Countermeasures Season 3 Episode 3 Podcast Transcript: Biothreats

[00:00:02] Narrator Globalization, geopolitical conflicts, climate change, and advancements in technology are making the biological threat landscape more complex than ever before. This is Countermeasures, where we explore health threats impacting communities around the world. Brought to you by Emergent, a leading public health company that delivers protective and life-saving solutions to communities around the world. From zoonotic disease to bioweapons, orthopoxviruses, and more. We’ll explore what it means to protect public health and how preparedness today can lead to a safer tomorrow.

Whether naturally occurring or man-made, the next biological threat may already be taking shape. The COVID-19 pandemic demonstrated how fast an outbreak can ripple across borders, and how our health systems can struggle to keep up. The impact of biothreats stretches beyond health, shaping economies, national security, and public trust. In this episode, we explore what it means to be prepared for a biological threat, how governments and industry are working to protect people, and what could happen if we don’t get it right. We’ll hear from Wolfgang Philipp, Principal Advisor and Chief Science Officer at the Health Emergency Preparedness and Response Authority, also known as HERA. And Christopher Frech, Senior Vice President for Global Government Affairs at Emergent BioSolutions and Chairman for the Alliance of Biosecurity. Together, they offer perspectives from both sides of the Atlantic on how to strengthen biodefense, build public-private partnerships, and prepare for future threats. We begin with Christopher Frech, who explains what qualifies as a bio threat and how governments decide which threats demand the greatest attention. 

[00:01:50] Christopher Frech So, what qualifies as a bio threat? The Department of Homeland Security reviews threats to the public or to the warfighter, and it makes what’s called a material threat determination regarding those threats. The list is known as a material threat list, and then that drives scenarios, which drives requirements, and then the development and the procurement of medical countermeasures, vaccines or therapeutics, to protect the public. The Public Health Emergency Medical Countermeasures Enterprise is the interagency advisory board that advances national health security to coordinate that research and development against those threats. 

[00:02:34] Narrator Biothreats can materialize in different ways. Some emerge naturally, others may be caused by human actions, accidental or intentional. While distinguishing between these is important, the need to be prepared to act quickly doesn’t change. 

[00:02:48] Christopher Frech Distinguishing between naturally occurring outbreaks or intentional acts like bioterrorism is really driven in part and personal by the source of the threat itself. So naturally occurring. If we looked at a map around the world, anthrax is ubiquitous in the soil. And in many cases, you’ll have cases of subcutaneous or cutaneous anthrax exposure, the skin, often in animals that’s then connected to humans, or in the case of man-made, where it’s a deliberate attack. We think back to the 2001 anthrax attacks on Capitol Hill, where someone put anthrax in an envelope and sent it to Capitol Hill offices, and then people are exposed. Often, the man made attacks are very targeted, or they’re having great magnitudes because they’re trying to have a really large impact. So weapons of mass destruction versus someone coming across and digging up anthrax in the soil. 

[00:03:53] Narrator The 2001 anthrax attacks reshaped U.S. preparedness. The attacks revealed how few vaccines and therapeutics were available to be rapidly distributed in the event of an emergency, and prompted the creation of modern biodefense programs. 

[00:04:07] Christopher Frech That question around investing in stockpiles and vaccines and treatments, I think has been one that’s a really important one. And really, those 2001 anthrax attacks kind of brought to light the fact that the government didn’t have U.S. government, in this case, didn’t have all of the vaccines and therapeutics to protect the public against these threats. And it realized that it also needed these products before they occurred, so that they were available to use them when it occurred. And the U.S. then, through Project BioShield in 2004, 2005, put forward a bunch of policies and programs that would act as an incentive to the development and procurement of these products going forward. I think a really great example of recent on how that’s worked really effectively is the recent series of outbreaks to mpox. Even though mpox wasn’t listed as a material threat per se, it is an orthopox family of viruses. And because the U.S. had been focusing on smallpox, we had products that were stockpiled and developed, and in this case, even licensed, that were available to respond going forward in that case. Botulism is another example of how it’s worked really good because it’s a bioterrorism threat, yet on an annual basis, there’s endemic cases of botulism that occur every day where those products are used to protect the public against that illness. 

[00:05:46] Narrator Stockpiles can save lives, but they’re only as strong as the systems that sustain them. In Europe, building such a system has been a recent focus. The Health Emergency Preparedness and Response Authority, or HERA, was created by the European Commission in 2021 after the COVID-19 pandemic exposed vulnerabilities in health systems across the continent. Wolfgang Philipp, who was part of leading the creation of HERA and is currently principal advisor and chief science officer of HERA, talks a little bit about the mission and some of the early initiatives HERA has identified to help prepare for future threats. 

[00:06:23] Wolfgang Philipp The basic mission is to make sure that medical countermeasures in Europe are available and accessible, in particular when it comes to pandemic preparedness, also to outbreaks, to epidemics, and also to biological threats, including other threats that could further develop. So it’s an end-to-end organization. We have functions across the whole value chain that starts basically with ways of early detection. We have threat assessments. We work on intelligence function, epidemic intelligence function. We support research and development into new medical countermeasures. And when I talk about medical countermeasures, that means things like vaccines, therapeutics, drugs like antibiotics or antivirals in particular, but also other things like diagnostics for rapid diagnostics or even materials for better PPE. All of this goes into preparedness and response to biological threats, but also chemical threats, not just naturally occurring, but also man-made. It also goes down further to functions like procurement and stockpiling, as well as deployment of many countermeasures. We have a kind of a setup like BARDA, the U.S. agency. That was the initial thought to set up an agency or to set up an entity that functions a little bit like BARDA, making sure that medical countermeasures against biothreats and other threats are coming to the market. Here we’re talking about materials or medical countermeasures that not necessarily have a real economic basis, which means not for the rollout in the larger market, but require specific investments, in particular with the public. HERA is doing this with a large budget, or we are investing this into development and research and development, into stockpiling, into late stage development as well. So our main job is really end to end making sure that medical countermeasures are available to member states, because that is relatively complicated. Member states act on their own, but the ultimate goal is to work in complementarity, aligned and in a coordinated way. On top of that, we have been coming up, at least the commission has been coming up, with a proposal for a preparedness union. And that is in in the implementation now, that’s of 2025. We have been recently coming up with a new medical countermeasures strategy and a stock stockpiling strategy for a deeper implementation of measures to deal with biothreats in the future. 

[00:09:10] Narrator Whether it’s the U.S. Strategic National Stockpile or the EU’s HERA, both efforts share the same goal to be ready before the next emergency, not after it begins. Biothreat preparedness doesn’t just depend on governments. Many vaccines and countermeasures exist because of collaboration between public and private sectors. Christopher explains why industry must be at the table long before an outbreak starts. 

[00:09:37] Christopher Frech The role of private industry, I think, is a really important one because going back in time, the government realized that industry wasn’t able to do this on their own, or government wasn’t able to do this on their own. And industry needed a level of clarity and certainty, and in fact, in some cases, incentives to have them respond to meet the needs of government to protect against the public, particularly given that many of these products don’t have a natural commercial market, right? They’re not going to be commercially available. They’re actually products that you hope to never use but you know you need. And so that role of industry plays a vital one because without industry, government’s not going to have these products. And without government, industry is not going to make these products along the way. So it comes down to really communication and coordination and having industry at the table early on so that they can understand what it is that the government’s concerned about, and then what those products need to look like in terms of developing and characteristics to be able to respond to meet that need and thus have them available to respond should that threat occur. 

[00:10:52] Narrator Strong public-private partnerships require trust, communication, and sustained investment over time. Christopher says that commitment is often tested by a cycle called crisis to complacency. 

[00:11:04] Christopher Frech Often in this space, you see movements of crisis to complacency occur. We have an event that occurs, we throw a lot of money at it, and then we forget about it, and we take that money away and we move on to something else. In 2006, 2007, 2008, we saw an Ebola crisis occur. We saw a knee-jerk reaction from the government on an emergency supplemental. Then we saw the Zika crisis occur, and they said, okay, forget about Ebola, pivot to Zika, and that resources went there. As we think about it from a perspective of what are those top policy priorities to improve readiness over the next five years. And certainly, I think starts with communication coordination and alignment between government, governments, and industry. As we talked about that earlier, right, there’s that public private partnership, the operative word in that statement is partnership. Partnership requires you to do things differently. It’s not a transaction. It requires you to communicate what are your concerns and what are those realities that may exist to be able to respond to meet those concerns. I think it also means that you need to have robust, consistent, and sustainable funding, recognizing that you’re preparing for something that’s in the future that may or may not occur. 

[00:12:30] Narrator While the United States works to sustain partnerships through programs like Project BioShield, Europe is developing its own models for cooperation. Wolfgang describes how HERA has built new alliances across sectors and across borders. 

[00:12:45] Wolfgang Philipp Surge-ready manufacturing capacities is difficult to answer. The question is always what is the end point? What is affordable and also what is feasible? So we have a couple of samples that show that we are working towards that goal. We are working with our international partners, we are working with industry on matchmaking, we are working on supply chain resilience through the diversification of sources of materials that you need for development of critical medical countermeasures and also to reduce our dependency of, in particular, non-EU suppliers, is here a key focus. But for many of the things that’s not feasible, we have been working with the U.S. as well and some other countries into this direction. The second example, and that’s more practical, we have created a network of ever warm production capacities for vaccines, which is known as EU FAB. And that’s a network actually designed to maintain state-of-the-art facilities in a state of readiness, capable of rapidly transitioning and producing vaccines in the event of a health crisis. So EU FAB is one of these elements that was that even started basically a concept creation started even before HERA was created. We are also investing in biomedical research and in innovative platforms that would support more flexible manufacturing capacities and technologies. And then what I mentioned already before, in terms of vaccine readiness, we have created the European Vaccines Hub, and that is including an end-to-end approach, including scalable manufacturing of vaccines. So that the idea is here really to work with industry, but also with other funders to cover all relevant aspects of vaccine development, but also of large scale production. And for this, there’s many things that can be done. 

[00:14:40] Narrator In addition to preparedness between EU member states, Wolfgang says that international cooperation is the cornerstone of any effective preparedness system. 

[00:14:49] Wolfgang Philipp That needs to be organized at an international, ideally global level with the partners we can trust or we trust. And that’s what we’re doing. We have been setting up memorandum of understanding agreements basically on how to cooperate with like-minded partners in multiple countries, agencies like the US BARDA, in Japan, SCARDA or AMED, and Canada, the newly created Emergency Response Canada, but also with the Africa CDC or agencies like WHO and others, philanthropies like the Bill & Melinda Gates Foundation, and so on and so forth. And cooperation here really is always targeted in specific areas that could be medical countermeasures developments, that could be alignment of of ideas, that could be exchange of information, but it could also be setting up new systems like, for example, a global wastewater system. So the point is we are doing this not just through paper, but also through financing of projects and programs, like for example, in Africa, where the EU is heavily engaged through programs that we finance for WHO and many others, like programs that we finance also with EU member states to increase the manufacturing capacities for vaccines in Africa through a program that’s called MAV+ and many other things. 

[00:16:14] Narrator Misinformation is not just a European concern. In the United States, Christopher says that rebuilding public trust is now a core part of national preparedness. 

[00:16:25] Christopher Frech Misinformation and public skepticism has certainly been something that has undermined responses in the past and is  certainly a current challenge in the current public health paradigm, and certainly one that kind of we saw the ups and downs throughout the COVID years of how people responded to the information. I think there has to be, first and foremost, a bit of transparency in our public health officials and our government officials. That challenge, I think, becomes difficult at times. And as we saw in the past, it changed from one day or one week to the next. I also think that there is value in practice and making people better aware. 

[00:17:13] Wolfgang Philipp When we talk about response capacities, so public trust, not just into the acceptance of the use of medical countermeasures, but also on any kind of guidance like public health guidance or other guidance that would need that would be provided in a bio threat emergency, in a complex situation, in a pandemic, in certain phases to react. So it is very critical that requires definitely credible but also proactive communication by credible people and organizations. Not to react all the time, to run misinformation. Really, we need to come up with more professional, proactive means of communication. And that should lead to better belief in science, better belief in capacities of authorities like health or security structures. But all of this needs a constant push through the channels that actually reach the different social groups, not just those that might be the most difficult to reach, but the broad population. 

[00:18:16] Narrator Trust, transparency, and coordination determine whether preparedness plans translate into real-world action. Wolfgang says that Europe is now taking those lessons to heart, embedding cooperation and flexibility into every new preparedness measure. 

[00:18:35] Wolfgang Philipp So we have a solid plan that has been developed and whether implemented now with member states. With discussion with member states, with experts, and also with our agencies, EU agencies active or relevant in this field, and particularly  Medicines Agencies. Agency, we will have assessed several factors, such as the impact of a medical countermeasures on our response capacity to cross-border air threats, in particular, obviously biothreats, their time critical effectiveness, potential vulnerabilities in supply chains, so for lead times or availability. 

[00:19:11] Narrator Even as the world invests more in preparedness, the landscape of biological threats keeps changing. New technologies are reshaping science. Climate change, population movement, and geopolitics are all adding pressure. 

[00:19:25] Christopher Frech Geopolitical factors, certainly like global conflict have an extraordinary impact on this area and on bioterrorism, biothreats, preparedness and response. Certainly, we start with the uncertainty of the world that we live in and the factors that are there, both either state actors or in some cases, non-state actors or lone wolf actors, and their ability to kind of move forward. The government will look at threats as having two components. One is intent. So I intend to do harm. And the second is capability, the ability to do harm. And certainly with biothreats, there’s a bit of a dual use issue there that they’re not difficult necessarily to acquire, and they’re not difficult to actually execute with regard to a threat. In addition to that, other factors have become really important too, right? The movement of products, supply chain shortages, the uncertainty of the time. All of those factors call into question and raise the challenges of being able to prepare and respond to a threat. In the biodefense world, you’ll often hear a lot of guys will talk about and girls, preparedness equals deterrence. If I’m prepared against a threat, it makes it less likely that threat will occur because, at least in a man-made scenario, my adversaries will look to something else to use in that. And certainly the fact, and we’ve learned this through the experience during COVID, the need to be prepared before you need to be able to respond. 

[00:21:09] Narrator Wolfgang Philipp says preparedness now has to mean being ready for the unexpected. 

[00:21:14] Wolfgang Philipp We are preparing for a range of threats that starts with obviously with respiratory viruses that have a pandemic or epidemic potential. We are also looking into vector-borne diseases accelerated by climate change and also we are stockpiling materials for chemical, biological, radiological and nuclear threats. There’s always gaps in preparedness, response capacities that’s an inherent part of the of our business basically. When it comes to close the gaps in our biodefense capacities, is we should see that the world has changed. I mean, there’s much more pressure now by state actors, by rogue states, which is becoming more and more problematic, in particular when we talk about biothreats that is certainly. That is also partially driven, for example, by tech developments which enable faster and more efficient manipulation of molecules, agents or organisms. We will always have gaps. We still have gaps in the availability of vaccines, in the availability of therapeutics, and that’s still for a large number of prominent threats. We see also still underinvestment in biotech. We might need to invest more into the sector to increase our resilience here. We see uneven biosafety and biosecurity capacities. We see, let’s say, suboptimal MCM readiness in general. We have learned at least a couple of lessons, not just from the COVID pandemic, but also from all of the other pandemics and attacks that we have seen over the past 20 years. So in Europe, not just with the creation of HERA, which has a specific role, but also with strengthened mandates for the European Center for Disease Prevention and Control that goes into better and stronger epidemic intelligence, surveillance, and also risk assessments around certain scenarios, with stronger mandates for the European Medicines agencies, but also on the legislative side, for example, with regulations around how to coordinate response to biothreats, to epidemics, to pandemics, or in general to health emergencies in Europe. 

[00:23:27] Narrator While preparedness must evolve, so must the partnerships that sustain it. 

[00:23:32] Christopher Frech What makes me optimistic about our ability to better prepare for the next bio threat? I think for a long time, certainly I’ve been in this working on these issues for 16 plus years, and I’ve seen an evolution of how people are thinking about this and realizing it. And it really starts with that threat realization and understanding what the threats are and what the consequences are. I think for the world, COVID was a real wake-up call around some of these theories that we were talking about when they became realities. And COVID was an extreme case that the world all saw at the same time. But we saw breakdown of supply chains. We saw the nationalistic views of hoarding products or keeping products and not letting products go across the border. But I think people now think about this as a real thing and realize that this is something that we actually do need to prepare for and we need to continue to respond to, and it’s increased the amount of communication, coordination, and awareness that didn’t exist, pre COVID that now, today is actually providing for greater preparedness and response for a myriad of threats, should they occur down the road.

[00:25:04] Narrator Preparedness is a shared mission. It requires science, trust, and sustained cooperation across every border and every sector. As Wolfgang reminded us, viruses do not stop at borders. And as Christopher explained, preparedness itself is a form of deterrence, a way of ensuring that when the next biological threat emerges, the world isn’t caught unprepared. And though the next threat may look different, the same principles apply. Collaboration, transparency, and a commitment to science-driven results. The real test of preparedness is not how we respond after a crisis begins, but how we choose to build before it happens.