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Online Event: The Scramble for Vaccines and the COVAX Facility

August 19, 2020

J. Stephen Morrison: Good morning, or afternoon, or evening depending on where you are. Welcome to this event, The Scramble for a Vaccine and the COVAX Facility. I’m J. Stephen Morrison, senior vice president here at CSIS in Washington, D.C., where I direct our Global Health Policy Center. This event today is part of the work – the ongoing work of the CSIS Commission on Strengthening America’s Health Security. We established that commission in 2018. It is extending its work in the midst of the pandemic through the fall of 2022. These issues we’ll be treating today are central and vital to the work that we are undertaking.

Peggy Hamburg, one of our commissioners, will be presiding today. She recently stepped down as foreign secretary at the National Academy of Medicine, is the immediate past chair and president of the American Association for Advancement of Science, and former FDA commissioner, and former commissioner of health in the city of New York. We published last week an analysis that is a companion to this event. That is – that analysis is a CSIS brief: Is it possible to avert chaos in the vaccine scramble? It’s available at CSIS.org. This event grow out of that work. The proposition there is that nationalism dominates the scramble for vaccines and there’s a certain high risk that low-income countries – lower-middle-income countries will be left out and subject to great delay and uncertainty, and that this will have destabilizing consequences.

And we have in our paper examined Operation Warp Speed, examined what the Chinese are up to, and the Europeans are up to. And put a focus on a very promising new initiative that we’ll hear about in a moment from Peggy, the ACT Accelerator and, within that, the COVAX Facility for Vaccines, led by Gavi and CEPI. Timing for this event is quite important, as Congress weighs new COVID funding facility in the Senate Republican bill. We’ll hear later there’s money in that for Gavi for procurement and distribution. If that step were to be taken, it would be a big step forward in terms of broadening the United States’ approach. We are arguing in that work for such a broadening that would blend nationalism and the U.S. approach with a more aggressive and active internationalism. We’ll hear more about that.

Our other speakers today: Nikolaj Gilbert, president and CEO of PATH, based in Seattle. And Nikolaj kindly has agreed to join our commission. His predecessor, Steve Davis, was a very active member of the commission Nikolaj, we’re delighted you’ve joined the commission, and thank you so much. We’re joined by Kendall Hoyt, assistant professor at Dartmouth University School of Medicine. Kendall, thanks for joining us. We’ve drawn heavily upon your writings – your many writings in the analysis that we put forward today, in which you lay out the rationale and the underpinnings of these efforts at more collective action with respect to financing, and developing, and procuring, and distributing vaccines. We’re also joined by Nicole Lurie, strategic advisor to the CEO at The Coalition for Epidemic Preparedness Innovations, CEPI as it’s called. She’s the former assistant secretary for preparedness and response at Health and Human Services Department. Thank you so much, Nicki, and thank you Kendall, for being with us today.

I’m going to turn the floor over to Peggy Hamburg to lead this conversation. Thank you all.

Margaret “Peggy” Hamburg: Well, thank you, Steve. And as you can see, we have a very distinguished and experienced group of panelists. And we really do want to have this as a discussion. This is a critical time to be focused on vaccines. I think it’s fair to say that the whole world is very actively waiting and hoping for a vaccine or vaccines to be developed. This is seen as a critical measure of protection against what has proven to be a devastating disease, COVID-19. And there’s a lot of reason for optimism, but there also are some real concerns. Certainly, the scientific community has galvanized in unprecedented ways, working across sectors and across borders in order to try to develop candidate vaccines and test them. And that has been extraordinary.

On the other hand we recognize that this is a global pandemic, and that in order to really combat and control a global pandemic, we need to ensure that people around the world have access to critical public health tools, importantly vaccines. Yet, there’s enormous sense of both responsibility and nationalism around developing vaccines and access to vaccines that could limit availability, as vaccines certainly are hard to develop and get them through the whole research process, and difficult to manufacture. And for a global response, we will need literally billions and billions of doses.

So we’re going to be talking about those challenges today, the opportunities and the challenges. And we’re going to be talking in particular about an innovative new model to try to address the issues around how to encourage accelerated research and development of important vaccine candidates, but also how they can be produced and distributed in ways that take an international perspective and a perspective of equity, and a public health-driven distribution approach.

So we’re going to be talking a lot about the COVAX activity. And there is a slide, just to help the audience get a bit more grounded in what is COVAX. COVAX is the vaccine pillar of something called the ACT Accelerator, which seeks to speed up development, production, and equitable access to diagnostics, therapeutics, and vaccines. Sort of three elements of the necessary tools for an effective medical and public health response. This was launched in April, and it was really launched as a collaboration of both governments – importantly including the European Union and their president – but also philanthropy and not-for-profit organizations coming together, recognizing this critical need as this global pandemic was unfolding.

As I said, COVAX represents the vaccine pillar of this ACT Accelerator. And it’s co-led by an organization that you just heard about, CEPI, the Coalition for Epidemic Preparedness and Innovation, which was started actually after the Ebola outbreak, in order to try to do research and development for vaccines against certain pathogens of pandemic potential. The foresight of that is now quite appreciated. And it’s also co-led by Gavi, The Global Alliance for Vaccines and Immunization, which is an entity that was created actually back in 2000 in order to try to provide vaccine to the poorest – children in the poorest countries through market-shaping, reducing cost of vaccine, and helping to support countries with vaccination programs, working with critical partners in an alliance.

So the COVAX facility is actually administered by Gavi, which now has a fairly long history of working in terms of procurement and distribution of vaccines. And it will be – the COVAX facility is seen as a marketplace through which many countries, rich and poor, can have access to a diversified and actively managed portfolio of vaccines. The poorest countries need something like this, because they would have no way to actually develop or purchase vaccines for their countries’ needs, but high- and middle-income economies can also invest directly in COVAX to procure vaccines for their own populations. And we’ll talk later about why that may be highly desirable.

Then there’s also the Gavi COVAX advanced market commitment aspect of this enterprise. And that’s very important in terms of the ability through donor financing to secure COVID-19 doses, make the commitment for purchase ahead of time, and that will help to ensure the access for a very large number of low- and middle-income countries. And the goal is to deliver 2 billion doses of COVID-19 vaccine by the end of 2021. Now, this, of course, depends on the successful development, approval, and manufacture of vaccines – another huge challenge as we’re facing a previously unrecognized virus and disease. And we’ll talk more about that as well.

And just lastly I want to mention, before we turn to the panel, you know, the issues of funding, because all of this sounds good but it requires the resources – importantly dollar resources, although human resources and political commitment as well – to really realize the important goals. And an estimated 18.1 billion (dollars) is needed for COVAX to deliver on these goals. And the advanced manufacturing commitment needs about 2 billion (dollars) through 2021 and, to date, has raised 600 million (dollars). And CEPI needs about 2 billion (dollars) for initial field trials and has raised two-thirds. But clearly this is absolutely fundamental to the ability for all of this work to move forward. We have to do those studies.

And as more and more vaccine candidates are moving into human clinical trials, this is a critical gap in funding. And as Steve Morrison mentioned as he began this session, we do need to see broader commitment of countries. So far there are a large number of countries, I think it’s 76, that have indicated interest in committing. But we need those countries to truly step up to the plate and make those commitments firm.

And sadly, the United States has not participated in any of the initial launch meetings, planning meetings, or made any active commitment. Currently on the Hill there is consideration of monies to support international programs, including money for Gavi and, potentially, money for CEPI. And this is a critical time to advance those efforts to ensure that the United States plays a critical role in this, you know, very innovative and, you know, really essential international activity to help develop and equitably distribute vaccine. And that’s really what we want to talk about today.

So I will now turn to the panelists. I don’t think we need the slide. Thank you. And I’ll start with Nicole Lurie to really start the discussion. She, as you heard, has a long history of working in the realm of public health preparedness and responding to epidemics and pandemics, including H1N1, Ebola, Zika, and now COVID-19. And you know, is also an American citizen, has worked for the U.S. government. And I was hoping, Nicki, you could sort of lay out for us a little bit why this initiative is so important, and why it is, in fact, in the U.S. national interest, despite all of the investments the U.S. is currently making in its own vaccine development programs for COVID – so-called Operation Warp Speed. But why is it also of value for the U.S. to invest and commit to a program like COVAX?

M.D., Nicole Lurie: Sure, Peggy. And thanks for the question. I think what’s important to remember – and I think we hear this a lot – that nobody wins this race unless everybody wins. That we are not safe until everyone is safe. But I think from the U.S. perspective there are a couple of really important components. It is obviously in our own interest, to be sure, not only that there are safe and effective vaccines for Americans, but that there are safe and effective vaccines for the rest of the world, so that we can end this pandemic. We’re seeing right now what we call a lot of vaccine nationalism.

Understanding lots of countries are taking care of their own needs, which they need to, and we’re seeing countries make all kinds of bilateral deals to get vaccine. That’s only going to drive up the price of vaccine for everyone. The U.S. is invested in a number of candidates. We are optimistic. We don’t know if they’re going to be successful. We don’t know if they’re going to generate enough doses. And so this idea of the U.S. supporting and buying into a larger pool of candidates so that it hedges its bets, it sees COVAX, in some sense, as an insurance policy for itself, makes really, really good sense.

And then finally, just thinking about our own economic recovery. Our economy can’t recover just by vaccinating Americans. Our economy is going to need markets around the world to be strong and functional for our own economy to recover. And that means vaccinating people around the world, probably starting with the first tier of frontline workers, like we’re likely to do in the U.S.

Peggy Hamburg: Thank you, Nicki. And I’ll turn now to Kendall Hoyt, who has been working to sort of study some of the issues around models of collaboration, but also thinking about when the market doesn’t always work to address a critical public health or global need, and why would a model like this be necessary? Why can’t the free market just recognize these needs? Why do we need to – Nicki’s just laid out a critical set of reasons why it’s in the U.S. national interest. But why more broadly do we need to proceed in ways that might be different than we might normally expect in a – in a global marketplace?

Kendall Hoyt: Yeah. And that’s a very good question. You know, this is – demand is high, right? The market does work. This is not a market failure. But you know, it’s – competition is sort of a time-honored way to generate innovation. You know, but in this case it might actually hinder efforts to develop a COVID vaccine, and to make it equitably available. So in a free market, you know, vaccines are going to go to the highest bidder, and there’s limited supply early on. And we did a model of the market, and it shows that if you allow free market forces to operate, it’s going to cost 13 times more than if we were to do a collective procurement under a global mechanism, such as COVAX. So the cost.

It’s also going to reduce access to the vaccines that are available, if you do it through these bilateral deals, right? So you want – you know, COVAX will allow this equitable distribution, you know, on the basis of need and vulnerability, as opposed to nationality and ability to pay, right? And as Nicki said, we all have a vested interest in ending chains of transmission as quickly as possible. So it would get in the way of that. And furthermore, you know, allowing the free market to operate through these bilateral deals is going to create incentives for protectionist measures, export controls, things that will snarl supply chains and which will then hinder development and extend the amount of time that it takes for us to effectively roll out vaccines. So those are some reasons to consider.

Peggy Hamburg: Thank you. Thank you.

And now, turning to our European colleague, let me welcome Nikolaj Gilbert both to our panel and to his new leadership role at PATH. And actually, I understand that as we’re speaking – it’s this morning here in Washington, D.C., where I am – he has movers at his home in Denmark, in Copenhagen, to help prepare him to make the journey to Seattle where PATH is located. And PATH has a long history of forging partnerships across sectors and across borders with government, with philanthropy, with not-for-profit organizations, and the private sector. So that perspective clearly is important as we’re thinking about how to shape and hopefully support the success of a novel entity like COVAX.

So I was hoping you might be able to speak a bit to the set of issues about how do you make partnerships work, why is this partnership so critical now, and potentially, you know, provide a little non-U.S. perspective on vaccine nationalism versus globalism.

Nikolaj Gilbert: Thank you so much, Peggy. And it’s a pleasure to be with you all today.

Those are big questions that you – that you raised. And I would say there is also some good news. And this is, obviously, a great timing for having a discussion on this topic. I mean, since we became aware of COVID-19 there’s been an unprecedented global collaboration in the R&D space in the scientific community. That is great. It has meant that R&D efforts have been able to be accelerated at an unprecedented scale. That’s really great news. This is why it’s probably realistic that we’re going to have a vaccine available in a short – in a short timeframe.

Also what we have seen in terms of partnerships and global collaboration is a way of breaking down the barriers between public and private sector. And we talk about the COVAX, we talk about ACT Accelerator. And all of these new innovative approaches are actually built upon the foundation of private and public partnerships, academic institutions, universities, pharmaceutical companies, and so forth. So this is how we at PATH have been operating for the last 40 years. And we have seen how this is actually extremely effective and can help accelerate development.

And now, in a way, this needs to be proven at a completely unprecedented scale, and with so many actors. So actually we are seeing new models, and I think this COVAX Facility is a unique approach, which is actually trying to also, you could say, pull in all the countries around the world – no matter if they are low-income countries, high-income countries. Everyone has a role to play in this global effort to get a vaccine out that works, that’s safe, efficacious, and become available to all.

But obviously, it’s not only the science piece, it’s also the manufacturing piece. And I think you mentioned this in your introduction, that for all these number of candidates of vaccines, for those to be produced, and manufactured up front, we need to start that work now. And that means that we need to, you know, use all the resources and innovative approaches to really prepare that and provide the funding that is needed for that effort.

And for the European perspective, I know we talk about nationalism in the U.S. context today. What I would say as a Danish citizen, and I’m sitting from here in Europe, that nationalism has also been a part of the response here in Europe. Obviously, starting on protection of equipment, who has the access to that, and then it went on. I mean, how do you make sure who should get access to the vaccines first? Now we see the European Commissioner – the head of the commission, Ursula von der Leyen, is actually pushing hard and has been very helpful in pledging conferences to actually launch the facilities and giving their support from the European Union side.

And the latest is that to counteract nationalism that the EU is now negotiating on behalf of all member states with manufacturers and producers, which is a new approach. And they would have to deliver on that approach, otherwise probably the government – national governments are also going to maybe turn towards a more nationalistic approach, which I don’t hope. So COVAX is really a great response for the world, in that sense.

Peggy Hamburg: Thank you. You know, I almost wonder, is nationalism even possible when it comes to vaccines or other areas of bioscience product innovation and development? For one thing, science is a global enterprise now, and the underlying work behind all of these vaccines has been, you know, I think, you know, very collaborative and very international. Also, so many of the companies really are multinational in terms of how they do their work, you know, labs in one place, manufacturing facilities somewhere else, critical supplies coming from different countries, et cetera.

And of course, studies have to be done where there are cases. And while, you know, the U.S. is not proud of its number of cases at the moment, it does mean that we have a lot of opportunity to do clinical trials. But in China, for example, because they have more successfully controlled the spread of this novel coronavirus, they’re actually having to go to other countries to do their clinical trials. So there’s just a lot of – in the real world, there’s a lot of crossing of borders and requirements for collaboration, or benefits from collaboration no matter what.

So I’m sort of curious – you know, maybe I’ll go back to Nicki first on this, do you – do you really think it would be possible for the U.S. to just try to go it alone? And you’ve watched how this has unfolded in other instances. And I should say, in framing the question also, you know, would we be where we are if China hadn’t posted the genome in early January, in terms of our ability to develop important medical countermeasures? Obviously, the science has unfolded quickly, and as it has spread. People have gotten access to isolates without a problem. But that’s been another issue with vaccine development and collaboration in the past.

So I was just sort of curious, Nicki, from the years of experience that you now have had thinking about and working on these issues.

Nicole Lurie: It’s such a good question, Peggy. And I’ll just reflect that when I first got into this whole field the world looked pretty different. There were lots of efforts at collaboration, particularly in the public health side, on the surveillance side, between the U.S. and other countries around the world. But from a scientific perspective, you know, the U.S. scientific enterprise – particularly in bioscience – was really the envy of the world. What I feel like we’ve seen over the time that I’ve been doing this work is that a lot of the world has caught up in so many ways.

As you said, we’ve got lots of vaccine development and manufacturing going on in China. We’ve got vaccine development and manufacturing going on in Europe. We have lots and lots of interdependencies. But for those interdependencies to function, I think that the relationships have to be built on a basis of collaboration and trust. And the U.S. is in a sort of precarious position right now because it’s been choosing, by and large, to go it alone in a lot of different ways. And so my perspective as an American now working with a number of global organizations is that we’re viewed with increasing amounts of skepticism about whether we can be trusted.

I hope that we can. And certainly, the scientific advancements that have been made both in the United States and across the world come from this whole area of global collaboration and science. But you also know, when push comes to shove, sovereign leaders are under a lot of pressure to protect their own populations first. And it takes an enormous amount of leadership and skill in explaining to explain to one’s citizens around the world that taking care of my citizens also involves taking care of citizens around the world. If this hasn’t shown us that infectious diseases know no borders, none have.

So on the one hand, we’re all dependent on this collaboration to an incredible degree. On another hand, just as we’ve seen these sort of lockdowns, and export controls, and import bans with personal protective equipment and all kinds of supplies, and we’ve seen lots of border closures around the world, this kind of nationalism is still alive and well. And I think it’s going to really inhibit our ability to deal with this pandemic and, frankly, for the U.S. to sort of continue to regain trust as a trusted international partner going forward. And that’s an issue that’s of huge concern to me.

Peggy Hamburg: And Kendall, I know that you’ve done work on sort of trying to think about and frame vaccines as a global public good. And that is, I think, from my perspective as a public health professional, certainly true. But that’s a hard thing to communicate in many instances, especially in the context of a crisis like this, where every country is trying to look after their own. What – can you tell us a little bit about the work you’ve done in that domain?

Kendall Hoyt: Sure. But just to refer back to the first question a little bit, about nationalism, I would say that, you know, our political instincts are not in sync with the practical realities of research and development in the globalized world today. And that’s – so that problem is part of the answer, I think, to the global public goods problem. And one of the things that I’d like to see, you know, are creating some of the institutions and frameworks that will make collaboration more easier – an easier political sell, and sort of reduce some of the disincentives.

You know, Tom Bollyky and Chad Brown had sort of this idea for an investment fund, or a – you know, a pandemic agreement. And I sort of envision something like a treaty, right, that could come into force when there’s a pandemic, with a code of conduct, you know, that nations would agree to, whether it’s, you know, sharing samples and data in a timely fashion, coordinating on clinical trials, adopting harmonized protocols, or, you know, agreeing not to have export controls, or price gouging. I mean, you can think of a whole range of things that we would all agree to up front that would allow for a much more streamlined response, a much more rational response in the moment.

But you know, in addition to that, you know, I’d like to see – you know, there are others things that we can do. You know, it’s sort of – these viral spillover events are, like, you know, greenhouse gas emissions. You know, and you need ways – all the tools and strategies to solve them collectively. And so, you know, there’s the political side that you could do with a treaty. But then COVAX actually is a very important economic piece. It’s a tool that allows us to collaborate effectively and efficiently to pool our risk.

And, you know, a lot of the building blocks of what we need are already there. You know, whether it’s CEPI, whether it’s Gavi, whether it’s the WHO. It’s – you know, and how they’ve all come together to create something like COVAX. So recognizing the value and the power of these institutions to create the institutional framework that we need to produce vaccines as global public goods, and investing them as part of this larger project, I think is where we need to go.

Peggy Hamburg: Well, certainly treaties are not easy to undertake, but one could even imagine in the process of trying to think about what might be in a treaty you could make a lot of important progress forward in sort of laying out all the different issues, you know, many of which you just touched on, that can become barriers to effective collaboration. And I think that it would be unlikely that in the current state of politics in this country, and probably many others, that we could really forge such a treaty. But as an exercise, I could see it would have real value.

And getting away also from this either/or mentality – you know, these sort of false dichotomies – because the U.S. can pursue efforts to get vaccine for use in our own country, but also participate in international collaborative efforts like COVAX. And in fact, it’s a sensible strategy, as was touched on already, because it allows you to distribute your risk, and it allows you to diversify your portfolio, so to speak, because we don’t know, you know, which vaccine is going to make it over the finish line – hopefully more than one. But it is – it is really a critical time.

Kendall Hoyt: And I would agree. I think contracts are a step back from a treaty and yet enforceable, right? And it’s sort of a more incremental way to – a lever for social change of this nature. And I think CEPI has been very forward-thinking in this way.

Peggy Hamburg:

Yeah. I want to turn now to Nicki and then come back – unless Nikolaj has a comment specifically on this point.

Nicole Lurie:

Yeah, so just to – to just build on Kendall’s comment for just a minute. Part of the reason we’re in this conundrum is because in all of our global pandemic preparedness, there were a number of things that we didn’t necessarily anticipate. And again, as an American, you know, we – I appreciate very much the fact that the U.S. government has this end-to-end financing system. It can pay for the basic science. It can pay for vaccine development. It can pay for the manufacturing. It can pay to buy doses and distribute it to its citizens.

But the rest of the world isn’t organized that way, right? And as we got into vaccine development we realized there was no entity to pay for the scale of manufacturing that needed to happen. There was no entity that could make an advanced market commitment to purchase doses so that the manufacturers would actually manufacture doses. And so that’s really why COVAX and the facility came into being. We’re sort of making that up as we go. But in the next pandemic, to Kendall’s point, we can’t be passing the tin cup raising money for these activities. We have to have sort of a global system that lets this happen much more easily, much faster, and with much more predictability.

Peggy Hamburg: So now, Nikolaj, I want to let you make whatever comments you wanted to make, but also, you know, you’ve been watching this from the perspective of what’s happening in Europe, but anticipating joining an organization based in the U.S. But the European Commission – the European Union, as you noted, you know, really has stepped up to the plate in terms of leadership for shaping the ACT Accelerator and, importantly, the COVAX vaccine pillar of that effort. And very generous in terms of the pledging and fundraising.

On the other hand, we’re seeing some of the countries in Europe advancing bilateral agreements, and the EU creating its own vaccine initiative as well. So lots of these different tensions coming out. So, you know, how important do you think it is to find the right balance, as these efforts to go forward? Do you think that as – after the idea of the ACT Accelerator was launched that the sort of backseat nationalism energy began to take hold and, and may be pulling away support from COVAX? What’s the perspective, and how important is that adherence of the European Commission behind this effort?

Nikolaj Gilbert: Thanks, Peggy. Before I dive into the European situation, just a comment on the nationalism question that you raised, and the vaccine trends that we have seen over the last couple of years. So there is a decreasing interest overall in vaccine before COVID-19 hit us. Actually, supply of vaccines to many diseases around the world that are affecting maybe Africa, Southeast Asia and others, there has been a declining trend in terms of interest. And that’s, obviously, due to profitability as well for many private sector companies. So we were already on a – on a declining interest in terms of a vaccine capacity. Then COVID-19, obviously, hit us all. And now we need to, you know, pick that – pick that up around the world.

And my point in this is that the U.S. market, from a pharmaceutical or biotechnology perspective, is the most profitable in the world, right? So it’s a very interesting market for all major pharmaceutical companies in the world. So it’s very difficult when, obviously, the U.S. administration are approaching you to, you know, get access to your products – in this case, a vaccine. It could also be therapeutics, right, which is also something we have seen. So that I just think that the pharmaceutical, the biotech industry also has a role to play in this whole thing about – and we’re seeing this a bit with the ACT Accelerator, that they’re coming along.

I still think that we need that collaboration, that collective mindset also coming more firmly out, so that other – so that governments around the world can see that it actually doesn’t pay off to do these bilateral deals, because if they see other countries start to do that, there will be a pressure from the citizens of that country to actually, you know, pursue those deals. And that can be hard for any politician to actually counteract that.

On the European – on the European question, I think we are – as we talked about, there is a solidarity now in terms of let’s try to do this together. There is a big difference – I don’t know if it’s the same in the U.S. – but in Europe, so the money that is being provided for development assistance, which could, for example, finance the COVAX facility and the advanced market commitments for the low-income countries – that is part of some pockets of money in the European Commission and also in the national budgets. So that money can be allocated solidarity in terms of the global, you know, development budget from European countries.

And then there are the national, you know, health authority ministries who are actually responsible for purchasing medicine and so on. And that’s what is making this more complicated because you have two streams of, you could say, funding. But I think the COVAX facility is actually designed well for that. So you have the availability for your own citizens, but then you can contribute, via your development assistance, to this facility. And I could imagine that this model could also work for United States. So I think it’s quite a great model, as I said. And Europe has shown that you can actually protect your citizens but also be part of the—these international efforts.

Peggy Hamburg:

Thank you. Steve, you’ve been quiet. It looked like maybe you wanted to comment.

J. Stephen Morrison:

Thank you. Well, I’ve been listening intently. This has been a terrific discussion. I have two points. The first, on the whole question of diplomacy and treaties, keep in mind the dominant factor today is the clash between the United States and China, which is worsening. The provision – ever day there’s another set of provisions enacted into this. That clash, which is escalating, has paralyzed the U.N. Security Council, and it has – it has dominated to such an extent that we see a – with the exception of the pledging conferences organized in May and June – we see a void of high-level diplomatic activity in this period, which is shocking and astonishing. That you have a planetary crisis of health, and economics, and stability, and you do not have high-level diplomacy at the level of state leadership looking at this with any kind of, OK, how are we going to work collaboratively toward this?

So that’s just a very cautionary remark about the dominance of this clash and the way it is shaping the responses. The United States – you can – you can make the case that it has a legacy of leadership that it can pull back, it can reembrace, that it’s going to have surplus capacity in terms of production agreements. It is in its own self-interest to be able to hedge its bets, as Kendall and others have pointed out, and Nicki. Gavi is a trusted partner – a known and trusted partner in the United States. CEPI’s opinion in U.S. circles is very – the opinion of CEPI’s very high. The problem is how do you crack through and get some initial action that reaches outside of the nationalist approach? I remain optimistic that some pathway will be found. I think with the 3 billion (dollars) in the Senate bill put forward by Republican leaders toward supporting Gavi is one of those workarounds to push us into that zone.

The second point I want to make is let’s not forget what’s going on among lower-income and lower-middle-income countries. They witnessed this winter and spring the – they had a very raw experience in witnessing the free-for-all market for PPEs, for test kits, for ventilators, for remdesivir, and the like. They’ve – and we’ve spoken with folks, like Kalim Abdool Karim in South Africa, and William Pape in Haiti, and they just expressed the deep frustration that they cannot do the things they need to do to control this response, because of the broken marketplace dominated by the high-income countries.

Second thing is Africa, much of this surge has come late. There were very effective lockdowns in March, which delayed things. But they became untenable long term. And now we’re seeing a massive surge. Look at what’s happening in South Africa. And there’s a lot of anxiety around what lies ahead. U.N. Undersecretary General Mark Lowcock put forward a $10.3 billion appeal – the largest in U.N. history – on emergency humanitarian and health response. They are seeing multiple crises right around the country in low- and middle-income countries. Extreme poverty, food scarcity, economic stress, health infrastructure damage, rebound epidemics as immunization programs collapse.

So that’s the context in which people are making the case now that we have to begin to think ahead and act very – on an urgent basis. And Gavi and CEPI have the institutional capacity to move this forward. But we do have a really serious political problem in trying to move forward in time. Thank you.

Peggy Hamburg: Well, thank you. Very insightful comments. Very sobering comments, as well. And a powerful reminder of just what challenging times we live in, and a powerful reminder about the importance of leadership within a nation and among nations to achieve so many critical goals.

You know, coming back – you ended your comments, Steve, you know, talking about the capacity of Gavi and CEPI to realize the goals of COVAX. And of course, it’s a much broader coalition than that that will be necessary to make this possible. But it is a new idea, a very fragile organization in very early stages. And you know, I know Nicki is working night and day on trying to make it work. You know, what do you think are the key challenges right now, and the biggest concerns? Obviously getting the money needed to do trials is going to be key, but there are many other issues as well. And of course, all overlaid on the uncertainty of the science, of course.

Nicole Lurie: Sure. Well, you know, I think first, as you said, I would come back and say there’s so much of this that relates to money and the financial situation. So as you started out by noting, CEPI estimated that it needed about $2 billion to – basically, to deliver vaccine candidates that were viable to the world. Part of that delivery of the vaccine candidates is the final R&D. And a lot of that is in clinical trials, right, which still need to be funded. And we still need to raise about $700 million or so to get that work done.

In addition, as I think we’ve sort of alluded to, we’ve talked about manufacturing. But, you know, one of the strategies for CEPI and for COVAX is to be sure that there’s manufacturing capacity distributed around the world, in part as a counter to some of the nationalism so that if any one country wants to lock down its doses, you’ve got capacity to manufacture other places. And also just because of the considerations about equity, and access, and ultimately capacity building.

So all of that involves transfer of technology one way or another to manufacturing facilities around the world. And there are really good manufacturing facilities around the world. That’s a great thing. But the ability to scale them up, and to manufacture those doses – and at the end of the day, as you know, there’s a global race to get that many vials and syringes, and there’s a global glass shortage. And so just like we’re arguing and fighting about the supply of PPE, we’ve been having this in the background, you know, a bidding war and a challenge about a global glass supply, just as one of those many examples.

And then you’ve got to be sure that you can get the regulatory agencies around the world together to be coordinated, to have good – and they’ve been great so far – but to take good scientific looks at the vaccine candidates, but also the manufacturing processes, to be sure that the vaccines are going to be safe, and pure, and all those things, before they’re used in populations. So those are some other things. And then finally I would say, even after vaccines are authorized for use, different countries have really different abilities to monitor vaccine safety post-emergency authorization or post-licensure. And that’s another place where global collaboration is going to be really essential.

Peggy Hamburg:

Yeah. Well, that’s going to be very, very important. And also if there are multiple vaccine candidates out there, vaccines that are in use, making – and they require multiple doses, making sure that we actually know who’s getting which vaccine, and that they get the right vaccine as their second dose and, you know, certainly would be nice if we could begin to understand also which vaccines work better for which subpopulations. So there’s a lot of interesting and important work still to be done on the R&D side, as well as on the safety monitoring. And it all argues also for a lot of transparency and exchange of information, you know, both within a country, making sure we’re collecting, but also collaboration with others as we’re learning more about these vaccines, and also about the human immune response to this virus and the nature of the virus.

So we don’t have too much time left. Let me turn to Nikolaj who, of course, is just coming into his role at PATH. I think he said that he began in early January, just as we were learning about this novel coronavirus and thinking about all of its implications. But given the experience of PATH in spearheading critical partnerships, and working across sectors and across countries, and looking now at COVAX, what do you think are the sort of critical issues, the time-urgent challenges that have to be addressed, the things that we cannot let pass if we want to see success?

Nikolaj Gilbert:

Well, thanks a lot. PATH, we have – we have many, many vaccine candidates in our portfolio. And obviously, when COVID-19 hit the world January we put all those aside, and now working with CEPI, Gavi and others to actually try to help out to get some of these candidates forward and through clinical programs. At the same time, as we talked about, the manufacturing capacity for vaccines, it’s there but it’s in a very clustered way. A lot in South Asia. So how do we actually make sure that more manufactures are upscaled and, you know, security of production, quality, and all this. So we are actually helping some of these potential manufacturers to actually uplift their skills and be ready to actually be producing billions of doses of potential vaccine.

So I think that work which we talked about, the R&D component, which CEPI is driving, the vaccine production supply chain needs to happen simultaneously. And then there’s something we haven’t discussed so much, which is the distribution of the vaccine. I mean, how do we – how do we get it out there when it’s – when it’s available, and at the right price and so forth? And that’s really difficult. We have seen now with other immunization programs that they have really gone down, which is really bad for measles, polio, and all the other things we are vaccinating for. So how do we get that infrastructure up and running again, and actually being put back into use for the potential coronavirus vaccination? That, I think, is the piece we also need to make sure we get ready urgently.

Peggy Hamburg:

Yes. Thank you.

So, Kendall, turning to you now, I’d like you to have an opportunity to comment on this set of questions. And also, as we’re moving towards closure, you know, maybe offer a few thoughts. Are you optimistic or pessimistic about whether or not we’ll be able to find a path through this current scramble towards vaccines that will enable and support the kind of global collaboration we’ve been talking about, and offer an alternative to vaccine nationalism? And then I’ll ask the other panelists that same ending question before we conclude.

Kendall.

Kendall Hoyt: I think the most hopeful thing that I could say, you know, in a world where diplomacy is not always an option, is that I think the work that PATH is doing to boost production, that CEPI’s doing to work on technology transfer agreements to distribute manufacturing capacity, that is diplomacy by other means. That is one way to be effective in this environment. And COVAX will be a very interesting demonstration. This is going to be a test of nationalism versus collective efforts.

And, you know, I would put my money on COVAX, just from a pure risk probability perspective. So Operation Warp Speed, one of the largest, most well financed nation-based approaches. I think we have maybe six. And the research says, you know, once you’re in human trials, probability of success is 17 percent, right? So if you’ve got six the you’ve maybe got a 67 percent chance. Whereas, COVAX has close to 10 candidates, right? So you’re – the chances of them having a successful candidate are good, probably better.

And simple self-interested rationale is some vaccine for my most vulnerable population is better than no vaccine, which in a lot of countries are going to get locked into agreements with no vaccine. And COVAX is going to look like a viable alternative. So regardless of how many countries actually sign up initially right now, and what their budget is right now, I think over time the logic will play in its favor. And I’m hopeful that we’ll have a chance to build on these institutions going forward.

Peggy Hamburg: Well, thank you. I’m glad – heartened that you are going to put your money on COVAX. It’s too bad, though, that you don’t have a couple billion to spare for that effort. (Laughter.)

But, Nicki, are you optimistic or pessimistic?

Nicole Lurie: So I’ll tell you, for me one of the most inspirational set of calls I’ve been on recently has been calls of countries who had expressions of interest to join COVAX. You know, in addition to the traditional Gavi countries there were maybe 95 countries who got a call for two days. And these are countries who are often adversaries in many other different areas of politics and competition, and all the other sorts of reasons that people can think of to fight one another. And there they were, all on the phone together, thinking through and learning about how they might join forces to procure a vaccine. And so that actually made me incredibly optimistic, that we could find a way forward through this.

They also seemed to recognize – and I want to maybe end with this point – that if we want to do this, and we want to be successful, especially about getting doses early and enough doses so that we don’t devolve into some global food fight about doses, we have to get money to put down on raw materials and manufacturing, and all of those other things. And that is a really, really urgent need. The amount of money needed is something like the amount that’s four or five days of global GDP loss that we are facing now. So while it seems like a big number, in the big scheme of things it’s really not. And I think if you spread that across all the countries that can afford to do it, it’s not such a terrible problem. It’s solvable.

Peggy Hamburg:

Good. Well, Nikolaj, pessimistic or optimistic?

Nikolaj Gilbert:

Well, you know, the last six months have proven that the world has a common vision and a common purpose to find a vaccine against COVID-19. We have seen unprecedented collaboration across a nation, scientific collaboration, political collaboration. And it’s almost like a moon landing that we’re going to do together . So I am an optimist. I think we have proven that we can break down barriers between us. And I think with the leadership together we can – we can move this forward. And we have the infrastructure now with COVAX. It’s there. So it’s just a matter of, you know, getting it to work.

Peggy Hamburg:

Yeah. And, Steve, we don’t have much time, but do you want to provide any last thoughts, as we come to a close?

J. Stephen Morrison: Sure, thank you very much. And thank you, Peggy, for masterful moderation this morning. And I want to offer special thanks to my colleague Anna Carroll for all her work in pulling this all together, and to the production team led by Clifton Jones in putting this together.

My feeling – I agree with much of what’s been said, that Gavi and CEPI have been impressive in this period. They have been fast. They’ve been visionary. They’ve taken risks. They’ve been bold in their thinking. And the numbers required look like big numbers, but they aren’t. If we can find – if we can get over this hurdle and secure the baseline that is required, they will be able to do great things and have enormous impacts. And we need to keep our eye on the ball on the urgency of getting to that point under very difficult circumstances.

And I think we need to be very realistic now. We are heading into this next phase. It’s going to be a very, very difficult next couple of years. And we need to brace ourselves for that. We’re going to need to be fairly rugged in the way we go about putting these plans forward, and aware that it’s going to be a turbulent and very difficult environment in many of these low income and lower-middle-income countries as we try to press ahead. But there’s no choice. And I think all of you have shown just how much ingenuity and intellectual capacity and commitment has been brought to the table. And I thank all of our speakers who’ve been with us today, who really have been intellectual and institutional leaders in this field. So thank you.

Peggy Hamburg:

Well, thank you all. Thank the panelists. Thank you to you, Steve, for your tremendous leadership at CSIS, and to Anna Carroll, Clifton Jones, and the whole CSIS team.

I think this is it. It’s a close. Thank you all.

(END)

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