Publications

In late December 2019, a cluster of unexplained cases of viral pneumonia occurred in Wuhan, China.1 This initial cluster of patients with what soon became known as coronavirus disease 2019 (COVID-19) heralded the arrival of a new pandemic caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To date, close to 90 000 cases have occurred in more than 60 countries with approximately 3000 deaths. The World Health Organization (WHO) has declared these events a Public Health Emergency of International Concern.

Effective communication about medical countermeasures—including drugs, devices and biologics—is often critical in emergency situations. Such communication, however, does not just happen. It must be planned and prepared for. One mechanism to develop communication strategies is through the use of prospective scenarios, which allow readers the opportunity to rehearse responses while also weighing the implications of their actions. This article describes the development of such a scenario: The SPARS Pandemic 2025-2028. Steps in this process included deciding on a timeframe, identifying likely critical uncertainties, and then using this framework to construct a storyline covering both the response and recovery phases of a fictional emergency event. Lessons learned from the scenario development and how the scenario can be used to improve communication are also discussed.

Aerial spraying of products to kill larvae or adult mosquitoes is a public health measure used to control vector-borne diseases. In some outbreaks, the intervention has evoked controversy and community resistance. This study evaluated how local opinion leaders in US localities affected by Zika think about community engagement in public health policies for outbreak response. In December 2017 through March 2018, 4 focus groups were convened in Houston, TX, New Orleans, LA, Miami, FL, and Brooklyn, NY. They discussed a hypothetical scenario that featured vector control by aerial spraying. Participants (N = 20) more readily accepted this vector control method under 4 conditions: They were informed of alternatives, benefits, and risks for human health and the environment. Public health claims were backed by objective evidence and an authority figure genuinely working in the community’s interests. They received timely notice about how to mitigate toxin exposure. And, aerial spraying helped to protect vulnerable individuals. The community engagement requirements of the local opinion leaders resonate with core principles of recent public health ethics frameworks: namely, personal autonomy, transparency, reasonableness, and solidarity. Participants foresaw problems with community consent in an era of growing social media use and mistrust in governmental and scientific authority. They also debated whether health authorities should use moral-based arguments, in addition to science-based ones, to communicate aerial spraying’s risks and benefits.

Clade X was a day-long pandemic tabletop exercise conducted by the Johns Hopkins Center for Health Security on May 15, 2018, in Washington, DC. In this report, we briefly describe the exercise development process and focus principally on the findings and recommendations that arose from this project.

Clade X was a day-long pandemic tabletop exercise conducted by the Johns Hopkins Center for Health Security on May 15, 2018, in Washington, DC. Many details of the exercise are available online, including videos, background documents, and fact sheets.In this report, we briefly describe the exercise development process and focus principally on the findings and recommendations that arose from this project.

During the 2014-15 domestic Ebola response, US states developed monitoring and movement restriction policies for potentially exposed individuals. We describe decision-making processes and factors in the development of these policies. Results may help health officials anticipate potential concerns and policy influencers in future infectious disease responses. Thirty individuals with knowledge of state-level Ebola policy development participated in semi-structured interviews conducted from January to May 2017. Interviewees represented 18 jurisdictions from diverse census regions, state political affiliations, and public health governance structures as well as the US Centers for Disease Control and Prevention (CDC). Limited and/or changing guidance and unique state-level public health, legal, and operational environments resulted in variation in policy responses. Federal guidance developed by the CDC was an important information source influencing state-level policy responses, as was available scientific evidence; however, other external factors, such as local events, contributing experts, political environment, public concern, news media, and the influence of neighboring states, contributed to additional variation. Improvements in timing, consistency, and communication of federal guidance for monitoring and movement restrictions at the state level—along with balanced approaches to addressing ethical concerns, scientific evidence, and public concern at the state level—are considerations for policy development for future disease responses.

CRISPR, a powerful gene-editing technology, is revolutionizing the life sciences and medical research. The technology has also become democratized. Costs to use CRISPR are low and decreasing, kits are available to make the use of CRISPR straightforward, and there is a rapidly growing scientific literature describing CRISPR methodologies and novel applications. However, like other powerful advances in the life sciences, CRISPR raises biosecurity concerns: it could be misused for harm, and it lowers technical barriers to biological weapons development. This essay describes the history and dissemination of CRISPR as genome-editing techniques have become widespread, outlines potential biosecurity concerns, and recommends actions governments and scientists may take to reduce biosecurity risks. While it is not possible to eliminate biosecurity risks from the misuse of biotechnologies, including CRISPR, steps can be taken to increase security while allowing this powerful technology to remain widely available for beneficent purposes.

The Center for Health Security commends the issuance of the Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health, on September 19, 2019, which has the potential to significantly improve the nation's capacities against influenza. As noted in the executive order, influenza is the preeminent pandemic threat the world faces. Unlike many pandemic threats, however, seasonal occurrences of the infection provide a yearly stress test of our influenza pandemic mechanism. Recent years have seen severe seasonal strains of the virus inundate hospitals, spark spot shortages of antivirals, and expose stark deficiencies in vaccine technology. These events have unfortunately demonstrated that, were a severe pandemic to occur today, the United States is not sufficiently prepared to withstand such an event without major societal disruption.

Vaccines are the cornerstone of the management of an infectious disease outbreak and are the surest means to defuse pandemic and epidemic risk. The faster a vaccine can be deployed, the faster an outbreak can be extinguished. To date, however, the pharmaceutical response to emerging infectious diseases and bioterrorism has been characterized by a “one bug, one drug” approach, in which specific medical countermeasures—effective vaccines and therapeutics—are developed, manufactured, and deployed. This is a process that is often measured in decades.

Five years ago, the world was on a precipice. An outbreak of Ebola that had started in Guinea spilled into neighboring Liberia and Sierra Leone. None of the affected countries had recorded an outbreak of Ebola before, and the response was challenged by lack of public health capacities, community distrust of healthcare workers, poor communication, and difficulties reaching affected populations. International health officials expressed concerns about the potential for further spread of the virus throughout the continent, and, ultimately, more than 11,000 people lost their lives.

We propose here changes to the U.S. government policy on potential pandemic pathogen (PPP) oversight and implementation, emphasizing transparency of the review process and the content of the review, publication of the review in advance, responsible publication of enhanced PPP research, high-level signoff on approvals of enhanced PPP experiments, and the need for a signi?cant effort to establish a common international approach to enhanced PPP work. We advocate that the U.S. government recommend, and non-U.S. government funders and journals adopt, a set of best practices that would extend important considerations of biosafety and biosecurity to all work on enhanced potential pandemic pathogens regardless of funding source.

Coronaviruses (CoV) are a family of RNA viruses that typically cause mild respiratory disease in humans. However, the 2003 emergence of the severe acute respiratory disease coronavirus (SARS-CoV) demonstrated that CoVs are also capable of causing outbreaks of severe infections in humans. A second severe CoV, Middle East respiratory syndrome coronavirus (MERS-CoV), emerged in 2012 in Saudi Arabia. More recently, a novel coronavirus was identified in Wuhan, China, in December 2019.

On July 26, 2019, the workshop “Biosafety and Biosecurity in the Era of Synthetic Biology: Meeting the Challenges in China and the U.S.”, co-hosted by Johns Hopkins Center for Health Security and Tianjin University Centre for Biosafety Research & Strategy, was held in Washington, D.C. of the United States. The goal of this workshop was to bring technical and policy experts from China and the U.S., as well as experts from Europe, together to develop a mutual understanding of each country’s current governance structures and to begin a dialogue on what is required to promote global biosafety and biosecurity.

The scientific enterprise satisfies the innate human urge to understand the world; these efforts have led to both improvements and dangers to society. The storied history of relationships between scientists and citizens suggests that the lines between these 2 sectors of society are often blurred. Here we discuss these relationships on the context of animal welfare. We briefly outline the history of animal welfare in research, and the entry of citizens into the discussion, leading to the Animal Welfare Act of 1966. The commitment of scientists to society, in this context, is the act of whistleblowing in research. As medical and life sciences technologies continue to expand at breathtaking rates, the landscape that both scientists and citizens must navigate increases in complexity. We discuss the responsibility of both the scientist and the citizen, as members of the voting public, in the face of the challenges of the future.

In recent years, interest has grown in gender as a useful analytical perspective to examine the impact of particular means and methods of warfare. Multilateral debates on chemical and biological weapons, however, have not systematically considered the relevance of sex- and age-disaggregated data on the effects of these weapons, nor knowledge of gender dynamics, in the implementation of the Biological and Chemical Weapons Conventions (BWC and CWC, respectively). Such information and perspectives, however, can contribute to States’ preparedness and enhance the effectiveness of assistance under CWC article X and BWC article VII. Moreover, it could help to increase resilience and to aid recovery from chemical or biological incidents. Ultimately, a gender-responsive approach can help States to enhance the security and well-being of all their citizens.

This volume focuses on Global Catastrophic Biological Risks (GCBRs), a special class of infectious disease outbreaks or pandemics in which the combined capacity of the world’s private and government resources becomes severely strained. These events, of which the 1918 influenza pandemic is emblematic, cause severe disruptions in the normal functioning of the world, exact heavy tolls in terms of morbidity and mortality, and lead to major economic losses.

According to the 2015 Global Burden of Disease Study, diarrhea ranked ninth among causes of death for all ages, and fourth among children under 5 years old, accounting for an estimated 499,000 deaths in this young age group. It was also the second most common cause of years lived with disability (2.39 billion YLDs). The goal of the WHO/UNICEF Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhea (GAPPD) is to reduce deaths from diarrhea in children under 5 years of age to less than 1 per 1000 live births, by 2025. Development of new and improved vaccines against diarrheal infections is a fundamental element of the strategy towards achieving this goal.

We report the heterologous expression, structure, and antimicrobial activity of a lasso peptide, ubonodin, encoded in the genome of Burkholderia ubonensis. The topology of ubonodin is unprecedented amongst lasso peptides, with 18 of its 28 amino acids found in the mechanically bonded loop segment. Ubonodin inhibits RNA polymerase in vitro and has potent antimicrobial activity against several pathogenic members of the Burkholderia genus, most notably B. cepacia and B. multivorans, causative agents of lung infections in cystic fibrosis patients.

Since the inception of gene synthesis technologies, there have been concerns about possible misuse. Using gene synthesis, pathogens—particularly small viruses—may be assembled “from scratch” in the laboratory, evading the regulatory regimes many nations have in place to control unauthorized access to dangerous pathogens. Progress has been made to reduce these risks. In 2010, the US Department of Health and Human Services (HHS) published guidance for commercial gene synthesis providers that included sequence screening of the orders and customer screening. The industry-led International Gene Synthesis Consortium (IGSC) was formed in 2009 to share sequence and customer screening methods, and it now includes the major international gene synthesis providers among its members. Since the 2010 HHS Guidance was released, however, there have been changes in gene synthesis technologies and market conditions that have reduced the efficacy of these biosecurity protections, leading to questions about whether the 2010 HHS Guidance should be updated, what changes could make it more effective, and what other international governance efforts could be undertaken to reduce the risks of misuse of gene synthesis products. This article describes these conditions and recommends actions that governments should take to reduce these risks and engage other nations involved in gene synthesis research.

The 2014–2016 Ebola outbreak was a wake-up call regarding the critical importance of resilient health systems. Fragile health systems can become overwhelmed during public health crises, further exacerbating the human, economic, and political toll. Important work has been done to describe the general attributes of a health system resilient to these crises, and the next step will be to identify the specific capacities that health systems need to develop and maintain to achieve resiliency.

From April 29 to May 1, 2019, the Johns Hopkins Center for Health Security and the Thailand Ministry of Public Health’s Department of Disease Control co-hosted a meeting of the Southeast Asia Strategic Multilateral Biosecurity Dialogue in Phuket, Thailand. This dialogue began in 2014 as a bilateral Track II dialogue between Singapore and the United States and expanded the following year to include Indonesia and Malaysia. The Philippines and Thailand were added as observers in 2017, and they became full participants starting with this year’s meeting. The purpose of this dialogue is to examine biological risks facing the United States and the Southeast Asia region—including natural, accidental, and deliberate. This dialogue aims to facilitate cross-border and regional engagement and collaboration and identify novel solutions and share best practices in combatting priority threats.