Twenty Years of Project BioShield

This transcript is from a CSIS event hosted on July 11, 2024. Watch the full video here.

Julie Gerberding: Welcome to CSIS, where today we’re celebrating the 20th anniversary of BioShield and its legacy. I’m Julie Gerberding. I’m the CEO and president of the Foundation for the National Institute of Health, but I also wear another hat as the co-chair of the Bipartisan Alliance for Global Health Security together with my co-chair, former Senator Richard Burr.

The BioShield Act was signed into law in 2004, but it was really precipitated in the aftermath of the anthrax attacks in 2001. And I look back on that time when I was at CDC not with fond remembrance, because that was really a wakeup call to our nation that we really needed to take bioterror threats seriously and we need to had – we needed to have a comprehensive approach to dealing with chemical, biologic, radiologic, or nuclear threats.

So that was really the opportunity to take advantage of the wakeup call and recognize the need for some true innovation in the way we approach countermeasures for these CBRN threats. I don’t like to think of a silver lining, but I do think that what happened in the construct of BioShield really was an exemplar of innovation in the setting of crisis. And for the past 20 years, it’s really proved the value of that initial investment.

The delivery of bioproducts or countermeasures from BioShield has, I think, surprised everyone. I think there have been 37 programs initiated and the stockpile has already benefited from 27 of them. So that is a remarkable achievement to prosecute a portfolio of agents and get them into our Strategic National Stockpile in that period of time.

Now, BioShield was established in 2004. The Pandemic and All-Hazards Preparedness Act, PAHPA, actually provides the authorization. And it’s that authorization that will be one of the topics we discuss today because we have not yet reauthorized PAHPA, and that creates some uncertainty and some vulnerabilities in the program. And that’s one of the reasons why we wanted to have this roundtable, to really dive into some of these leaning-in issues that will be relevant as we go forward.

The congressional markups look like BioShield will fare fairly well compared to other agencies. I think there’s a proposed $10 million plus-up, but that may not be enough. So we’d like to talk a little bit about sustainable financing and what that really means, the balance between the threats we are anticipating and the investments that we’re able to make.

And I think we also recognize that we’re in an election year. We will have new congressional members coming up. Many of them are not familiar with PAHPA, many of them are not familiar with BioShield, and some of them may not even really be familiar with the legacy of the last 20 years in the aftermath of the initial investment. So we’ve got to pay attention to the lessons that we’ve learned from COVID-19, but we also have to learn from our experience in executing BioShield and ensuring that we can sustain it.

So I’m joined today with my co-chair, former Senator Richard Burr, who is currently the principal policy advisor and chair of the Health Policy Strategic Consulting Practice at DLA Piper. Did I get that right?

Senator Richard Burr:

 Good job. I can’t remember now. (Laughter.)

Dr. Gerberding: And certainly has been an incredibly valuable member of the Alliance, and his leadership and his experience have really served us well. Senator Burr really was instrumental in not only the legislation that resulted in BioShield, but also the original PAHPA legislation. I think we kind of think of him as the father of our biosecurity in the United States, at least from a congressional perspective.

And our other guest, Dr. Gary Disbrow, is the deputy assistant secretary and the director of the Biomedical Advanced Research and Development component of Health and Human Services, and is responsible for executing on BioShield. He really joined BARDA in 2007 and has led the advancement of a number of those products that are currently in the stockpile or on the way to the stockpile.

So we’re going to dive into some of these issues, but I wanted to kind of start with a look back with you, Senator. Kind of looking back 20 years, what do you see as the biggest accomplishments of BioShield? And what are your overall reflections on the value that it’s brought to our national security?

Sen. Burr: The biggest accomplishment was that I did this at 14 years old. (Laughter.) I was – I was a bright young man.

No, listen, as you described, BioShield was really the byproduct of an anthrax attack and an imagination that said what else can happen. And we’d come off of 2001, where our imagination from a standpoint of what terrorism could do wasn’t as big as it should have been. So I think members thought very big then, and we thought about all the different threats that could come at us, and as you and I have talked before, focused – not only it was anthrax in the rearview mirror, but H5N1 – it’s strange that we’d be talking about it again – was also a concern that we had. And I like to say that we went through a three-year period of legislating where we accomplished some really, really big things really outside the box for government.

And Gary and his predecessors have done a wonderful job of shepherding the mission of what BioShield was there for, and they deserve all the credit in the world. But you know, as you’ve alluded to the 20 years has not been a smooth interstate highway. Members of Congress have very short memories, and when there’s not an immediate threat the first thing is they think about reducing the funding levels. And as Gary knows, it’s a – it’s a struggle to try to leverage the federal dollars with everything else in the marketplace to get innovators to create a product that can become a countermeasure. And we have to do that at a time where we don’t necessarily know what the need for the product’s going to be. So they really do tie it to our ability to purchase, and if there’s not a purchase then you diminish the enthusiasm by the private sector to participate.

I think, Julie, when we created BARDA we believed that big pharma would jump up and say, yay. I’m sure Gary’s heard from his predecessors that’s not what happened. Big pharma ran because they’ve been in bed with the federal government before and it was not a – it was not a pleasant experience. So BARDA and the directors have built this from scratch, and it’s about relationships with innovators all around the world specifically trying to develop technologies that address threats that were designated, believe it or not, by the Department of Homeland Security and not by the health-care community.

Dr. Gerberding: So you have not been there all 20 years, but you’ve been at least watching for 20 years and accountable for most of that time period. What do you see as the biggest – what are you most proud of?

Gary Disbrow: So, as the Senator mentioned and you mentioned earlier, the number of products that have been supported. So of those products, we have 26 FDA approvals of 22 products, because our mandate is that we also support indications for special populations so some of the – some have been originally licensed for adults and then we get the pediatric indication.

The collaboration we have in the interagency. So several of those products transitioned from our colleagues at NIH, Department of Defense. CDC was involved in many of the assays that can only be done at the CDC for some of our products.

And the ability to have those available. So they are now licensed and they are available in the Strategic National Stockpile, and that is the quickest response. And for the threats that we’re facing it’s going to be an immediate event with tens to hundreds of thousands of people being exposed, so you have to have the products available immediately.

But as the Senator mentioned, it was not all, you know, smooth sailing. At the beginning under Project BioShield we were limited to firm-fixed-price contracts, and that’s why I think we couldn’t get large pharma involved. And so a firm-fixed-price contract in the government puts all the risk of development on the developer, even though there’s a guaranteed procurement if they’re successful. And so with that type of contract they ran into development issues and they couldn’t raise private capital to overcome those issues, so we – you know, the contracts were down-selected.

And then you mentioned PAHPA. That has been the biggest boost for the success of Project BioShield because it allowed us to invest in advanced research and development and de-risk development for our partners, and we could support them under advanced research and development until they had the dataset that the FDA requires for potential use of the product during a declared emergency, and then we could transition those successful programs under ARD over to Project BioShield. So there was a much lower risk.

So I think just the ability to say that we now have those products available, that it was an interagency collaboration, and then of course a collaboration with our private-sector partners.

Dr. Gerberding: So you and I, Senator, have written an article about the importance of reauthorizing a lean PAHPA. It apparently didn’t have any impact so far. (Laughter.) But tell us why that’s important in this context.

Sen. Burr: Because PAHPA is the architecture for everything that goes on in BioShield and our biodefense mechanism. And I think members who are new to Congress might think, well, this has been around for 20 years; do we really need it anymore? And the fact is, Julie, that every five years for reauthorization of PAHPA we looked at what worked and didn’t work and we made the change every five years.

When PAHPA was created, only the President of the United States could declare emergency use. And in one of the instances – I can’t remember which one of the threats – we ran into a situation where there was a delay at getting the President to sign off for pediatric use, and we actually had 30-plus kids that died because of it. Immediately, in 2017, we changed it and we moved emergency-use authorization to the FDA director.

And what I want members to understand and the public is that this is a great example of how Washington is supposed to work; that we look at what actually happened, determine what was successful, change what was broken, and make the change permanently in the legislation. And I believe even under the proposal that we’re looking at, they’re making changes in PAHPA that I think might be positive based upon what we’ve learned.

Dr. Gerberding: Well, that – the spirit of bipartisanship is something that perhaps was an obvious government requirement in the context of 9-1-1 and then the anthrax attacks that followed, so you had kind of the advantage of the crisis to really drive that alignment. What do you think happened? Because we’re certainly not there today.

Sen. Burr: Well, we’re not there today because I think that people have chosen where they can to make threats political to some degree. And the truth is that there is no right or left in a pandemic. When COVID hit, nobody asked when you went in are you a Republican or a Democrat. Nobody on Capitol Hill looked and said, we got to – we’re going to do this or we’re going to do that based upon whether you’re red or blue.

The challenging thing for us is to educate members of Congress why this early intervention is absolutely so important. I’m convinced today that if the architecture of PAHPA hadn’t existed there’s no way we would have had a vaccine in 12 months because we would have still been trying to figure out the process of authorities that you had to go through. But PAHPA provided the certainty. And the administration chose it, ran it; 12 months, we had a vaccine.

I wish it was that easy with all of them. But as Gary knows, these – the development of countermeasures is a very lengthy process. And it’s one that when you lose the trust of either side of the partnership, then it just drops.

Dr. Gerberding: You know, the concept of all hazards is – you know, that’s a very big universe, and we know some hazards and we can imagine some hazards, but many of them are situations where we don’t have time to take 12 months to manufacture something.

Dr. Disbrow: Right.

Dr. Gerberding: These are instant threats. CBRN – you know, chemical, radiation, nuclear – you need things now. You can’t wait 12 months to put out a countermeasure. So how are you thinking about refreshing that capability? And how do you choose which threats you’re going to go for first?

Dr. Disbrow: Well, so when we started, I mean, we looked across the programs that were in early development at any of our interagency departments that we could pull forward and advance those. The first product that was licensed, the PBS-supported product, was in 2012. That was Raxibacumab, that we developed with GSK, an anthrax antitoxin.

And so we look across the threat space and we now have 21 MTDs – material threat determinations – that have been issued by the Department of Homeland Security. We look at where we have gaps. We look at our requirements – is it a vaccine and a therapeutic and a diagnostic; for chem, it’s not; it’s mostly treatments for individuals who are exposed – and try to make our investments impactful for where we have gaps.

But as you mentioned, it’s sustaining those, replenishing those. And as the Senator mentioned, it’s a long process. We need to be a good partner with industry to show them that we are committed to this long term; and then, once we’re manufacturing the products, be able to partner with the companies and give them a 10-year horizon on what our potential procurements might be. And that’s very difficult when we have annual appropriations because it’s – we’re uncertain if it’s going to go up or down. We always hope it goes up. But we really have to be able to provide that sense of commitment to the companies so that they know what scale to manufacture at and what capability to maintain.

So we could be very good at having capacity, but capacity is a building and tanks that you can manufacture stuff in; it’s not the people. Capability is the people, meaning that if something happens, you know, they can immediately start manufacturing. You don’t have to hire and bring people like we did for COVID in many of the companies that we were working with. But – so that they can turn that on immediately. But again, having them available in the SNS – licensed products that can be immediately deployed – that is the key for true preparedness.

Dr. Gerberding: And then replenishing them when the expiry –

Dr. Disbrow: And replenishing them, correct.

Dr. Gerberding: Yeah.

Sen. Burr: And, Julie, remember that we – all of this happened not in a static world. The amount of international air travel that increased from 2004 to today is phenomenal, so you couldn’t design the risk based upon then and apply it now. So Gary and everybody who works on this has to take into account the societal and global changes that have happened. And where we might have had two years to prepare for COVID if there wasn’t this international travel, we had a matter of days, weeks, or months.

Dr. Gerberding: And that’s going to be the case going forward.

Sen. Burr: Yeah.

Dr. Disbrow: It is. And if I could just build off that, the original MTDs didn’t anticipate state actors. And you know, that is a huge concern today and probably moving forward. So we are working with the intelligence community to reevaluate the current threats that we have MTDs for, as well as look at the landscape of potential new threats.

Dr. Gerberding: That flexibility in a year-to-year budget environment is really hard to sustain, isn’t it?

Dr. Disbrow: (Laughs.) It is.

Dr. Gerberding: As you know what you need to do, but you – and you have to complete the job you started, but at the same time you have to be able to flex and anticipate what might be coming next and make sure that you can start the process of addressing that.

You mentioned war manufacturing, really, the ability to turn on manufacturing on a dime when you need it, but there are other things going on in the world of manufacturing as well; for example, the Inflation Reduction Act and some other legislation that’s affecting how our life-sciences companies are approaching their manufacturing plan, their nearshoring, as we saw with the supply chain issues in COVID-19 and the political surround of all that. How is that affecting your decision-making?

Dr. Disbrow: So we’re always – through COVID, we made significant investments in onshoring or expanding domestic capacity. So through the Industrial Base Management and Supply Chain Division within ASPR, they have invested $17 billion for domestic production of APIs, PPE through BARDA and our Pharmaceutical Countermeasure Infrastructure Program. We made over $3 billion investments in active pharmaceutical ingredients, BSL-2 lines, vials, needles, and syringes, all the active starting ingredients to manufacture those, especially for mRNA.

My concern moving forward is, again, you need substantial dollars to sustain that infrastructure that we established. And I’m already concerned that without dollars, the companies can’t maintain the people and the space, you know, without additional funding. And so we have a real chance that we’re going to go back to where we were in December of 2019, because we’re not making those additional investments to sustain it. But we always look for the best technology when we’re investing. We are looking primarily in the U.S., through our contracts. If it’s a company that is located overseas and they manufacture overseas, we work with them to try and transfer that technology to the U.S. for manufacturing.

It’s easy to do in some cases, much harder to do in other cases. Especially for, like, antibiotics, which have limited manufacturing capacity here in the United States, because it’s specialized, often takes a single manufacturing facility for one compound. But we are trying to make sure that is onshored, or at least if the API is manufactured overseas is that we still finished here so that it is here in the United States.

Dr. Gerberding: Does the outlook for your funding support your confidence that that’s realistic?

Dr. Disbrow: So for the sustainment of what we made investments for COVID, no. I saw the House markup as well. Pleased to see in the current environment a modest increase for Project BioShield, a modest increase for the Strategic National Stockpile – which is also responsible for replenishing these products. The way I look at it is the funding that is necessary is on the order of funding that the Department of Defense gets. So the Department of Defense has an industrial base that is completely here in the U.S., and it fulfills all of their requirements. I know we’ll never be able to get that level of funding, but it is going to take significant funding if they truly want onshoring and everything manufactured here. It was a 50-year process offshoring pharmaceuticals. And pharmaceuticals is a global industry. It is going to take significant time and money to bring that back.

Sen. Burr: And what did we learn in COVID? Logistics is important. And it was a logistics nightmare. And I will say, it’s the one area that I’m concerned that we didn’t learn from, because we’re not doing the things today that – outside of Gary’s mission – but we’re not doing the things today to make sure that we don’t have a similar logistics problem, even if the threat and the countermeasure is totally different.

Dr. Gerberding: Well, you know, you’re talking about onshoring our capacity and our capability. But the threats may be offshore. You know, the source of the threat very well is somewhere else in the world. And what we’re doing with U.S. taxpayer dollars is primarily focused on securing America’s biosecurity. But we’ve seen examples where the assets that you have accomplished have actually had global relevance. We just used mpox as an example, where the – or, the smallpox vaccine that is in the Strategic National Stockpile was used successfully for mpox. So how are you factoring in, or what is the authority that you have to really include that dimension of planning in your – in your MTDs?

Dr. Disbrow: Yeah. It’s a – it’s a great question. So we purchase to fulfill the USG requirement. And this goes to a very important point, is that the manufacturers we work with, our partners, establish manufacturing capability to fill the USG requirement. And so we really need our international partners to leverage the significant dollars that we have invested in the development of these products and also stockpile those products. Because what that does is it sends a signal to the companies that they can expand their manufacturing capability so that it’s larger than just the USG need. An example of where that worked really well is the Merck vaccine, Ervebo.

Dr. Gerberding: Ervebo. (Laughter.)

Dr. Disbrow: Tongue twister. So we worked with Merck and Gavi, and were able to establish an international stockpile. So we shared the capability that we established with Merck for manufacturing. And now there is a global stockpile as well as the U.S. stockpile. And that really supported the sustainment of that manufacturing. And, as you mentioned for Jynneos, that’s an example where, you know, it didn’t go as well.

Dr. Gerberding: Smallpox.

Dr. Disbrow: Yeah. So when mpox arose and it became prevalent in countries that – where it was not endemic, there was an immediate shortage of the vaccine because they were only manufacturing vaccine at a level to meet the USG requirement. And so at the time countries made small procurements but there had been no additional sustained procurements from those countries. So the company can’t really expand its manufacturing capability because there’s no guaranteed purchase from any other country besides the U.S. government.

So we really need to have our international partners leverage what we have invested in, the products that we have developed, so that there is a bigger market. And we don’t always have this issue of any time that there’s an event, and it could even be a small event, it’s going to lead to an immediate shortage of product.

Dr. Gerberding: I want to come back to your –

Sen. Burr: But this also – let me just say this. This also spurs the need for us to really focus on small molecule oral countermeasures, because our ability to produce them isn’t limited to sophisticated manufacturing that we find in the United States. A lot of things you can 3-D print today. And if you’re not having to ship things over, and you can just download and start, it changes the whole game. But it doesn’t address the really sophisticated items that are long in development.

Dr. Gerberding: Yeah, the long – the large molecules, the vaccines, those are tough. And I want to come back to Ervebo in a minute, but you’re mentioning this importance of engaging with global partners to, you know, participate in the manufacturing interface. What are the mechanisms for doing that? How do you actually translate that great idea into something that creates a policy environment where that becomes more feasible?

Dr. Disbrow: We have multiple communications and engagements with groups like HERA, which is now in Europe doing similar things to what BARDA is doing. SCARDA, which is in Japan, again, doing similar things to what BARDA does, but, you know, for their respective countries. And letting them know, you know, what we have licensed, helping them through the process. Because I know what it was like, you know, starting an agency – or, well, a division within an agency in 2007. I think I was the fourth federal employee hired on the CBRN side. (Laughter.)

So it’s – they have a lot of, you know, issues, and they’re trying to work through those issues. But really just trying to help them understand contracting and what is an incentive for industrial partners, because we’ve had a really good track record working with our industry partners. But really is to just share information. You know, we do it with CEPI, with HERA, with other international groups, with some countries like Israel, to let them know what we have available and also encourage them to take advantage of, again, our significant investments that we’ve already made.

Dr. Gerberding: Are the private sector companies participating in those conversations?

Dr. Disbrow: They do.

Dr. Gerberding: Yeah.

Dr. Disbrow: We introduce them, you know, to the companies so that they can have those conversations. Some of it is most of the products – well, the products that we’ve supported are primarily licensed in the FDA. For HERA to purchase products, they need those to be licensed by EMA, for the European Union. And so they have to work with the company, because it’s kind of like a chicken and egg scenario. The company doesn’t want to go through all of the work to get an EMA approval if there’s no purchase, and HERA will only purchase if there’s an EMA approval. So really working with them to identify ways that they can work through that, you know, perhaps a tender that, you know, there would be a guaranteed procurement if you did get EMA approvals.

Sen. Burr: We’re getting rid of chickens, remember that.

Dr. Disbrow: Yeah. (Laughter.)

Sen. Burr: You know, it’s because of BARDA that we went from egg-based to cell-based vaccines.

Dr. Gerberding: Yeah. Ervebo. You know, we’ve just seen in COVID, 12 months from start to vaccine. And obviously that didn’t happen because we had no preexisting science. It happened because it was building on science and evolution of vaccines that had already been in progress, based on the 2003 SARS outbreak, the coronavirus work also related to MERS. Ervebo actually is a little bit like that. A lot of people don’t know that Ervebo really got started by the Canadian government. The initial virology was worked out – or, the vaccine immunology was worked out there. And then a small biotech company in Iowa picked it up, and we’re in the process of developing it, when we needed it, and able to fast forward. Merck, in short notice, was able to cooperate with that company in Iowa to move it forward.

And I bring this up only because it illustrates the complexity of getting from point A to point B in a vaccine world, but also all of the players that build the science and really participate in the partnerships that have to come into fruition. It’s complicated. And it –

Sen. Burr: Yeah. And the cautionary note is we saw something in COVID vaccine manufacturing that some of us in Washington thought we’d never see, competitors that made somebody else’s vaccine. We would make a real mistake if we thought that was the pathway forward permanently. So we’ve got to take into account that we may never see that again. And that’s why, as we think about – as they think about – (laughter) – I can point to him now. As they think about manufacturing in the future, this is not just about domestic manufacturing. It’s about having the capabilities to manufacture globally.

Dr. Gerberding: A network.

Sen. Burr: It’s got – it’s got to exist.

Dr. Gerberding: And yet, even in that situation where, you know, we didn’t need a global population worth of vaccine, we needed to solve a particularly severe outbreak in Western Africa, the manufacturing was still a bottleneck. And, you know, kind of had to repurpose and act fast. And I think what we learned during that period of time when I was at Merck, when this was all happening, we learned that in a crisis companies will do what they can do to be helpful.

But then when they do their after action and they look at what – you know, what did that cost? What was the opportunity cost of that engagement? Everybody was proud of the contribution that it made, but the opportunity costs have to be factored into this. So the more you can plan, and procure in advance, and stabilize, reduce the need for an emergency, the better off we all are. I don’t think we should count on industry to always be able to jump in in a crisis and help. It’s just not realistic.

Dr. Disbrow: Yeah.

Sen. Burr: And, Julie, there’s also a point here that you’ve got – your memory has to be long. (Laughter.) When we first started gaming the response for anthrax, we learned a really, really important thing. If anthrax became a national concern versus a city, how do we distribute cipro? We went to great lengths and, through a process of elimination, what wouldn’t work, we ended up with one thing – the U.S. postal service.

Dr. Gerberding: The Post Office.

Sen. Burr: Now look at the process we went through to determine how we were going to get COVID testing out. And thank goodness – we lost a couple of months – but finally they said, Post Office. I mean, we learned that in the early 2000s. And that’s the advantage to having this information memorialized and individuals who have been there for a while, because most of the things we’ve run into we anticipated.

We saw with H5N1, when the first threat came up in the early 2000s, that manufacturing capacity was a problem. So what did we do? We invested in three partnerships with private sector companies to build vaccine manufacturing facilities designed so if H5N1 became an epidemic or a pandemic, we would automatically go in and take over the plant, and we would make production just for the U.S. population. And over a 15-year period – only one of them existed when we got to COVID.

Dr. Disbrow: Yeah. And if I could just – building off that point, you know, the global network of manufacturing – we also have to make sure that it’s right-sized. Because there’s a lot of interest in countries having their own manufacturing capability. And so there’s a lot of efforts going on in Africa, fully supported, the hub and spoke model. But we need to make sure that whatever we build there is sustainable, and understand, you know, what vaccines they’re going to make on a routine basis, so that they can be sustainable. Or else we’re not going to have those facilities in a couple of years.

And so it’s really about making sure that, you know, the investments are correct, that we’re right-sizing the facilities, that they’re manufacturing things that can sustain them inter-pandemics, or we’re going to have an issue again. And then one other point that you made about COVID and the manufacturing is, I always – everybody thought we would be able to do the clinical trial. Didn’t know what the results were going to be. But manufacturing, as you mentioned, was still the biggest risk. And, you know, we were able to get it done, but it’s a huge risk.

And so moving forward, I am hearing many groups talk about emerging infectious disease that will take it to phase two. That’s OK for the clinical aspect, but we really need to validate at commercial scale the manufacturing process because if you don’t do that you’re looking at lead times of 12, to 18, to 24 months to ramp up that manufacturing to commercial scale. And we don’t have, you know, that time during a pandemic. So while we’re doing the phase one and the phase two studies, we also need to focus on the manufacturing aspect of that.

Sen. Burr: And we also went to great lengths, you might remember, because 50 percent of our available vaccine required a freezer storage. And we went to great lengths to produce freezers all around the world to be able to store the Pfizer vaccine.

Dr. Gerberding: Yeah. You know, you’re talking about sort of memory. And you’re talking about the challenges of manufacturing. But when you put these things together, the first thing that comes to my mind is exercising. And when we exercise, we exercise a lot of things. I always feel like in the – during my time in government, we spend a huge amount of time exercising for an influenza pandemic based on the H5N1 situation that was popping up now and then during that period of time.

And we exercised a lot of dimensions of it, but we didn’t exercise things like how many ventilators and what we were going to do about that. We didn’t exercise the manufacturing challenges that would be necessary to really get to global scale. So even in a, you know, very well-developed, three-year curriculum of exercising for a pandemic, there were still things that we didn’t – we didn’t complete. And I think that exercising isn’t a routine. We don’t do enough of it. And we don’t involve all of the sectors that would need to come in play.

The other thing that we didn’t exercise, just to be complete, is the fact that we were going to need to provide economic support for people who were asked to quarantine or isolate. And that’s still – you know, we invented it during COVID, but we hadn’t really planned for that in advance. So where do we stand in terms of our rehearsal, and our imagination, and our practice going forward?

Dr. Disbrow: (Laughs.) So it’s interesting that you brought that up, because we did the Crimson Contagion exercise about a year and a half or two years before COVID. And agree with you that you know the exercise – it’s one thing to bring all the people in the room and have that conversation, but so many things that were not discussed during Crimson Contagion became blatantly apparent day one. You know, supply chain issues. You know, global supplies shutting down, and where were we going to get supplies?

And so we do do the exercises. The most important thing, from my perspective, in the exercise is to know who’s doing what and who to talk to. Who our interagency partners are that have capabilities and expertise that we can leverage to let people know what we have available and what they can leverage from us versus going through the, you know, day one, day two, through those exercises.

It’s really about, as you mentioned, you know, institutional memory of going through something like this and everything that happened. I mean, we had to work with the Department of Defense to fly swabs over from Italy because that was the major manufacturer.

You know, things like that do not come up in an exercise, but I agree we really need to – there’s been numerous after action reports that have been done but it’s really to collectively look for people who went through it of, you know, what really happened in the first 30 days and how can we, you know, be better prepared 30 days before the next pandemic occurs and maintain that capability.

Dr. Gerberding: What is your biggest worry?

Dr. Disbrow: From the threat perspective? Everything. (Laughter.)

In all seriousness, you know, I’m concerned – you know, proud that we have and, you know, encouraged that we have products in the Strategic National Stockpile. They’re not enough. We do not have sufficient funding to meet the requirement.

We saw this in mpox. We had limited supply because we don’t have a requirement for mpox for BARDA. We have one for smallpox and the primary smallpox vaccine is ACAM2000. But even states that didn’t have mpox cases wanted vaccines and antivirals.

So even though you may have a localized event like an anthrax attack, I think jurisdictions outside of that area are going to want vaccines and anti-toxins and antibiotics and we just simply don’t have sufficient quantities.

So my biggest concern is that even though we’ve made significant progress is if we’re still not as prepared as we need to be.

Sen. Burr: And I’ll answer in a way that he can’t so I’ll answer for him.

The fact that nation states might see this as the 21st century tool versus guns and knives and carry out acts that are purely intentional with chemical biologics.

Dr. Gerberding: I mean, you know, in 2001 we saw what a few envelopes could do to a country and in COVID we saw what an outbreak on a submarine or a ship could do to a navy.

So, you know, we have exposed our vulnerabilities that everyone has, you know, experiencing the same vulnerabilities but how you maintain that national security balance in the setting it’s serious and it’s urgent and we need to authorize PAHPA, right? (Laughter.)

So, you know, you’re sitting in a very hot seat right now in the context of the infectious outbreak that we’re experiencing in the U.S., and we’re not here to talk about avian influenza in dairy cattle, et cetera, but I know you have recently procured a vaccine and are prepared to initiate a vaccine program if something changed and we needed to be more worried about human cases.

How do you think about that and, you know, who makes the decision about when we push that button or pull that trigger?

Dr. Disbrow: So as far as the manufacturing of the vaccine, I mean, as part of a preparedness and response organization we see this as part of preparedness, and so our national pre-pandemic influenza vaccine stockpile program, or the NPIVS, which one of the earlier programs you talked about, Seqirus down in Holly Springs, North Carolina, is part of that, through that program each year we work with the CDC and we develop candidate vaccine viruses against strains that are of concern.

And it just so happened that prior year we made CVVs to astrakhans and wigeons which are H5 vaccines, and we had that available – small amounts of that available. We have to do a clinical trial for safety and immunogenicity because this is a pre-pandemic vaccine. But we had small amounts in prefilled syringes. But because of the number of cases – it’s still only at four – the risk to human health in general is low and no segment is being recommended for vaccination.

We thought it prudent to fill additional bulk material that we had just in case so we’re in the process of filling an additional 4.8 million doses of that vaccine, which is well matched. We’ve had – (clears throat) – excuse me – our colleagues at CDC have taken the serum samples from people who’ve been vaccinated with that vaccine and tested it against the strain from Texas and it does give good cross reactivity.

But it’s all part of preparedness. We have to look at our budget to determine do we have annual dollars available. We’ve had to realign annual appropriations under pandemic influenza to support that manufacturing. We’re hoping to get some of the remaining COVID dollars that the department has available that we might be able to support that manufacturing.

So that – those are the triggers. It’s part of the preparedness. We may never need it but we need to make sure it is available if there’s a policy decision that is made to roll it out.

Dr. Gerberding: And I think Americans would be really happy to hear that, you know.

But it does bring up one thing that’s not in the stockpile and that’s trust – trust in vaccines and trust in government and, you know, that may not be the first thing you’re thinking about in your preparedness agenda but, certainly, having a vaccine in the stockpile is one thing. Getting people to use it as another. So I know that’s got to be on your mind as well.

Dr. Disbrow: It is. And so USDA and HHS briefed the Doc Caucus yesterday, and this was brought up about bringing back that trust by being transparent. And part of that transparency is sharing information with the public – what we know, what we don’t know; sharing information with our, you know, congressional members and their staff. We have a weekly update with staff members. We have weekly press conferences on what USDA and HHS are doing together. We have an outside panel of experts that we meet with every week to share what’s been going on.

So, you know, from a product development standpoint of what we’re responsible for it’s really just to share the information that we have. We’ve already reached out to state and local health officials to let them know what the vaccine would look like that comes to them, that it’s co-formulated with adjuvant, that it’s in prefilled syringes, and we will have some multi-dose vials so that they know what we have available.

Dr. Gerberding: What to expect, yeah.

Dr. Disbrow: And that has been helpful. They’ve been receptive to that. But it’s really about sharing information and, hopefully, building that trust again.

Dr. Gerberding: What are you seeing?

Sen. Burr: I don’t have to watch it anymore. (Laughter.)

No, listen, I think I share all the things that Gary’s talked about. It’s important that we notice what’s changed. He’s now incorporated in his lingo on H5N1 USDA. The American people haven’t heard about agriculture being involved in the past. We’ve got to reset what the definition is for the American people of what pandemic preparedness and prevention is going to be, and that’s why I’m hopeful that the new office at the White House it’s not just something that you turn on when everything’s gone bad.

It’s something that you utilize to coordinate across USG what everybody’s responsibility is and the buttons they need to push on a continual basis to be ready. That’s Gary as it relates to partnerships and development. It’s surveillance. It’s CDC. It’s all of these things coming together.

And, Julie, I think the thing that shocks me is – and I’m going to say this and Gary may correct me – I’m not sure that we’ve leveraged technology the way that we should about dealing with future threats yet. And I think if we wait until the private sector wants to incorporate AI or another technology into drug discovery, vaccine development, whatever, we’ve just asked for a huge delay to come.

I think that we need to be focused on looking at what are the things that we can do. How can we leverage technology to do surveillance differently? How can we do technology to do drug discovery faster? How can we do it to fill in some of the clinical work?

It doesn’t mean that we go out and we ask USG to accept all these but we ought to be practicing this just like we do the response. You know, people have asked me why did North Carolina handle COVID so well. It’s real simple. We practice every year – hurricane season – so we understand the logistics challenges we run to. We know where we’re going to have impediments and we had just exercised that prior to COVID. So it was really simple. The muscle memory was there.

Other states that have yearly disasters they exercise, and those states responded well to COVID. States that don’t exercise didn’t respond as well because they didn’t know how to mobilize either the emergency management component or the private sector in partnership, and that was something we do every time we have an incident like this. So if I could pick one thing I would tell you it’s technology, because we need to know what’s possible, and if it proves to be a big success then it may be we want to launch the effort with USG agencies before the private sector ever does.

Dr. Disbrow: And if I could just add to that, we’re actually – hopefully, you’ll be pleased – pulling innovation in. We saw so much innovation during COVID. We have an entire division within BARDA, the Division of Research Innovation and Ventures, that invest in those early technologies.

We’re also looking at, you know, improvements in manufacturing technology – continuous manufacturing, better ways to make monoclonal antibodies, the AI for drug discovery. And so we’re supporting those decentralized clinical networks, which I think is going to be really important to make sure that everybody feels like they’re involved in those clinical trials, which I think might help vaccine uptake potentially.

Sen. Burr: And, listen, to BARDA – in BARDA’s defense, BARDA went through 10 years where the contract process was so antiquated that it’s amazing that they got anything done – (laughter) – and it’s a great example that when you ask why are we doing it this way, this is the way we’ve always done it. And we’re just at a point in time where we’ve got to present how we do it differently.

Dr. Gerberding: Well, for 20 years you’ve made progress. I think that’s obvious, and there’s something to celebrate here so congratulations. Thank you, Senator, for your fatherhood – (laughter) – and thank you for your leadership and your commitment.

As we kind of come to the end of our time together I’d love to know if you could deliver one message to your colleagues in Congress and your stakeholders as well what would you most want them to know about what’s essential for the future success of BioShield? I’ll ask you first because they’re your friends.

Sen. Burr: I would probably suggest that there’s still people that are in Congress that were there in 2000 and they understand exactly why we did what we did. Talk to them. Learn from them.

When we got into COVID what was the number-one suggestion that the health care community said? Go out and read “The Last Pandemic,” The book on it, and it gave you a perspective as to what could happen. Nobody envisions something like that.

Members of Congress have to understand what led us to do BARDA, to create PAHPA, to put in this investment up front, because it in a lot of ways saved our butts with COVID, and the American people will expect us to be faster and much more effective next time.

Dr. Gerberding: Going forward.

How about you?

Dr. Disbrow: So we’ve made significant progress, we still have a long way to go, and that we can’t do this alone. We need our private sector partners. Whether they’re large pharmaceutical companies, midsized biotech companies, small innovators, we need them to partner with us so that we can make those advances in the next set of products that are FDA approved, and we also need our interagency colleagues. So it takes a lot of teamwork to really make this program a success.

Dr. Gerberding: Well, Gary, Senator, I really appreciate your time here and your candid conversation. This has been a hopeful conversation but also a humble conversation about what we’ve learned and the work that’s ahead of us.

So I hope we can work collaboratively with all of our partners to continue to build on your messages. I thank you on behalf of the Alliance – the Bipartisan Alliance – and my co-chair, but also really respect and appreciate your even making time for this given everything that’s on your plate right now. So thank you for that.

And, of course, I thank our audience for participating. I thank the members of the Bipartisan Alliance on Global Health Security. I certainly thank Steve Morrison at CSIS for his overall leadership in this domain; to Michaela Simoneau for her support for our coalition; and to Eric, our audio visual technician, and his team for making this broadcast possible.

Thank you. Thank you for joining us.

 (END.)