pharmaceutical companies, is there any way they could leverage power at that point? What could they do differently next time to not be in the situation where they’re giving up so much in these contracts?

ZR: There are a few points here. The first is: How in the world did we develop a set of  institutions that essentially allowed a handful of corporations to call the shots in a once-in-a-century public health crisis? COVID-19 has exposed gaps and vulnerabilities in many institutions, but perhaps the most striking indictment is of the way in which we research, develop, and produce medical technologies.

So you had this situation where governments gave really billions of dollars to these corporations with limited, in some cases, unlimited, no pun intended, in other cases, rights to some of the technology. And so never again should a pharmaceutical corporation receive huge sums of funding without some protection built in for the public interest. Governments can require that corporations, as a condition of accepting funding, set reasonable prices, provide doses to lower and middle-income countries, share technology with international institutions like the World Health Organization. These were all possibilities, but very few of them were actually realized because governments did not make those choices. And so that, I hope, is one of the lessons we draw from this pandemic. It’s about how we let billions of dollars in public funding translate into tens of billions of dollars of private profits.

SC-F: What would you say to those people who would potentially counter and say, well, if they put all these stipulations on the public funding, they wouldn’t have created the drugs or they wouldn’t have had the incentive, this whole argument?

ZR: The part that I find fascinating about the innovation argument in this context is that we know, for example, that Pfizer has made, or is on track to make, $34 billion this year. We know that any vaccine, even if it had come with some public interest condition, would be one of the most valuable and sought-after products in the history of the world.

If you remember the start of the pandemic, many of the companies were very tepid about getting involved and the ones that were some of the fastest movers were the ones that were getting huge amounts of government funding and support, like Moderna for example.

SC-F: You’re quoted in The New York Times article that you mentioned earlier talking about the potential future risks for new vaccines and treatments based on mRNA technology. What could the future consequences of these kinds of contracts be if Moderna and Pfizer are able to replicate these kinds contracts in the future and keep this kind of monopoly power over mRNA technology?

ZR: mRNA technology holds a lot of promise. Many people are excited about the technology and what it might mean for global health, for pandemics, but also for things like cancer vaccines and other infectious diseases. And so, if a handful of companies are allowed to control mRNA technology going into the future, then there is a risk that we repeat some of the mistakes that we have made already as a global community—that we see not enough access in low- and middle-income countries, that we see high prices, that we see all these consequences of having monopolies on life-saving technology.

And, again, mRNA technology has uniquely benefited from federal investment right from the beginning. Moderna’s company name is a combination of modified RNA. The concept of modifying mRNA was successfully shown in a study by two academics, which were funded by the National Institutes of Health. And so it just shows the critical role of the federal government and the need for the federal government to continue to act to make this a public good.

SC-F: I just wanted to broadly ask you about COVAX, which was supposed to provide vaccines to lower-income countries. I think groups like Public Citizen kind of predicted from the beginning that it would not achieve what it was said to be achieving. Why has it indeed been such a failure in terms of the ideals that were set out for it?

ZR: COVAX is structurally flawed. COVAX is important, but insufficient. It’s almost been a year since Public Citizen put out a report called “COVAX’s Choices.” And in that report, we pointed out how COVAX was making a set of decisions about intellectual property, about technology transfer, about pricing that will leave it very vulnerable. And, in the year that has passed, we have seen many of the devastating consequences of those choices. We have seen, for example, COVAX struggling enormously because India restricted exports from one of the largest suppliers because of the Delta variant. And this was not predictable, but it was not completely unforeseeable. Everyone recognized the kind of precarity of relying on a handful of suppliers to vaccinate the world.

And that is part of why we were calling for open sharing of vaccine technology, because all manufacturers around the world who were qualified to make vaccines should have been able to make vaccines as quickly as possible. And the fundamental point, which I keep returning to, is that COVAX did not do enough to address the artificial scarcity caused by intellectual property. There were other initiatives at the World Health Organization that called for open sharing of technology. And COVAX thought it could play ball with pharma and look where it’s gotten. COVAX has delivered 400 million doses this year, which sounds like a lot until you realize that that’s probably enough for 200 million people, depending on how many J&J doses there are.

And so for the world’s solution for vaccinating developing countries to have only vaccinated close to 200 million people nearly a year after the vaccines have come out is devastating. It’s hard to overstate the failure of COVAX to anticipate some of these problems and address them. And, of course, that being said, it’s not entirely COVAX’s fault because rich countries did what they did as well. But everyone should have understood from the beginning that this was what was going to happen.

SC-F: You mentioned manufacturers in developing countries that are equipped to produce mRNA vaccines. I was wondering if you could speak a little bit more to how this pandemic has demonstrated the importance of creating local manufacturing capacity globally and how far we’ve gotten, at this point, in terms of creating this local capacity?

ZR: If you look at the pandemic, and if you look at who got vaccinated first, in the vast majority of cases, the countries that had vaccine local production were able to vaccinate their own populations first. And the countries that did not have either vaccine production or enough money to place advance orders were the ones that are now getting vaccinated last. And so distributed vaccine production is critical to both addressing this pandemic, but also to building back better, to equipping the world to address future pandemic threats. In terms of where we’ve gotten, there have certainly been promising initiatives. The World Health Organization is trying to set up an mRNA hub in South Africa when they’re trying to reproduce the mRNA COVID-19 vaccine. But those initiatives have lacked sufficient funding, and they’ve also lacked, fundamentally, access to the technology.

That’s where a lot of the issues lie because the technology itself actually shapes everything, in a sense. The technology shapes what kind of production you’re going to have, how much investment you need, what kind of skills you need to train for, what kind of people you need to bring on. And so the U.S. government so far has largely provided funding to some developing country manufacturers in India and South Africa. What the U.S. government has not done is to actually get American manufacturers to work with developing country manufacturers in new partnerships to produce the drug substance and the drug product to ultimately produce the vaccines. Instead, they’ve provided additional capital to bolster some of the existing partnerships. But much, much more needs to be done.

And this actually leads to a helpful story that I think might be illustrative here, which is that the U.S. government has actually some modest precedent for doing this kind of work. Around 2006, the U.S. government was very concerned about avian flu and what it might mean for the world. And so, at the time, the U.S. government, working in partnership with the World Health Organization, actually helped developing country vaccine manufacturers increase capacity. They provided funding, they provided technical assistance, they brought over some manufacturers to come to North Carolina and get some training. And so the question that needs to be asked is, if the United States were willing to do this in anticipation of a future pandemic, then why is it not doing it already for this existing pandemic? And so the U.S. government could, once again, work with the WHO to provide technical assistance, to provide funding, to transfer technology.

SC-F: The last question I wanted to ask you is: How do we get Americans, more broadly, who’ve had access to the vaccine, who now might have access to the booster shots, how do you convince these people that vaccines for other people all around the world are important to them, and that they should be pushing their government to show more leadership in this area?

ZR: There are three reasons, at least. I think if folks remember what the pandemic was like for them in the winter of 2020, before the news that the Pfizer vaccine had come out, before they could frankly get access in rich countries, how scary the pandemic felt, how awful day-to-day life was for some people. That’s still the case for a lot of people around the world. They are learning to live with an unacceptable reality.

The second point is more of a self-interested perspective, which is that it’s become a cliché now, but really the longer the virus continues to spread, the more opportunities it has to mutate and the greater chance there is that there is some new variant that escapes the protection offered by existing vaccines. So, if we want to end the pandemic, we have to vaccinate the world.

And then, third, we live in such a globalized society now that the pandemic will rear its ugly head in many different ways in our lives, even if folks in a handful of rich countries are vaccinated and everyone else is not. We see that with supply chain disruptions. We see that with shortages. We see that with traveling and tourism. At the beginning of the pandemic, remember everyone was saying, “We’re all in this together” and now, almost two years in, we see that that was not the case. But there are still things we can do to help ensure that everyone does make it out of this pandemic.

SC-F: How hopeful or pessimistic would you be, if there’s a future pandemic, that things would play out differently?

ZR: Because the people who end up reading this have mobilized and demanded more from their elected leaders and because we secured unprecedented investment and interest in distributed mRNA manufacturing, I am optimistic that next time around will look different.

Read more about access to medicinesbig pharmaCOVID-19equalityInequalityintellectual propertyPharmaceutical Industryvaccine

Zain Rizvi is Research Director with Public Citizen's Access to Medicines Program. He is an expert on pharmaceutical innovation and access to medicines. He has provided technical assistance to state and national governments, coordinated civil society coalitions, and published on intellectual property, access to medicines, and global health.

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