Publications

This article examines the biosecurity and biodefense implications resulting from the recent creation of horsepox virus, a noncirculating (extinct) species of orthopoxvirus. Here we examine the technical aspects of the horsepox virus synthesis and conclude that orthopox synthesis experiments currently remain technically challenging—and will continue to be so, even once this work is published in the scientific literature. This limits potential misuse by some types of nefarious actors. We also examine the implications of one stated purpose for the recreation of horsepox virus: the development of a smallpox vaccine. If the development is successful, it could take advantage of US government incentives for the priority FDA review of medical countermeasures (MCMs) against biosecurity threats. However, if this case leads to the determination that this incentive is counterproductive for security, the newly created priority review voucher program should be more clearly defined or limited based on need. Limiting the program could have costs that require further consideration, however, as general incentives for biodefense medical countermeasure development are required for MCMs to be available. Finally, while the recreation of horsepox virus was not technically trivial, nor was it cell-free, this experiment was a de facto demonstration of already assumed scientific capabilities.

Almost a century ago, a new and deadly strain of influenza spread around the world, shutting down schools and businesses and filling hospitals well beyond their capacity. In the end, the 1918 flu pandemic claimed the lives of approximately 50 to 100 million people, and it infected about one-third of the global population. Since then, medical care has vastly improved, and science has made major gains in vaccines and medicines. Yet the potential remains for a lethal strain of influenza or other contagious pathogen to overwhelm global health care systems by spreading at a rate that outpaces our ability to respond. In such a calamitous scenario, neither the United States nor other countries would be well enough equipped to contain it, increasing the potential for a true national or global catastrophe.

Last week, Houston-area hospitals displayed great resiliency as they faced catastrophic flooding from Hurricane Harvey's relentless rains over several days. However, some vital hospital services—understandably—experienced significant disruptions. Health systems nationwide can learn vital lessons from Texas' planning and response to further strengthen their own preparedness and "harden" their facilities to all hazards.

The Johns Hopkins Center for Health Security is working to analyze and deepen scientific dialogue regarding potential global catastrophic biological risks (GCBRs), in a continuation of its mission to reduce the consequences of epidemics and disasters. Because GCBRs constitute an emerging policy concern and area of practice, we have developed a framework to guide our work. We invited experts from a variety of disciplines to engage with our underlying concepts and assumptions to refine collective thinking on GCBRs and thus advance protections against them.

Policy-makers and practitioners have a need to assess community resilience in disasters. Prior efforts conflated resilience with community functioning, combined resistance and recovery (the components of resilience), and relied on a static model for what is inherently a dynamic process. We sought to develop linked conceptual and computational models of community functioning and resilience after a disaster.

Due to increasing rates of antimicrobial-resistant infections and the current inadequacy of the antibiotic pipeline, there is increasing interest in nontraditional approaches to antibacterial therapies. We define “traditional” agents as small-molecule agents that directly target bacterial components to exert a bacteriostatic or bactericidal effect, and “nontraditional approaches” as antimicrobial therapeutics that work through other means (ie, not a small molecule and/or utilizes a nontraditional target). Due to their atypical features, such therapies may be less susceptible to the emergence of resistance than traditional antibiotics. They include approaches such as monoclonal antibodies, virulence disruptors, immunomodulators, phage therapies, microbiome-based therapies, antibiotic potentiators, and antisense approaches. This article discusses both the developmental and regulatory advantages and challenges associated with each of these technologies. By identifying existing regulatory and developmental gaps, we hope to provide a sense of where focusing resources may provide the greatest impact on successful product development.

A scientific understanding of the threat posed by biological weapons is critical to determine biodefense priorities, set preparedness and response policies, and implement prevention and mitigation measures. The United States is committed to upholding the Biological and Toxin Weapons Convention (BWC)[1] and 18 U.S. Code 175,[2] which make it a crime to knowingly possess a biological agent, toxin, or delivery system for use as a weapon or if the material is not intended for peaceful purposes. For the purposes of defense, the U.S. government (USG) has deemed it necessary to conduct risk assessments and characterize the threat posed by biological weapons use to the U.S. homeland. Yet, the data required to develop risk assessments are largely insufficient; there are large gaps in our knowledge and understanding regarding biological weapons.[3] We often have limited data on the biology of many potential biological threat agents (e.g., their dose–response profile, behavior under different conditions, and environmental persistence), and rather limited understanding of the intentions of adversaries who possess or seek to possess biological weapons. This uncertainty about both the biology of a threat agent as well as its likelihood of use makes effective decision making about biodefense resource prioritization difficult.

A severe influenza pandemic could overwhelm hospitals but planning guidance that accounts for the dynamic interrelationships between planning elements is lacking. We developed a methodology to calculate pandemic supply needs based on operational considerations in hospitals and then tested the methodology at Mayo Clinic in Rochester, MN.

The Ebola epidemic of 2014–2016 was a fast-moving, multidimensional emergency that presented unprecedented challenges for the multi -lateral system. In response to the outbreak, which was spreading exponentially in Guinea, Liberia, and Sierra Leone, Secretary-General Ban Ki-moon established the UN’s first-ever emergency health mission, the UN Mission for Ebola Emergency Response (UNMEER). UNMEER was mandated by the UN General Assembly in September 2014 to scale up and coordinate the activities of the UN presence on the ground working to stop the outbreak, which eventually claimed over 11,000 lives.

This report asks: Was UNMEER needed? Was it properly structured? Did it deliver? And what broader lessons can be learned from the experience of UNMEER for UN crisis response?

Despite increasing and significant global risks from emerging infectious diseases (eg, SARS in 2003, H1N1 in 2009, MERS and Ebola in 2014), federal powers to conduct accurate surveillance and nontherapeutic countermeasures are antiquated and, at times, ineffectual. After several prior attempts to modernize its rules over the past decade,¹ the US Centers for Disease Control and Prevention (CDC) issued a notice of proposed rulemaking (NPRM)² on August 15, 2016, to modernize its powers to control communicable diseases pursuant to the Public Health Service Act (PHSA).³ Through October 14, CDC has received more than 15,000 public comments on its NPRM.

This is a checklist of actions for healthcare, public health, nongovernmental organizations, and private entities to use to strengthen the resilience of their community's health sector to disasters. It is informed by the experience of Hurricane Sandy in New York and New Jersey and analyzed in the context of findings from other recent natural disasters in the United States. The health sector is defined very broadly, including—in addition to hospitals, emergency medical services (EMS), and public health agencies—healthcare providers, outpatient clinics, long-term care facilities, home health providers, behavioral health providers, and correctional health services. It also includes community-based organizations that support these entities and represent patients. We define health sector resilience very broadly, including all factors that preserve public health and healthcare delivery under extreme stress and contribute to the rapid restoration of normal or improved health sector functioning after a disaster. We present the key findings organized into 8 themes. We then describe a conceptual map of health sector resilience that ties these themes together. Lastly, we provide a series of recommended actions for improving health sector resilience at the local level. The recommended actions emphasize those items that individuals who experienced Hurricane Sandy deemed to be most important. The recommendations are presented as a checklist that can be used by a variety of interested parties who have some role to play in disaster preparedness, response, and recovery in their own communities. Following a general checklist are supplemental checklists that apply to specific parts of the larger health sector.

Blood products are critical to the success of both routine healthcare delivery and emergency response efforts. Ensuring the safety and availability of blood products presents nations with considerable collection, screening, and distribution challenges that are often exacerbated by public health crises, particularly mass-casualty events involving traumatic injuries. However, recent outbreaks of Ebola and Zika virus disease have also illustrated the importance of securing blood product supplies during ongoing infectious disease emergencies. The United States and other nations should consider enhancing existing mechanisms for sharing medical countermeasures by creating formal agreements for sharing blood products during public health emergencies.

Events in the United States and internationally have shown the kinds of great stakes and consequences that often follow epidemics and disasters. Consider the series of health security shocks since 2001: National fear during the anthrax letters events, with impact on all 3 branches of the US government. The respiratory transmissible SARS and MERS viruses spreading via airplanes and hospitals, sometimes by super-spreading individual patients. Human cases of H5N1 bird flu with a case fatality rate of 50%. The sudden emergence and global spread of 2009 H1N1. The congenital malformations following Zika infections—the first mosquito-borne illness to cause such malformations. The terrible mortality and wide spread of Ebola across multiple countries in West Africa, with imposition of large-scale quarantines and costly economic disruptions to trade and travel. The widespread disabling of the healthcare system during major US hurricanes. The use of chemical weapons in war in the Middle East, breaking years of international taboo against it. Discovery of smallpox in an insecure box in a US government lab. The radiation risks and uncertainties over large areas following the Fukushima tsunami and nuclear power plant accident. High-containment laboratory accidents involving important live pathogens.

According to the US National Bioeconomy Blueprint (2012), applications emerging from synthetic biology and other biotechnologies “can allow Americans to live longer, healthier lives, reduce our dependence on oil, address environmental challenges, transform manufacturing processes, and increase the productivity and scope of the agricultural sector while growing new jobs and industries.”(p1) In addition to benefits to these diverse aspects of American life, biotechnology's potential effect on growing the economy is thought to be immense. Synthetic biology, a technical area that aims to make biology more useful and easier to engineer, is a top 10 key technology for the 21st century, according to the World Economic Forum. BCC Research, a market analysis company, expects the synthetic biology market to grow rapidly from $2.7 billion in 2013 to $11.8 billion in 2018, with a compound annual growth rate of 34.4% over a 5-year period from 2013 to 2018.

In the past 15 years, a series of infectious disease emergencies—the anthrax attacks in 2001, the rapid global spread of severe acute respiratory syndrome (SARS) in 2003, the 2009 influenza A (H1N1) pandemic, the emergence and international spread of the Middle East respiratory syndrome coronavirus (MERS-CoV), the largest Ebola epidemic on record, and the emergence and spread of Zika virus—have increased global political concerns about emerging infectious disease threats and deliberate epidemics. Among these events, Ebola and Zika serve as stark reminders that, if left unchecked, infectious disease outbreaks that originate in one country can produce profound international human, political, and economic consequences. Limited public health and healthcare infrastructure in West Africa quickly enabled Ebola to rapidly spread to multiple countries, resulting in unprecedented levels of illness and death. The suffering caused by the epidemic led to social unrest and economic distress that threatened to undermine decades of US investment aimed at bringing political stability to the region. To help end the epidemic, the US Congress appropriated more than $5 billion in emergency funds.

Beginning in 2017, new federal leadership can take important steps to vitalize the role of private citizens and businesses as well as faith-based and community-based organizations in the larger public health emergency preparedness (PHEP) enterprise. A broad consensus exists that government on its own cannot effectively and equitably manage epidemics and disasters. Past events repeatedly demonstrate that actions by citizens and civic groups have helped to curtail the impacts of extreme events and to prompt a more complete recovery from mass trauma. Nonetheless, the full potential of nongovernment forces in disaster readiness, response, and recovery has yet to be realized. Community engagement can enhance the quality of emergency planning, improve protections for vulnerable populations, multiply preparedness and response assets, and, ultimately, save more lives. The incoming administration in concert with Congress has an immense opportunity to enhance the country's resilience to catastrophic health events by steadily investing in robust partnerships between local public health authorities and the communities they serve.

Over the past 10 years, US health security has been threatened by a series of infectious disease events: the 2009 influenza outbreak, the emergence of Middle East respiratory syndrome (MERS), the Ebola outbreak in West Africa, and the rapid spread of Zika virus throughout the Americas. In each of these events, inadequate information has delayed initial detection of the outbreak, and a lack of understanding about the underlying epidemiology of the viruses hindered control efforts. As the ongoing US response to Zika illustrates, delays in detecting and responding to outbreaks can exacerbate their human and economic tolls. While the United States continues to struggle to understand how Zika virus can spread and cause serious disease, more than 37,000 cases have already been identified in the United States and its territories. Each one of these cases must be investigated by health authorities to ensure that they do not spread their infection. In particular, pregnant women must be followed closely, as Zika can cause fetal death or severe birth defects. It is estimated that each baby who is born with Zika-related birth defects will cost families and the US healthcare system up to $10 million.

In the years following the 9/11 attacks, the leadership, resources, and expertise that public health agencies across the country can bring to bear on the response to infectious disease emergencies and other catastrophic events took on additional urgency and importance. In light of this expanded mission, Congress appropriated funds to support public health preparedness at the state and local levels, one result of which was the Centers for Disease Control and Prevention (CDC) Public Health Emergency Preparedness (PHEP) program. Several recent infectious disease emergencies—chief among them the Ebola epidemic in West Africa and isolated cases in the United States (2014-15) and the ongoing Zika virus pandemic—have challenged national health security and demonstrated a need for continued investment in domestic public health preparedness and response infrastructure.

Preparing our hospitals and other healthcare facilities for disasters is a national security priority. Disasters occur nearly every day in the United States, and the frequency is increasing. This includes such diverse events as storms, droughts, wildfires, floods, earthquakes, chemical and industrial accidents, burns, mass shootings and bombings, and epidemics. All sickened or injured people require a well-prepared public health and healthcare system. The number of people killed by disasters depends not only on the severity of the event itself but also on our ability to respond effectively and treat the ill or injured. This is true of all disasters, whether they are natural disasters like earthquakes and hurricanes or manmade disasters like terrorism. It is also true of infectious disease epidemics, whether of natural or manmade origin.

Following the anthrax and 9/11 terrorist attacks of 2001, Presidents Bush and Obama both prioritized and supported investment in federal programs aimed at improving US defenses against health security threats, including major disasters; naturally occurring infectious disease epidemics; accidental releases of chemical, biological, or radiological materials; and chemical, biological, radiological, or nuclear (CBRN) terrorism.