Pandora Report: 6.18.2021

Michelle Grundahl, a Biodefense MS student, shares her take on the recent meeting of the National Biodefense Science Board. A new report highlights the compound security threats caused by the “convergence of climate change with other global risks,” such as the COVID-19 pandemic. The Pandora Report is taking a short break, but we will be back soon with news and analysis for all things biodefense!

Biodefense Board Discusses Future of US Pandemic Preparedness

On May 26, 2021, the National Biodefense Science Board (NBSB) held a (virtual) public meeting that discussed actions that the United States needs to take to be better prepared for the challenges posed by public health emergencies such as pandemics, “Disease X,” and other biological threats. NBSB is the federal committee that advises the office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS). During the meeting, the NBSB presented their recommendations to ASPR from its new report on ‘filling critical gaps’ in health emergency preparedness, response, and recovery. In addition, NBSB was briefed on the CDC’s new initiative to improve its data collection and analytical capabilities to improve information sharing and situational awareness during a public health emergency. Michelle Grundahl, a student in the Biodefense MS Program, shares her insights on the event. Read Grundahl’s article here.

Emergency Use Authorization (EUA) and the Future of the Korea Bioscience Industry

HyunJung Kim, PhD candidate in the Biodefense Program, published an article – Emergency Use Authorization (EUA) and the Future of the Korea Bioscience Industry (written in Korean) – in Monthly Chosun magazine. After the presidential summit between the United States and South Korea last month, Samsung Biologics, based in Seoul, and Moderna, based in Massachusetts, concluded an agreement for Samsung Biologics to produce Moderna’s COVID-19 vaccine in Korea. While Korea has developed the second biggest biologics production capacity in the world, next to the United States, Korea lags in the development of new vaccines and therapeutics. Kim reviews the expansion of Korea’s Emergency Use Authorization (EUA) policy from in-vitro diagnostic kits to medical countermeasures. He points out that the new EUA policy contains provisions that hamper the development of Korea’s biopharma industry by encouraging the Korean government to import medicine from abroad instead of investing in innovation at home by small and medium-sized biotech companies. Read Kim’s article here.

Reading the Nuclear Tea Leaves: Policy and Posture in the Biden Administration

Joseph Rodgers, a Biodefense PhD student, and Rebecca Hersman, Director of the Project on Nuclear Issues (PONI) at CSIS, released a report regarding nuclear policy in the Biden administration. The nuclear policy community is once again in the grips of pervasive anxiety that US nuclear policy -encompassing force modernization decisions, declaratory policy, and perceptions of adversary nuclear threat and risk – is either about to dramatically change or fail to change as dramatically as it should. In a polarized community characterized by mistrust and a highly politicized discourse, it is not surprising that the public conversation is filled with competing perspectives that seek to ensure that their voices are heard before the policies are set. As such, the current discourse appears particularly noisy. The greatest controversy centers on the modernization of the nuclear force, in particular the future of the Intercontinental Ballistic Missile (ICBM) force and commitment to the full triad of nuclear delivery systems, the role and primacy of nuclear weapons in our overall deterrence declaratory policy, the relative threat posed by Russia and China as drivers of US nuclear policy, and the relevance and utility of arms control in managing and reducing these threats. Read the report here.

Iraq National Pathogens List

Iraq has published a new national pathogens list that will guide the country’s approach to biorisk management. The list of human, plant, animal and zoonotic pathogens was produced by the interagency National Biorisk Management Committee. The national pathogen list will become part of Iraq’s system for regulating the import, export, and transfer of dual-use materials. In addition, the list will be used to determine appropriate biosafety and biosecurity measures that laboratories will need to implement. The Iraq National Monitoring Authority played a key role in the development of the list. Mahdi Al Jewari, senior chief biologist at INMA, was a visiting fellow with the Biodefense Graduate Program at George Mason University in 2015. He and Biodefense program director Dr. Gregory Koblentz described Iraq’s effort to develop a comprehensive national biorisk management system in a 2016 article.

The World Climate and Security Report 2021

The Expert Group of the International Military Council on Climate and Security (IMCCS) released its second annual World Climate and Security Report, which highlights the compound security threats caused by the “convergence of climate change with other global risks,” such as the COVID-19 pandemic. The report shows that the growing pace and intensity of climate hazards will stress military and security services as they are deployed to climate-driven crises, while also handling direct climate threats to their own infrastructure and readiness. The authors urge security institutions around the globe to act as “leading voices urging significantly reduced greenhouse gas emissions, given recent warnings about the catastrophic security implications of climate change under plausible climate scenarios.” Key risks outlined in the report include overstretched militaries, escalating climate security risks across all regions, and insufficient climate security adaptation and resilience solutions. Key opportunities outlined in the report include embracing predictive modeling and climate risk assessment methodologies as well as updating and developing international laws and mechanisms to include environmental and climate security impacts. Read the report and summary here.

The Ruthless Hackers Behind Ransomware Attacks on US Hospitals: ‘They Do Not Care’

A string of ransomware attacks on hospitals has been carried out in recent months. These attacks have forced some medical facilities to suspend surgeries and delay medical care. They are also costing hospitals millions of dollars. The Wall Street Journal tracked the major attacks conducted by a specific group, a gang of Eastern European cybercriminals known as the “Business Club” previously and Ryuk more recently, that has ties to Russian government security services. It is the “most prolific ransomware gang in the world,” responsible for one-third of the 203 million attacks in the US in 2020. It is estimated that the group accrued at least $100 million in paid ransoms last year. Bill Siegel, CEO of the ransomware recovery firm Coveware, plainly stated: “They do not care. Patient care, people dying, whatever. It doesn’t matter.” The assaults launched specifically at hospitals during the pandemic exposed concerning gaps in cybersecurity for the nation’s health systems. In this day in age, hospitals are highly dependent on computers, especially given the push to digitize patient records.

Carbis Bay G7 Summit Communique

The leaders of the G7 – Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States – met in Cornwall on 11-31 June with the primary aims of beating the pandemic and building back better. The group released a communique outlining its agenda for global action. First, they will work to end the pandemic and prepare for the future by driving an intensified international effort, starting immediately, to vaccinate the world by getting as many safe vaccines to as many people as possible as fast as possible. Additionally, they will work to reinvigorate our economies by advancing recovery plans that build on the $12 trillion of support put in place during the pandemic. Efforts will be made to secure future prosperity by championing freer, fairer trade within a reformed trading system, a more resilient global economy, and a fairer global tax system that reverses the race to the bottom. Further, the group seeks to protect the planet by supporting a green revolution that creates jobs, cuts emissions, and seeks to limit the rise in global temperatures to 1.5 degrees. Finally, the members aim to strengthen partnerships with others around the world and embrace its values as an enduring foundation for success in an ever-changing world. Read the full announcement here.

Exploring Science and Technology Review Mechanisms under the Biological Weapons Convention

The United Nations Institute for Disarmament Research (UNIDIR) published a study that “seeks to inform discussions on establishing a dedicated and systematic S&T review process under the BWC through an examination of existing S&T review-type mechanisms employed in different regimes beyond the BWC, a survey of States Parties views on a possible review mechanism and a study of past and present discourse on this issue in the Biological Weapons Convention (BWC).” Study methods included assessing review-type mechanisms employed in regimes beyond the BWC; semi-structured interviews with experts; review of past BWC proposals; and a survey of the views of BWC States Parties. Though not all States Parties support the idea of a BWC science and technology review mechanism, and even those who desire such a mechanism differ in the details, two types of potential models became evident. The first is a limited-participation model that would loosely resemble mechanisms used in organizations such as the OPCW, and would draw from a group of 20–30 qualified geographically-representative technical experts nominated by States Parties. The second is an open-ended model that would allow any interested State Party to send (and fund) a maximum of one or two expert participants in the review process. Read the study here.

Event – Pandemics and Global Health Security Workshop

COVID-19 has exposed just how unprepared governments, corporations, and societies are for a global pandemic. While the SARS-CoV-2 virus is only the most recent threat to global health security, it will certainly not be the last. Threats to global health security continue to evolve due to the emergence of new infectious diseases, globalization, advances in science and technology, and the changing nature of conflict. Pandemics and Global Health Security is a three-day virtual, non-credit workshop designed to introduce participants to the challenges facing the world at the intersection of pandemic preparedness and response, public health, national security, and the life sciences. Over the course of three days, participants will discuss how the biology and epidemiology of SARS-CoV-2 contributed to the emergence of that virus as a global pandemic, lessons learned from Operation Warp Speed about the development of medical countermeasures, obstacles to hospital biopreparedness, challenges to science communication during a pandemic, the bioethics of resource allocation during a public health emergency, the future of global health security, and the role of science and technology in preventing and responding to pandemics. The workshop faculty are internationally recognized experts from the government, private sector, and academia who have been extensively involved in research and policy-making on public health, biodefense, and security issues. Live, interactive sessions will include Dr. Rick Bright, The Rockefeller Foundation; Dr. Nicholas G. Evans, University of Massachusetts-Lowell; Dr. Andrew Kilianski, Department of Defense; Dr. Gregory D. Koblentz, George Mason University; Dr. Jennifer Nuzzo, Johns Hopkins Center for Health Security; Dr. Saskia Popescu, George Mason University; Dr. Angela L. Rasmussen, Vaccine and Infectious Disease Organization-International Vaccine Centre; and Jessica Malaty Rivera, COVID Tracking Project. The workshop is organized by the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University and will be held virtually on July 19-21, 2021. Each day will run from 9am to 12:30pm ET. The course fee is $500. Register here.

Let Scientific Evidence Determine Origin of SARS-CoV-2, Urge Presidents of the National Academies

A statement from the Presidents of the National Academies of Science, Engineering, and Medicine (NASEM) strongly encourages the use of scientific evidence in the investigation of the origin of SARS-CoV-2. Marcia McNutt, President of the National Academy of Sciences; John L. Anderson, President of the National Academy of Engineering; and Victor J. Dzau, President of the National Academy of Medicine write:

“The origin of SARS-CoV-2, the virus that causes COVID-19, and the circumstances of the first cases of human infection, remain unknown.  Science is our best tool to ascertain, or to understand to the extent possible, the origins of SARS-CoV-2 and COVID-19, which could help prevent future pandemics.  However, misinformation, unsubstantiated claims, and personal attacks on scientists surrounding the different theories of how the virus emerged are unacceptable, and are sowing public confusion and risk undermining the public’s trust in science and scientists, including those still leading efforts to bring the pandemic under control. 

We urge that investigations into the origins of SARS-CoV-2 and COVID-19 be guided by scientific principles, including reliance on verifiable data, reproducibility, objectivity, transparency, peer review, international collaboration, minimizing conflicts of interest, findings based on evidence, and clarity regarding uncertainties.  In the case of SARS-CoV-2, there are multiple scenarios that could, in principle, explain its origin with varying degrees of plausibility based on our current understanding.  These scenarios range from natural zoonotic spillover (when a virus spreads from non-human animals to humans) to those that are associated with laboratory work. Scientists need to be able to evaluate all of these scenarios, and all viable hypotheses, with credible data.  Data accessibility, transparency, and full cooperation from China, of course, will be essential for a proper and thorough investigation. 

Although much still needs to be done to stop the pandemic, particularly in developing nations, science has made remarkable headway, especially through the rapid development of effective vaccines. The same scientific robustness, rigor, and cooperation should be applied to examining important questions about how the pandemic began.”

We May Never Know Where the Virus Came From. But Evidence Still Suggests Nature.

Dr. Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, and Dr. Stephen Goldstein, a virologist at the University of Utah, emphasize that we may never uncover the origin of the novel coronavirus that has wreaked havoc on the world. At present, however, the evidence still suggests that SARS-CoV-2 is the product of nature. For instance, the genome sequence of the virus was analyzed by a group of prominent evolutionary virologists who assessed that it was “overwhelmingly unlikely” that there was laboratory manipulation. The worry that the virus could have come from a high-containment laboratory, specifically the Wuhan Institute of Virology (WIV), has surged in recent weeks. The two scientists assert that the work of laboratories and institutions like WIV are critical to preparing for and responding to pandemics. Additionally, they “agree that researchers should continue to study whether the virus could have emerged from a lab, but this cannot come at the expense of the search for animal hosts that could have transmitted SARS-CoV-2 to humans.” Rasmussen is among the distinguished faculty for the upcoming Pandemics and Global Health Security Workshop hosted by the Biodefense Graduate Program.

It’s Time to Talk About Lab Safety

Dr. Filippa Lentzos, a senior lecturer in science and international security at King’s College London, and Dr. Gregory Koblentz, Director of Biodefense Graduate Program, launched GlobalBioLabs.org, an interactive web-based map of global Biosafety Level 4 facilities and biorisk management policies. Lentzos shared that the aim of the project is to “increase public knowledge about Biosafety Level 4 labs, and importantly, to strengthen national and international virus management policies.” In their research, the two scholars found that there is “significant room for improvement in the policies in place to ensure that these labs were operated safely, securely and responsibly.” Regardless of the origin of SARS-CoV-2, the risk of laboratory accidents and incidents rises as the number of laboratories in the world expands. The new map includes 59 laboratories, the majority of which are in Europe with a total of 25 labs. Only 17 of the 23 countries that house BSL-4 laboratories have national biosafety associations or are members of international partnerships. About 60% of BSL4 labs are government-run public-health institutions, leaving 20% run by universities and 20% by biodefence agencies. Only three of the 23 countries with BSL4 labs – Australia, Canada and the US – have national policies for the oversight of dual-use research. The primary concern is that an accident could trigger the next pandemic. At a national level, Koblentz and Lentzos recommend that “countries with BSL-4 labs should have whole-of-government systems that can conduct multidisciplinary risk assessments of proposed research for safety, security and dual-use activities, such as certain gain-of-function research, that have significant potential to be repurposed to cause harm.” At the international level, they recommend that “structures be put in place to systematically oversee maximum containment facilities.”

SARS-CoV-2 Variants of Interest and Concern Naming Scheme Conducive for Global Discourse

The Virus Evolution Working Group of the World Health Organization convened a group to determine a naming system that will “enable clear communication about SARS-CoV-2 variants of interest and concern.” SARS-CoV-2 is the causative agent of coronavirus disease 2019 (COVID-19), and, as with all viruses, it continuously adapts to changing environments via random genome mutations. There have been several mutations of SARS-CoV-2 since its emergence, and the naming of them has been based on three nomenclature systems, each of which has its own scientific method to classify and name lineages. This means that one variant could have multiple names. To simplify communication and information sharing, a new system was developed for the naming of Variants of Concern and Interest. The new labels use the Greek alphabet. The tables below show the new labels of Variants of Interest and Variants of Concern, respectively.

The US Has Hit 600,000 COVID Deaths, More Than Any Other Country

It has been 15 months since the first confirmed death due to SARS-CoV-2 was reported in the US, and the novel virus has now taken the lives of 600,000 people across the nation. The vaccines have slowed the trend from thousands to hundreds of deaths per day. At present, there are about 375 deaths per day on average, a major decline since January with an average of 3,000 per day. Many Americans are vaccinated or in the process of becoming so, helping to further overcome COVID-19; however, an alarming number of people are reluctant to get vaccinated.

Biodefense Board Discusses Future of US Pandemic Preparedness

By Michelle Grundahl, Biodefense MS Student

On May 26, 2021, the National Biodefense Science Board (NBSB) held a (virtual) public meeting that discussed actions that the United States needs to take to be better prepared for the challenges posed by public health emergencies such as pandemics, “Disease X,” and other biological threats. NBSB is the federal committee that advises the office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). During the meeting, the NBSB presented their recommendations to ASPR from its new report on ‘filling critical gaps’ in health emergency preparedness, response, and recovery. In addition, NBSB was briefed on the CDC’s new initiative to improve its data collection and analytical capabilities to improve information sharing and situational awareness during a public health emergency.

The NBSB’s All-Hazards Science Response Working Group draft report, Filling Critical Gaps: Comprehensive Recommendations for Public Health Preparedness, Response, and Recovery from the National Biodefense Science Board, is the result of a September 2020 request from ASPR to NBSB to review the 2007 Homeland Security Presidential Directive 21 (HSPD-21). HSPD-21 is the national strategy for ‘Public Health and Medical Preparedness’ that was formulated during the George W. Bush Administration as part of its strategy to protect the health of Americans during disasters. ASPR asked NBSB to answer three questions:

1) What, if any, of the 2007 focus areas (biosurveillance, countermeasures stockpiling and distribution, mass casualty care, or community resilience) should remain as highest priorities for capacity development by HHS? 

2) How might those focus areas be modified, updated, or expanded to promote additional advances in public health and medical preparedness in the United States? 

3) What should be new HHS focus areas for public health and medical preparedness, if any?

The key finding of the NBSB report is that the United States should always be prepared to “implement an immediate, effective, and coordinated public health response that is guided by scientific knowledge and protected from undue political influence…insulated from political considerations, with the ability to independently develop, directly distribute, and frequently update public health messages with scientific principles in mind, guided by analysis of available data, with inputs from the nation’s leading experts.” To achieve that objective, NBSB made five recommendations to enhance the country’s disaster preparedness and response based on strengthening One Health biosurveillance and situation awareness, enhancement of medical countermeasures, reinforcing health workforce readiness, increasing health facility resilience, and improving communication with the public during health crisis.

The NBSB’s first recommendation is to use a One Health threat assessment for biosurveillance and situational awareness. One Health is holistic approach that considers the systems involved in achieving optimal health outcomes for humans, animals, plants and their shared environment. NBSB recommended that federal departments, public and private research institutions, and private sector organizations should engage in One Health collaborations to protect against emerging human and animal disease risks. A One Health approach would continuously assess emerging human and animal disease risks by using research and predictive data capabilities (based on artificial intelligence) to assess patterns of animal, agricultural, and human health. Proactively discovering biothreats, including zoonotic or arthropod-borne disease, would create improved situational awareness about high consequence risks.  

The board specifically suggests the enhancement of medical countermeasures (MCM), manufacturing, and supply chain. The report provides detailed examples of this approach, and advises that the production of vaccines, drugs, personal protective equipment, and diagnostics should all be “on-shored” inside the United States for quick production and scale-up. For example, active pharmaceutical ingredients, as well as finished products, can be made in the United States instead of imported from foreign suppliers. In addition, assessment of emergency medical countermeasures and diagnostic tools, as well as readiness for manufacturing them, should be an ongoing process. Also, mechanisms for infectious disease, vector-borne and zoonotic disease research and related drug development require investment in computer modeling, in-vitro models, and better animal models. To support these goals, NBSB recommend that incentives should be provided to support private sector innovation. The board also suggests improving the transparency of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to increase information sharing among relevant Federal agencies and private sector partners.  The PHEMCE – led by ASPR – consists of coordinated federal preparedness activities and medical countermeasures for natural, accidental, and intentional threats. Federal interoperable capabilities should be ready to be deployed systematically to proactively manage zoonotic and infectious diseases, climate change, supply chain shortages, workforce shortages, and additional threats to health security.

The health workforce is another focus area for achieving readiness and resilience during a public health crisis. The nation’s workforce needs more infectious disease specialists who are the first responders during an outbreak or a pandemic. The NBSB suggested that the training curriculum for health professionals should include disaster preparedness, emergency response, epidemic control, and training to use personal protective equipment. Likewise, first responders and incident commanders would benefit from additional emergency response education related to health threats and disasters. A critical point identified by NBSB is the need to review  Emergency Support Function (ESF)-8 of the National Response Framework which coordinates of public health and medical services in response to a natural disaster, terrorist attack, or other incidents of national significance. Another astute point is the consideration of the need for childcare, eldercare, and pet care to be available for health workers and first responders during disasters.

NBSB also identified health facility readiness and resilience (and the general soundness of healthcare systems) as having room for improvement as well. Some examples of improvements that are desperately needed are stronger health facility cybersecurity, better hospital collaborations for resource sharing (including staff), and planning for weather disasters overlapping with simultaneous health threats. As a lesson learned from COVID-19, telehealth and health license portability should continue post-pandemic. During COVID-19, health appointments could be held remotely online, and health professionals could work outside of their licensed jurisdictions. Since electronic health records are available over the internet, health professionals could see patients from anywhere.  

The NBSB also recommended improving public communication by developing and disseminating “timely, accurate, consistent, and trusted advisories, public health messages, and clinical guidelines” during a health crisis. Clear, consistent scientific messages should not be influenced by political concerns. Their communication recommendation noted that there should be an alignment of information using social media and local organizations. The goal is to provide accurate information to everyone; no one in society should be left out of receiving crisis communications.

The recommendations contained in this report build on previous reports by NBSB on how to “accelerate research and develop goals to prevent infectious diseases disasters.” For example, the May 13, 2020 report, Medical Countermeasure Research and Development Goals to Prevent Infectious Disease Epidemics, recommended nine items for the early detection and identification of pathogens, including early activation of MCM, coordination mechanisms, rapid MCM development pathways, adequate infrastructure and emergency funding – and the management of public trust. Another May 2020 report, Integrating Clinical Disaster Response Training with Community and State-Based Emergency Planning, recommended continued collaborations between clinical practitioners and disaster management authorities. That previous report focused on medical recommendations for healthcare organizations, local health departments, incident commanders, and emergency medical services to improve their capacity for disaster response, recovery, and mitigation.

The NBSB also heard from Dr. Daniel B. Jernigan, Deputy Director for Public Health Science and Surveillance, about the Centers for Disease Control and Prevention (CDC) Data Modernization Initiative. The CDC now has greater capacity to use electronic data and centralized laboratory reporting. They can receive and share massive data through the cloud. The CDC is still aiming for an even more modern, integrated, real-time public health surveillance data.  This initiative involves four core areas for strengthening core surveillance capabilities: 1) syndromic surveillance, 2) electronic case reporting (eCR), 3) electronic laboratory reporting, and 4) vital records. Syndromic surveillance can reveal local symptom trends by comparing hospital and health reports. Dr. Jernigan discussed real-time data surveillance during COVID-19, which used county-level monitoring of COVID-like Illness (CLI). Anomaly detections and syndromic surveillance programs, such as BioSense, are cloud-based.  Electronic case reporting is the real-time automated information exchange of electronic health records between public health agencies. Reporting laboratory results electronically reduces the turn-around time of waiting for results, allowing for faster intervention. Electronic lab reporting existed before COVID-19, but it was not automated or truly robust. Also, having up-to-date information on vital records, such as death certificates, is important for public health decision-making.

The goal of the CDC’s data modernization plan is to collect accurate data, including from non-traditional sources that can forecast health threats, that can be shared easily with partners. Under this model, data would flow through the same data hubs, where a single data upload would inform various partners in a hub and spoke model. Faster access to larger data sets will allow for interoperability and dashboards that inform forecasting and decision-making. Combined data-set platforms can be used to create pandemic dashboards. Timely, high-quality data sharing is now scalable and the process can be used during future outbreaks to reduce the burden of manual reporting. Data standards for electronic data exchange and electronic data linkage, using databases such as the National Notifiable Diseases Surveillance System (NNDSS), will bolster the mapping of notifiable diseases.

Together, the draft report by the NBSB’s All-Hazards Science Response Working Group and the CDC’s data modernization plan can help strengthen public health emergency preparedness and response in the United States so that we can prevent pandemics – and be ready for unknown threats.  

Pandora Report: 6.11.2021

June is National Pet Preparedness Month! The FDA approved a new drug for the treatment of smallpox. The SARS-CoV-2 virus is here to stay.

Pet Preparedness Month

June is National Pet Preparedness Month! Pet parents should include animals in emergency plans: have an evacuation plan, microchip your pet, and develop a buddy system. You can also build a kit for your pet with food, water, medicine, a first aid kit, grooming items, and a photo of you with your pet. As the summer heat sets in, remember to keep your pet hydrated and do not leave them in a hot car. Also, mind hot pavement for their paws!

A new article in Disaster Medicine and Public Health Preparedness explores the evidence regarding the use of trained dogs to detect COVID-19 infections. Detection dogs are a promising non-invasive, efficient, and cost-effective screening method for SARS-CoV-2 infection. Read the article here.

Science & Tech Spotlight: Digital Vaccine Credentials

Digital vaccine credentials can confirm that a person has been vaccinated or tested negative for COVID-19. They can be a tool to reduce the disease’s spread, and allow travel and other activities to resume safely. Users of such credentials can provide their COVID-19 information on a mobile device through a secure, digital code for fast and contactless scanning. Airports and other venues could process larger numbers of people more quickly with these credentials than with paper vaccine cards. However, challenges that may limit the use of these credentials include concerns about the security and privacy of users’ health data. Read the full report from the US Government Accountability Office (GAO) here.  

HHS Launches First Venture Capital Partnership to Develop Transformative Technologies to Combat Future Pandemics, Other Health Emergencies

Through the BARDA Ventures program, the Biomedical Advanced Research and Development Authority (BARDA – part of the HHS Office of the Assistant Secretary for Preparedness and Response – is launching a partnership with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats. Through this partnership, BARDA intends to provide GHIC with a minimum of $50 million over five years with potential for up to $500 million over 10 years. GHIC will launch a global health security fund with matching capital from other investors. This partnership will allow direct linkage with the investment community and establish sustained and long-term efforts to identify, nurture, and commercialize technologies that aid the US in responding effectively to future health security threats.

FDA Approves Drug to Treat Smallpox

The Food and Drug Administration (FDA) approved Tembexa (brincidofovir) to treat smallpox. Though smallpox was eradicated in 1980, there are worries that it could be deployed as a bioweapon. The disease spreads via direct contact among humans and symptoms arise 10-14 days after infection. Symptoms include fever, exhaustion, headache, backache, and the telltale rash consisting of small, pink bumps progressed to pus-filled sores before it crusts over and scars. As an eradicated disease, the efficacy of Tembexa was evaluated in animals infected with viruses that are closely related to the variola virus, and was determined by measuring animals’ survival at the end of the studies. Efficacy and safety were adequate for FDA approval. The most common side effects are diarrhea, nausea, vomiting, and abdominal pain.

Gene Drives Are What’s Next

The next meeting of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), a federal advisory committee that provides recommendations to the NIH Director and a public forum for the discussion of the scientific, safety, and ethical issues associated with emerging biotechnologies, will be held on 25 June 2021. The meeting will discuss a Draft Report of the Gene Drives in Biomedical Research Working Group, which was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to “consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology” and “outline conditions (if any) under which NIH could consider supporting field release of gene drive modified organisms.”

Review of Recounting the Anthrax Attacks

Dr. R. Scott Decker is a retired supervisory special agent for the Federal Bureau of Investigation (FBI) and he published the book, Recounting the Anthrax Attacks: Terror, the Amerithrax Task Force, and the Evolution of Forensics in the FBI. Al Mauroni, director of the US Air Force Center for Strategic Deterrence Studies, wrote a review of the book, dubbing it “a valuable book for understanding how the FBI developed its case for the Amerithrax investigation, not just for the legal community that engages in bioterrorism cases, but for the defense community that engages in the policy aspects of this issue.” The FBI eventually attributed the anthrax attacks to Bruce Ivins, a research scientist working at the Army’s Fort Detrick laboratories. Read the review here.

The Forever Virus: A Strategy for the Long Fight Against COVID-19

The SARS-CoV-2 virus is here to stay. The novel coronavirus cannot be eradicated, because it infects over a dozen different species. Due to vaccine supply shortages and vaccine hesitancy, global herd immunity is “unreachable.” Even if every human on the planet could be vaccinated today, the virus would persist in various animal species. That said, vaccination must remain a primary goal in order to contain the disease. Though many hoped that the virus would be the cause of a short-term crisis, it is proving to be a chronic crisis against a very resilient pathogen. This is, in part, a result of many nations failing to heed the early warning signs and take the threat seriously, allowing grave damage to occur. “As a wealthy, powerful, and scientifically advanced country, the United States is optimally positioned to help lead the long fight against COVID-19.” And, in order to do this, the US must repair its reputation as a global public health leader. Beyond US leadership and support, the entire global framework for pandemic response needs a reboot. A recent report recommends elevating pandemic preparedness and response to the highest levels of the United Nations via the creation of a “global health threats council.” This council would be led by heads of state, separate from the World Health Organization, and “charged with holding countries accountable for containing epidemics.”  

Dr. Rick Bright, Senior Vice President of Pandemic Prevention & Response at The Rockefeller Foundation, is among the contributors of this piece. Bright is also among the distinguished faculty for the upcoming Pandemics and Global Health Security Workshop hosted by the Biodefense Graduate Program.

The “Legal Epidemiology” of Pandemic Control

The centrality of law as a public health intervention has been undeniable during the COVID-19 pandemic. In just the first half of 2020, more than 1,000 laws and orders were issued by federal, state, and local authorities in the United States in an effort to reduce disease transmission. Legal interventions include stay-at-home orders, mask mandates, and travel restrictions, as well as more particular rules for business operations, alcohol sales, curfews, and health care. Given their heavy use, importance, and obvious socioeconomic side effects, and the social and behavioral complexities of their implementation, one might have expected the National Institutes of Health (NIH), other research funders, and the research community to jump to the work of determining the right mix, intensity, and enforcement approaches of legal restrictions to control transmission with the least and most equitably distributed harms. No organized research program emerged. Funding for scientific evaluation of legal effects and public health systems research was paltry, at a time when hundreds of thousands of lives, the socioemotional development of millions of children, and billions of dollars in economic activity directly depended on questions about control measures, enforcement methods, the organization of the health system, and the many ways in which law was immediately influencing vulnerability, resilience, and social behavior. It is past time for a broad recognition in our health system that law is a ubiquitous treatment, one to which hundreds of millions of people are routinely exposed. The imperative is to scale up the infrastructure for at least three kinds of research: study of the mechanisms, effects, side effects, and implementation of laws designed to influence health, such as COVID control measures; research on how the legal infrastructure of the US health system — the allocation of powers and duties, as well as limits on authority — influences the effectiveness of the system; and perhaps most important for addressing health equity, studies of how laws that may appear to have no health purposes — such as the tax code, minimum wage, and labor rules — shape the social determinants of health.

The COVID Lab-Leak Hypothesis: What Scientists Do and Don’t Know

Most scientists say SARS-CoV-2 probably has a natural origin, and was transmitted from an animal to humans. However, a lab leak has not been ruled out, and many are calling for a deeper investigation into the hypothesis that the virus emerged from the Wuhan Institute of Virology (WIV), located in the Chinese city where the first COVID-19 cases were reported. On 26 May, US President Joe Biden tasked the US Intelligence Community to join efforts to find SARS-CoV-2’s origins, whatever they might be, and report back in 90 days. Scientists don’t have enough evidence about the origins of SARS-CoV-2 to rule out the lab-leak hypothesis, or to prove the alternative — that the virus has a natural origin. Many infectious-disease researchers agree that the most probable scenario is that the virus evolved naturally and spread from a bat either directly to a person or through an intermediate animal. Most emerging infectious diseases begin with a spillover from nature, as was seen with HIV, influenza epidemics, Ebola outbreaks and the coronaviruses that caused the SARS epidemic beginning in 2002 and the Middle East respiratory syndrome (MERS) outbreak beginning in 2012. In theory, COVID-19 could have come from a lab in a few ways. Researchers might have collected SARS-CoV-2 from an animal and maintained it in their lab to study, or they might have created it by engineering coronavirus genomes. In these scenarios, a person in the lab might have then been accidentally or deliberately infected by the virus, and then spread it to others — sparking the pandemic. There is currently no clear evidence to back these scenarios, but they aren’t impossible. Read the breakdown of knowns and unknowns here.

Biden Would Slash Pentagon Money for Pandemic Prevention

President Biden proposed halving the Pentagon’s budget for the leading US government program for preventing, detecting, and responding to global disease outbreaks – the Biological Threat Reduction Program. The Biological Threat Reduction Program “finds and fights emerging global diseases that can threaten US troops and, ultimately, the world’s population.” This is a move that “even the White House’s staunchest allies on Capitol Hill oppose as the nation continues to grapple with the COVID-19 pandemic.” The proposed cut arose despite the assessment of US intelligence agencies and scientists that “pandemics will become increasingly common and as COVID-19 still rages in many countries and hangs on in America.” “The US military has been a leader in research and development of coronavirus vaccines and in disseminating them,” and the Pentagon plans to spend $500 million in FY22 on COVID-19 response and preparedness for future pandemics, despite the funding slash.  

COVID-19 Air Traffic Visualization

The RAND Corporation released a report, COVID-19 Air Traffic Visualization: COVID-19 Cases in China Were Likely 37 Times Higher Than Reported in January 2020, which presents strong evidence that China’s reported COVID-19 caseload was undercounted by a factor of nearly 40. In this report — one of several from a RAND Corporation team examining the role of commercial air travel in the coronavirus disease 2019 (COVID-19) pandemic — researchers use RAND’s COVID-19 Air Traffic Visualization (CAT-V) tool to estimate the likely number of infections in China in early 2020. The tool combines COVID-19 case data from Johns Hopkins University with detailed air travel data from the International Air Transport Association. From December 31, 2019, to January 22, 2020, China reported a daily average of 172 cases of COVID-19 among its residents. This number of confirmed cases was equivalent to just one per 8.2 million residents in the country per day. Using the detailed flight data over that same period of time, it was determined that the five countries most at risk of importing COVID-19 from China were, in descending order of risk, Japan, Thailand, South Korea, the United States, and Taiwan. But far fewer than 8.2 million passengers flew from China to the five countries over that 23-day period. Just more than 1 million passengers flew from China to Japan and Thailand each, while slightly more than 750,000 flew to South Korea, 500,000 flew to the United States, and fewer than 400,000 flew to Taiwan (as illustrated in the map below). Thus, all of these passengers from China totaled fewer than 3.7 million, for an expected COVID-19 exportation rate of less than one case to all five of these countries combined. However, COVID-19 cases were already being reported in all five countries during this time. This trend would be exceedingly unlikely given the low reported case count in China. Read the report here.

Why Contact Tracing Couldn’t Keep Up with The US COVID Outbreak

A survey from NPR and the Johns Hopkins Center for Health Security found that many state health departments are “winding down the contact tracing programs they scrambled to grow last year.” Even though coronavirus infections are tapering off in most parts of the country, public health experts recommend maintaining a smaller workforce able to stay on top of ongoing outbreaks. This is a significant change from last winter when the US suffered from a shortage of people to respond and deliver case investigation and contact tracing. Adriane Casalotti of the National Association of County and City Health Officials likened the scramble to find these workers as “trying to build the plane while flying it.” Beyond the lack of personnel, there was an absence of federal leadership and communication from authorities (namely, the Centers for Disease Control and Prevention as well as the White House). Additionally, there did not exist a uniform approach for contact tracing programs. Low responsiveness was another challenge. An analysis of 14 contact tracing programs from June to October 2020 published in JAMA Network Open found that “no contacts were reported for two-thirds of persons with laboratory confirmed COVID-19 because they were either not reached for an interview or were interviewed and named no contacts.” A recent poll by the Harvard TH Chan School of Public Health and the Robert Wood Johnson Foundation found that only 52% of Americans trust the CDC, while the numbers for state and local health departments were even lower. Distrust also inhibited the utility of digital tools for contact tracing. For instance, in Utah, an app called Healthy Together used GPS location for contact tracing, but much of the population was uninterested in using it and unwilling to download it.  

BSL-4 Laboratories

Recently, Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University launched GlobalBioLabs.org, an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. Lentzos shared that the aim of the project is to “increase public knowledge about Biosafety Level 4 labs, and importantly, to strengthen national and international virus management policies.” Regardless of the origin of SARS-CoV-2, the risk of laboratory accidents and incidents rises as the number of laboratories in the world expands. The new map includes 59 laboratories, the majority of which are in Europe. Only 17 of the 23 countries that house BSL-4 laboratories have national biosafety associations or are members of international partnerships. The primary concern is that an accident could trigger the next pandemic. Watch a recording of the webinar launching the site here.

Pandora Report: 6.4.2021

The Biden administration has released its fiscal year 2022 budget, which includes an increase of almost $1 billion for global health programs. Syrian President Bashar al-Assad remains in power. Register for the upcoming Pandemics and Global Health Security Workshop!

Biden’s FY22 Budget

The Biden administration released its fiscal year 2022 (FY22) budget, which includes an increase of almost $1 billion for global health programs. There is also a section of the budget that provides “discretionary funding for the Centers for Disease Control and Prevention (CDC) — the largest budget authority increase in nearly two decades — to restore capacity at the world’s pre-eminent public health agency.” In regard to the fight to end the COVID-19 pandemic, the budget provides $1 billion in foreign assistance to “establish Global Health Security Agenda capacity building programs in additional nations and increase investments in crosscutting research and viral discovery programs to detect and stamp out future infectious disease outbreaks.” In total, global health security funding is $905 million, a 376% above the FY21 enacted level. Funding for tuberculosis totals $319 million and funding for malaria totals $770 million, both matching the FY21 enacted levels. Funding for neglected tropical diseases totals $103 million, also matching the FY21 enacted level. KFF outlines a detailed comparison of funding for global health efforts between FY22 and FY21 here.

Ahead of the budget release, KFF analyzed the historical trends in US funding for global health, finding that funding through regular appropriations increased by almost $10 billion since FY 2001. Most of this increase is due to the establishment of President’s Emergency Plan For AIDS Relief (PEPFAR), the Global Fund, and the President’s Malaria Initiative. Over the last decade, the US has offered nearly $12 billion in emergency supplemental funding for infectious diseases, but  90% of that funding was provided in the last year in response to the COVID-19 pandemic.

‘A Perilous Point’: Global Agencies Call for $50 Billion Investment to Combat COVID-19

A statement from the World Health Organization (WHO), the World Bank, the World Trade Organization (WTO), and the International Monetary Fund (IMF) urges investment of up to $50 billion to “boost manufacturing capacity and supplies and ease trade rules to ensure equitable distribution of vaccines and other medical products.” Additional funding to COVAX, the global vaccine distribution initiative, “could be widened to 40% and, possibly 60% by the first half of 2022.” COVAX has administered nearly 2.4 billion doses across 92 low and middle-income countries. But, an additional $8.3 billion is needed as the current resources would only cover about 30% of their populations through early 2022. According to an IMF analysis, “added investment could generate an estimated $9 trillion in additional global output by 2025.”

It’s No Joke: Borat Turns to Johns Hopkins Scientist for Serious COVID Vaccine Talk

Dr. Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security, shares her vaccine expertise for British comedian Sacha Baron Cohen’s latest moviefilm. One of the topics Nuzzo addressed was the conspiracy theory that the COVID-19 vaccines are being used as vehicles to insert microchips into people. She clarifies, “a microchip wouldn’t fit through the tiny needle used to inject COVID-19 vaccines.” Nuzzo is among the distinguished faculty for the upcoming Pandemics and Global Health Security Workshop hosted by the Biodefense Graduate Program.

Operation Warp Speed and Beyond Toolkit

The Operation Warp Speed and Beyond Toolkit has been developed for cleared and uncleared industry partners working on Operation Warp Speed (OWS). It provides OWS partners with the resources they need to better protect the important work they are doing. While some of these resources were developed with cleared contractors participating in the National Industrial Security Program (NISP) in mind, the guidance and information provided apply to any industry partner working on sensitive information that is sought after by an adversary, regardless of classification level or designation.

On September 10, 2020, Operation Warp Speed industry partners were invited to participate in a webinar that provided an overview of insider risk, cybersecurity, counterintelligence threats, and industrial security best practices. In case you were unable to attend the live webinar, you may view a recording of the webinar here.

WHA74: Strengthen Global Preparedness for Health Emergencies

The 74th World Health Assembly (WHA) concluded on 31 May, and it focused on ending the COVID-19 pandemic and how to prevent the next one. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO), called for beginning negotiations this year on an international treaty to enhance pandemic preparedness. Though such a treaty was not adopted at this year’s WHA, member states agreed to create a working group that would look at the benefits of a treaty, a convention, or an international agreement. In late November, the ministers from the WHO’s 194 member states are set to convene and decide whether or not to start such negotiations. To the dismay of many, the WHA did not adequately consider a very current and critical topic: “a plan to vaccinate the world and end vaccine inequity.” No resolution or strategy was put forward to achieve global equitable vaccination. Thomas Schwartz, executive secretary of Medicus Mundi International, stated, “Unfortunately, the WHA is still not [a] place for member state[s] to be challenged, and the full transparency, with all sessions being live webcast, does not provide the setup for critical self-reflection.” On a better note, the WHA did pass two resolutions “advocating for government support for the Gender Equal Health and Care Workforce Initiative to address gender inequities in the health and care workforce.”

One for All: An Updated Action Plan for Global COVID-19 Vaccination

The Rockefeller Foundation released a new report, One for All: An Updated Action Plan for Global Covid-19 Vaccination, that calls on the “G7 and other donors to step up so that COVAX closes its US$9.3 billion funding gap by June 2nd, allowing it to unlock an additional 1.8 billion doses of vaccine, enabling 92 low- and middle-income countries to vaccinate half their adult population.” The lack of equitable vaccine distribution leaves much of the global population unvaccinated, posing a threat to ending the pandemic. Thus far, about half of North Americans and over one-quarter of Europeans have been vaccinated, but only about 14% of South Americans, 5% of Asians, and 1.2% of Africans. Further, 80% of vaccines have been administered in high- and upper-middle income countries, leaving low-income countries vulnerable and unprotected. The report provides a 5-point action plan to scale equitable vaccination around the world: (1) share more sooner; (2) make more quicker; (3) build in the global South; (4) support delivery systems; and (5) close the financing gap. Dr. Rick Bright, Senior Vice President of Pandemic Prevention & Response at The Rockefeller Foundation, is among the contributors of this report. Bright is also among the distinguished faculty for the upcoming Pandemics and Global Health Security Workshop hosted by the Biodefense Graduate Program. Read the report here.

Event – Pandemics and Global Health Security Workshop

COVID-19 has exposed just how unprepared governments, corporations, and societies are for a global pandemic. While the SARS-CoV-2 virus is only the most recent threat to global health security, it will certainly not be the last. Threats to global health security continue to evolve due to the emergence of new infectious diseases, globalization, advances in science and technology, and the changing nature of conflict. Pandemics and Global Health Security is a three-day virtual, non-credit workshop designed to introduce participants to the challenges facing the world at the intersection of pandemic preparedness and response, public health, national security, and the life sciences. Over the course of three days, participants will discuss how the biology and epidemiology of SARS-CoV-2 contributed to the emergence of that virus as a global pandemic, lessons learned from Operation Warp Speed about the development of medical countermeasures, obstacles to hospital biopreparedness, challenges to science communication during a pandemic, the bioethics of resource allocation during a public health emergency, the future of global health security, and the role of science and technology in preventing and responding to pandemics. The workshop faculty are internationally recognized experts from the government, private sector, and academia who have been extensively involved in research and policy-making on public health, biodefense, and security issues. Live, interactive sessions will include Dr. Rick Bright, The Rockefeller Foundation; Dr. Nicholas G. Evans, University of Massachusetts-Lowell; Dr. Andrew Kilianski, Department of Defense; Dr. Gregory D. Koblentz, George Mason University; Dr. Jennifer Nuzzo, Johns Hopkins Center for Health Security; Dr. Saskia Popescu, George Mason University; Dr. Angela L. Rasmussen, Vaccine and Infectious Disease Organization-International Vaccine Centre; and Jessica Malaty Rivera, COVID Tracking Project. The workshop is organized by the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University and will be held virtually on July 19-21, 2021. Each day will run from 9am to 12:30pm ET. Prior to June 18, the course fee is $400. Starting June 18, the course fee is $500. Register here.

The Assad Regime Continues

On Wednesday, Syrian President Bashar al-Assad voted to extend his rule, “casting his ballot in an ex-rebel bastion where a suspected chemical weapons attack in 2018 prompted Western air strikes.” Syria has been in a decade-long conflict that has killed hundreds of thousands of people and forced half of the country’s population from their homes, all under Assad’s regime. The election was held despite a peace process led by the United Nations that called for voting under international supervision. Unfortunately, this week’s vote will allow Assad seven more years in power, extending his family’s rule to nearly 60 years.

Last month, the members of the Chemical Weapons Convention (CWC) voted to suspend Syria’s rights and privileges under the treaty. The CWC prohibits the use, production, and stockpiling of chemical weapons. The suspension is a “modest step” toward holding Syria accountable for its chemical weapons attacks and reinforcing the global prohibition against chemical weapons use. In 2013, Syrian forces deployed nerve gas on neighborhoods near Damascus, killing about 1,300 people. Unfortunately, the international responses to Syria’s atrocities have been lackluster. Despite the latest vote, the “Assad regime could continue to maintain, expand, and employ its illegal chemical weapons arsenal as a terror weapon against opposition forces and civilians.” A possible next step in the event that Syria does not comply with the CWC is to refer Syria to the UN Security Council (UNSC). Another option would be to “demand a challenge inspection in Syria pursuant to Article IX of the CWC to clarify outstanding inconsistencies with its stockpile declaration.”

WHO Gives Virus Variants New Names, Drawing from Greek Alphabet

The World Health Organization (WHO) has established a less technical method for naming the new variants of the novel coronavirus using the Greek alphabet. For example, B.1.1.7 is now Alpha. The tables below crafted by Bloomberg shows the new names for the variants of concern and the variants of interest.

Fall 2021 Courses in the Biodefense Graduate Program

If you are a Schar School student looking for another interesting class to take this fall, the Biodefense Graduate Program is offering two fascinating courses: Global Food Security (BIOD 726) with Philip Thomas and Building Health System Resilience (BIOD 610) with Dr. Saskia Popescu.

Global Food Security (BIOD 726) analyzes threats to food security globally including those related to climate change and environmental degradation; animal and plant diseases; access to clean water; agricultural terrorism; and antimicrobial resistance. It explores the national and global health, economic, social, and ethical impacts of these disruptive forces. The course also examines strategies for enhancing the security of the global food production and supply system.

Building Health System Resilience (BIOD 610) will provide students with a foundation in how healthcare systems prepare and respond to pandemics, disasters, and biological events. The ability of healthcare systems to respond to biological threats will have impacts at the community, national, and international levels. Health resilience in the United States is a particular challenge given multiple stakeholders, economic factors, and regulatory fragmentation. Students will review case studies, such as Ebola, Hurricane Katrina, 9/11, and COVID-19, to examine the unique challenges of building and sustaining the resilience of the American healthcare and its role in global health security.

Schar School Open House

You’re invited to attend a virtual open house to learn more about the Schar School of Policy and Government and our academic programs. The online session will provide an overview of our master’s degree programs and graduate certificate programs, student services, and admissions requirements. Attendees will be provided with an application fee waiver for the Fall 2021 graduate application. Biodefense applicants are eligible for funding from the Diane Davis Spencer Foundation Scholarship. The fall application deadline is July 15th. The Open House will be held virtually on 9 June at 6 PM EST. Register here.

BSL-4 Laboratories

Last week, Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University launched GlobalBioLabs.org, an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. Lentzos shared that the aim of the project is to “increase public knowledge about Biosafety Level 4 labs, and importantly, to strengthen national and international virus management policies.” Regardless of the origin of SARS-CoV-2, the risk of laboratory accidents rises as the number of laboratories in the world expands. The new map includes 59 laboratories, the majority of which are in Europe. Only 17 of the 23 countries that house BSL-4 laboratories have national biosafety associations or are members of international partnerships. The primary concern is that an accident could trigger the next pandemic.

Pandora Report: 5.28.2021

The 74th World Health Assembly is underway in Geneva; you can watch the webcast here! Listen here as Dr. Saskia Popescu, an assistant professor in the Biodefense Graduate Program as well as an alumna, will be interviewed on the With Good Reason podcast today, 28 May. The lab leak theory for the origin of COVID-19 is gaining traction.

Schar School Open House

You’re invited to attend a virtual open house to learn more about the Schar School of Policy and Government and our academic programs. The online session will provide an overview of our master’s degree programs and graduate certificate programs, student services, and admissions requirements. Attendees will be provided with an application fee waiver for the Fall 2021 graduate application. Biodefense applicants are eligible for funding from the Diane Davis Spencer Foundation Scholarship. The fall application deadline is July 15th. The Open House will be held virtually on 9 June at 6 PM EST. Register here.

74th World Health Assembly

The 74th World Health Assembly (WHA) is underway until 1 June, and it is taking place virtually. The WHA is the decision-making body of World Health Organization (WHO), and it is attended by delegations from all WHO Member States. The primary functions of the WHA are to determine the policies of the WHO, appoint the Director-General, supervise financial policies, and review and approve the proposed budget. The theme of this year’s meeting is, “Ending this pandemic, preventing the next: building together a healthier, safer and fairer world.” On Monday, United Nations Secretary-General Antonio Guterres called for the “application of wartime logic in the international battle against COVID-19.” Guterres explains the pandemic as being “at war with the virus.” WHO Director-General Tedros Adhanom Ghebreyesus lamented the “scandalous inequity” of vaccine distribution that is perpetuating the pandemic. Though COVID-19 is the main topic of this year, other issues include proposals for WHO reforms and the exclusion of Taiwan. Taiwan maintains hope that it will be granted a seat at the WHA meeting. The nation’s successful handling of COVID-19 for more than a year and a half has brought renewed attention to Taiwan’s absence from the WHA.”

MCMi Program Update on FDA

The Food and Drug Administration (FDA) plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. The FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. The FDA works closely with interagency partners through the US Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE, or Enterprise) to build and sustain the MCM programs necessary to effectively respond to public health emergencies. The FDA also works closely with the US Department of Defense (DoD) to facilitate the development and availability of MCMs to support the unique needs of American military personnel. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), requires the FDA to issue an annual report detailing its medical countermeasure activities. This report responds to that requirement for the latest fiscal year available. The FY 2020 report includes a snapshot of the Agency’s COVID-19 response efforts through September 30, 2020. Read the report here.

DHS Exploring New Methods to Replace BioWatch and Could Benefit from Additional Guidance

The Department of Homeland Security (DHS) is following the agency’s acquisition policy and guidance to acquire Biological Detection for the 21st Century (BD21). This system-of-systems concept—an assembly of technologies to gain higher functionality—is intended to combine various technologies, such as biological sensors, data analytics, anomaly detection tools, collectors, and field screening devices to enable timelier and more efficient detection of an aerosolized attack involving a biological agent than the current biodetection system. The BD21 program is early in the acquisition lifecycle and DHS has not yet selected the technologies to be used. Potential technologies are still being analyzed to demonstrate that certain components of the overall concept are feasible, such as an anomaly detection algorithm.

However, BD21 faces technical challenges due to inherent limitations in the technologies and uncertainties with combining technologies for use in biodetection. For example, biological aerosol sensors that monitor the air are to provide data on biological material in the environment, but common environmental material such as pollen, soil, and diesel exhaust can emit a signal in the same range as a biological threat agent, thereby increasing false alarm rates. Program officials report that the risk of false alarms produced by biological sensor technologies could be reduced by using an anomaly detection algorithm in addition to the sensor. However, it is too early to determine whether integration of an anomaly detection algorithm will successfully mitigate the false alarm rate. Specifically, because the algorithms have never been developed and used for the purpose of biodetection in an urban, civilian environment.

BD21 program is following the agency’s acquisition policy and guidance to mitigate technological risks in acquisition programs, and plans to conduct technology readiness assessments (TRA) along the way. In 2020, DHS issued a TRA guide, but it lacked detailed information about how the department will ensure objectivity and independence, among other important best practices GAO has identified. If DHS follows GAO’s best practices guide, decision makers and program managers will be in a better position to make informed decisions at key acquisition decision events. Read the report here.

The Eroding Norms Against Chemical Weapons Use Will Need More Than Another Syria Censure to Survive

Last month, the members of the Chemical Weapons Convention (CWC) voted to suspend Syria’s rights and privileges under the treaty. The CWC prohibits the use, production, and stockpiling of chemical weapons. The suspension is a “modest step” toward holding Syria accountable for its chemical weapons attacks and reinforcing the global norm of prohibition against chemical weapons use. In 2013, Syrian forces deployed nerve gas on neighborhoods near Damascus, killing about 1,300 people. Unfortunately, the international responses to Syria’s atrocities have been lackluster. Despite the latest vote, the “Assad regime could continue to maintain, expand, and employ its illegal chemical weapons arsenal as a terror weapon against opposition forces and civilians.” A possible next step in the event that Syria does not comply with the CWC is to refer Syria to the UN Security Council (UNSC). Another option would be to “demand a challenge inspection in Syria pursuant to Article IX of the CWC to clarify outstanding inconsistencies with its stockpile declaration.”

Will Biden Blink Over Navalny?

This week, Jen Psaki, the White House Press Secretary, announced that President Biden and Russian President Putin will meet in Geneva, Switzerland on 16 June. This highly anticipated meeting comes as relations between the US and Russia plummet to a historic low since the Cold War. The US is compelled to respond to the use of chemical weapons as a result of the first round of sanctions under the Chemical and Biological Weapons Control and Warfare Elimination Act. This first set of penalties was in response to the Novichok attack on Alexei Navalny, and included “personal sanctions on seven senior Russian officials believed to have been involved in the decision to poison and later imprison the opposition leader, who was arrested upon his return to Moscow in January, as well as penalties on several entities involved in Russia’s chemical weapons program.” Thus far, Russia has not made any effort to signal its intent to not use these weapons again, so a second round of sanctions is required by law. The administration hopes that the upcoming meeting will “restore predictability and stability to the US-Russia relationship.” The Biden administration must tread carefully, however, as severe sanctions before the summit could derail the interaction but overly mild sanctions could be perceived as “too soft.” Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, explains, “There’s a tension between wanting to punish Russia for its use of chemical weapons but, at the same time, allowing for the relationship to improve between the countries on strategic issues.”

Launch of GlobalBioLabs.org

GlobalBioLabs.org has officially launched! This is an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. An accompanying policy brief, entitled Mapping Maximum Biological Containment Labs Globally, was also released. This brief is offered by Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University. The map is available here and the report is available here.

COVID-19 Lab Leak Theory

On Wednesday, President Biden implored the US intelligence community to “redouble their efforts” in determining the origin of SARS-CoV-2. This is an about-face from the previous reliance on the World Health Organization to investigate the origins of the pandemic. This is a shift from the assessment that the novel coronavirus emerged naturally, jumping from an animal species to humans. The theory that the virus may have escaped from the Wuhan Institute of Virology in China is gaining traction, but is far from conclusive. The Adminsitration’s message follows a letter from 18 prominent biologists published in the journal Science that calls for a new investigation into all conceivable origins of the novel coronavirus, and implores Chinese laboratories and agencies to “open their records” for independent analysis. They write:

“As scientists with relevant expertise, we agree with the WHO director-general, the United States and 13 other countries, and the European Union that greater clarity about the origins of this pandemic is necessary and feasible to achieve. We must take hypotheses about both natural and laboratory spillovers seriously until we have sufficient data. A proper investigation should be transparent, objective, data-driven, inclusive of broad expertise, subject to independent oversight, and responsibly managed to minimize the impact of conflicts of interest. Public health agencies and research laboratories alike need to open their records to the public. Investigators should document the veracity and provenance of data from which analyses are conducted and conclusions drawn, so that analyses are reproducible by independent experts.”

On the other hand, many researchers find the tone of growing demands for an investigation to be “unsettling.” There are worries that the “volatility of the debate could thwart efforts to study the virus’s origins.” These demands are also exacerbating existing tensions between the US and China, an unfortunate development with crucial meetings about curbing the pandemic and preparing for future health emergencies underway and upcoming. Global health policy experts assert that it is critical for the world to “work together to curb the pandemic and prepare the world for future outbreaks.” Actions needed immediately include the expansion of vaccine distribution and the reform of biosecurity rules, such as standards for reporting virus-surveillance data.

Event – Pandemics and Global Health Security Workshop

COVID-19 has exposed just how unprepared governments, corporations, and societies are for a global pandemic. While the SARS-CoV-2 virus is only the most recent threat to global health security, it will certainly not be the last. Threats to global health security continue to evolve due to the emergence of new infectious diseases, globalization, advances in science and technology, and the changing nature of conflict. Pandemics and Global Health Security is a three-day virtual, non-credit workshop designed to introduce participants to the challenges facing the world at the intersection of pandemic preparedness and response, public health, national security, and the life sciences. Over the course of three days, participants will discuss how the biology and epidemiology of SARS-CoV-2 contributed to the emergence of that virus as a global pandemic, lessons learned from Operation Warp Speed about the development of medical countermeasures, obstacles to hospital biopreparedness, challenges to science communication during a pandemic, the bioethics of resource allocation during a public health emergency, the future of global health security, and the role of science and technology in preventing and responding to pandemics. The workshop faculty are internationally recognized experts from the government, private sector, and academia who have been extensively involved in research and policy-making on public health, biodefense, and security issues. Live, interactive sessions will include Dr. Rick Bright, The Rockefeller Foundation; Dr. Nicholas G. Evans, University of Massachusetts-Lowell; Dr. Andrew Kilianski, Department of Defense; Dr. Gregory D. Koblentz, George Mason University; Dr. Jennifer Nuzzo, Johns Hopkins Center for Health Security; Dr. Saskia Popescu, George Mason University; Dr. Angela L. Rasmussen, Vaccine and Infectious Disease Organization-International Vaccine Centre; and Jessica Malaty Rivera, COVID Tracking Project. The workshop is organized by the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University and will be held virtually on July 19-21, 2021. Each day will run from 9am to 12:30pm ET. Prior to June 18, the course fee is $400. Starting June 18, the course fee is $500. Register here.

Pandora Report: 5.21.2021

Congratulations to Dr. Yong-Bee Lim and Madeline Roty, MS for being awarded as Outstanding Students of the Biodefense Graduate Program! Register now for the early bird rate to the Pandemics and Global Health Security Workshop. Dr. Angela Rasmussen discusses the latest changes to the CDC’s COVID-19 guidance.

Outstanding Students of the Biodefense Graduate Program

This year’s Outstanding Biodefense Master’s student is Madeline Roty, who graduated from the University of Michigan School of Nursing in May 2019. Her interests include healthcare preparedness, global health, and health education. Maddie was an active and vibrant member of the Biodefense community and served as President of the George Mason chapter of the NextGen Global Health Security Network. She was also an active contributor to Biodefense program’s blog and newsletter, The Pandora Report, and co-authored an article on Mynamar’s chemical weapons program that we published in the Bulletin of the Atomic Scientists.

Yong-Bee Lim is this year’s outstanding Biodefense PhD student. Yong-Bee earned a Presidential Fellowship when he entered the PhD program after completing his MS in Biodefense. Yong-Bee’s promise as a biosecurity expert was recognized by the Center for Health Security at Johns Hopkins University when they selected him for the prestigious Emerging Leaders in Biosecurity Initiative. Yong-Bee’s dissertation on community labs and the do-it-yourself (DIY) biology movement has generated new knowledge and insights into this important and poorly understood community. His research identified the assumptions and flaws in the narratives used by the DIYBio and biorisk communities to discuss the risks and benefits DIYBio labs. His research will play a key role in helping bridge the gaps between the DIYBio and biorisk communities.

Event – Launch of GlobalBioLabs.org

You are invited to a public webinar, held on the side lines of the seventy-fourth World Health Assembly, to launch www.globalbiolabs.org, an interactive web-based map of global Biosafety Level-4 facilities and biorisk management policies. An accompanying policy brief, entitled Mapping Maximum Biological Containment Labs Globally, will also be released. This briefing is offered by Dr. Filippa Lentzos of King’s College London & Dr. Greg Koblentz of George Mason University. Register here.

An Israeli Airstrike Damaged Gaza’s Only Lab for Processing Coronavirus Tests, Officials Said.

The only laboratory in Gaza capable of processing COVID-19 tests has been rendered temporarily inoperable due to an Israeli airstrike. The strike targeted a nearby building in Gaza City, but shrapnel and debris damaged the laboratory and the administrative offices of the Hamas-run Health Ministry. According to Dr. Majdi Dhair, director of the ministry’s preventive medicine department, the damage will force the laboratory to shut down for at least a day, and testing will be paused. This means a delay in COVID-19 testing but also other tests for diseases like HIV and hepatitis C. Based on official data, merely 1.9% of the two million people in Gaza have been fully vaccinated.

Health Systems Resilience in Managing the COVID-19 Pandemic: Lessons from 28 Countries

Health systems resilience is key to learning lessons from country responses to crises such as coronavirus disease 2019 (COVID-19). In this perspective, a new article in Nature Medicine reviews COVID-19 responses in 28 countries using a new health systems resilience framework. Through a combination of literature review, national government submissions and interviews with experts, the researchers conducted a comparative analysis of national responses. They report on domains addressing governance and financing, health workforce, medical products and technologies, public health functions, health service delivery and community engagement to prevent and mitigate the spread of COVID-19. This work synthesizes four salient elements that underlie highly effective national responses and offer recommendations toward strengthening health systems resilience globally. Read the article here.

New International Expert Panel to Address the Emergence and Spread of Zoonotic Diseases

The launch of the new One Health High-Level Expert Panel is intended to “improve understanding of how diseases with the potential to trigger pandemics, emerge and spread.” The new panel will advise four international organizations: The Food and Agriculture Organization of the United Nations (FAO); The World Organisation for Animal Health (OIE); The United Nations Environment Programme (UNEP); and The World Health Organization (WHO). The goal is to develop a “long-term global plan of action to avert outbreaks of diseases like H5N1 avian influenza, MERS, Ebola, Zika, and, possibly, COVID-19.” The panel will function under the One Health approach, which “recognizes the links between the health of people, animals, and the environment and highlights the need for specialists in multiple sectors to address any health threats and prevent disruption to agri-food systems.”

US Lags Behind Russia and China in Sending COVID-19 Vaccines to Struggling Nations in Need

At present, about 37% of Americans are fully vaccinated, but many nations are struggling to vaccinate their populations and are turning to Russia and China for more doses. On Monday, Biden announced that the US will send 20 million doses of COVID-19 doses to nations in need; this is in addition to the 60 million doses of AstraZeneca’s COVID-19 vaccine. The US has ordered enough COVID-19 vaccines to inoculate its population two-fold, but the world needs billions more doses. The World Health Organization announced that the world is at risk of “vaccine apartheid.” Dr. David Agus, a CBS News medical contributor, described worldwide vaccinations as a “moral imperative.” Agus asserts that if other countries do not or cannot vaccinate their people, new COVID variants could arise and endanger us all. In total, the US has offered to pledged to provide 80 million doses; however, China and Russia are set to deliver around 600 million doses each globally.

Event – Pandemics and Global Health Security Workshop

COVID-19 has exposed just how unprepared governments, corporations, and societies are for a global pandemic. While the SARS-CoV-2 virus is only the most recent threat to global health security, it will certainly not be the last. Threats to global health security continue to evolve due to the emergence of new infectious diseases, globalization, advances in science and technology, and the changing nature of conflict. Pandemics and Global Health Security is a three-day virtual, non-credit workshop designed to introduce participants to the challenges facing the world at the intersection of pandemic preparedness and response, public health, national security, and the life sciences. Over the course of three days, participants will discuss how the biology and epidemiology of SARS-CoV-2 contributed to the emergence of that virus as a global pandemic, lessons learned from Operation Warp Speed about the development of medical countermeasures, obstacles to hospital biopreparedness, challenges to science communication during a pandemic, the bioethics of resource allocation during a public health emergency, the future of global health security, and the role of science and technology in preventing and responding to pandemics. The workshop faculty are internationally recognized experts from the government, private sector, and academia who have been extensively involved in research and policy-making on public health, biodefense, and security issues. Live, interactive sessions will include Dr. Rick Bright, The Rockefeller Foundation; Dr. Nicholas G. Evans, University of Massachusetts-Lowell; Dr. Andrew Kilianski, Department of Defense; Dr. Gregory D. Koblentz, George Mason University; Dr. Jennifer Nuzzo, Johns Hopkins Center for Health Security; Dr. Saskia Popescu, George Mason University; Dr. Angela L. Rasmussen, Vaccine and Infectious Disease Organization-International Vaccine Centre; and Jessica Malaty Rivera, COVID Tracking Project. The workshop is organized by the Biodefense Graduate Program at the Schar School of Policy and Government at George Mason University and will be held virtually on July 19-21, 2021. Each day will run from 9am to 12:30pm ET. Register here.

The Evolving Nature of China’s Military Diplomacy: From Visits to Vaccines

A new report by Meia Nouwens of the International Institute of Strategic Studies details the Chinese military’s place in China’s COVID-19-related foreign policy. The People’s Liberation Army’s (PLA) military-to-military cooperation in response to the global coronavirus pandemic signals a growing role for the military within China’s diplomatic activities. Historically, the PLA played a minor role in Chinese foreign policy. However, in the wake of a more nationalist and assertive Chinese foreign policy, the PLA’s role in national diplomacy and security strategy has grown to serve both strategic and operational goals and has reached new heights in the context of the coronavirus pandemic. Military-to-military COVID-19-related engagement has taken place within a larger context of Beijing’s expanded diplomatic efforts to improve China’s global reputation following its initial delayed and mishandled response at the start of the coronavirus outbreak in 2020. Publicly available data shows that COVID-19 military diplomacy began in March 2020, when the PLA sent protective equipment and clothing to Iran. In February 2021, the PLA began to donate COVID-19 vaccines to overseas militaries. The PLA’s vaccine assistance to 13 countries globally fits within a wider vaccine-centric diplomatic effort by the Chinese government but so far has been far smaller in scale. Geographically, the PLA mostly engaged with countries in the Asia–Pacific and Africa. The PLA’s activities were usually framed within the ‘responsible stakeholder’ narrative that China sought to promote through its civilian aid diplomacy. It is likely that the PLA sought to cooperate with militaries wherever it could and focused on countries with which it already enjoyed established friendly relations, rather than using the PLA’s military diplomacy to establish new strategic relations. The PLA’s military diplomatic activities relating to the coronavirus demonstrate that the PLA will increasingly play a greater role in China’s foreign diplomacy, in line with President Xi’s instructions. Read the report here.

Why Did the CDC Change Its Mask Guidance Now?

Last week, the Centers for Disease Control and Prevention (CDC) updated its guidance on mask wearing and social distancing such that vaccinated individuals are now able to go mask-free much more often. Though the underlying science is “solid,” the communication of these new recommendations was given with little prior notice and without satisfactory explanation to the public. Dr. Angela Rasmussen, a research scientist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, discusses these latest changes. Animal studies, clinical trials, and real-world data are showing that the “vaccines provide exceptional protection against symptomatic COVID-19.” Indeed, vaccinated individuals are unlikely to get sick when exposed to the virus. The data are also showing that the COVID-19 vaccines are “very effective at preventing infection in the majority of those vaccinated, with the exception of older people and those who are immune compromised.” Rasmussen also points out that recent studies reveal that “most vaccinated people who do get infected are not shedding enough infectious virus to spread it efficiently to others.” Though there have been “sustained declines” in new cases, prevalence and immunization rates differ by region and community. Many states and businesses have lifted their mask requirement policies, but the lack of a vaccination verification system leaves only the honor system. The guidance is intended to incentivize vaccination, but vaccine accessibility remains low for many people. Rasmussen encourages public health leaders to improve transparency and public engagement with guidance in the future.

Opinion: Vaccines Didn’t Stop the Yankees’ COVID-19 Outbreak. But the Case Proves How Well They Work.

Dr. Zach Binney, a sports epidemiologist and assistant professor at Oxford Oxford College of Emory University, and Dr. Angela Rasmussen, a research scientist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, examined the New York Yankees as a case showing the efficacy of the COVID-19 vaccines. Last week, nine fully vaccinated members of the Yankees tested positive for SARS-CoV-2. Among the nine cases, at least seven show no symptoms. So far, the only individual to exhibit symptoms is third-base coach Phil Nevin, and it is possible that Nevin will be the only case in which the vaccine “failed.” Put simply, Nevin may have been able to develop a high enough viral load to spread the virus to the other eight cases, but their “vaccinated bodies likely fought it off quickly before they could develop symptoms or transmit it.” Though vaccines do not eliminate the possibility of infection, they do eliminate the risk of severe disease and death. “It is likely the vaccine worked as expected on the Yankees: it prevented many more cases, only allowed the virus to spread from one person and reduced disease severity.”

Just 12 People Are Behind Most Vaccine Hoaxes on Social Media, Research Shows

Research has found that 12 people – dubbed the “Disinformation Dozen” – are the sources of most of the misleading claims and falsities about COVID-19 vaccines, which have spread across Facebook, Instagram, and Twitter. It is estimated that the Disinformation Dozen are responsible for 65% of the shares of anti-vaccine misinformation on social media platforms. The group includes anti-vaccine activists, alternative health entrepreneurs, and physicians, some of whom have multiple accounts across platforms. Though these dozen culprits have not been completely ejected from the platforms, their posts have been labeled misleading and false claims have been removed. Despite the efforts to counter misinformation and disinformation, false narratives continue to take hold.  A survey of US parents found that more than 25% do not intend to vaccinate their children.

Implementation of the International Health Regulations (2005)

The Review Committee provided for in Chapter III of Part IX of the International Health Regulations 2005 (IHR) released its report on the implementation of the IHR. The main objectives of the report were to: (1) assess the functioning of the IHR; (2) assess the ongoing global response to pandemic H1N1; and (3) identify lessons learned to strengthen preparedness and response for future public health emergencies. The three overarching conclusions are: (1) core national and local capacities called for in the IHR are not yet fully operational and are not now on a path to timely implementation worldwide; (2) WHO performed well in many ways during the pandemic, confronted systemic difficulties and demonstrated some shortcomings; and (3) the world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency. The report’s recommendations include streamlining the management of guidance documents, reinforcing evidence-based decisions on international travel and trade, and developing and applying measures to assess severity. Read the report here.  

Pandora Report: 4.30.2021

This is World Immunization Week! The US is donating up to 60 million doses of the Astra Zeneca COVID-19 vaccine to the global vaccine effort. This week also marks the first 100 days of the Biden administration, which has already seen 200 million COVID-19 doses administered in the US.

World Immunization Week

The last week of April is World Immunization Week! World Immunization Week promotes the use of vaccines to protect people of all ages from disease. Every year, vaccines save millions of lives as one of the most successful health interventions. Despite their efficacy, nearly 20 million children worldwide are not vaccinated, leaving them vulnerable. This year’s theme is “Vaccines bring us closer,” which urges “greater engagement around immunization globally to promote the importance of vaccination in bringing people together, and improving the health and wellbeing of everyone, everywhere throughout life.” The World Health Organization’s campaign aims to increase trust, confidence, and investments in vaccines.

In great news, a vaccine against malaria, a disease that kills over 400,000 people each year, has proven 77% effective in early trials. The trial included 450 children in Burkina Faso and the shot was found to be safe and showed “high-level efficacy” over one year of follow up.

Epidemics That Didn’t Happen

In this COVID-19 era, we are constantly reminded of gaps or failures in pandemic preparedness; however, a new resource is offering examples of effective preparedness by showcasing epidemics that never hit or that were largely tempered. The examples include Yellow Fever in Brazil, Ebola in Uganda, Anthrax in Kenya, Monkeypox in Nigeria, and COVID-19 in Mongolia and Senegal.

Though anthrax is often associated with bioterrorism, it is an ancient disease that is found naturally in soil. The anthrax bacterium can infect livestock and wildlife, which, in turn, infect humans when their contaminated meat is consumed. In 2019, a local herder and two students located in a town in Kenya became very ill after eating the meat from a dead cow. All three were diagnosed with anthrax. A volunteer who had been trained by the Kenya Red Cross Society’s Community-Based Surveillance system, immediately sent an SMS alert to the system. This alert notified local health and veterinary authorities, and quickly spurred action to contain the outbreak. Ultimately, there were four human cases and one death. This and the other case studies highlight that outbreaks can be contained and epidemics can be prevented with strong preparedness and response measures, protocols, and activities.

Spillover or Endemic? Reconsidering the Origins of Ebola Virus Disease Outbreaks by Revisiting Local Accounts in Light of New Evidence from Guinea

New research published in the BMJ Global Health journal finds that the 2021 outbreak of Ebola virus disease (EVD) in Guinea originated in viral resurgence from a persistently infected survivor from the major 2013–2016 epidemic 5–7 years ago, prompting an urgent need to re-evaluate whether past EVD epidemics hitherto considered as independent zoonotic spillovers may have had similar origins. In the article, researchers reconsider local accounts from the West African epidemic that trace its origins to people, dismissed until now as implausible. The authors reinterpret existing scientific accounts of other alleged spillovers, finding that several past outbreaks probably originated in persistent infections over even longer latency. By recalibrating the balance between “spillover” and “flare-up,” they suggest that EVD manifests less as a series of discrete epidemics and more as an endemic disease in humans over long timescales and wide areas, helping to account for the increasing frequency of episodes. The authors recommend that more collaborative, respectful approaches with local communities are needed to understand the origins of outbreaks, to address them and to support rather than stigmatize sufferers and survivors. Read the article here.

India’s COVID-19 Crisis Prompts Global Response

India is currently experiencing a severe surge in COVID-19 cases, the worst in the pandemic. In fact, India broke the global daily record for the number of COVID-19 cases for a fifth straight day, with more than 350,000 new infections reported. Hospitals are facing critical shortages of oxygen and remdesivir, an antiviral used to treat hospitalized COVID-19 patients. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said, “the situation in India is beyond heartbreaking.” President Biden spoke with Indian Prime Minister Narendra Modi about sending raw materials for its Covishield vaccine to help quell the crisis.

How COVID-19 Prepared the Military for Future Biological Warfare

Although the COVID-19 pandemic shut down much of society or transitioned it into a remote format, the vast majority of the military’s missions continued. These missions include activities ranging from air transportation to basic training. Since most of these activities cannot be conducted over Zoom, the military was forced to improvise and adapt operations to keep forces healthy, and were largely successful. According to Lt. Gen. Brian Robinson, deputy commander of Air Mobility Command, the pandemic is one of the few, if not only, times in which the military has “faced a true challenge to how it commands and controls its forces on a global scale.” The COVID-19 outbreak on the aircraft carrier Theodore Roosevelt provided important lessons about how to respond in a biological attack. The disease spread rapidly on the ship and led to the ship’s skipper pleading with Navy leadership for help, a plea that was leaked to the media. Lt. Cmdr. Brian Pike stated that the ship’s outbreak reveals the need to consider deploying technical experts in the detection and surveillance of biological threats on Navy ships to contain infectious diseases. Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, asserts that improving detection capabilities on a vessel should entail monitoring the health of the crew and preparing for a situation in which the first sign of an attack is the presentation of symptoms. To do so, the Navy may need to add personnel that are skilled in disease surveillance or specially train existing personnel.  

Navalny’s Novichok Poisoning Was Putin Sending the World A Message, Experts Say

In August 2020, Alexei Navalny, an Russian opposition leader, was poisoned with a Novichok, an agent banned by the Chemical Weapons Convention. After being hospitalized in Germany, Navalny returned to Russia and was imprisoned. In response to rising international pressure, Putin gave a “fiery state of the nation speech” that warned other nations to not attempt to cross the unspecified “red lines” in regard to Navalny. Navalny’s recent court appearance saw him at the end of a three-week hunger strike, and there are fears he may be close to death. He is not the first to be poisoned with a Novichok; Sergei and Yulia Skripal were poisoned in 2018. According to Dr. Gregory Koblentz, Director of the Biodefense Graduate Program, prior to the Skripals, the Novichok was not thought to be a weapon of assassination. Further, at that time, only about a dozen laboratories in the world were equipped to detect it. This means that the number of other enemies of the Kremlin that have been victims of a Novichok is unknown. As a clear and odorless agent, it is among the most lethal nerve agents known. Some experts are interpreting the Novichok poisonings as warnings to those who oppose Putin, but also as a message to NATO nations that “Russia is using a forbidden chemical weapon that Russia says it doesn’t have — that it can harm not only its own citizens but citizens in any city, any country outside of Russia.”

Harris to Tell UN Body It’s Time to Prep for Next Pandemic

On Monday, Vice President Kamala Harris will address the United Nations in a virtual speech to make the case that “now is the time for global leaders to begin putting the serious work into how they will respond to the next global pandemic.” This speech will come near the 100-day mark of the Biden-Harris administration. According to excerpts, Harris will provide an overview of what the administration wants to focus on: improving accessibility to healthcare; investing in science, healthcare workers, and the well-being of women; and boosting capacity for personal protective equipment (PPE) and vaccine and diagnostic test manufacturing.

Hospital Management of Blast Event Casualties: We Aren’t Prepared

By Maddie Roty, Biodefense MS Student

At the end of January 2021, I attended a virtual session of the Hospital Management of Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Incidents course offered by United States Army Medical Research Institute of Chemical Defense (USAMRICD), the United States Army Medical Research Institute of Infectious Disease (USAMRIID), and the Armed Forces Radiobiology Research Institute (AFRRI). This five-day course expanded on the Medical Management of Chemical and Biological Casualties Course, which I attended in October 2020, to include a wider array of casualties from weapons of mass destruction (WMD). This course was also of greater relevance to me as a registered nurse because it focused not on military field management, but also on civilian hospital preparedness for managing mass casualties. The course consisted of a series of lectures regarding incident command, assessment, triage, and treatment of WMD casualties. Each day focused on a different threat, with the final day featuring a tabletop exercise to apply our new knowledge. The chemical and biological sessions were largely a review from MCBC and covered material I was already familiar with through my coursework as a master’s student in the Biodefense program at the Schar School of Policy and Government, so while the review was appreciated, the most captivating sessions for me were about conventional bombings and blast effects.

Blast events, meaning explosions caused by bombs, are a surprisingly common occurrence in the United States. In 2019 alone, there were 715 explosion events, including 251 bombings, not including failed or foiled incidents. It was unnerving to learn that a survey of seven U.S. cities conducted after the 2004 Madrid train bombings, which caused 191 deaths and 1,800 injuries, found that none of these cities had the capacity to respond to a mass casualty event of this magnitude. As we progressed through the lectures, gaps in preparedness for treatment of casualties from an explosive event became obvious to me compared to what I had learned in nursing school.

A blast creates three blast zones – the epicenter, the secondary perimeter, and the periphery. These zones are important for hospital management because different injuries can be anticipated depending on which zone the patient was in at the time of the event. There are the expected trauma injuries that are obvious to even an untrained eye. Of particular interest for me were primary blast injuries, which are caused by blast waves and affect air and fluid-filled organs such as the lungs, ears, and parts of the gastrointestinal tract. These types of injuries are internal and can have a delayed onset or non-obvious symptoms. I did not learn about these types of injuries in nursing school. We also did not learn that ruptured eardrums (tympanic membrane ruptures) and bruising in the pharynx (pharyngeal petechiae) are associated with greater morbidity in bomb victims or that we should assess for blocked blood vessels (air embolisms) or collapsed lungs (pneumothoraces), even in the absence of symptoms, as these are common consequences of blast waves.

I thought this knowledge gap might be remedied during on-the-job training, so I contacted a friend who works in an emergency department as a nurse. She told me they did not receive specific training for blast events, but they were taught to assess for trauma in mass casualty events. It was stressed repeatedly during this course that blast events are not like other mass casualty events, as they may or may not result in obvious signs of trauma. I would anticipate that if a significant blast event occurred in the United States, many critically ill patients would not receive timely or appropriate care simply due to lack of knowledge about the effects of these events.

I am very grateful to have had the opportunity to receive this education from some of the world’s leading experts in the field. The COVID-19 pandemic has, hopefully, elucidated the necessity of hospital preparedness, even for CBRNE events that seem unlikely but could happen anywhere at any time. Increasing training, education, planning, collaboration, and funding for management of casualties caused by bombings and other blast events should be a priority for health care systems. This is not just a health issue; it is a matter of national security. 

Understanding the Challenges of Hospital Preparedness for CBRNE Incidents

By Marisa Tuszl, Biodefense MS Student

My interest in how well prepared hospitals are to respond to a chemical, biological, radiological, nuclear, or explosive (CBRNE) attack was sparked last fall after I took two different, but equally fascinating courses, on the topic. In October, I attended the US Army’s Medical Management of Chemical and Biological Casualties (MCBC) course and during the fall semester I took a course on building healthcare system resilience with Dr. Saskia Popescu who teaches in the Biodefense program at the Schar School of Policy and Government at George Mason University. While the Army course focused on the threats posed by chemical and biological weapons and managing military casualties in the field caused by these weapons, Dr. Popescu’s course focused on the readiness of civilian hospitals to respond to a range of hazards. My curiosity about the intersection of CBRN weapons and hospital preparedness led me to take Hospital Management of Chemical, Biological, Radiological, Nuclear, or Explosive (HM-CBRNE) Incidents course offered by the United States Army Medical Research Institute of Chemical Defense (USAMRICD) and United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The week-long, virtual HM-CBRNE course presented an opportunity to improve my understanding of how hospitals can manage these types of incidents, the Federal programs and protocols that are in place to provide assistance, and the most common challenges confronting hospital preparedness.

The first day of the course provided a foundation regarding the Federal guidelines for responding to a CBRN incident, such as the National Response Framework (NRF) and National Incident Management System (NIMS), and the response systems in place within healthcare facilities, such as the Hospital Incident Command System (HICS). The subsequent days were focused on the different types of CBRNE threats covered by the course, how the nature of these different threats affected planning, decontamination, triage, and response efforts, and the overall role of the different incident command and management systems in planning and response. Altogether, the buildup of information was designed to prepare us for a capstone exercise at the end of the week in which we utilized a traditional HICS to handle an unknown event in real-time.

The capstone exercise was my favorite part of this course because everyone in our group held a specific role in the HICS organizational chart and we had to work together to triage incoming patients to determine whether they were routine patients, required emergency care, or were victims of the incident and required special medical attention. In addition, the proctors threw curveballs at us during the exercise which required each team to work together to come up with solutions to these new problems. In my role as the Situation Unit Leader, I had to keep track of the patients and available beds in the emergency department to ensure a smooth distribution of patients throughout the hospital and mitigate any surge capacities, if possible, during the incident. Though this was a virtual exercise, it revealed several real issues that hospitals can face as they attempt to handle an unknown public health emergency, such as communicating with other hospitals to ensure that each has adequate resources, making sure that memorandums of understanding (MOUs) are in place before an incident, having a location for families to be directed to avoid confusion and traffic at the hospital, having capabilities to decontaminate patients, and turning over beds in an efficient manner to prevent overfilled emergency departments. The capstone exercise displayed how important it is for localities to have emergency planning committees and perform hazard vulnerability analyses to determine what threats are the most probable for them. The after-action session also allowed the two teams that participated in the capstone exercise to discuss the similarities and differences in their planning and response techniques to the same event. Thus, we were able to learn how others handled the event and gained insight into additional complicating factors such as the possibility of multiple threats or emergencies occurring concurrently and the difficulties in utilizing volunteers and external partners during a major incident.

All in all, the HM-CBRNE program supplied me with an invaluable educational experience for learning about the “ins-and-outs” of hospital emergency management. This course was beneficial in providing myself and the other participants with the tools to identify potential CBRNE incidents and the protocols to respond accordingly. As with the MCBC course, USAMRIID and USAMRICD did a great job in utilizing a virtual platform to provide practical information on hospital preparedness to an array of participants.

The Challenge of Triage for CBRNE and Mass Casualty Incidents

By Deborah W Cohen, Biodefense Graduate Certificate Program

Imagine you have travelled across the country to attend a professional conference. While attending a presentation, the session is suddenly interrupted by news that other attendees are falling ill from a chlorine leak at the conference center’s pool. There are sounds of sirens and chaos outside. The presenter asks everyone to stay calm. They resume their presentation, but about an hour later a handful of individuals in the room begin to fall ill. As you being to wonder if this is connected to the incident outside at the pool, you suddenly become incapacitated and fall off your chair. The last thing you see is first responders wearing hazmat gear entering the room. 

This was the initial stage of the scenario for the Tabletop Capstone Exercise on the last day of the U.S. Army’s Hospital Management (HM) – Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) Incidents training course held in late January 2021. I was assigned to the RED HOSPITAL response team which was comprised of military and civilian members. As the scenario unfolded, we organized a response utilizing the doctrine, tools, and planning concepts of the Hospital Incident Management System (HIMS) taught during the first four days of the course. 

Many kinds of emergency incidents happen in our communities. The scenario to which we responded could have been caused by a “conventional” emergency or a terrorist attack involving a chemical agent and a biological agent. The nature of the attack would be determined through an investigation using evidence collected during and after the response. The disaster response, however, must start immediately and be premised on the National Incident Management System (NIMS) guided by the National Response Framework (NRF). The NRF is the national emergency management doctrine formulated by the Office of the Assistant Secretary of Preparedness and Response (ASPR) in the Department of Health and Human Services. The NIMS provides federal support to state and local incident managers and is designed to be scalable, flexible, and adaptable to all types of incidents. 

This emergency management system was put in place by Homeland Security Presidential Directive 5 in 2003 which sought to “enhance the ability of the United States to manage domestic incidents by establishing a single, comprehensive national incident management system.” The guiding principles of the NIMS are the template for local Incident Command Systems (ICS). By way of background on nomenclature, Incident Management Systems (IMS) are more comprehensive in scope than Incident Command Systems (ICS).  IMS also deal with the longer term direct and indirect effects of an event in a community. ICS can be thought of as aa component of IMS dealing more narrowly with specific urgent actions of getting an incident under control.  However, ICS and IMS are designed to be compatible with each other. The ICS operates on the principle of “unity of effort” which provides the multiple organizations responding to an incident a way to coordinate and focus their efforts efficiently by setting aside overlaps and competition across authorities and jurisdictions.Local hospitals are required to prepare for and respond to disasters using the Hospital Incident Command System (HICS) in compliance with NIMS. One of the ways that HICS improves emergency planning, response and recovery is by clearly designating who is responsible for different roles across the response command organization such as incident command, security, medical technology, personnel, finance, supply, logistics, public information, liaison services, and transport.  Since compliance with NIMS is a condition for any healthcare facility to receive Federal assistance, the adoption of ICS by first responders and HICS by healthcare organizations enables government and non-government entities to respond cooperatively to an incident.

The week of training provided by the HM-CBRNE course covered the properties of each of the CBRNE threats and their respective hospital management protocols. These threat-response relationships were further illustrated by incident scenarios. In these scenarios, triage was, for me, the main component that best characterized the realities of emergencies.  In contrast to the Medical Management of Chemical and Biological Casualties (MCBC) Course that I attended last year, which focused on battlefield triage, this course also included lessons on triage in a  civilian community setting.

We learned about three types of triage systems that hospitals use for trauma casualties that are not specifically designed for CBRNE incidents: (1) field triage conducted at the scene of an incident to match available resources with patients; (2) inter-hospital sorting for the transfer of more seriously injured patients to higher level care facilities; and (3) mass-casualty sorting and prioritizing during a disaster. There is also a reverse triage system to sort hospital patients for discharge. These triage systems support the creation and utilization of surge capacity by hospitals to deal with mass casualty incidents, which resonates today with the challenges posed by the COVID-19 pandemic.  Triage of casualties caused by a CBRNE incident can be complicated by the unique effects of these weapons as well as by pre-existing conditions among patients and the impact of psychological trauma. 

The U.S. Army uses three types of “sorting” systems for triage: medical treatment, decontamination, and evacuation. For medical treatment, there are four categories of triage: Immediate, Delayed, Minimal, and Expectant (IDME). In medical triage, Immediate cases require intervention within a few minutes using the ABCDDs: Airway, Breathing, Circulation, Decontamination, and Drugs. In CBRNE events, immediate intervention can also use the (MARs)2 system:  Mask, attention to issues of Massive hemorrhage, Airway, Antidotes,Respirations, and Rapid removal of contaminants. Delayed cases can tolerate a short postponement of medical attention. Minimal patients are those with minor, stable, or resolving injuries that can tolerate a longer delay in treatment.  Expectant patients will not survive without the use of scarce resources that could otherwise be used for possible survivors.  For a civilian community setting, triage of CBRNE casualties will be handled differently.  Four different triage systems for CBRNE casualties, each with their own advantages and limitations, have been developed: (1) Rapid Assessment of Mentation and Pulse (RAMP); (2) Sort Assess Life-saving Treatments Treatment and/or Transport (SALT); (3) Simple Triage and Rapid Treatment (SMART); and (4) Simple Triage and Rapid Treatment (START).

A second triage system developed by the military is for decontamination and it depends on the type of agent and exposure involved. It is typically conducted concurrent with medical triage. For decontamination, the sorting categories are Immediate, Operational, and Thorough. The Assistant Secretary for Preparedness and Response (ASPR) and its partners have developed a protocol for decontamination triage based on a tool called the Primary Response Incident Scene Management (PRISM).

The third triage system is for evacuation which includes Urgent, Priority, and Routine (UPR) sorting categories.  Triage for evacuation is based on the determinations of medical triage and time factors. Patients who can be matched with available treatment and are most likely to survive and recover will be evacuated. Patients in the Urgent category are those who need treatment within two hours. Priority triage is for those who need treatment within four hours. Routine triage patients can wait for up to 24 hours for treatment. The Routine group of evacuees will also include terminal patients.

Col. (ret.) James M. Madsen, MD, the Army presenter, explained that while all triage methods are based on on-the-scene determinations of urgency, survivability, and resource availability, mass-casualty and CBRNE triage is different from other kinds of triage in several ways. For triage of victims of a CBRNE incident, the speed of operation is even more critical, personal protective equipment (PPE) is always needed due to the risk of contamination, verbal communication is difficult, hands-on exams may not be possible, and first responders are sorting simultaneously for medical treatment, decontamination, and evacuation. CBRNE triage schemes are very challenging as they must quickly account for the clinical implications of the specific CBRNE agent to which the victims have been exposed. For instance, the length of the latent period before symptoms manifest, the risk of secondary contamination, and the existence of specific antidotes varies among different chemical warfare agents. The most important message about triage for mass casualties and CBRNE incidents is that while there are many methods under development, there is no consensus about the best option to employ in every case. It was sobering to learn that current triage methods are not adequate for the complex situations, conditions, and circumstances that characterize the evolving landscape of CBRNE and terrorism events.