Characteristics of Microbes Most Likely to Cause Pandemics and Global Catastrophes.

Predicting which pathogen will confer the highest global catastrophic biological risk (GCBR) of a pandemic is a difficult task. Many approaches are retrospective and premised on prior pandemics; however, such an approach may fail to appreciate novel threats that do not have exact historical precedent. In this paper, based on a study and project we undertook, a new paradigm for pandemic preparedness is presented. This paradigm seeks to root pandemic risk in actual attributes possessed by specific classes of microbial organisms and leads to specific recommendations to augment preparedness activities.

Southeast Asia Strategic Multilateral Dialogue on Biosecurity.

A strategic multilateral dialogue related to biosecurity risks in Southeast Asia, established in 2014, now includes participants from Singapore, Malaysia, Indonesia, Thailand, Philippines, and the United States. This dialogue is conducted at the nonministerial level, enabling participants to engage without the constraints of operating in their official capacities. Participants reflect on mechanisms to detect, mitigate, and respond to biosecurity risks and highlight biosecurity issues for national leadership. Participants have also identified factors to improve regional and global biosecurity, including improved engagement and collaboration across relevant ministries and agencies, sustainable funding for biosecurity programs, enhanced information sharing for communicable diseases, and increased engagement in international biosecurity forums.

A pandemic agreement is within reach.

At the end of May, 194 member states of the World Health Organization (WHO) will meet for the World Health Assembly. Negotiations underway now will determine whether they vote then to adopt a pandemic agreement. For the past 2 years, discussions have focused on articulating essential components of a robust and equitable architecture for pandemic preparedness and response. Despite this, talks have failed to produce sufficient consensus on a detailed draft, prompting the intergovernmental negotiating body to propose a "streamlined" version. The new text, released on 16 April, consolidates provisions for research and development, technology transfer, pathogen access and benefit sharing (including pandemic products such as medicines and vaccines), with many particulars deferred to future procedures. Ultimately, success of the agreement will depend on these details and implementation. Nevertheless, member states shouldn't bypass the consensus reached to date, but continue progress to adopt this agreement.

Strengthen oversight of risky research on pathogens.

Policy reset and convergence on governance are needed.

The Biological Weapons Convention should endorse the Tianjin Biosecurity Guidelines for Codes of Conduct.

The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists are a set of ten principles designed to promote responsible science and strengthen biosecurity governance. They should be broadly adopted, including being endorsed by the Biological Weapons Convention at its 9th Review Conference in November 2022.

An analysis of International Health Regulations Emergency Committees and Public Health Emergency of International Concern Designations.

INTRODUCTION: Nine events have been assessed for potential declaration of a Public Health Emergency of International Concern (PHEIC). A PHEIC is defined as an extraordinary event that constitutes a public health risk to other states through international spread and requires a coordinated international response. The WHO Director-General convenes Emergency Committees (ECs) to provide their advice on whether an event constitutes a PHEIC. The EC rationales have been criticised for being non-transparent and contradictory to the International Health Regulations (IHR). This first comprehensive analysis of EC rationale provides recommendations to increase clarity of EC decisions which will strengthen the IHR and WHO's legitimacy in future outbreaks. METHODS: 66 EC statements were reviewed from nine public health outbreaks of influenza A, Middle East respiratory syndrome coronavirus, polio, Ebola virus disease, Zika, yellow fever and coronavirus disease-2019. Statements were analysed to determine which of the three IHR criteria were noted as contributing towards the EC's justification on whether to declare a PHEIC and what language was used to explain the decision. RESULTS: Interpretation of the criteria were often vague and applied inconsistently. ECs often failed to describe and justify which criteria had been satisfied. DISCUSSION: Guidelines must be developed for the standardised interpretation of IHR core criteria. The ECs must clearly identify and justify which criteria have contributed to their rationale for or against PHEIC declaration. CONCLUSION: Striving for more consistency and transparency in EC justifications would benefit future deliberations and provide more understanding and support for the process.

Clade X: A Pandemic Exercise.

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.

The Joint External Evaluation of Taiwan: The External Evaluators' Perspective.

A team of experts from the Johns Hopkins Center for Health Security conducted an independent external assessment of Taiwan's capabilities under the International Health Regulations 2005 (IHR), using the IHR Joint External Evaluation (JEE) tool adopted by the World Health Organization and the Global Health Security Agenda. In this article we describe the methods and process of the assessment, identify lessons learned, and make recommendations for the government of Taiwan, the JEE process, and the JEE tool.

After Fukushima: managing the consequences of a radiological release.

Even amidst the devastation following the earthquake and tsunami in Japan that killed more than 20,000 people, it was the accident at the Fukushima Daiichi nuclear power plant that led the country's prime minister, Naoto Kan, to fear for "the very existence of the Japanese nation." While accidents that result in mass radiological releases have been rare throughout the operating histories of existing nuclear power plants, the growing number of plants worldwide increases the likelihood that such releases will occur again in the future. Nuclear power is an important source of energy in the U.S. and will be for the foreseeable future. Accidents far smaller in scale than the one in Fukushima could have major societal consequences. Given the extensive, ongoing Nuclear Regulatory Commission (NRC) and industry assessment of nuclear power plant safety and preparedness issues, the Center for Biosecurity of UPMC focused on offsite policies and plans intended to reduce radiation exposure to the public in the aftermath of an accident. This report provides an assessment of Japan's efforts at nuclear consequence management; identifies concerns with current U.S. policies and practices for "outside the fence" management of such an event in the U.S.; and makes recommendations for steps that can be taken to strengthen U.S. government, industry, and community response to large-scale accidents at nuclear power plants.

Biosurveillance where it happens: state and local capabilities and needs.

In recent years, improved biosurveillance has become a bipartisan national security priority. As has been pointed out by the National Biosurveillance Advisory Subcommittee and others, building a national biosurveillance enterprise requires having strong biosurveillance systems at the state and local levels, and additional policies are needed to strengthen their biosurveillance capabilities. Because of the foundational role that state and local health departments play in biosurveillance, we sought to determine to what extent state and local health departments have the right capabilities in place to provide the information needed to detect and manage an epidemic or public health emergency-both for state and local outbreak management and for reporting to federal agencies during national public health crises. We also sought to identify those policies or actions that would improve state and local biosurveillance and make recommendations to federal policymakers who are interested in improving national biosurveillance capabilities.

Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts.

In a public health emergency involving significant surges in patients and shortages of medical staff, supplies, and space, temporarily expanding scopes of practice of certain healthcare practitioners may help to address heightened population health needs. Scopes of practice, which are defined by state practice acts, set forth the range of services that licensed practitioners are authorized to perform. The U.S. has had limited experience with temporarily expanding scopes of practice during emergencies. However, during the 2009 H1N1 pandemic response, many states took some form of action to expand the practice scopes of certain categories of practitioners in order to authorize them to administer the pandemic vaccine. No standard legal approach for expanding scopes of practice during emergencies exists across states, and scope of practice expansions during routine, nonemergency times have been the subject of professional society debate and legal action. These issues raise the question of how states could effectively implement expansions for health services beyond administering vaccine and ensure consistency in expansions across states during catastrophic events that require a shift to crisis standards of care. This article provides an overview of scopes of practice, a summary of the range of legal and regulatory approaches used in the U.S. to expand practice scopes for vaccination during the 2009 H1N1 response, and recommendations for future research.