The Avian Flu Crisis and Its Global Ramifications

Panelists discuss the international implications of the current avian flu outbreak, how the virus may continue to evolve and spread, and how the United States and other countries should address the crisis.

BOLLYKY: Great. Good morning. I’m Tom Bollyky. I’m the director of the Global Health Program at the Council on Foreign Relations. Welcome to this morning’s session on “The Avian Flu Crisis and its Global Ramifications.”

So it began in Texas a little over a year ago. While we’ve been tracking H5N1, avian influenza, since 1996, monitoring its spread in migratory birds and poultry, the discovery of this virus in dairy cows on a panhandle farm marked a new and alarming shift in the risk profile around this pathogen. The spread of this virus to mammals, of course, makes it easier to spread to other mammals, which, of course, includes humans. And the more that it does spread, the more opportunities the virus may do so in a way that changes it in a manner that might make it easier to transmit from human to humans. Dairy cows are in regular contact with people. And of course, cows are on farms with other mammals, like pigs, that have been known to spread viruses to humans in the past.

Over the last year, this outbreak has spread to more than a thousand dairy farms in at least seventeen U.S. states. Seventy Americans have had sporadic infections. Most of those have been mild, but six have been hospitalized, five without known contact with the virus. One individual has died in Louisiana. An individual with pre-existing health conditions, but still. The outbreak has spread to our neighbors. In Mexico, there was a few months ago a fatal human case involving a three-year-old girl. In Canada, eighteen in British Columbia have been hospitalized in critical condition with a locally acquired H5N1 infection. An estimated hundred million birds in the United States have been infected. And culling efforts to contain the spread of the virus or the outbreak on poultry farms spurred the largest jump in U.S. egg prices since 1980. We have detected now the spread of the virus to an estimated forty-eight mammalian species.

All this is to say it is fair to conclude that we are not winning in our efforts to contain H5N1. And this outbreak has been putting pressure and finding gaps in our surveillance and mitigation systems and creating urgent needs for more investment and prepositioning of countermeasures and initiatives to prepare the public for what might be coming. We are, of course, doing so in a difficult context. The United States and many other countries are still reeling from the COVID-19 pandemic. And it has spurred a shift, certainly in this country but in others, around the politics of public health. The first hundred days of the Trump administration has brought an upheaval in global health and its associated institutions. That’s been true in the United States, but other countries as well.

So we have the perfect people to discuss what has been happening with H5N1, and what it means in this changed context. You have their biographies in your pamphlets, so I will just ruthlessly truncate them down to their current titles.

Paul Friedrichs is the adjunct professor of surgery at the Uniformed Services University. He’s a former deputy assistant to the president and the inaugural director of the White House’s Office of Pandemic Preparedness and Response Policy.

Nicki Lurie is the executive director of preparedness and response and the U.S. director at the Coalition of Epidemic Preparedness Innovations.

Mike Osterholm is the regents professor and holds the McKnight Presidential Endowed Chair in Public Health and director of the Center of Infectious Disease Research and Policy at the University of Minnesota.

We’re going to start with Mike, who’s going to talk about the current state of the outbreak. Move to Paul, who is going to talk about the state of mitigation and surveillance. And move to Nicki, who’s going to lead off with remarks on countermeasures. We’ll speak for about a half-hour and then try to leave lots of time from questions from this large and good audience. And with that, I will remind you all that this meeting is on the record. And turn it over to Mike, to start us off with where are we in this outbreak and what has changed since it started a little over a year ago?

OSTERHOLM: Well, first of all, thank you very much, Tom. And it’s great to be with my dear friends and colleagues, Paul and Nicki, on this talk.

Tom, you’ve done a very nice job of laying out the general framework for where we’re at. But let me take a step back, because I think that, from historic perspective, this virus has been trying to teach us a lesson for more than twenty-five years. And I’m not sure how we’re doing at learning of that lesson. Just to remind people, when this first emerged, as you pointed out, in 1996, in waterfowl in China, at that time it was a virus of concern. But it really didn’t take on major importance until 1997 when eighteen individuals in Hong Kong, in the markets of Hong Kong, became infected. Six died. And at that time, there was a major purge and culling of poultry, not only from Hong Kong but from the Guangdong province that supplied Hong Kong with these birds.

And I can remember very distinctly several flu experts at that time saying, thank God we’ve now avoided the next pandemic that could have happened. I would remind everyone here that there is going to be a next pandemic. And, as we say often, the pandemic clock is ticking we just don’t know what time it is. And I think the real point that we’re all talking about H5N1 from is not about eggs, not about chickens, not about cows, but will it cause the next influenza pandemic in humans? And I think that’s really in the bottom-line message.

But having been involved with this, and I actually had the opportunity to spend time in Indonesia, Malaysia, Vietnam, and Thailand back in the 2003 to 2007 time period, when I too was convinced this was the next pandemic about to come, and I just want to give some perspective. Because during that time, from 2003 and 2009, at the reemergence of this virus in humans, there were 468 cases of classic influenza, a truly serious respiratory illness, in which 282, over half, died from it. And then from 2010 to 2014, the numbers just gradually reduced. It wasn’t because of control measures we necessarily had in place, but we went to 233 cases in humans, of which 125 died.

And then we kind of, you might say, came to almost a sweet spot in all of this, from 2015 to 2019, where we had a hundred cases and forty-eight deaths. And of those, most of those actually occurred in the Nile River Valley, ironically, not in Southeast Asia. And surely not here in the Americas, as we think about it. I just remind people, in 2012 I was on the National Science Advisory Board for Biosecurity, when two of the really outstanding researchers influenza came to the NSABB with information actually supporting the fact that we were probably just one or two mutations away from this becoming the next major pandemic. I think you could have actually seen the nail marks into the metal seats we were all sitting in as we went through this information.

Well, needless to say, as I just shared with you, the case numbers just continued to dwindle. And actually, from 2020 to 2024, realizing that influenza—or, the COVID pandemic played some role in this, both in terms of potential occurrence but also in reporting, there were only twenty-six cases in humans and four deaths. And then along comes this new clade, 2.3.4.4b, which, as you pointed out, actually had major impact on wildlife species around the world. And one of the things that it did that was also remarkable was the very high level of infection in migratory waterfowl. That meant the whole world was vulnerable, because once they started to spread the virus it wasn’t about production animals anymore. It was really about wherever these birds went.

And for the past three years, as we’ve known now, we have been dealing with this panzootic situation in any number of animal species. But the big question is, what is the risk for humans? And a year ago right now, I was probably not one of the more, how to say, popular speakers on this issue, because I raised concerns about saying, you know, this virus has been trying to teach me something for a long time. And I don’t know if I’ve learned it yet. Is this likely to be the virus cause of the next pandemic? And I think this is still up in the air. I don’t think we know. I think there is something about H5N1 that has had so many throws at the genetic roulette table. And it hasn’t done it.

And if we look no further now today, and we look at even when we get to the point of looking at genotypes as opposed to just clades, you know, we have the D1.1, D1.2. We have the B3.13, where we’ve seen differential activity in wild birds. We’ve seen it in other mammal species. And we’ve also seen it on cattle. One thing I will leave you all with here is, uncertainty. How many of us, a year ago today, knew that cows udders were remarkably great factories for making flu virus? How many of us—and I could go through a laundry list of these kinds of issues. People today are very concerned about cats. I understand that. I was actually in Bangkok when large cats there in the zoos were fed the culled poultry, of which many of these cats died shortly of flu. You know, this was in 2003-2004. Some of the lessons we’ve already learned. There’s something unique about felines.

So I think the point that I want to just leave you with here is this is a very important issue. Do I have a sense that this is going to cause the next pandemic? Unlike some who said, yes, it’s just a matter of it’s going to happen, they could be right. And if they are, obviously preparedness now is even more important than preparedness tomorrow. But if they’re not right, it doesn’t mean that this isn’t a critical time to understand the impact that influenza can have. There will be another influenza pandemic. It could be as bad or worse than 1918. And I think that what we have to do today is talk about—don’t count on the fact that there are just fewer cases in humans, there are fewer cases in dairy cattle, there are fewer cases in poultry. We have to talk about the fact that this still means that tomorrow could be the day of the new pandemic.

So with that, I just leave you with a perspective to say I actually know less about flu today than I did ten years ago. And that’s a very humbling experience to admit that, but I think it’s true. So thank you.

BOLLYKY: Great. Thank you, Mike. Couple of questions just to follow up on that, and then—before I turn to Paul. Do we have any sense—you know, again, they are seventy—roughly seventy confirmed cases. Do we have any sense of what the real number of cases might be in the U.S.? And I think a lot—some people have been surprised by the general mildness of those cases, relative to what people had expected with the high case fatality rates in the past. What do you draw from what we’ve seen? So what’s the true denominator of cases out there and what do we—what are you drawing from what we know about the seriousness of this?

OSTERHOLM: Yeah. Thanks, Tom. And that is a really very important question. Let’s make it very clear that—and since there are a number of people in the audience today that may not be fully up on the immunology and virology of influenza. (Laughs.) There are basically two types of receptor sites, the binding places where the virus can enter into a human cell. And there are those that are primarily what we call avian receptor sites, that basically are able to readily transmit the virus between avian species, and now we know including other mammals. Humans have those receptor sites in their eyes, in particular, some in their upper respiratory tract. But the receptor sites for humans that we worry about, that we’ve seen, for example, in swine, that we see in humans actually are deeper in the lungs. And they’re a different receptor site.

Most of the illnesses that we’ve seen with this in humans have been infections with that original bird receptor site virus. And it’s largely been conjunctivitis and some upper respiratory-type symptoms, but not the deep pulmonary infection that results in the more severe influenza. That is one that we are obviously concerned about. And remember, a pandemic of influenza only happens when not only do humans get infected, but then humans transmit to other humans. And so one of the other challenges we have is also understanding, when am I infected, and when am I infectious?

One of the things that I think has been notable is, as many of us have been following for years, what is the sentinel animal that we’ve used in the past to make us more informed about what might be coming? Swine. Because swine actually have those receptor sites deeper in their lungs, as humans have. Also they have receptor sites for the bird virus itself. And so we’ve always seen them as a sentinel animal. And it’s been remarkable, the absence of influenza infection in swine that we’ve seen around the world. Not just in the United States, but around the world. And so I think that this is, at this point, what explains the human illnesses. At this point, I see no evidence that someone who is infected with the bird receptor virus is transmitting that human to human in a way that we would expect to see respiratory transmitted influenza.

BOLLYKY: Great. Thank you for that.

Paul, so, as Mike said, we’ve been preparing for this for a long time. Influenza was meant to be the next big pandemic, not coronavirus. There are systems on surveillance and mitigation set up to address it. How have those systems performed so far in this outbreak?

FRIEDRICHS: Well, thanks, Thomas, first for the invitation to be here, and, second, thanks for having me go after Mike because my IQ goes up transiently whenever he briefs. So I’ll probably get better answers. And you can easily see why he was one of the people that we called on almost weekly during the time that we were in the White House trying to help integrate federal efforts on this.

I think I’ll start with a point—and like Mike, I’ll pull up just a little bit, and say that one of the big take-home messages from this outbreak that is involving multiple species is that the responses within the different communities of very well-trained, very committed, very dedicated professionals is very different. And early in the response one of the things that we learned was you could take a Harvard-educated, well-trained human public health expert and have her talk to a very well-trained veterinary health expert from the top veterinary school in the country—they would use the same words, and successfully talk right past each other. And so, you know, one of the big lessons learned from this is that we’ve talked a good game about a one health approach, but there is still work to be done in ensuring that everyone has the decoder ring to understand what each of the communities is saying.

And this goes far beyond just being able to talk with one another. This also includes the ability to share information. If you look at what is required to be reported by the World Health Organization, and the timing to do so, it’s different than what’s required by the World Animal Health Organization, with much more stringent requirements for the latter, which requires a longer period of time to collect that data before it’s actually submitted. And so there’s been, you know, frequent assertions that there were disagreements between the animal and the human side, I don’t think that’s true, as much as it is that the two systems have been designed over decades to be different.

That having been said, neither in the animal space nor in the human space do we have the global surveillance that we need to detect emerging outbreaks. And unfortunately, where we were building those systems, through our investments through the U.S. Agency for International Development and through PEPFAR and similar programs, the decisions to reduce or to eliminate that funding will slow the opportunity to build those surveillance systems on the human and the animal side. There were also some really outstanding investments underway to improve lab security and lab capabilities around the world. And many of those have also been cut, which will reduce the capacity around the world to do the sort of surveillance work that helps to detect outbreaks and to, hopefully, contain them in that local area before they become a regional or a global problem.

Domestically, the federal government is in a position that many people don’t fully appreciate. So the Constitution assigns very specific powers to the federal government. And it does not include public health responsibilities. Those are actually state and local official responsibilities. And I’m smiling ruefully, because I lost track of the many of times—the number of times that I was lambasted for not directing Governor X or public health official Y to do something, by people who really don’t understand our domestic system in which it is the governor’s responsibility to coordinate that response across their animal and human public health officials, with support from the federal government.

That’s particularly relevant to your question about surveillance and mitigation measures, because over time the federal government had become the primary source of funding for those animal and human public health capabilities, both for surveillance and for response. And large swaths of that funding, or large chunks of that funding, appear to have been either paused or eliminated, which is creating significant challenges for state and local public health officials. And that’s on top of really dramatic shortfalls in staffing that they were facing at the end of the pandemic. By some estimates, the United States was short nearly 400,000 public health workers across the country in 2023.

Many of those jurisdictions relied on the federal funding from CDC, and from USDA, and from others to help them hire staff to fill in those shortfalls. With that funding no longer existing, it is important to recognize that that will further degrade state and local capacity and make it more difficult for state and local officials to respond when there’s an outbreak on a poultry farm, or a dairy farm, or in a kindergarten somewhere. And we’re seeing that now, with requests coming in and not being filled because the staff and the resources no longer exist to do so. That will, in all likelihood, increase the risk of outbreaks spreading more quickly and causing greater human and animal impacts.

On the animal front, I want to really commend our USDA colleagues. Mike talked about migratory birds and pigs. There’s been a long-standing program to provide surveillance in those different species. And we relied heavily on that to track the spread of this outbreak. I am concerned that not only is the funding for that being diminished, but we’ve also seen many of the staff involved in that leaving the USDA, which will further increase our vulnerability. Similarly, it looks like about half of the leading state level federally funded veterinarians have accepted the early retirement program, which will further degrade our ability to respond.

All of that builds a picture in which we had an integrated program that was helping us to lower the spread, both within dairy farms and between dairy farms and poultry flocks. But much of the funding and the staffing that conducted that is being withdrawn. And so over time, it will be interesting to see, as Mike said, if the virus mutates in a way which decreases risk, which we should all hope for, or if it remains the same, if these cuts create further challenges in our ability to control this outbreak and mitigate its impact.

BOLLYKY: Great. So this outbreak is at the intersection of a number of larger trends, right? It arguably has arisen given shifts in climate and what that might do for migratory birds, the industrialization of agriculture, as you say, in the U.S. it’s taken advantage of a constitutional system or a system of governance around public health that is not conducive to a national response to an outbreak of a respiratory pathogen. Are we past the point of containing threats like this, and needing to shift in other areas? Are we past the point of containing this particular threat? And are we, where Mike was talking about, looking at surveillance of sentinel species or indicators of a change in the character of this outbreak? And if so, what does that mean specifically for the form of surveillance we should be pursuing? Is it wastewater, is it something else?

FRIEDRICHS: Yeah, so, you know, I really want to commend Dr. Mandy Cohen, who was the director of the CDC from August of 2019 until this past January. She and her team did some extraordinary work in rethinking what surveillance for human outbreaks could look like. And in fact, made tremendous progress on improving and expanding wastewater surveillance for COVID, for flu, for mpox, and then for H5N1. Similarly, they made tremendous advances in partnering with local, state, and industry leaders in developing automated surveillance systems that allowed data to flow directly from—anonymized data to flow from the electronic health records to the CDC, to give us the best visibility that we’ve ever had about what was happening around the country from those participating institutions. And then we partnered also with the DOD and the Veterans Administration to provide similar data from those facilities.

So I think that it is possible, and we were on track to build the best surveillance system on the human side that we have ever had with real-time, multifactorial surveillance tools that were helping us to see what was happening in a way that we had never been able to do so before, and in a way that reduced the work that had to be done at the state and local level. It’s very difficult to assess what will be left after the changes that have been implemented over the past hundred days. And I fully recognize that we are facing, as a nation, the incredible challenge of reconciling a $7 trillion a year budget with $5 trillion a year of revenue. That is a tremendous, existential problem for us to solve.

I do think that there are opportunities to sustain and continue to improve these remarkable advances that were made in bio-surveillance, without significant increases in budget. I’m very concerned, however, that by making broad cuts in personnel without being specific about who you are losing—or, who we are losing, and broad cuts in funding for state, local, and federal surveillance capabilities—we appear to be on track to have less visibility into what’s happening in the human or the animal space today than we did even in 2019. And that should concern all of us.

BOLLYKY: Great. Nicki, you’ve been patient. I don’t think Mike or Paul has given us much hope on what we’re seeing in terms of H5N1 to date. I’m hoping we have better news on the countermeasure space for you to share with us. Please.

LURIE: Well, I’d say sure. And yes or no, it’s absolutely a pleasure to be here. And thank you for inviting me. And, again, wonderful to be amongst old friends. So Mike’s comments really bring me back. I haven’t been doing this anywhere near as long as Mike. But Paul’s comments sparked an incredible memory of going around the country somewhere in around 2005 and doing exercises together with agriculture and veterinary experts and human health experts. And what did we learn? That they used the same words, and they meant different things, and they had different chains of reporting and talking to one another. And here we are now, as my friend Bruce Gellin would say, doing the same thing, only louder. And, you know, louder makes you beat your head against the wall and gives you a headache, but that’s really about it.

So on the countermeasure side, I’m going to talk very briefly about the countermeasures themselves. And then maybe put some of this in a global context, because, after all, I’m at CEPI, and our focus really is about equitable access to vaccines. You know, I think, you know, broadly we talk about needing diagnostics, needing therapeutics, and needing vaccines. Diagnostics are certainly within reach, as are rapid diagnostic tests, for H5, if we needed to use them. What is nowhere within reach is rapid, large-scale manufacturing and procurement of those things on a global scale. And that is for a whole variety of reasons that we can get into in a bit.

On the therapeutic side, we have had one, now two antivirals, also Combivir and Bloxivir, for a pretty long time. You know, how well they would perform in preventing or really curtailing a pandemic is anyone’s guess. Right before we went live here we were talking with Paul about efforts to treat infected animals with oseltamivir, and all of our concerns about how much resistance will likely emerge from that. And we’ve already seen in other areas, signs of Bloxivir resistance. So I’m not very sanguine about that.

Monoclonals really came to the fore, I think, during COVID. And there’s a lot of excitement about monoclonals. But they’re really expensive. We’ve seen through COVID and we’ve seen already through flu a tremendous risk of viral escape as the virus mutates. And right now, they require IV administration—expensive, time consuming, difficult. Again, not fit for global use. I think there’s a lot of excitement about some of the newer monoclonals that people are finding in camelids, things like camels and llamas. But those things are still programs in development.

And then on the vaccine side, we’ve had flu vaccines for a really long time. They are of—in a good year, of moderate effectiveness. And we know that we’ve been working on making and stockpiling flu vaccines for a long time. We’ve taken a look now on what is the capacity of the world to make flu vaccines. You know, and the estimates, you know, post-COVID range from four to eight billion doses. But that’s over a pretty long period of time. And the willingness of manufacturers to get in and stay in the game is really degrading since COVID. And I’m worried that it’s going to degrade further with some of the newer views about vaccine regulation coming out of the United States.

The other thing to really talk about here is that capacity is almost all egg-based capacity, and some cell-based capacity. We know those things are slow. We know that they’re bound to have all kinds of problems in development. And not sure that we can really count on a fast response with vaccines if we had to make H5 vaccines at scale right now. So that takes us to needing a better vaccine, a better antigen. And it takes us to needing to do something on a rapid response platform, whether it’s mRNA, or baculovirus, or some of the newer methods.

And I think this is right now where CEPI has been putting a lot of effort, working now on using artificial intelligence to design better antigens. You know, artificial intelligence—the first vaccine that was licensed for COVID by artificial intelligence was SK Bio in South Korea, called SKYCovione, with an antigen developed at the University of Washington and transferred there. We’ve been working with colleagues at Houston Methodist, and Harvard, and the University of Washington, and others to try to develop better antigens using AI, to transfer those into some of those rapid response platforms, and at least get to the point where we test out and can demonstrate, I hope, that they do better than the wild-type vaccine, and we take them through at least phase one so that if we have to press go, we can do it. Our view is you have to lean forward, you can never make up for lost time. And we don’t want to be in a situation of having to make up for lost time.

We’ve also been working with manufacturers around the world, because we all understand that you have to have distributed manufacturing around the world. And here, I’d say we’ve done some exercises and a lot of deep dives with a lot of them. And while we’re encouraged that there’s manufacturing capacity around the world, there are two really long poles in the tent that I think are relevant for this audience. The first is financing. Nobody’s going to do anything, whether it’s to make diagnostics, to make therapeutics, or to make vaccines, without somebody putting in early financing to take some of the risk away. The U.S. government did that in COVID. CEPI did that in COVID. But nobody’s making an advanced purchase commitment for vaccines for populations in the developing world.

The U.S. high-income countries, Canada, across Europe, Australia, et cetera, have made advanced purchase commitments for the existing platforms, and with manufacturers should they make—need to make a H5 vaccine. Nobody’s made an advanced purchase commitment for the group of low- and middle-income countries, that we saw very left out in COVID and we will see left out again. And even those manufacturers who can do it, aren’t going to do it without a country, or a bank, or somebody else putting in financing. When we’ve talked to those manufacturers, maybe there’s one that has a preexisting relationship with a bank where they could get a loan to get going and to share the risk, if they wanted to manufacturer risk. So if we talk about doing anything fast, even on a rapid response platform, the whole system of financing that and making the commitments to procure, and putting the market incentives in place to do it, just isn’t there.

The other thing I want to really highlight is the regulatory environment, which is pretty uncertain. So we all understand that if you need to make a flu vaccine, you can change the strain from year to year, if it’s in egg-based vaccine or in cell-based vaccines. But right now, the mRNA platforms, the baculovirus platforms, even if they might now have licensed vaccines, the regulatory environment is such that regulators will not accept yet anything that looks like a strain change, even if they have a flu vaccine. So that’s going to be a really big hurdle. And, again, it’s not clear what the changes at FDA and the regulatory environment are going to mean there. It may well mean that the U.S. and the FDA is just behind the rest of the world. It’s not a position I think we want to be in either. But I do want to point out those two big, long poles in the tent.

And the third, of course, is vaccine confidence. I think we’re all understanding very much the implications of that here in the United States. But we’re not alone in that. It’s, at this point, nearly entirely a global phenomenon that we have to contend with. So even if we had vaccines, and they’re great vaccines, and we have a way to give them to people, we need a way to restore trust in governments, as you’ve pointed out so well, Tom, and restore trust in vaccines. So I’ll stop there.

BOLLYKY: Great. I’m going to ask Nicki just a couple of follow-up questions, but I want to prime the audience because after that I will turn it over to you. So you can already start to raise hands and get in the queue.

Nicki, of course, for most people in a general audience like this, their familiarity with a pandemic and the use of countermeasures in a pandemic, of course, is from COVID. How would this look different? What would be different about an influenza pandemic, and how we would—the role of countermeasures, or who you’d need to give it to, when you need to give it to? What should we be prepared for? So that will be question one. Second is, since we’re not likely to be going back to January 19^th, either on the domestic level or the global level, you’ve mentioned financing and the regulatory environment, vaccine confidence, of course. What should we be prepositioning now? What is the—what are the most important things to do to preposition now, given this change in environment, you know?

LURIE: Great questions, Tom. And I would maybe think that the answers to some of those questions vary from country to country. But in terms of what this would look like now, you know, first of all, you know, there’s the question of the risk groups, right? And it’s traditionally older and immunocompromised people, children, and pregnant women who you need to worry about. And I think we would need to be in that situation again.

I think if a pandemic were to evolve right now in the United States, we would have tremendous—I worry that we would, at least in large swaths of the country, have tremendous resistance to the non-pharmaceutical interventions—the social distancing, the mask wearing. Those sorts of things that have been tried and true public health interventions for years and years and years. We still are not at the point where we’ve got a comfortable, inexpensive, highly effective, easy-to-wear mask for healthcare workers to protect them. And we’ve learned a ton about how to protect healthcare workers. We’ve learned a ton about a lot of this. We still have a long way to go there. And I think an awful lot of people would die before there was general acceptance of public health measures.

On the countermeasure front, I think for the U.S. it’s going to really depend on how rapidly the U.S. government decided to recognize that there was a problem and needed to invest or reinvest in developing these countermeasures and manufacturing them at scale. I can tell you that for COVID, you know, we at CEPI called the manufacturers we were working with before the sequence was posted. And we told them that when the sequence was posted we wanted them to shift gears and start working on a COVID vaccine. And, you know, two weeks later we had contracts in place. And three weeks later, we actually provided the first million dollars to Moderna, because there wasn’t a color of money in the U.S. And around about March, the U.S. got really serious about it and put Operation Warp Speed in place. And we all know what the results of that were.

So I think what it would look like next time really depends a little bit on that. But I would say that countries around the world don’t want to be in a situation anymore where they are reliant on the U.S. or reliant on countries in the Global North to be able to develop and make countermeasures. And so there’s a lot of effort now going on about not only surveillance, but I’m leaning forward in a number of those areas to do that, both in terms of manufacturing capacity, in terms of regulatory innovation, which is really quite interesting. And you’re seeing a lot of regulatory innovation come out of the EU. And I believe that we’ll see more regulatory innovation come out of the African continent really quite soon.

One of the things that I’m hopeful about is the financing environment. And there’s been a lot of talk about day zero or day one financing, which isn’t really day zero or day one. It turns out everybody’s got a definition of day zero that’s different. But the G-7 lenders, the G-20 lenders, all the banks, have really been getting to get—the World Bank have been getting together and saying, what does the financing environment need to look like so that we can not only help countries—which is what the World Bank does—but help developers and manufacturers take actions sooner than they would? They’re going to be looking for co-funding from countries. And particularly in the United States I think there will be a really open question about what the stance will be. I’ll stop there.

BOLLYKY: Great. Really helpful, Nicki.

I’m going to turn it over to the audience now. As a reminder, this discussion is on the record. I will call you in the order that you raise your hands. Please state your name and affiliation. Please try to limit yourself to one question, and make it sound like a question. Please, Anthony, you first.

OPERATOR: (Gives queuing instructions.)

We’ll take our first question from Anthony Yuen.

Q: Hi. Thanks so much for the talk. It’s really informative. My name is Anthony Yuen. I’m with the Clinton Health Access Initiative, but I work mostly on malaria.

My question is—so given the steep funding cuts that have affected—and the human and animal surveillance and research response capabilities that, you know, the speakers have talked about, both in the U.S. as well as in a lot of sort of developing countries that benefit from USAID, PEPFAR, PMI funding. I’m curious, you know, what other countries—are there other countries, and if so, which, that are sort of next-best positioned to be global leaders in terms of detecting, being prepared for, deploying rapid response, coordinating a global response to sort of avian flu? Is it the U.K., the EU, China? Curious. Is there an obvious player that would fill in a vacuum, if U.S. capabilities continue to deteriorate? Thank you.

BOLLYKY: Paul, do you want to start?

FRIEDRICHS: Yeah, if I may. I would say that, you know, from the perspective of the nearly two years that I spent working, first, on the NSC, and then in the Office of Pandemic Preparedness and Response, the short answer is there is no other country that has invested as much in global health as the United States. We have been the backbone. And in fact, we created many of these programs going back to the founding of the United Nations, and UNICEF, and the World Health Organization. There’s no question that some of these organizations, and I’ll say the World Health Organization is a great example, are in need of reform. There’s also no question that when the world faced an existential threat in 2020, the country that stepped forward with the largest investments to foster not only research but also manufacturing and distribution, was the United States. No other country stepped forward with similar scope or magnitude of capabilities and resources.

And I want to foot-stomp another aspect of that, Anthony, because beyond the resources—Nicki mentioned Operation Warp Speed. And there’s a misperception that, you know, somehow a decision was made in March, magic happened in May, and in December we had vaccines. And I’ve been told that the big lesson learned from this was that, you know, the United States will just bail everybody out again the next time that there’s an outbreak. That’s absolutely untrue. The reality of Operation Warp Speed was that it built on twenty years of foundational research funding at the NIH, and the National Science Foundation, and DARPA, and other agencies, on the specific virus that we were confronting in 2020. It also built off of decades of research into vaccine delivery and therapeutic platforms that the United States led the world in funding.

The brilliance of Operation Warp Speed was it de-risked the combination of what we had learned from those years of research so that manufacturers could take what we thought was likely to be the most promising candidates for diagnostics, therapeutics, and vaccines, and then test them in a way that assured that they were safe and effective before they were deployed around the world. But I think the key point there is that it took not just funding to do that, in an exigent event. It took decades of commitment to foundational research across the United States and around the world to have the knowledge that we needed to be able to move forward. And fortunately, two of the six vaccine candidates, as an example, proved to be incredibly safe and effective. And we’re not seeing any similar interest in any country around the world stepping up and funding the gaps that are being created with some of the resourcing decisions that have been unveiled in the last hundred days.

LURIE: I think what we are seeing is a number of countries, high-income countries, trying to start BARDA-like organizations. You know, you have HERA in the EU, you have SCARDA. There are a whole—

FRIEDRICHS: Canada.

LURIE: Canada, Italy. You got Japan. You got a bunch of those. But they are all very nascent. They don’t have that financing. But, to Paul’s really important point, they are all incredibly dependent on the years of scientific research and development in order to get to the point where they might develop and finance manufacturing—which is, in and of itself, a separate issue. You’re not going to do this without maintaining an incredibly strong, robust, creative scientific base. And I don’t think there are—is a country—somebody who is just going to step up and say, no, we fill in the gap. And frankly, we don’t want, as a country, to be in that situation either.

BOLLYKY: Great. Why don’t we take the next question? Monique.

OPERATOR: We’ll take the next question from Monique Mansoura.

Q: Good morning. Grateful to you all for your leadership. Mike, for your decades of mentorship.

Yesterday I was at CFR. And we were asking the question, who will pay for future weather disasters? And the question I asked them is the question I’ll ask you all now. We face a multitude of threats—global threats, national threats. You could also look at Africa and look at the epidemic of cancer and noncommunicable diseases. Nicki, I 100 percent agree, financing is the number-one issue. It’s not a new issue. It has been a perpetual issue for this mission since its inception, early after 9/11. What are your perspectives on lumping versus splitting the investments that we make in risk mitigation, and how we engage communities to not just focus on the threat of the day but really the collective threats that a community or corporation faces, and doesn’t have the luxury of being able to just pick or finance one? And what metrics do we have? Because that’s key to the financing piece, is knowing that your investments is going to lead to an enhanced state of preparedness, or protection, or risk mitigation. Over.

BOLLYKY: Great. Mike, do you want to start on broadly surveillance systems?

OSTERHOLM: Well, yeah, first of all, you know, you could—you have to unpack a lot of things here, so let me try just to summarize it. Remember that influenza and coronaviruses are both unique kinds of infections, where we have not had any evidence of historically durable protection occurring as a result of either infection or necessarily from vaccine. And so this isn’t as simple as a mumps, measles, and rubella kind of picture, where some people think you just invite a bit of vaccine, give it one time, and you’re done and out, OK? So one of the challenges we have is we always are going to have to be prepared to respond to that particular pathogen causing the pandemic at the time we have it. Remember, in 2009 we had an H1N1 vaccine that already existed, a seasonal flu. And yet, when the new pandemic strain emerged that vaccine was not protective, and we had to come up with a new vaccine.

So the point of it is, will we have to come up with a new vaccine, as such, at the time of the recognition of the pandemic? And I will just disavow anyone right now the thought that we can prevent pandemics. If you’re going to have either influenza or coronavirus emerge, they’re going to emerge. And by the time you pick it up, they’re long gone. They’re out the door. And so we have to be prepared at that point. The ideal would be to have a vaccine that covers across a variety of different antigen types in such a way that—in fact, this is where we often use the term “universal influenza.” And I just want to say today I am really concerned and challenged more than I was yesterday about this because of the announcement from the White House yesterday, about this heavy investment now that they’re making in this 1950s technology for a vaccine. We’ve already been there, done that. And we know that basically chemically treating whole virions, the virus itself, actually results in loss of epitope-based protection. And I don’t know that—I worry that we’re now going to focus all on just that.

Our center has led this issue for the past ten years doing vaccine roadmaps for influenza and coronaviruses. And this is not an easy, simple slog. This is like building an aircraft carrier. As Paul can tell you, once there is a commitment to build an aircraft carrier, it’s a fourteen-year process, minimum. And you’re committed from day one to go fourteen years. We fund influenza vaccine research by the year or two year time period. And that doesn’t result in a long-term commitment then it has that. So I think we have to fundamentally change how we look at pandemics, how we look at the vaccines. We need long-term investment. We don’t need short-term. We’re going to need to do a lot more work to figure out just which antigens might give us more durable protection. And, as Nicki pointed out so well, and in the end, it doesn’t matter if you have the best vaccine in the world. If you can’t make it or you can’t get people to take it, it’s just a vaccine. It’s not a vaccination.

BOLLYKY: Paul, did you want to say something quickly?

FRIEDRICHS: If I may, just to expand a little bit on what Mike said there. You know, I do commend the new administration for taking a hard look at the R&D portfolio. We spend tens of billions of dollars on research projects. And it—you know, I can vouch for the fact, we tried for a year from the White House to get visibility into what we, the United States government, were paying for. And it was incredibly difficult. And it should not be. There should be much greater transparency in what each department and agency is spending money on. And in fact, when we looked at it there appeared to be some real opportunities to rationalize the portfolio. Do we really need forty-eight federally funded trials on a particular question? Could we maybe get by with just forty, and spend that money on things that we’re not spending any money on right now? Those are the right questions to ask if we’re going to really thoughtfully get after this question is, what are the threats that are out there? And as Nicki and the CEPI team have really done an exceptional job of.

We should be trying to develop countermeasures for all of the pathogens of pandemic potential, and at least have those available, ideally, for phase one testing, but at a minimum have those designed computationally so that when there is the next unexpected outbreak we’ve already done that foundational work and can move quickly forward. So I commend the administration for wanting to take a hard look at the R&D portfolio. I think that is actually well needed. We tried to do that and there’s much work still to be done. I hope that it will result in a very broad, well-balanced portfolio that mitigates multiple threats going forward. Thanks.

BOLLYKY: Great. We have four questions. I want to make sure we can try to get to them all. So I’m going to take them in twos. So first Alex and then Henry. And if you keep your questions short, we should be able to get to everyone.

Q: Hi. Alex Wallace (sp) from ESA Business School.

Very quick question for Nicole. And that is, you said that there’s no mask—easy-to-use mask for healthcare workers still. And I’m just curious, that seems like of all these issues an easy one to solve. Why has that not happened?

BOLLYKY: Great. Henry.

Q: Hi. Henry Willis with the Meselson Center at RAND.

And I would welcome if the speakers could say more in the context of avian flu events if they see any gaps in bio-surveillance that might be emerging, or new capabilities that maybe should be developed?

BOLLYKY: Great. Nicki, do you want to start with the one directed to you?

LURIE: Sure. I mean, on masks—I mean, we’ve come a long way. There are mask designs out there. We understand a lot more about the science. But, you know, the issues are mostly about money, about how much are you willing to pay for these, who’s going to manufacture them at scale, how are they used in general day to day. And, frankly, now the supply chain, where do they come from? You will recall in COVID we had a lot of issues with domestic supply. And I think it’s often a lot more exciting to put your energy and effort into other kinds of technologies and scientific developments than it is something as simple as a mask. But as long as I’ve been in this business, we haven’t solved this problem. We’ve come close. We’ve gotten closer. But we are not there. And particularly protecting first responders and healthcare workers in the next pandemic is absolutely an imperative.

Henry, I think to your question, I think, gosh, there’s lots of gaps in bio-surveillance, both on the human side and on the animal side. And I would say it is—in surveillance itself, it is in the analysis of data and it is in the sharing of data. And there are gaps—and then using the data. So I think there are gaps in all of those steps along the way. I think there are a lot of people who feel like there’s a lot of appeal in some new-found methods in terms of—and there’s a lot of attraction in AI and others. All of these new things still have this really big problem of being able to separate out signal from noise. And I want to highlight that in particular because each time we hear about a new way of doing things, it’s really a question about signal to noise. And the more you get bombarded with noise, the more you disregard the signal. And, you know, we can’t be there.

BOLLYKY: OK. Mike, Paul, anything to add on bio-surveillance? Does layering help us get rid of the noise, or does it add just more noise to sort through? Mike, please.

OSTERHOLM: No, I think, first of all, surveillance is a critical piece. And we could do so much better in this country if we, in fact, have that kind of electronic medical record connection and if we put resources into surveillance. You know, while it wasn’t a frequent event, during the last pandemic we had fax machines serving as a primary means of communication between local and state health departments and hospitals. You know, what are we doing with that? So I think that there’s much more we could put in together here. Again, remember that all bio-surveillance is going to do is tell you, you now have a pandemic. It’s not going to help you prevent it. OK? You think of it that way. And so the point, though, is that the earlier you can intervene, whether it is basically securing a vaccine, but preparing the public for what they can do in terms of mitigation from what we call that kind of, you know, public health intervention, I think that surely is what’s going to be important. I don’t anticipate we’ll have the ability to vaccinate large proportions of our population within day one of a pandemic.

FRIEDRICHS: I would just add to that, that on the surveillance front I’ll offer a note of optimism. I think it is absolutely plausible that within the next three and a half years the United States could have the best bio-surveillance system in the world. We have all of the attributes. We have a remarkable ability to share information, when we choose to do so, and some really outstanding research being done in this area. And to Nicki’s point about signal versus noise, some of the most exciting research is being done in the computational space, especially when it comes to wastewater and environmental screening. We also have some tremendous knowledge that we’ve gathered on how to improve safety within buildings, which we’ve not acted on, which could fundamentally change the risk calculus for schools and for other places where you have a lot of people in a small space so that during the next pandemic there’s no question about whether people go to school or not, because we’ve adapted the schools in a way that they are a safe environment in which children can continue to learn. Those are all doable today, should there be the will to do so. So I’m actually optimistic that it is quite possible to leverage that.

On the PPE front, I’ll tell you that I was deeply saddened yesterday to see that a grant that we had worked very hard to help the CDC award to the National Academy of Science was canceled. One of the big lessons learned from this H5N1 outbreak was, as imperfect as the masks are that we have for health care workers, they’re awful for people who are working on a dairy farm or in a poultry operation. And, I mean, just awful. And, you know, we had firsthand experience talking to workers. And they’re, like, look, you know, we won’t wear them because it’s actually worse having them on than not having them on. And so we had spent a lot of time designing a study, the National Academies had agreed to take the lead on this, to bring in the world experts, spend several days coming up with the state of the art on how to improve PPE specifically for those at risk from H5N1. And that was just canceled yesterday, which I think is a tragic step backwards for a problem that we know is not going away.

BOLLYKY: Great. Syra, Margaret, if you can you keep your question to about twenty seconds each, we’ll let everybody respond quickly.

Q: Absolutely. Thank you. So, Syra Madad. I work at New York City Health and Hospitals as a chief fire preparedness officer.

My question is, so President Trump, you know, has his—you know, he shared his tariff plan, and in particular China is retaliating with 84 percent tax on American imports. And we know that 90 percent of our PPE still comes from China. Right now we’re in a period of lull for H5N1. Obviously, we’re still seeing a lot of activity but in terms of human cases we haven’t seen any confirmed yet. And obviously, you know, that that could be underreporting, or whatnot. But we have this period right now. And I worry that when we get back to bird migration season this upcoming year, we’re going to start seeing explosive amounts of cases again. So what are your thoughts, just, you know, on the PPE front, just going with that particular topic as working in healthcare? Obviously, we don’t want to see mask shortages again, but the fact that there’s this new tariff now into this—you know, this plan, what are your—what are your thoughts just on that?

BOLLYKY: Great. Margaret, quickly.

Q: Yes, thanks. Margaret Manto with NOTUS.

Could you talk a little bit more about how you’re seeing vaccine manufacturers responding to the, you know, slightly more hostile regulatory and funding environment where they’re also being pushed to bring manufacturing back to the U.S.? Like, how are they handling that?

BOLLYKY: Great. So to our speakers we are at time, so we have about two minutes I can probably get away with extending, but that’s about it. So that’s collectively. So turn it over to Mike to go first.

OSTERHOLM: Yeah. Let me just say on the mask issue, first of all, we’re talking about N95 respirators, just to be clear. And actually, we have a high level of capacity in this country to make those. And in fact, the respirators that are made in Asia actually often have different face sizes that are more adapted to that population. And so therefore we don’t import very many. We actually use a high level of capability here in this country.

I think the second point, though, that we just remember that about 90 to 94 percent of all N95 respirator use in this country is for industrial use; is not related to infectious diseases. And so the capacity is actually there to shift some of that in a time of great need. But like we just talked about with vaccines, companies are not going to invest in keeping lines open making N95 respirators until the day that there’s a purchase order for those to be delivered. And so that’s the challenge we run into right now.

BOLLYKY: Great. Paul, Nicki, twenty seconds each on the vaccines.

FRIEDRICHS: I was in California two weeks ago meeting with CEOs of some large pharmaceutical companies. And they are mystified. They are trying to understand the evolving dynamic. I think we’re seeing this not just in the pharmaceutical industry, but multiple companies that are withdrawing their—got their financial guidance for this year, because they’re trying to understand what’s happening. Until there’s greater clarity in what the United States is going to do, these companies are stuck in the unenviable position of being asked to do things without understanding the environment in which they’re being asked to do them. And they are very willing. They’ve been great partners in previous outbreaks, and I think will continue to be so. They just need some certainty about what it is that the United States market is going to look like.

BOLLYKY: Great. Nicki.

LURIE: I think “certainty” is really the key word. And they need that early in the game. Yeah.

BOLLYKY: Terrific. This has been a really rich session. I am grateful to our speakers. I hope you all are as well. And really appreciate their time, and expertise, and sharing it with us today. Thanks very much, all. See you soon.

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