Publications

In January 2018, Dr. David Evans from the University of Alberta and his colleagues published a scientific paper describing the synthesis of the horsepox virus de novo. Horsepox doesn’t cause infection in humans, but another related virus—Variola major—causes smallpox. The publication of the horsepox synthesis process lowers technical hurdles for making smallpox de novo. This commentary argues that there are serious potential adverse implications of this work that don’t justify the purported benefits. It also makes the case that there should be a new norm related to experiments that increase pandemic risks and that there should be more transparency and stronger oversight for biological research and science that increases pandemic risks.

On July 10, 2018, in Washington, DC, the Johns Hopkins Center for Health Security hosted a meeting on global health security in South Asia. The goal of the meeting was to discuss health security challenges in South Asia and to identify opportunities for implementation of health security initiatives. The speakers included high-level participants from the government of Pakistan, the World Bank, the US Centers for Disease Control and Prevention, the US Department of Health and Human Services, the US National Academies of Science, and from other academic, nonprofit, and government organizations. The meeting was sponsored by the Project on Advanced Systems and Concepts for Countering WMD (PASCC; sponsored by the Defense Threat Reduction Agency, DTRA) of the US Air Force Institute for National Security Studies. The highly interactive meeting presented an important opportunity to focus on the health security challenges facing South Asia and to identify paths forward, and it emphasized the importance of dialogue in bringing together multiple disciplines, sectors, and countries, extending even beyond the region. As one participant noted, “A health risk anywhere is a health risk everywhere.” This document is a summary report of the meeting discussions.

Rapid medical countermeasure (MCM) dispensing is an important intervention during a public health emergency. In the United States, MCM planning and exercising efforts have largely focused on dispensing therapeutics, with less emphasis on mass vaccination operations that would require additional specialized staff and infrastructure. Difficulties in distributing vaccines during the 2009 H1N1 influenza pandemic highlighted the need for enhanced planning and exercising of plans for conducting mass vaccination campaigns. In Taiwan, seasonal influenza mass vaccination campaigns are conducted annually, which both mitigate the effects of seasonal influenza and serve as functional exercises for mass vaccination operations during a pandemic. To identify lessons that can be applied to mass vaccination planning in the United States and elsewhere, we conducted an in-person observation and data review of Taiwan’s annual seasonal influenza mass vaccination efforts in October 2017.We offer findings and recommendations for enhancing preparedness for seasonal and pandemic influenza and other public health emergencies that would require mass vaccination.

To gather broad input on the forthcoming US Global Health Security Strategy, the Johns Hopkins Center for Health Security convened more than 70 public and private sector global health security stakeholders for a meeting on July 30, 2018, in Washington, DC. The purpose of the meeting was for stakeholders to engage in discussion regarding the US Global Health Security Strategy and provide recommendations to the USG for this strategy. This report on the recommendations is based on participant discussions. This document does not represent consensus of the meeting participants, but rather reflects the Center’s interpretation of what was discussed and our recommendations.

National investments to facilitate prompt access to safe and effective medical countermeasures (MCMs) (ie, products used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear threats, or emerging infectious diseases) have little merit if people are not willing to take a recommended MCM during an emergency or inadvertently misuse or miss out on a recommended MCM during an emergency. Informed by the Expert Working Group on MCM Emergency Communication, the Johns Hopkins Center for Health Security developed recommendations for achieving desired public health outcomes through improved MCM communication based on a review of model practices in risk communication, crisis communication, and public warnings; detailed analysis of recent health crises involving MCMs; and development of a scenario depicting future MCM communication dilemmas. The public’s topics of concern, emotional requirements, capacity for processing information, and health needs will evolve as an emergency unfolds, from a pre-event period of routine conditions, to a crisis state, to a post-event period of reflection. Thus, MCM communication by public health authorities requires a phased approach that spans from building up a reputation as a trusted steward of MCMs between crises to developing recovery-focused messages about applying newly acquired data about MCM safety, efficacy, and accessibility to improve future situations.

Paper submitted by the United States and presented by Gigi Gronvall at the August 2018 Meeting of Experts on Review of developments in the field of science and technology related to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. This paper considers several emerging biotechnology capabilities that may have implications for the Biological Weapons Convention (BWC), in view of their “dual use” implications for bioweapons development. It includes sections on: Gene editing; Metabolic pathway engineering; Gene drives; and Gene synthesis. The paper briefly describes some of the legitimate applications and benefits of these technologies, identifies challenges to realizing these benefits, and describes the nature and impact of their potential BW applications, to permit a balanced assessment. It then describes a recently developed framework for evaluating risks of misuse and identifying mitigation options. Finally, the paper highlights the need for greater international collaboration and harmonization of approaches to address potential biosecurity threats that might result from applications of biotechnology.

The Johns Hopkins Center for Health Security conducted a Track II multilateral biosecurity dialogue between Singapore, Malaysia, Indonesia, and the United States—with observers from the Philippines and Thailand—in Nusa Dua, Indonesia on April 18-20, 2018. Dialogue topics included national biosecurity priorities as well as ongoing and emerging biosecurity threats facing Southeast Asia countries, ranging from emerging infectious diseases to advances in biotechnology to bioterrorism. Participants discussed national-level biosecurity programs and shared lessons from their experiences, building on trusted relationships established over several years of this dialogue with the aim of improving national capacity and collaboration across the broad scope of biosecurity issues.

It is important to distinguish between predicting the emergence of infectious diseases and their trajectory (see E. C. Holmes et al. Nature 558, 180–182; 2018). It is currently impossible to predict emergence, but feasible and effective to predict the trajectory.

Advances in synthetic biology hold great promise, but to minimise security threats, national and international regulation will need to keep pace.

The adenovirus vaccine and benzathine penicillin G (BPG) have been used by the US military to prevent acute respiratory diseases (ARD) in trainees, though these interventions have had documented manufacturing problems. We fit Poisson regression and random forest models (RF) to 26 years of weekly ARD incidence data to explore the impact of the adenovirus vaccine and BPG prophylaxis on respiratory disease burden. Adenovirus vaccine availability was among the most important predictors of ARD in the RF, while BPG was the ninth most important. BPG was a significant protective factor against ARD (incidence rate ratio (IRR) = 0.68; 95% confidence interval (CI) 0.67–0.70), but less so than either the old or new adenovirus vaccine (IRR = 0.39, 95% CI 0.38–0.39 and IRR = 0.11, 95% CI 0.11–0.11), respectively. These results suggest that BPG is moderately predictive of, and significantly protective against ARD, though to a lesser extent than either the old or new adenovirus vaccine.

Community engagement (CE)—involving citizens and civil society in the formulation, implementation, and assessment of policies and programs affecting their well-being – is a centerpiece of US health and security doctrine and growing feature of local problem solving. In disaster and epidemic management, CE is tied to the move from a government-centric to whole-of-community model and shift from readiness and response to resilience aims. Government cannot mount an effective response singlehandedly given finite resources, rigid structures, and limited local knowledge. By encouraging citizen and civil society input, authorities also foster social connectedness, cross-sector collaboration, and collective problem solving which together enhance disaster resilience.

This article describes what may be done by scientists and by the biotechnology industry, generally, to address the safety and security challenges in synthetic biology. Given the technical expertise requirements for developing sound policy options, as well as the importance of these issues to the future of the industry, scientists who work in synthetic biology should be informed about these challenges and get involved in shaping policies relevant to the field.

The domestic response to the West Africa Ebola virus disease (EVD) epidemic from 2014-2016 provides a unique opportunity to distill lessons learned about health sector planning and operations from those individuals directly involved. This research project aimed to identify and integrate these lessons into an actionable checklist that can improve health sector resilience to future high-consequence infectious disease (HCID) events.

This article describes the use of “red teaming” to analyze and forecast biological threats to U.S. national security. Red teaming is a method whereby participants adopt an adversarial perspective, and is used to stimulate critical and creative thinking without some of the flaws of other types of threat assessments, including mirror-imaging. Red team analysis is prevalent in the military, security, and commercial realms. There have been widespread calls from government and private organizations to analyze biological threats with a red teaming approach, in order to prioritize resources and to counter a wide array of biological agents. This paper includes a timeline of historical examples of both biological red team simulations and vulnerability probes, and discusses the challenges of conducting realistic, cost-effective modeling of biological agents. Finally, we propose additional analytical tools to the UK Ministry of Defense’s red team framework for the future development of structured, biological red team exercises, and discuss other existing future-oriented threat assessments in this realm.

The Johns Hopkins Center for Health Security conducted this study to elucidate the characteristics of naturally occurring microorganisms that constitute a global catastrophic biologic risk (GCBR).

GCBRs are defined as “those events in which biological agents—whether naturally emerging or reemerging, deliberately created and released, or laboratory engineered and escaped—could lead to sudden, extraordinary, widespread disaster beyond the collective capability of national and international governments and the private sector to control. If unchecked, GCBRs would lead to great suffering, loss of life, and sustained damage to national governments, international relationships, economies, societal stability, or global security.”

In chapter 3, “Ensuring Biosafety and Security,” Gigi Kwik Gronvall analyzes the trends driving the development of advanced biotechnologies, and notes that biology is becoming more industrialized and economically powerful, as important industries increasingly rely on biological manufacturing processes. She recommends that the United States and South Korea should expand their security cooperation in the areas of global health, gene synthesis, and medical and pharmaceutical research, as well as provide global leadership on safety standards.

Every few years, a new pathogen emerges from the shadows to threaten global public health. And every few years, the global public health community struggles to mount a timely and effective response. The incremental advances that have defined public health in the last half century have been repeatedly outpaced by fast-moving epidemics. From HIV to Ebola, most innovations in preventing and containing outbreaks have come from medical countermeasures like vaccines, diagnostics, and therapeutics rather than advancements in epidemiological practice.

In February 2018, the Johns Hopkins Center for Health Security (“the Center”) hosted a Track II dialogue on biosecurity between experts from the United States and the Republic of India. The dialogue, which was held in New Delhi, India, was organized in collaboration with the DBT-UNESCO Regional Centre for Biotechnology, an autonomous institute of the Department of Biotechnology (part of the Ministry of Science and Technology, Government of India). This was the fourth meeting of the dialogue, following previous engagements in Washington, DC, in September 2016 and November 2017, as well as a meeting in New Delhi, India, in February 2017.1,2,3 This effort is supported by the Project on Advanced Systems and Concepts for Countering WMD (PASCC, which is sponsored by the Defense Threat Reduction Agency, DTRA) of the US Air Force Institute for National Security Studies.

The re-creation of horsepox virus, an extinct orthopoxvirus with similarity to smallpox virus, has caused concerns in the biosecurity and biodefense communities that the technical capabilities achieved could advance the re-creation of smallpox virus by nefarious actors. The work is now published. While the authors went through due biosecurity diligence at their research institution and with the proper Canadian federal authorities, now that the experiments have been published, there is an opportunity to discuss the dual use risks and benefits of the research itself, as well as those associated with publication of such research—all of which challenge current policies. Here, an analytical framework is used to assess the risks and benefits of such dual use research, and relevant components of biosecurity policy and the biodefense enterprise (including the acquisition of medical countermeasures) in the United States are discussed. The authors emphasize the need to use such risk/benefit assessments at the onset of research and throughout its development, followed by an assessment for its responsible communication.

In November 2017, the Johns Hopkins Center for Health Security (“the Center”) hosted a Track II dialogue (i.e. a non-governmental engagement) on biosecurity between experts from the United States and the Republic of India. The dialogue, which was held in Washington, DC, was organized in collaboration with the Department of Biotechnology (part of the Ministry of Science and Technology, Government of India). This was the third meeting of the dialogue; the first was held in Washington, DC in September 2016, and the second in New Delhi, India, in February 2017. The effort is supported by the Project on Advanced Systems and Concepts for Countering WMD (PASCC, which is sponsored by the Defense Threat Reduction Agency, DTRA) of the US Air Force Institute for National Security Studies.