Dr. Lawrence (Larry) D. Kerr is the Deputy Vice President for Global Health and Multilateral Affairs at PhRMA. From 2015 to early 2022, he served as the Director of the Office of Pandemics and Emerging Threats within the Office of Global Affairs at the U.S. Department of Health and Human Services where he led a broad policy portfolio including global health security, influenza preparedness, countering antimicrobial resistance (AMR), and infectious disease threats (COVID-19 and DRC Ebola responses). Dr. Kerr served as the Director for Medical Preparedness Policy at the White House National Security Council Staff as the principal staff member responsible for developing policies regarding public health and medical resilience for biological events and AMR, including his role on the Ebola Task Force. From 2006-2013, he was the Senior Bio Advisor within the Office of the Director of National Intelligence. Dr. Kerr completed his Ph.D. in Cell Biology from Vanderbilt University in 1990, and his post-doctoral work in virology and immunology at the Salk Institute in San Diego, CA.

Editor’s Note: This interview was recorded in February 2022 before Dr. Kerr’s retirement from government service.

CTC: For the last six years, you served as Director of the Office of Pandemics and Emerging Threats at the Office of Global Affairs in the Department of Health and Human Services, having held a variety of positions related to public health policy and preparedness over the last 20 years in the executive branch and the intelligence community. But firstly, you are a scientist. You began your career leading a research lab at Vanderbilt University. What drew you to public service?

Kerr: I originally thought that I was going to go the traditional medical school faculty route while at Vanderbilt. I really enjoyed research science, teaching, and working in an academic health center. I was very fortunate that I was given the chance to do a Robert Wood Johnson Health Science Policy Fellowship, which brought me to Washington, D.C., and I have to admit, I caught the policy bug or “Potomac fever,” and found that when you had someone who had a science and medical background that was advising on making good policy, it was a critical skill set. After working on Capitol Hill, the opportunity to join the federal government arose, and by chance, I was working for Dr. Anthony Fauci at the NIH/NIAID when then President Clinton called to ask if he had anybody who had done policy work. I was sent to the Office of Science and Technology Policy, and that’s where I kind of cut my teeth, if you will, on policy development and what launched my career. It was that sense of contributing one’s scientific and medical skill sets to greater policy good for the public.

CTC: Could you explain the role that your office plays and its key focus areas?

Kerr: We are the one policy office within the Immediate Office of the Secretary of HHS that is focused completely internationally. Most people think of HHS and its domestic mission, or that the vast majority of HHS’ budget is Medicare and Medicaid, but we are the office that focuses on international policy. So everything internationally focused that the Secretary does—whether engaging the World Health Organization (WHO) or ministers of health around the world or the United Nations—our office works on that. My team is the one that deal specifically with the global health security agenda, working with the International Health Regulations at the WHO; preparing for pandemic influenza, which is how the office actually got its initial funding start; antimicrobial resistance, looking at future threats; and then a team that’s focused on emerging infectious diseases, which today means the COVID-19 response.

CTC: Looking back on your career in government, what aspect of your work are you most proud of?

Kerr: In the policy world, you’re often thinking in three, five, sometimes 10 years out. And I’ve been fortunate, being in the government 23 years, to actually see the outcome and impact of some early policy work. When I was in the National Security Council (NSC) in 2005 and wrote the National Strategy for Avian and Pandemic Influenza and worked with OMB [Office of Management and Budget] and Congress, we got $6.9 billion devoted to implement that Strategy. At the time, we were worried about H5N1 influenza being the next pandemic, but low and behold, in 2009 the H1N1 influenza pandemic strain became the pandemic. And while moderate in disease severity at the time, we had already started to see some of the benefits of implementing that 2005 Strategy domestically and globally. But even then, in the 2014-2016 Ebola outbreak in West Africa and particularly then in the COVID-19 outbreak, we saw all of the programs that we had put in place across the public health systems—the detection systems across our public health laboratories that had been built from those initial investments starting back in 2006—actually come to fruition. It’s been a very, very interesting look-back to see where those dollars are, the impact that they had, and then how they’ve impacted this pandemic.

CTC: Two years after the outbreak of the COVID-19 pandemic that has killed nearly a million Americans and a year after the rollout of the highly effective vaccines against it, what are the key lessons that you’ve learned or that you think we should be learning in preparing for the next pandemic?

Kerr: Whenever we go through tabletop exercises on pandemic preparedness, almost every single after-action review highlights communication and risk communication as top priorities to address during a pandemic. I would say, unfortunately, in this pandemic we saw a very deleterious politicization of the COVID-19 response arise early and continue in a way such that messaging around public health guidance, medical guidance, and simple personal measures to protect individuals, communities, states, and local governments just go down a route that I don’t think we ever, ever envisioned in pandemic preparedness. It truly eats at the soul of a public health person when you know that we have what are some of the most safe and effective vaccines that we have against any pathogen, that we have therapeutics that save lives, and there are still individuals and groups who, for reasons that are not aligned along public health and medical guidance, just oppose their use. We know we can save more lives, and it’s horrible not to be able to see that acceptance. I think it will be studied for decades, how the messaging and the communication went awry.

One aspect that really accelerated the development of those safe and effective vaccines/therapeutics was having the available resources to tap very quickly and to be able to really gather the breadth that the United States has in terms of basic science and innovation and to harness that to be able to get these countermeasures into people quickly. That availability of those resources, through Operation Warp Speed that then became the CAGa that is now H-CORE [HHS Coordination Operations and Response Element], really provided for groundbreaking vaccines in a time period that we’ve never seen before, and one we hope we’d be able to marshal once again if another pathogen comes to bear of epidemic or pandemic potential.

CTC: The COVID-19 pandemic caused unprecedented strain and stress on all healthcare systems. Certainly, we saw that here in the United States, but from your vantage point, looking across the globe, could you speak to the ways that public health systems can be improved ahead of a future pandemic?

Kerr: Unfortunately, in non-pandemic times, we often forget that the basis of our health systems lies in root public health disciplines and practices. And when you talk about the resources, the infrastructure, you mean the people, the money, the basic programs. They’re not sexy. For example, most people don’t think about getting children measles vaccinations and other childhood vaccines; it’s something that people take for granted, and there are diseases that we often don’t even talk about unless there’s an outbreak. But those trained public health professionals, with clinics and laboratories, whose data and results are networked to state and federal health officials are the systems that are in place to protect our people day-in and day-out so that it is rare that we experience those outbreaks. From 2005 to the present, we lost over 50,000 public health professionals across the United States, and that slow decline over the years is what has left us vulnerable and it’s in systems where you can’t just pay people and surge to regain it. That expertise is something that you need years of continued investment, mentorship, the availability of resources to provide for those when they are needed, not only day-to-day but in the surge during an epidemic or an outbreak condition.

You also have to make sure that your surveillance systems are finely tuned, that they are constantly operating. And in the United States, that is a challenge. We’re seeing now the debate play out between how the federal government operates versus how we work with basically 57 independent states and territories. It’s similar to the way we work with other countries, where the governors’ rights versus those of the federal government and the information exchange between the federal and state governments challenge a robust national pandemic response. Those systems and how that information is used to help and provide the best available guidance really is something that during non-pandemic periods we could definitely improve. And finally, continued investment in basic and applied research is what will get us the jump ahead for whatever that next pathogen of pandemic potential may be when it comes.

CTC: Operation Warp Speed, which you just referenced, saw the employment of vaccine development technology at an unprecedented pace and scale. How has Operation Warp Speed changed the way we will develop vaccines moving forward?

Kerr: Operation Warp Speed was something of a gamble. It was the brainchild of people who envisioned that the U.S. government could advance the development of vaccines with the vaccine manufacturers, at risk. Let’s say that there were six to eight vaccine candidates out there in the hopes, at the time, that even one would prove to be safe and effective. Remember, when this pandemic started, no one had ever developed a vaccine against a coronavirus. In fact, clinical trials of vaccines against known coronaviruses, such as SARS or MERS, had failed, so there was a gamble. The $10 billion investment in the initial six Operation Warp Speed candidates, fortunately for all of us and the entire globe, paid off. And the question is, should another pathogen—a non-influenza, a non-coronavirus—arise, would we be able to marshal the resources and the expertise to be able to do something similar in order to get countermeasures quickly into people?

CTC: In late 2021, as you’re aware, U.S. Army researchers announced that “preclinical study results show that the Spike Ferritin Nanoparticle (SpFN) COVID-19 vaccine developed by researchers at the Walter Reed Army Institute of Research … not only elicits a potent immune response but may also provide broad protection against SARS-CoV-2 variants of concern, as well as other coronaviruses.”1 How hopeful are you that the Walter Reed effort will succeed? Could a universal coronavirus vaccine be a gamechanger in reducing the severity and impact of future pandemics?

Kerr: Am I hopeful? Oh yes. It would be phenomenal. We are all hopeful. Pardon me if I’m a little bit war-torn, from my influenza days, however, because we’ve been looking for a pan-influenza or universal influenza vaccine for many, many years. And so, while I’m hopeful on one arm, on the other arm I’m saying, “OK, we need to be careful of Mother Nature and of hubris.” Mother Nature can create billions of variants, and humans can in no way match that. ‘Universal’ is also a concept that in lay terminology has an attractiveness. But does it truly mean across all sub-species and all sub-lineages? Or are we looking at, for example, taking SARS-CoV-2 off the table or an effective vaccine against one of its lineages? So, am I hopeful? Absolutely. We will just have to see how it actually does once these vaccine candidates make it into human clinical trials. Because the other thing is that Mother Nature has the ability to generate vaccine-resistant strains. And viruses do what viruses do best, which is mutate. So I’m hopeful, but we’ll see.

Lawrence Kerr

CTC: To pivot to synthetic biology, the 2018 National Strategy for Countering WMD Terrorism2 noted that “in contrast to chemical, radiological, and nuclear weapons, some biological agents are contagious and may thus spread in an uncontrolled manner. Furthermore, such agents are the only other class of WMD that has the potential to match nuclear weapons in the scale of casualties they produce.” However, retired Lieutenant General Michael Nagata stated in 2020 in our publication that “during my time as a CT [counterterrorism] operational practitioner, all the way through my final years as the senior CT strategist at NCTC [National Counterterrorism Center], the amount of energy, focus, and resourcing devoted to bioterrorism is a small fraction of what is still given today to more conventional threats.”3 For more than two decades, you have played a key leadership role in U.S. biosecurity efforts. How would you characterize the evolution of the United States’ approach to bio threats across the arc of your career? Are there assumptions that you’ve seen that have changed as a result of the COVID-19 pandemic?

Kerr: It’s a great observation. And as I think about it, I have to describe it in terms of a series of fits and starts, attention and then neglect. The anthrax attacks of 2001 initiated a profound surge and interest in resources, both financial and personnel, devoted to countering biological threats and biodefense efforts. In 2005, there were the counter-BW [biological warfare] efforts because of perceived intelligence threats overseas, and then with the 2009 pandemic, there was the change from counter-BT [bioterrorism] or BW to counter-bio threats. So, we saw an evolution in language from bio threats of natural, accidental, and man-made origin to encompassing all of them. In the 2017 National Defense Authorization Act, the mandate to create the National Biodefense Strategy was really the first time that we collectively as a government came together and looked holistically at these threats, whether man-made, natural, or accidental. And yet, the Strategy was completed, the implementation plan was created, the new American Pandemic Preparedness plan has been released, and the Global Health Security Strategy created, but none of these have been funded. And so, the problem goes back to, we have strategies, but strategies are pieces of paper that sit on bookshelves until they are actually funded and turned into programs that can operationalize these implementation plans. My concern is that we slide back into a period of neglect where these critical elements that Mother Nature is warning us about, and that intelligence is warning about, will not be addressed.

The second part of your question, my community, the flu community, for two decades has been saying the same thing: We predict the most likely pathogen to cause the next pandemic is influenza. Even to this day, there are at least 10 strains around the world circulating between predominantly chickens and humans that have already acquired pandemic potential, and we’re just waiting to see when Mother Nature will flip that next mutation that will allow human-to-human transmission. There are definitely guardians who are watching for this at all times, and many of us look back and said, “Wow, if this had been a flu pandemic, how very differently and more rapidly we would have been able to take care of it.” But that also puts us on guard: “OK, we’ve had a coronavirus. We know that flu is out there. What is the next one that we aren’t necessarily watching for right now?”

CTC: In August 2020, West Point scientists assessed that advances in synthetic biology and widening access to the technologies involved “is leading to a revolution in science affecting the threat landscape that can be rivaled only by the development of the atomic bomb.”4 Synthetic biology is an enormous force for good, but as the 2018 U.S. Strategy for Countering WMD Terrorism noted, “advances in biotechnology could theoretically allow even a single individual working in a laboratory to engineer pathogens that could have catastrophic effects.”5 What is your view of the transformative potential of threats from this sphere, and what can be done to prevent a bad actor from engineering a pathogen more virulent and even more transmissible than the virus that causes COVID-19?

Kerr: It’s a very salient question, and I agree with the assessment. A single bad, high-end molecular biologist that wishes to create a pathogen can do so. I gave a presentation to a PACOM [United States Indo-Pacific Command] commander years ago where I said entirely hypothetically, “If you give me the exact requirements for what you want to do to someone or a group—do you want to incapacitate? Do you want to kill? How many? For how long?—we can design you that pathogen. That is the power of biology.” And just thank God we have not seen anyone—single actor or state—use that power yet. But that is one of my fears, that should we see that day when actually it’s easier to make a biological weapon than it is to get a gun, what will happen? Because our defenses will not be ready for that when it arises. If you look at some of just the existing pathogens, the ones that we’ve worried about for many decades such as smallpox, we now have highly effective vaccines against them. We have highly effective therapeutics. But just a single-point mutation can change that, and it is possible that our therapeutics would be useless against that resistant strain.

Synthetic biology is a powerful tool that is being used for beneficent research that is allowing us to have the types of innovations that we have today. The ability to take, for example, the mRNA vaccines and evolve them to a new sub-strain—Omicron or Delta lineage—is being promoted by these advances in biotechnology. But those advances in biotechnology can be used for harm, and finding ways to deter that use is what the entire efforts around biosecurity and biosafety are all about.

CTC: Given your medical research background and your background on the security side, can you discuss other pathogens of concern when it comes to bad actors, such as antibiotic-resistant bacteria?6

Kerr: There are reasons that certain pathogens have repeatedly over many decades been looked at by non-state actors as well as state actors for their properties to do harm. When you look at pathogens such as anthrax, cholera, tularemia, Brucellosis, and plague, the list goes on and on, there are reasons that those have been selected by both former and current biological weapons programs, and the ability to then modify them to make them antibiotic-resistant certainly throws up challenges to detection and treatment. The time in which it would take us during a response to figure out that an antibiotic-resistant pathogen has been used and then what we have in our arsenal in order to be able to treat it, all of that would profoundly complicate a response, and so that absolutely remains a concern and one on which, during our biodefense efforts, we think about from both a detection, a medical response, and then in microbial forensics and attribution disciplines.

CTC: In January 2021, David Lasseter, then Deputy Assistant Secretary of Defense for Countering WMD, said, “What most concerns me are lethal, man-made, or genetically altered agents whose source is difficult to attribute.”7 How do you view the challenge of attribution? Do you share that concern, specifically when it comes to genetically engineered pathogens?

Kerr: I absolutely share that concern. If you look at the current situation, we do not know the origins of SARS-CoV-2 even two years later. We certainly have advanced our forensic capabilities, but you can see that they remain limited. And not only as it pertains to the origins of the actual virus, but what allowed this particular virus to proliferate and become epidemic within Wuhan that allowed the further spread then to become a pandemic? In 2009, we drafted a National Research and Development Strategy for Microbial Forensics—this was a combination of efforts of multiple intelligence agencies, the FBI, DHS, and several others—and funding went into that effort and there were significant efforts made and progress being made that would have certainly elevated our capabilities. Unfortunately, it’s an example where that program was defunded in 2013, and so again, it goes back to fits and starts. You need sustained investment because those are disciplines and professionals that need to culture those long-term strategies in order to get us possibly ahead of where an actor may be and advance forensic capabilities. It is certainly a discipline that I think needs attention and more resources.

CTC: How, if at all, has the pandemic changed your view of the security measures currently in place at laboratories and facilities handling dangerous pathogens?

Kerr: Again, we don’t understand where this virus came from. Certainly, questions have been raised as to whether or not it arose in a laboratory, whether it could have been a potential result from a laboratory accident, or neglect within a laboratory, but it simply reminds us that in all instances, the conduct of safe and secure laboratory practices must be maintained. Vigilance must be maintained around the globe. Biosafety is one aspect, and certainly understanding that when we talk about evolution in microbial sciences and the ability to manipulate organisms, we are dealing in areas that require higher and higher levels of safety and security. We’re seeing the proliferation of more BSL-3 and BSL-4 labs worldwide, and with that needs to come the expertise to be able to work in those facilities and the resources to be able to maintain what are very, very expensive labs to operate at that appropriate biosecurity level. So, I think there is appropriate concern that the globe needs to think about standards, and we don’t actually have any entity that now is responsible for those types of norms globally. Who would that be? Does it reside at the United Nations? Is it something that’s within the remit of the World Health Organization? I think this is an appropriate time for the world to think about what has happened in this pandemic, and what could happen with the state of our research environment, and try to improve our overall understanding and practice of good norms for biosecurity and biosafety.

CTC: How do you view the do-it-yourself bio community that has emerged in recent years and the potential for a deliberate or accidental threat emerging from these communities?8 As you just noted, there are still improvement areas and challenges when we talk about BSL-3 and 4 labs globally, given their proliferation.

Kerr: I’ve had the real honor and privilege of working with the iGEMb community for exposing young scientists to synthetic biology for over a decade now, and seeing high school and college students take on projects who have never dealt with biology before. They bring in different disciplines and they work on these projects and they’re doing what I would consider to be very high-end and progressive and innovative work; that is a community that has also really taken on the true elements of biosafety. From the very onset, when the students design something, there is an element of oversight where they are taught, is this responsible use at the level at which you will be working? Are the individuals trained in a proper way? And so, where there are systems in place around the DIY community, I think one sees very, very responsible conduct by the community for being not in an academic setting, or away from private sector or government oversight.

Do I fear that there could be that one bad actor out there that would be able to do something? Of course I do. It is balanced by the fact that there’s a lot of equipment and resources that are needed to really do ultra-high-end molecular biology, but those are also now bought often in kits that are available to anyone who can purchase them. Getting the actual pathogen is a different story. There are three overlapping elements that are needed to create a bioweapon: (1) the intent, motivation, and access to resources to develop such a weapon; (2) access to the desired pathogen; and (3) the scientific and technical skills to grow, manipulate, and disseminate that weapon. When these three circles overlap—having the intent to actually do harm combined with the skill set to manipulate a particular pathogen—you always worry about that. But my highest concern is that intersection of those three circles where that bad actor who has access to a particular pathogen attempts to create something that could potentially be used as a weapon. We have seen very good engagement between the domestic and international DIY amateur biologists with institutionalized and government bodies to seek guidance and advice in biosafety and biosecurity. These engagements are critical to promote safe and secure laboratory practices and to protect both the DIY biologists and the community in which they live. It’s progressing very well.

CTC: No terrorist group has come close to carrying out a highly lethal biological attack, and even the well-resourced Aum Shinrikyo cult in Japan in the 1990s fell well short.9 However, the landscape appears to be shifting in relation to this area, as in 2018, German police thwarted an alleged plot in Cologne in which a jihadi terrorist in the West for the first time successfully produced the toxic biological agent ricin.10 In your assessment, how has the bio terror threat landscape changed, specifically as it pertains to terrorist use, and what types of terrorist threat actors or groups are the most cause for concern from your vantage point?

Kerr: My time in the intelligence community really heightened my concern around the class of terrorists that really don’t care about blowback effects. That is often the group that we describe as ‘the apocalyptic actor.’ At one point in time, there were 3,000 named apocalyptic groups around the world— for example, environmental terrorists who believe that humans are basically a contaminant to the Earth and therefore really don’t care about synthesizing an antidote to themselves or to protect followers, but are solely interested in annihilation of humans. Fortunately, we have not seen any of those gain capabilities yet, but clearly with a philosophy or an intent like that, that certainly raises a high level of concern around, if they were to acquire a pathogen and the skill set to use it, what could potentially be done.

With regard to potential threats posed by an individual bad actor, a group—whether it be militant or philosophical, all the way through to state actors—I think there’s high concern in each one of those areas, but there are significant challenges, too, to finding one bad actor or understanding the true capabilities of an organized group. And then there are really profound difficult targeting and collection challenges associated with nation-states. So, there’s no easy answer to these threats. Long-term, time-on-target analysis and collection needs to be done in order to really understand them better.

CTC: You make such an important point about the blowback question, and a key obstacle for the most sophisticated of actors, state actors, for deploying pathogens as biological weapons, is concern their own population or others they don’t wish to target could also become infected. But one analyst has noted, “the merger of the biological data revolution with computing power,” especially machine and deep learning, has opened up the possibility of “ultra-targeted biological warfare” whereby “malicious actors could deploy a biological weapon over a broad geographic area but only affect targeted groups of people, or even individuals.”11 And in 2020, the U.N. Institute for Disarmament Research warned that “access to millions of human genomes—often with directly associated clinical data—means that bioinformaticists can begin to map infection susceptibilities in specific populations. This kind of information could also be used to develop ethnically targeted weapons.”12 How concerned are you about the potential future threat of ultra-targeted biological warfare?

Kerr: It is a concern, and clearly, the more that we in legitimate, beneficent science understand host-pathogen interaction, the way in which our immune systems as humans respond to pathogens, and the way that we can manipulate the immune system in order to respond gives us greater insights into how one could philosophically, theoretically operationalize in a laboratory the concept of genetic-based targeting. It is a concern. I think we are still a distance away, and hopefully, ethics and norms that demonize even going down such routes will preclude the development of such weapons. But we have seen, for example, in the case of the reports from China of gene-edited babies,13 there may be societies that do not follow the same ethical standards and norms that we do. And so, it is a concern that as biology progresses and the ability to manipulate both pathogens as well as our own human immune systems increases, that such threats, which are still in the realm of science fiction today, could actually become reality. I think it is something where we need to have people attuned to these concerns and then have a community that is aware of and constantly following its progress so as to assess whether or not there are adversaries seeking such capabilities.

CTC: You mentioned that strategies are pieces of paper unless they’re resourced and supported, so to pick up on that thread, a report published in the U.K. in February 2022 called for the Biological Weapons Convention (BWC) to be revamped as it is currently “not fit for purpose” because it is “poorly funded and supported at the UN and has no organisation to regulate and police it.” The report contrasted the Biological Weapons Convention with “the Chemical Weapons Convention (CWC) policed by the Organisation for the Prohibition of Chemical Weapons (OPCW) [which] has removed most proscribed chemical weapons from the globe and is well-funded and well-supported by most members of the UN.”14 This November, governmental delegates are due to gather in Geneva for the Biological Weapons Convention Ninth Review Conference.15 Ahead of the conference, the U.S. government has stated, “the status quo is neither acceptable nor up to the task” and that it is necessary to “examine possible measure to strengthen implementation of the Convention, increase transparency, and enhance assurance of compliance” in order to address “not only the latest challenge [of the COVID-19 pandemic], but those that may lie ahead whether natural, accidental or deliberate in origin.”16 How can the Biological Weapons Convention be strengthened, and how hopeful are you that this can be achieved?

Kerr: I am hopeful that it can be achieved. The BWC is the one overriding norm that we can point to, to say, “As a biologist, as a life science person, as any discipline associated with the life sciences, the philosophy is ‘do no harm.’” The BWC is the set of principles by which individuals and nations follow that guidance and through which nations can report their progress towards achieving transparency in their work with pathogens—solely for defensive purpose. So, can the BWC be strengthened? Absolutely. Those are matters of intense policy debate right now to try and figure out what does that actually mean, while also allowing the advances and beneficial science to be achieved and not do anything that would harm that progress but putting up any barriers to the nefarious or bad use of the life sciences. What exactly those measures should be, I don’t have an answer for you today. They’re a matter of ongoing debate, and this is something where there are literally weekly interagency meetings with the NSC to try to define what those could be.

There are ways of trying to promote greater transparency, but doing so in a responsible manner such that, for example, we aren’t revealing intellectual property and trade secrets that we need to protect both within a government, within academia, and within the private sector. So, it’s this delicate balance that we walk, and trying to find those you know exact steps to strengthening the BWC is something that is being worked on as we speak.

CTC: Is there anything else you’d like to add?

Kerr: The counter BW world is small compared to the nuclear world. Of ‘NBC’ [nuclear, biological, chemical], the ‘B’ is always the smallest portfolio of the three files, and it always has the smallest community and the smallest amount of resources to address the threat. I wonder whether the pandemic may change that a little bit to create a more robust community and hopefully get the resources that are needed—and not just from a pandemic threat potential, but also the recognition that biology has the ability to topple governments and to create instability in entire global systems. While we’ve seen what Mother Nature can do, we certainly need to do everything we can to make sure that a man-made pandemic is prevented to the maximum extent possible.     CTC

Substantive Notes
[a] Editor’s Note: CAG is an acronym for the HHS-DOD COVID-19 Countermeasures Acceleration Group.

[b] Editor’s Note: “The iGEM Foundation is an independent, non-profit organization dedicated to the advancement of synthetic biology, education and competition, and the development of an open community and collaboration. This is done by fostering an open, cooperative community and friendly competition.” For more, see the iGEM website at igem.org

[1] Walter Reed Army Institute of Research, “Development of WRAIR’s Pan-Coronavirus Vaccine Shows Promise,” Health.mil, December 28, 2021. See also “Preclinical studies support Army’s pan-coronavirus vaccine development strategy,” Walter Reed Army Institute of Research, December 16, 2021.

[2] “U.S. National Strategy for Countering Weapons of Mass Destruction Terrorism,” December 2018, p. 6.

[3] Paul Cruickshank and Don Rassler, “A View from the CT Foxhole: A Virtual Roundtable on COVID-19 and Counterterrorism with Audrey Kurth Cronin, Lieutenant General (Ret) Michael Nagata, Magnus Ranstorp, Ali Soufan, and Juan Zarate,” CTC Sentinel 13:6 (2020).

[4] J. Kenneth Wickiser, Kevin J. O’Donovan, Michael Washington, Stephen Hummel, and F. John Burpo, “Engineered Pathogens and Unnatural Biological Weapons: The Future of Synthetic Biology,” CTC Sentinel 13:8 (2020).

[5] “U.S. National Strategy for Countering Weapons of Mass Destruction Terrorism,” December 2018, p. 1.

[6] For more on this, see “Fight Against Superbugs Crucial to America’s Biodefense,” Pew, February 1, 2019.

[7] Stephen Hummel, Paul Cruickshank, and Don Rassler, “A View from the CT Foxhole: David Lasseter, Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction,” CTC Sentinel 14:1 (2021).

[8] For U.S. law enforcement awareness of this issue, see Kristina Hummel, “A View from the CT Foxhole: Edward You, FBI Weapons of Mass Destruction Directorate, Biological Countermeasures Unit,” CTC Sentinel 10:7 (2017).

[9] William Rosenau, “Aum Shinrikyo’s Biological Weapons Program: Why Did it Fail?” Studies in Conflict & Terrorism 24:4 (2001); Dina Fine Maron, “Weaponized Ebola: Is It Really a Bioterror Threat?” Scientific American, September 25, 2014.

[10] Florian Flade, “The June 2018 Cologne Ricin Plot: A New Threshold in Jihadi Bio Terror,” CTC Sentinel 11:7 (2018).

[11] Filippa Lentzos, “How to protect the world from ultra-targeted biological weapons,” Bulletin of the Atomic Scientists, December 7, 2020.

[12] Kelsey Lane Warmbrod, James Revill, and Nancy Connell, Advances in Science and Technology in the Life Sciences: Implications for Biosecurity and Arms Control (Geneva: UNIDIR, 2020).

[13] Editor’s Note: “China jails ‘gene-edited babies’ scientist for three years,” BBC, December 30, 2019.

[14] Hamish de Bretton-Gordon and Arnab Basu, “Future Biological Threats and Mitigation,” Kromek Group, February 2022.

[15] According to the website of the United Nations Office for Disarmament Affairs (accessed April 22, 2022).

[16] “Remarks to the 2021 Biological Weapons Convention Meeting of States Parties, Ambassador Bonnie Denise Jenkins, Under Secretary for Arms Control and International Security,” U.S. Department of State, November 22, 2021.

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