COVAX Past, Present, and Future: A Conversation with Dr. Seth Berkley

Katherine E. Bliss: Hi and welcome to CSIS. I’m Katherine Bliss, Senior Fellow and Director for Immunizations and Health Systems resilience at the CSIS Global Health Policy Center. On behalf of the CSIS Commission on Strengthening America’s Health Security, it’s my pleasure to welcome you to this conversation about challenges, lessons learned, and opportunities for improving the global distribution of COVID-19 vaccines with Dr. Seth Berkley, CEO – chief executive officer – of Gavi, The Vaccine Alliance.

Now, Seth was last here on this very stage in February of 2020 as cases of COVID-19 were starting to increase in Europe, particularly in Italy. The occasion was an event looking back over Gavi’s first 20 years and ahead to Gavi’s replenishment and next phase of work. But already, even at that point, we talked quite a bit about the new coronavirus outbreak and how it might unfold. In particular, we discussed the importance of international cooperation – solidarity, really – in the face of the pandemic and how institutions might need to be reformed or even retrofitted to ensure equitable access to new technologies like vaccines that could help respond to the outbreak. Just a few months later, in April of 2020, the global community did come together to launch the Access to COVID-19 Tools Accelerator. It placed a special emphasis on ensuring globally equitable – (audio break) – COVID – (audio break) – diagnostics, and vaccines.

COVAX is the vaccine pillar within the ACT Accelerator. And within COVAX – which Gavi co-leads with the World Health Organization and the Coalition for Epidemic Preparedness and Innovations, or CEPI – Gavi oversees vaccine procurement and distribution through the COVAX facility. It also manages the Advanced Market Commitment to provide the 92 eligible lower- and lower-middle-income countries with COVID-19 vaccines.

So we’re here today to talk about COVAX – its past, its present, and its future. So, Seth, welcome back to CSIS.

Seth Berkley, M.D.: Thank you so much.

Dr. Bliss: So when we spoke about a year ago – and of course, at that point it was by Zoom as opposed to in person, but this was for the inaugural episode of our podcast series Pandemic Planet – you said that the work of setting up COVAX over the previous six months had been kind of like building a sailboat when you’re in a storm in the middle of the high seas. Now, it’s certainly no secret that it hasn’t always been smooth sailing. And if you’ll permit me to extend the metaphor, you’ve been in uncharted waters a lot of the time.

Now, early on, COVAX placed a big bet on the AstraZeneca vaccine with plans for manufacture by Serum Institute of India. But then, when the Delta variant caused a huge COVID surge in India in April of 2020 the government instituted export controls, and those have only recently been lifted.

At the same time, the market for vaccines has been very difficult to read. First, it was high-income countries going around COVAX and pursuing bilateral deals focused on national interest. Then, we saw industry prioritizing sales to the highest bidders. But we’ve also seen the African Union negotiate bilateral deals with vaccine manufacturers and then PAHO – the Pan-American Health Organization, which is part of the World Health Organization but also maintains its own regional vaccine procurement – step forward with plans of its own. China moved quickly to provide more than a billion doses to paying customers. But at the same time that all of this was going you also – you also faced some challenges in negotiating with the mRNA vaccine manufacturers like Pfizer and Moderna.

So, you know, on top of all this we’re seeing, you know, the forecast that was at 1.2 billion has been, you know, revised now down to 1.4 billion by the end of 2021. And we’re seeing the push for boosters in high-income countries for older populations and also now access to vaccines for children threaten to claim significant volumes of vaccine as well.

But, you know, on the bright side, we’re also starting to see a whirlwind of diplomatic effort: the U.S.-led global summit, the COVID-19 summit in September; the recent G-20 ministerial; the ministerial last week, Secretary Blinken’s COVID-19 meeting with foreign ministers; and now we’ve got the upcoming World Health Assembly and a commitment to host a heads-of-state summit by President Biden in 2022.

So I want to start by looking back at the past. And COVID doesn’t have a long history, but it has a rich history for such a short time of being. How did things get off track with some of the forecasting and assumptions about available supplies and manufacturing? And what would you say are kind of the main lessons learned from this short period from April of 2020 until now?

Dr. Berkley: So thank you. That was a very long set of questions and history, some of which I actually don’t think is correct. And so what I’d like to do is maybe go back and give a slightly different perspective on some of this but answer the question on, you know, why we are where we are and what could be different.

So, first of all, the conversation on COVAX actually started in Davos in January. And the question at that point was: Is this the big one or is this just a dress rehearsal for the big one? And the planning for this began because we knew what happened in the previous pandemic around swine flu in 2009 and we didn’t want a repeat of that. And what happened at that time was, basically, wealthy countries bought up all of the doses that were produced and it took a very, very long time for doses to flow to the south. So the goal in putting together COVAX was to try to think about how we might approach that differently.

Now, if I want to start with lessons learned connected to that, we started, of course, with no money. We started with no bandwidth. And those are two important issues because, you know, Gavi is an organization known for being lean. Our overhead rate was 2.47 percent. So the donors love that, but it didn’t give us a lot of bandwidth to be able to scale. And of course, to be able to purchase doses we needed to raise finance. And we’ve successfully raised finance, but of course there’s a lag time to what you’re able to do.

So what’s interesting to me is to go back and look at what happened. And the reason we started with AstraZeneca is not for the reason that, you know, in a sense we had – we had problems negotiating with the – well, let me – let me be honest about it. So we, of course, looked at what vaccines might come quickly. We looked at the mRNA vaccines. We looked at AstraZeneca. The challenge was in the conversation with the mRNA vaccines they had already made commitments for those vaccines to go to wealthy countries. So when we discussed what the timeline would be, it was late and the cost was quite high, and most importantly they weren’t vaccines that had characteristics that were ideal for developing countries. One was a minus-80-degree vaccine for storage with a short shelf life and the other minus-20 (degrees). So at the end, we decided AstraZeneca would begin to be the main vaccines.

But we always – and this goes back to where CEPI started – you know, believed that what we should have is a portfolio of vaccines. So we’ve grown a portfolio. We now have the largest portfolio in the world with 11 vaccines that are moving forward. And of course, they come in in different timeframes. We – eventually, when as you described there were challenges with AstraZeneca, we did deals both with the main parent company – which was new to vaccines and they were doing this now by having an outsourcing of production to many different places, which created its own challenges – but also we facilitated transfer to the Serum Institute of India. And I know many people have said that’s a mistake, but I believe it’s the right thing to do. It’s still the right thing to do. And I think it’s proven by the fact that Serum was able to scale up and deliver over 1 billion doses to India during this time period financed through the technology transfers and money we put. But what happened, of course, is early on they stopped exports, and that of course meant that, you know, we had a problem. And so at that point, you know, that’s when we asked other countries to provide dose donations for us – in the interim, before our advance-purchase agreements, you know, came through.

So I think this other lesson – and I think it’s an important lesson – is, you know, will countries do the right thing? And I think it’s an important point because the right thing in a global pandemic is to look at this as a global issue, and that’s for the – that’s both for the – it’s the right thing to do in terms of, you know, taking care of others, but it’s also the right thing to do for self-interest because you’re really only safe if everybody’s safe. And in a situation where you have a fast-moving infection with new variants, you know, coming up around the world, if we don’t vaccinate we’re going to continue to have those new variants that are going to be able to move. So I think that the biggest question, in a sense, is not just can we next time have contingent financing available and surge capacity, but how do we get countries to take in mind this global need and not just the national need. And so we saw a lot of that.

So when we actually lay ourselves in front of where we were in swine flu, we actually did much better. We ended up with two-and-a-half times faster and seven times the number of doses and about 10 times the number of countries in the same time period. The first doses were in – delivered by COVAX 38 days after the first dose done in the U.K. So lots of good metrics. But what ended up stopping us was this vaccine nationalism. That was a real problem.

One last point –

Dr. Bliss: Some – yeah.

Dr. Berkley: Let me just one – make a last point, is – and that is when we finally did make deals with the mRNA manufacturers, the timelines, because of the vaccine hoarding that was going on in wealthy countries, for Pfizer-BioNTech we were able to get 1.2 million doses in the first half of 2021 and a total of 40 million across 2021. That’s all we could get. And we couldn’t get any Moderna doses. So at the end, I think one of the challenges is how do we make sure that these are shared across a global landscape.

Dr. Bliss: And so thinking about those mRNA vaccines, you know, that countries have donated them, now you’ve made deals with Pfizer and then Moderna, what would you have done differently from the beginning – I mean, beside the financing, which of course took some time to put together, is there – was there any strategy you would have done differently from the beginning to ensure those were part of that diverse portfolio?

Dr. Berkley: Well, there you go. (Laughter.)

Dr. Bliss: Well, I would have taken the Serum Institute of India and put it in Singapore.

Dr. Berkley: No, all joking aside, I mean, obviously, one of the things you can do is you can diversify the manufacturing base. But to have companies that have that bandwidth and ability to produce in large quantities quickly and high-quality is a skill that doesn’t exist in many places around the world. And of course, the challenge here was, you know, had that been Singapore, we would have saturated the marketplace in the first manufacturing run. So I mean, that’s one thing that could be done. But in terms of the mRNA manufacturers, the truth was – is that they were pursuing serving their marketplace and there was not, should I say, help from countries to kind of say, no, you also need to supply developing countries at that point.

Dr. Bliss: So Gavi was really the logical choice to lead in the procurement and delivery questions with COVAX, you know, along with lead the AMC, but in some ways this really meant moving away from just working with the 73 countries – the lowest-income countries that had really been so much a part of Gavi for the previous 20 years and really taking on engagement with a much larger set, in some ways. You know, was the – as you all kind of moved into this new level of engagement with countries around the world, was your board concerned about its core mission and financial obligations? And you know, were there sort of resources or assets or skills that Gavi, as an institution that had been, you know, focused just on that smaller group of countries, could have used and – you know, to really move forward this newer agenda?

Dr. Berkley: Well, the interesting debate was we had already begun to extend into some of the upper-middle-income countries, and – sorry, the lower-middle-income countries – and the question was how far to go with that. So we were working on a middle-income strategy because many of these countries had lower coverage with routine new vaccines than did the low-income countries than did the high-income countries. So we were already beginning those conversations. So everybody was pretty comfortable moving from the 73 to the AMC 92, and that debate went very well.

The more complicated debate was whether we also worked with the upper-middle-income and the high-income country, and in that group are, obviously, some countries that would get vaccines from no other source and had issues in terms of, you know, embargoes and challenges – small island states and others that would have a problem doing this. And so there was a debate back and forth. The one thing the board said that was very important is we don’t want those upper-income and upper-middle-income countries to hurt the Gavi balance sheet. So we had to, in essence, financially isolate those two. And that became a very important discussion point because in the upper-middle-income countries there were a number of countries that had very low credit ratings and had challenges, and how did we deal with guarantees.

The second thing that happened that was very interesting was when we opened this up and 195 countries joined. I think that’s an extraordinary number because it, in essence, was the largest gathering of countries coming together, you know, even – I mean, it actually exceeded the number in the Paris climate accords – to work together on a problem. It showed at least a desire to work together. But one of the things that the high-income countries said is we really want this as an insurance policy. We’re not likely to buy vaccines, you know, for routine. We’re already buying vaccines, but we don’t know if they’re going to work, and you know, if we got the wrong one, we want this. And so they ended up changing the terms. When we originally had a program that everybody would be able to have a confirmed access to vaccines, they wanted to set up some type of optionality. And that became fiscally quite complicated, and that led to a rethink. Now we’ve actually gone back for – for the self-financing countries, we’ve gone to a new version we’re calling 2.0 where we’ve tried to take that risk out so that if countries want to work with us they can work with us, but we don’t have to put together these very complicated risk-management ideas around it.

And let me just finish with one of the important ideas because you mentioned this issue of going to different regional bodies, et cetera. If we didn’t have COVAX, if we had started with countries alone, imagine if you had 200 countries that were buying five to 10 vaccines each. I mean, this is, you know, a “Lord of the Flies” scenario of complete chaos. Well, the same thing happens if you start having, you know, global/regional bodies, others, all competing with each other, all – and so, you know, the challenge is trying to create – the best marketplace would be a single marketplace that then was optimized for the best vaccines and optimized for, you know, getting the best prices, et cetera. But, obviously, the world wasn’t ready for that and it’s now fragmented. But I think the question next time is: Do we want to go back to a, you know, everybody does their own thing, or does there need to be some type of central focus?

Dr. Bliss: OK. Well, let’s go to the present or at least the very recent past. You know, one could argue that the reason or part of the reason that COVAX suffered some of these challenges in 2020 was that the Trump administration, which had earlier come in with a, I think, 1.16 billion (dollar) multiyear commitment for Gavi, did very little to support COVAX early on, until the very end of the year. And that was when the December 2020 emergency supplemental provided 4 billion (dollars), I think, over two years, and those funds were channeled through Gavi.

You could also say that U.S.-China tensions intensified under that period and that they have continued to be a complicating factor in, you know, this period as the Biden administration works to, you know, create an aligned approach among a diverse set of countries and to really address this vaccine-access crisis. Now, you know, the United States has committed to purchase this 1 billion doses of Pfizer. Chinese companies have contracted to deliver 550 million doses through COVAX and I believe, you know, have committed to deliver another 1.45 or so billion over the next year.

So, you know, I just wanted to ask you to reflect on kind of the recent history of the U.S.-China relationship and how that’s played out in the field of vaccines? You know, back in the ’60s, you know, there was the U.S. – the U.S.-Soviet collaboration around smallpox was actually a way to bring countries together, but you know, do you see possibilities for any, you know, potential collaboration, or do you think we’ve entered a new period of real conflicts and, you know, kind of in terms of this next phase of COVAX’s history? And how do you – how do you balance, you know, these U.S.-China relationships within the facility itself?

Dr. Berkley: So, you know, first of all, I actually – there was a piece Anne-Marie Slaughter did on Sunday in The New York Times and I thought it was quite interesting. It really captured this. I mean, when you have a global pandemic, when you have something that’s threatening the entire world, or if you’re talking about climate change or other issues, we need a new way of thinking about these problems because these are not about – yes, we have to deal with political boundaries and countries on a map and traditional alignments, et cetera, but we need all hands on deck to deal with those emergencies. And if we in those moments start to divide up and have favorites and non-favorites, it’s a very, very risky place to go.

And so I – the way Gavi has operated its whole time has been completely non-political. And what’s been interesting is when the countries originally joined COVAX, I mean, yes, it’s true China joined COVAX and China has been a donor, but so did Taiwan, and so did Macao, and so did Hong Kong, and you know, there were other examples like that. And we should be thinking about working in these situations across all countries. Frankly, you know, it was good – if you remember – and we discussed it at the time – when Ebola occurred in West Africa in 2015 – and it occurred at a place where there were no health systems, took a really long time to diagnose it – in some sense the fact that this occurred in China and they were able to publish the genome is what led Moderna to be able to 56 days later have a vaccine in a vial. So we have to keep in mind that we need global cooperation on these issues, and that’s an important part of what we do.

Now, at the moment that China did offer us doses – which, as you know, we did take – there were export bans on many other places. Those were the doses that were available and they were WHO prequalified. It made sense. But our goal at the end is to try to get the best-quality vaccines we can get that are most appropriate for countries in the volumes that they make. And the more we do that as a purchasing agent, the more we get rid of vaccine diplomacy and deals that, you know, create huge liens on countries and others for these products that are – that are really, you know, in front of us.

Dr. Bliss: So I want to go back to that podcast comment you made about, you know, that building COVAX was like building a sailboat in a storm on the high seas. You know –

Dr. Berkley: Yeah, I still believe it. I’m wearing my sailboat cufflinks, so.

Dr. Bliss: You’re wearing your sailing stuff. (Laughs.) All right.

You know, certainly, Gavi headquarters staff, Alliance partners, you know, have all faced unprecedented pressures and challenges, and you know, sort of, I think, you know, being pushed in different directions at different times over the past 18 to 20 months. But I wanted to ask you to say a bit about how the experience with COVAX has changed Gavi in terms of its mission and how it will carry out its work going forward. And you know, how challenging is it to continue to maintain a focus on COVAX while implementing your new work plan and continuing to maintain this effort on routine immunizations?

Dr. Berkley: So, first of all, let’s just talk a little bit more about COVAX. So COVAX is working. It is delivering. It’s delivered to 144 countries as of today about half-a-billion doses. But as important a number is 1.04 billion doses that have already been allocated. The difference between the doses delivered and the allocated relates to the speed of scaleup now.

And so our original goals were to deliver 950 million doses to AMC countries, 950 million doses to self-financing countries, and 100 million doses for the Humanitarian Buffer. And turns out self-financing countries did not want that 950 (million). They did a lot of deals. So those numbers have actually come down and we will deliver less than those numbers. But we will certainly get very close if we don’t get to the number we originally promised. And I think the challenge in thinking about this is that there was a moment where everybody wanted everything instantaneously, which is true in a pandemic, and that led to the kind of vaccine panics that existed. But I mean, you can’t make it happen that quickly.

Now, getting back to your broader question, the biggest frustration for us is, you know, we deliver more than half of the world’s vaccines, so we have a lot of experience in doing that. And the challenge is we normally predict out five years – we even have 10-year projections on what those are like – and in this case we just didn’t have that. It was moving too quickly. We moved to donations which came which short shelf life. We didn’t know what brands. And that let down countries because countries couldn’t plan well. For the countries that we had worked with, we had a relationship. We could explain that. For others, that we didn’t know well, it really looked like we didn’t understand the need to plan. But we just couldn’t get that type of certainty. As we move into purchased doses, we can get that type of prediction and move forward, although absorption capacity’s going to be critical.

Now, in terms of what’s changed, in Gavi we still have to focus. We’ve had three Ebola outbreaks since this started and we’ve had to provide vaccines there. We’ve had cholera outbreaks. We’ve had, you know, measles and rubella outbreaks, et cetera, et cetera. And it turns out we’ve been able to maintain routine immunizations. So it went down 30 to 40 percent in March and April of 2020. Because of the resilience of the health system, it’s back up now and it’s down to about 4 percent from the baseline at the end of 2020, which is the best of any health intervention. Still not good because it took us a long time to get each of those, you know, points up, but it shows the power of that system and the investment behind it. It may get worse in 2021, given the large volume of doses and some of the on-and-off lockdowns.

But it’s been very hard, as you say, for the staff because we want to focus on supporting countries for routine at the same time we want to focus on COVID. But COVID has become so politicized, some polarizing, and that has spread to the developing world, which is a real challenge.

Dr. Bliss: Well, let’s talk about that as we look toward the future. So, you know, now it sounds like the forecast for COVID-19 vaccines is mixed, somewhat. We’re likely to see increases in vaccine production on the near horizon, but there is still a concern that the lower-income countries will lag behind either because of the lack of financing to purchase vaccines or an inability to deliver those vaccines the last mile. And then, of course, there’s the challenge of actually getting people to want or demand the vaccines once they have access to them. And you know, if gaps continue as they are, you know, we could see, you know, a movement of, you know, the pandemic basically becoming a challenge in the poorest countries of the world. You know, if the history of HIV and TB is any indication, a plausible scenario is that the poorest countries would be stuck at very low coverage rates for some time.

So I don’t have a sailing metaphor here, but when you look into your crystal ball, how do you see 2022 unfolding? And how do you see COVAX, with what it’s learned over the last 20 or so months – 18 or so months, I guess – how do you see it resetting expectations and expanding its operations to really meet these needs?

Dr. Berkley: So 2020 was about supply insecurity and a challenge in supply. Right now we’re just flipping in most countries to issues on demand, and that’s going to be where we are certainly going into 2022.

Now, at the beginning of 2022 there will still be some supply issues. And we don’t know yet which manufacturers where, but there still will be issues. It won’t have stabilized. Hopefully, by the middle of the year, maybe, but you know, again, I don’t have the crystal ball that really can tell me that definitively.

But what we’ve learned about delivery is very interesting. So, initially, all the countries that we’ve gotten doses to have, you know, by and large been able to deliver them, but that’s with small doses. So, in essence, the small doses gave them time to begin to work on this. As we’ve now begun to scale up – and we look at every country on a weekly basis in depth but, you know, daily – we’ve seen somewhere between 18 and 25 countries that are having problems. Those are low-absorption countries. And in those countries, it’s a mixed bag of why. Some of them are hesitancy against certain vaccines or hesitancy in general. Some are just poor health systems and lack of health workers and others. They need intense engagement. So we’re focusing more and more on that subset of countries, and we may need to slow down delivery of doses or put it into different allocations to get them those doses in time.

The rest of the countries seem to be absorbing well. Now, again, when we get to very high volumes it’s going to be a challenge anywhere and we’ll have to see what the ultimate demand is going to be.

And so for planning it’s gotten very complicated. So, for 2022, we’ve changed, as I mentioned already, the self-financing paradigm. And what we need to do for all of the other countries is say: What is the goal you want – you, as a country? And that’s important because there’s been a set of goals that have been put out, 70 percent of every country by the middle of next year, and the Biden summit talked about doing it by the U.N. General Assembly of next year. But I think the question we’re going to have to ask is: Are countries – is that what they want or are they going to have the demand for that? From a planning point of view, we are planning towards something like that number. But in the – in the countries that have the demographic pyramids that are such that, you know, a large percentage of the population are young, getting to 70 percent means doing doses not just in adolescents, but pediatric doses in terms of numbers. And so there’s a number of planning assumptions that are going to have to be made to think about that.

So it’s really important to get a signal from countries, and that needs to be a signal that combines both the political ambition from the political leader but then also an understanding of what the health sector can deliver and what’s realistic for those countries and where they are. And you know, our job will be to work with them to try to move those forward as fast as possible.

Now, I haven’t mentioned variants. I haven’t mentioned booster doses. I haven’t mentioned, you know, things we may find out about vaccines. So there’s an enormous amount of uncertainty going forward. So the way we’re planning is we’re planning for an additional 600 million doses for 2022, of which a hundred million would be routine doses for the coverage levels and 500 million would go into a pandemic pool which in essence would act as a buffer for any of these other issues that are going to be coming up because of the enormous uncertainties. And you know, it’s important because there are many different estimates out there saying, you know, how many doses are available, how many are already in country, where they are. But we don’t have a definitive knowledge of that and we want to make sure that we have enough doses to provide people with it.

So we’ll be coming out with a new ask for that number of doses, some financing to pay for the auxiliary that are necessary for the dose donations. We’ve had commitments of up to 1.5 billion doses for dose donations, very generous to step up. But again, the timing of those and exactly what’s going to come with them needs to be made clear. And then, finally, an additional billion dollars for support for delivery.

Dr. Bliss: I can only imagine the spreadsheets that must be involved in forecasting all of these different issues.

Dr. Berkley: Well, it’s – I mean, it’s an important point for the audience to hear because normally you can get very complicated spreadsheets – (laughter) – and we can do that. In this case, there are unknowns upon unknowns upon unknowns. So you do the best you can, but the forecasts are changing on a daily basis – (laughs) – sometimes on an hourly basis – and yet we have to come up with the best numbers that are possible. And that’s what we’re trying to do.

Dr. Bliss: So back at the beginning, one of the – when we started this conversation, you said one of the reasons that you didn’t really approach the mRNA vaccine producers early on was that there was concern that with the deep cold requirements that they might not be suitable for all the countries that you work with. How are you finding countries preparing for delivering those vaccines? What kinds of challenges are you facing there?

Dr. Berkley: Yeah. So we’ve actually gotten ultra-cold chain out to the countries. Eighty percent of the countries that wanted it now have ultra-cold chain in place and is being used, and you know, we will be supplying other countries that want it. So that was a big – a big push to do it.

The challenge is not ultra-cold chain in a city and central storage, et cetera. That can be done. It’s a matter of having the planning and work to do it and training. The challenge is going to be how far down to the periphery you go. And right now, at least for the – for the Pfizer vaccine, you have 28 days at two to eight degrees. So if you can meticulously plan, you can keep it at ultra-cold chain at the central level or maybe at the district level and then take it out for a period of time. But you have to have the campaigns really, really worked out.

There is going to be a new formulation coming out of Pfizer which will have a little bit more shelf life and will also not require dilutant, which has been a challenge. But it still, unfortunately, my understanding is, will require ultra-cold chain. So that’ll be an important part of it.

And so the way we’ve thought about it is, how do we put a blend of vaccines available for a country? And you could see a situation where, you know, maybe in the capital city and the main, you know, large regional centers you could use mRNA vaccines with ultra-cold chain. Maybe for refugee camps or people in insecure areas you could use something like the Johnson & Johnson single-dose vaccine that would be very attractive in other areas. In the periphery where it’s stable, you could use, you know, a two-dose vaccine that is temperature-stable and a little bit easier to handle like AstraZeneca or Novavax or other. And what we need to move, again, is towards a program like that. The challenge in doing that is if everybody is donating or different regional bodies are buying different things, it becomes very hard to plan that. And that has been one of the other planning assumptions that’s made it difficult.

Dr. Bliss: Well, speaking of regional collaboration, there’s been a lot of diplomatic engagement lately, a lot of summits, a lot of ministerials, but some critics are saying that all of these different meetings are kind of more theater than actually productive and, you know, really kind of questioning the whole purpose of all of these gatherings. But then last week there was the announcement about the agreement between Johnson & Johnson and COVAX to make the vaccine available to people in conflict settings and other areas where there’s really not much state presence. I don’t know if that’s through the Humanitarian Buffer or –

Dr. Berkley: It’s Humanitarian Buffer.

Dr. Bliss: – in connection elsewhere. But there was also the announcement about the scorecards and accountability mechanisms. But you know, given some of these criticisms and because there are a number of these diplomatic gatherings on the schedule over the next several months, what can be done to make them more effective and useful from COVAX’s perspective? And you know, I guess in your relationship in particular with the United States, is there more that you need diplomatically from the U.S. government to help make some of these gatherings really move the agenda forward?

Dr. Berkley: So I think one of the critical issues is there becomes a time where it becomes more of a talking show than a delivery show. And I think what’s important now is we still have problems to solve. We still have to get doses out. We still have to make sure every country has access. We have to make sure people that are in refugee camps, et cetera, have access. So when we are solving problems like the Johnson & Johnson – and by the way, just as a plug, Johnson & Johnson is the only, you know, industrial vaccine manufacturer that has agreed to waive indemnification and liability. None of the others have. And that’s really important because if we want to have vaccines for those living in those places, they’re still covered by our no-fault compensation scheme but the difference is, is that a government can indemnify; a small humanitarian actor cannot. And so the challenge is getting this type of waiver available.

And by the way, there are not lawyers operating in these refugee camps. These vaccines have now been used in hundreds and hundreds of millions of people. It’s not like it was at the beginning. So we really do hope that all of the companies will eventually agree to this waiver in that very specialized situation in humanitarian buffers.

But going back to your broader question, I think the challenge here is working on improving the way we deliver. That’s the most important thing we can do in terms of preparing for the future. And you know, we are pivoting very quickly to the theoretical – what might be the new construct, which organization might be the best to run pandemics in the future. We need to make sure we deliver on this one. We need to learn from what we’re doing and we need to optimize on what we’re doing and make sure that those lessons, ultimately, are what drive future directions.

Dr. Bliss: So I want to –

Dr. Berkley: And then, sorry, I didn’t say one other thing, which is the U.S., by the way, has been a fabulous partner. We’re on – we’re on the phone with them two to three times a day. They’ve been working with us on not only – you talked about the deals we’ve been able to do on the mRNA manufacturers, but they’ve been big on dose donations and have moved those quickly and helped us with things like the Humanitarian Buffer and others. And I think that’s really important because although you did point out that perhaps the U.S. engagement on this on the international side started slowly, there certainly now is commitment. And I think the challenge is to make sure it doesn’t end up just a U.S. thing. What we want is the U.S. to use its diplomatic skills, its global leadership to bring everybody else along.

When the U.S. wasn’t doing the international, others stepped up. We have to make sure that we continue to have that process moving forward because, frankly, this is a long haul. We don’t know if we’re going to get worse variants. We don’t know if this is going to require, ultimately, regular doses. But if it is, we’re going to need to be working on this for a very long time coming forward, and we need to make sure we have everybody around the world working on it.

Dr. Bliss: So a few minutes ago when you were talking about some of the logistics and the planning and forecasting involved, you know, I wanted to come back to that and some of the capabilities that other organizations can bring to that. Here at CSIS, the Commission has a working group on the Department of Defense and what its capabilities might be, how they might evolve and change in future pandemics. Certainly, we saw in the Ebola outbreak in 2014-15 the military – not just the U.S. military, but others as well – were involved. Do you ever envision calling on the U.S. or other militaries to assist in or provide advice in the logistics and procurement, contracting, and some of these issues with which those kinds of organizations have experience?

Dr. Berkley: Well, I mean, first of all, the – one of our deals has already been done through the military here in the U.S., but also deliveries in many countries are being done by the military. Of course, we have to be sensitive to some of the rumor mills that are out there and some of the bad things that have been said about this vaccine and not increase vaccine hesitancy, but this should be an all hands on deck and we should be asking in every country what are the best – you know, which agencies are best able to do this and what skillsets.

And in terms of planning, we ought to be thinking about where we get the best data, the best planning to help us move forward. This is a very – this is the most complex vaccine rollout in history, and you know, it really does need to have everybody, you know, helping here.

What I think, you know, we don’t need is just people talking in the abstract about it. It’s really about trying to focus in on the problems that exist and fixing them.

Dr. Bliss: So I want to get to our audience and some questions from them, but I just want to come back to the conversation we had in February of 2020 about the global architecture for health security and for dealing with pandemic threats and just ask you, you know: In five to 10 years, will we still be working with COVAX and ACT-A? Will these institutions be around, or will we see newer and different global health institutions? And you know, when you’re giving a lecture 12 or 15 years from now, what overarching lesson would you share with the people creating those new institutions?

Dr. Berkley: So in terms of the lecture 12 years ago, the lecture I think is similar to the lecture I gave five years ago about the fact that these – you know, I gave a TED Talk on this. These events are going to occur and we need to prepare for them ahead of time. Not – at the time of Ebola, it was whatever it takes. Anything you need was the – (laughs) – was the message I got three months later. It was like, that was yesterday’s disease. We’re not going to do that. Hopefully, it’s going to be different at this time, but we need to plan and be thinking about this going forward as a – as a critical priority.

The language you used around this is interesting because COVAX is not an institution. And my own personal belief is we don’t need new institutions. We already have what it takes. What we need is to use networks. That’s the effective way to scale up and to scale back down. And the – and the nice thing about a networked approach is you bring the people you need. So WHO and UNICEF were groups we worked with out of the Alliance. CEPI was a group that was new. We had worked with CEPI, but not as intensely. They were able to enter and do what they needed to do. We’re working with the World Bank on certain aspects. We’re working with different groups. And I think that’s the effective way to do this.

Now, there needs to be money available, as we said, and there needs to be some keeping warm the tools that we need. But the reason that’s so important is if we were to create a new institution, the crazy thing about this is, you know, we might get a terrible ‘nother pandemic in a year. But it might be five years, it might be 10, it might be 15 years. And to keep that institution, all the people, everybody warm, the funds flowing, it’s very difficult. On the other hand, if in this interim period you build stronger vaccine delivery systems, you build and bring malaria vaccines, or new TB vaccines, or you improve the delivery of vaccines for cholera and hot spots, you prepare both in the institution, but you also prepare those in country to do a better job of delivery. That’s the way it ought to be done.

Now, I’m talking vaccines because that’s my space. But, you know, it’s the same thing as the Global Fund working on HIV, or TB, or other delivery of drugs. You are giving that practice, that skillset to countries. And that’s the way we’re going to lift up. So that’s what I’d like to see in the next pandemic, is that we’ve got the money available, we’ve got the systems kept warm, and we’ve innovated a lot for this particular one. We didn’t have labels for pandemics, we didn’t have not-fault compensations, we didn’t have standardized I&Ls, we didn’t have the EULs. All of those things, they need to be kept ready to go if we need them in the future. But that can be done with the existing systems.

Dr. Bliss: So it sounds like what you’re saying is keep providing the services that the existing institutions are already providing, perhaps provide some additional surge capacity. And then when there is a crisis the personnel are ready to go.

Dr. Berkley: Well, if I use the narrow example of Gavi – and we had talked about it ahead of time – we have a really interesting instrument called IFFIm, the International Financing Facility for Immunization. And the way that works is it is able to float bonds on the corporate bond market, based on guarantees. Had donors said there’s contingent financing available, if there’s a trigger event of a certain type – and you could specify what it is – we will then make money available, we could have on day one, back in January 20 when we were sitting in Davos we could have said: OK, we’re going to trigger this. Or maybe it would have taken till April, till it was declared a pandemic. But you have to figure out the trigger points. But then there would be money immediately to go out and make those deals, to begin to hire staff, to begin to prepare countries for whatever the countermeasures would be.

What happened instead is we launched COVAX at the – at the Gavi replenishment. We got some money at that point. It took us till the end of the year – so that was from June until December – to raise the first $2.4 billion. And then to mid the next year to raise the $10 billion that was necessary for the first tranche of doses. We have to do better than that. And I think the IMF has made the case over and over again. You know, they said, you know, spend $50 billion now because this already costs $12 trillion. And, you know, this is going to be a real cost-saving thing. We need to – we need to think of this this way. And this is where we can learn from defense, because in defense people do think that way. In health, we normally don’t.

Dr. Bliss: Well, I want to open the floor to some of the people in our audience. If you have a comment or a question we have microphones both – I think there’s a standing microphone over here. If you would please say your name and your affiliation and pose your question.

Question: Sure. Hi. Heather Ignatius from PATH. Thanks so much for being here today.

I really appreciated the sailboat analogy – the building the sailboat analogy in particular. I think countries are facing something quite similar as they prepare for the receipt of the doses, as they prepare for the delivery. And they’re trying to piece together how to – where it’s all coming from, what it’s going to look like, and how to get all the resources in place. And like Gavi, they don’t have a lot of surge capacity either. So I’d just like to hear a little bit more about what you’ve done to smooth that process for countries, and what more needs to be done to support them. Thanks a lot.

Dr. Berkley: Yeah, thank you for that question. It’s an interesting question. When this outbreak happened – and we were talking about it in the theoretical in the beginning before there were vaccines, et cetera. One of the interesting questions people say to me, well, developing countries aren’t prepared for this at all. I said, well, actually in some ways developing countries are more prepared because we do routine large campaigns, including in different age groups. Like, when we do a yellow fever campaign, you know, we’re doing kind of, you know, a wide age campaign to do that. The difference is, we get to prepare for multiple months ahead of time to do that. We’re able to provide finance. We line it up and it’s a limited time campaign. And so this has been a different experience, but needs to be built on those experiences.

So what we did initially is we thought we would not have to support delivery. This was another, by the way, learning, because initially the World Bank had originally said they had $12 billion, then $20 billion. The Asian Development, another $10 billion. So there was a lot of money available, theoretically, for countries. And so we thought they could pay for the delivery; we wouldn’t need to do it. But what we found out very quickly was that money went to some countries, not to others. It was available at different time points when vaccines were there. So we then took some money out of the core of Gavi, and then eventually asked and received money for delivery. And we’ve had now about a billion dollars. And what we’ve done is set up some quick mechanisms for countries to get access to financing that they can get. But it’s catalytic financing. It’s not to fund the whole health system, or anything else.

And the real question and the reason we’ve hesitated on asking for more money is we need a ground – a bottom’s up approach of looking at this. Because some countries are managing pretty well with their existing systems and don’t need a lot else. Others are pretty stuck. And so what we need to do is do it by country by country. Of course, we’ve had conversations with countries, but the level of detail we need and the verification of that is critical. But I think it can be done. It’s a matter of really looking at it, not – and I said country by country, but it’s even going to be, obviously, subnational regions, because in very large countries you’re going to need to deal with the places that have good coverage and have less good coverage, and what we can do there. But our goal at the end is equity. And therefore, we need to keep in mind the most difficult places, in addition to the easy to move places.

Dr. Bliss: Nicki Lurie, please.

Question: Hey, Seth, it’s great to see you not on a little square on Zoom. And thank you for being here. And thank you for weathering so many storms along the way, and still sailing.

One of the lessons, I think, you know, at least I take from this, and many others, is, as you’ve just been alluding to, you can’t be passing the tin cup in the middle of a pandemic. It doesn’t work. And so I’d be interested in hearing some of your thoughts – more thoughts about sort of what the financing system for the future looks like. It seems as though there’s a gathering consensus about, you know, the need to fund work in the interpandemic period. But so far, it seems as though, oh, we’ll just let the banks take care of things, you know, when we hit a trigger and we need surge financing, we need to do the kinds of things at risk that Gavi and CEPI did together during this pandemic, in terms of, you know, raw materials and manufacturing before you know they work, and making the advanced market commitments. Do you think the IFFIM model is a sufficient model? Or do you have additional thoughts about what that surge financing needs to look like globally, how it should be organized, and how we get there? Thanks.

Dr. Berkley: Yeah. It’s an important question, because what we found during this entire time is the most uncomfortable part of financing is at-risk financing. And that’s pretty uniform. And the at-risk financing component comes in many ways. It comes in being able to purchase doses and doing advanced purchase agreements before you know if the doses work. You have to accept that there’s risk there. It turns out this vaccine was pretty easy. Most of the vaccines worked. But that may not be true next time. I mean, I came off of working on HIV vaccines, as you know. And in that case, you know, we have no vaccines to show for that, although we’ve made enormous scientific progress.

And so I think the challenge is accepting that risk. And so whatever the new funding mechanism is, it has to accept risk. And so in work with the banks, what we found is that sometimes we have to take on the risk because their structure are not set up to take the risk, even if they have the money available. So what we need to decide then is are those the right financing mechanisms? And if they are, then they need to take on that risk. And if they can’t take on that risk. Then we need to allow those who can take on that risk to do that.

Most of the most important parts of that is to, again, get people comfortable ahead of time with that risk taking because, you know, if you go to a normal development donor and you say: We might waste – I’ll use that word intentionally – 10 percent or 20 percent of the money, it’s a very scary thought. And so, you know, how do you get people sensitized to if you want those there, you’re going to have to accept some failure? The R&D side knows it well, because you fund R&D, you don’t expect everything to work. But on the purchase side, it’s a different story. And so I think that’s the education process we have to do. We have to have triggers that are sensible.

We have to have finance that can allow them to take risks. And we need to work with institutions that are willing to embrace that risk, to obviously mitigate the risk as much as possible but, you know, be able and comfortable to be able to do that. And we’ve patched together very interesting risk, you know, mitigations, including with DFI, including with, you know, commercial insurance, like Marsh, working with, you know, private sector like Citibank, et cetera, et cetera, to do this. And so it can be done, but it needs to be done by – you know, in a way that optimizes the ability to work in this type of setting.

Dr. Bliss: Karl Hofmann from PSI.

Question: Thanks, Katherine. And thank you, Seth.

Your description of the way – the innovative ways you’re approaching risk, I wish that was more generalized across the entire development enterprise, let me put it that way. But you said at the end of one of your previous comments that it’s all about equity right now, which we certainly understand. I remember some years ago actually listening to you in Davos talking about, I would say, the other side of that, the sustainability approach that Gavi was really pioneering. And we know that’s, you know, a hugely important topic in all of our work as well. Talk about the tradeoffs between those two things – sustainability and equity.

Dr. Berkley: That’s a great question. So in a global pandemic, it’s got to be about equity first. And so we, of course, have had no co-financing for any of the vaccines. We’ve asked countries to provide – to get us to a certain level to protect countries’ health systems and countries. And I think that’s the way to think about it. Now, if we go to a routine vaccine program, do we start with co-financing? What should it look like? Should it be the same as it is for other vaccines or not? These are some of the debates.

Where I think it gets more interesting on this equity issue is – and we haven’t talked about this yet – is the issue of regional manufacturing. When Gavi started there were five manufacturers in 2000. Four of the five were high-income countries. One was in a developing country. Today we have 18 manufacturers, the majority in developing countries. We need more. And I know that that is what the world is moving towards. But one of the things we desperately need is a sustainability mechanism for those manufacturers, because if we just build a plant for COVID and have it there, it will – after the epidemic ends – it’ll end up being an elephant and won’t, you know, sustain itself.

So the challenge then is for those new plants to be thinking: How do we create a sustainable vaccine program for the world? So maybe we do some global vaccines. Maybe we do some regional vaccines. And then we have some excess capacity. And so I think those conversations are really important. And, you know, if we don’t do that, we will end up perhaps letting people down because we’ll have kind of a big push to get lots of manufacturing going, but without the ability to sustain it over time. So sustainability is always part of it.

It’s very interesting, on the co-financing part of Gavi, which is critical, we ended up with a reasonable year. We had a few countries that needed waivers, but most countries paid their co-financing. And we’re seeing this year we’re about where we should be in terms of receipt of co-financing. So countries now are, you know, believing that they have a role to play. They now have budget line items. And that’s a really good thing, from a development point of view, going forward.

Dr. Bliss: Well, we’ve gotten very close to the end of our time. And, Seth, I want to give you a moment to share any kind of last reflections before we close.

Dr. Berkley: You know, I think it’s very hard to be in the middle of a pandemic, or in the middle of a storm, and to be reflecting on all of these issues. But, you know, I think the challenge here, you know, goes back to where we started this conversation, which for me is how we have that global perspective. And the reason that’s absolutely critical, if it becomes a national perspective and it’s about nationalism or it’s about hording – you know, and we’ll see some of that, and we know that’s going to be there. But what we need to have is at least some of the leaders of the world understand that we need this global perspective, and therefore we need to set the system up in peacetime so it can deal with both, dealing with national interest.

And that – every political leader, of course, needs to take care of their populations. And that’s what they’re expected to do. But they also need to make sure that the world is a safe place for trade, commerce. And to do that, then they also have to pay attention to these global trends. And I just want to make sure that, you know, we end up coming out of this with countries with stronger systems, with a global system that is stronger, and with the ability to move forward on what the next evolutionarily certain pandemic will be.

Dr. Bliss: Well, thank you very much. I want to thank Mackenzie Burke, Michael Rendelman, and the CSIS AV team – including Mary, Dinesh, and Alan (sp) – for their efforts in really putting together this discussion this afternoon. And, Seth Berkley, CEO of Gavi, The Vaccine Alliance, I want to thank you for taking the time to share your reflections on the first year and a half of Gavi’s work with COVAX, the lessons learned and opportunities for enhancing impact and improving globally equitable access, and for your leadership – and I can’t resist it – in navigating the rough seas of COVID-19 vaccine delivery in 2020 and 2021. Thank you.

Dr. Berkley: Thank you. (Applause.)

(END)