Publications

Rasmussen et al. argue that “increasing oversight across virology or all microbe research would represent a misdirection of resources and would fail to provide a commensurate increase in safety or security” and “harm surveillance, antiviral discovery, monitoring for resistance to antivirals and vaccines, and other critical efforts.” On the contrary, a strengthened version of the recommendations of the National Science Advisory Board on Biosecurity (NSABB) is crucial for the success of microbiological science. Implementing these recommendations would reduce the risks of a deliberate or accidental pandemic, while using precious research resources efficiently, restoring trust in science, strengthening US leadership in biosecurity and biosafety, and safeguarding the biomedical research enterprise, as ASM itself has said.

On May 24 and 25, 2023, the Johns Hopkins Center for Health Security (“the Center”) co-hosted a dialogue (“the dialogue”) with the Regional Centre for Biotechnology of the Department of Biotechnology in the Indian Ministry of Science and Technology, in Washington, DC, to discuss biosecurity issues of importance to both India and the United States. The dialogue aimed to increase knowledge of prevention and response efforts for natural, deliberate, and accidental biological threats in India and the US; share best practices and innovations; examine opportunities for partnership and collaboration; develop and deepen relationships among dialogue participants; and identify issues that should be elevated to the attention of Indian or US government officials.

The Johns Hopkins Center for Health Security co-convened government officials and other stakeholders for a Southeast Asia Strategic Multilateral Biosecurity Dialogue meeting from April 26-28 in Cebu, Philippines. It was the first in-person meeting of this series since SARS-CoV-2 emerged in 2019. This is the meeting Report from the 2023 Dialogue Session. 

Providing a definitive diagnostic test in a disease emergency is critical to limit pathogen spread, develop and deploy medical countermeasures, and mitigate the social and economic harms of a serious epidemic. While major accomplishments have accelerated test development, expanded laboratory testing capacity, and established widespread point-of-care testing, the United States does not have a plan to rapidly respond, to develop, manufacture, deploy, and sustain diagnostic testing at a national scale. To address this gap, we are proposing a National Diagnostics Action Plan that describes the steps that are urgently needed to prepare for future infectious disease emergencies, as well as the actions we must take at the first signs of such’ events.

On January 10, 2023, the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health convened an in-person, not-for-attribution meeting of experts and practitioners from government, academia, and the private sector to discuss the US Biosafety & Biosecurity Innovation Initiative launched as part of a September 2022 Executive Order titled, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” The meeting focused on priority actions and efforts needed to enhance biosafety and biosecurity throughout the biotechnology research and development (R&D) and biomanufacturing lifecycles, while maximizing potential societal benefits, as well as safeguarding and boosting US national competitiveness. This report describes discussion on these topics undertaken by the experts who attended the meeting.
 

Few clinicians practicing in the United States have ever seen a case of monkeypox infection. However, a new, unusual, multinational outbreak of monkeypox that is unfolding rapidly makes it important to know what a case might look like. This is critical not only to permitting rapid and proper medical and public health interventions but also to helping to understand the extent and spread of the outbreak. The current outbreak—which includes confirmed or suspected cases in the United States, the United Kingdom, Spain, Portugal, Italy, Belgium, Sweden, France, Canada, Australia, Germany, and the Netherlands—appears to have a pattern of spread that does not mirror past outbreaks outside of Africa, almost all of which have been related to importation via flights from Africa or exposure to infected exotic pets (1). This unusual monkeypox outbreak should prompt all clinicians to be attuned to the possibility of this infectious disease. Clinicians who suspect they may have a patient with monkeypox should contact their state or local health department immediately.

On February 10 and 11, 2021, the Johns Hopkins Center for Health Security hosted a virtual meeting of the Southeast Asia Strategic Multilateral Biosecurity Dialogue. Due to health risks stemming from the COVID-19 pandemic as well as associated restrictions and protective measures implemented around the world, the dialogue meeting originally scheduled to be held in Cebu, Philippines, during 2020 was postponed. To continue the productive dialogue between the participating countries, a virtual meeting was held to specifically address challenges and lessons from the countries’ experiences with COVID-19.

On January 26 and 27, 2021, the Johns Hopkins Center for Health Security hosted a virtual dialogue discussion, focused on coronavirus disease 2019 (COVID-19) responses in India and the United States. The session explored lessons learned thus far and the path forward for both nations in responding to the pandemic. The meeting was held in collaboration with the Regional Centre for Biotechnology of the Department of Biotechnology in the Indian Ministry of Science and Technology.

COVID-19 has revealed what many public health practitioners have known for some time: our nation's disjointed and underfunded public health system lacks the ability to mount a coordinated response against novel epidemic threats. Our failure to invest in our nation's state and local governmental public health infrastructure, as well as key federal programs, risks a large loss of life from future infectious disease threats, and during crises, jeopardizes the economy and the normal functioning of society.

Among the most pressing issues in preparing for the global response to a pandemic are the design, development, manufacture, and dissemination of vaccines. In 2018 and 2019, we conducted 48 interviews with prominent leaders in public health, pandemic preparedness, vaccine design, and vaccine manufacturing about how they would respond to a sudden, urgent need to manufacture 2 billion or more doses of vaccine. Little did we know that this scenario would become a dire global challenge a few months later with the onset of COVID-19. The response to this pandemic has shown that when leading vaccine manufacturers are fully engaged in a global response, it might be possible for them to manufacture substantial doses of vaccine on timelines faster than previously envisioned. It is now hoped that hundreds of millions of doses of vaccine will start to be produced sometime in the end of 2020 or the start of 2021, and that billions of doses of vaccine could be produced in the months that follow. Whether these timelines can be met or not, it is crucial now, while the world is fully attuned to the terrible consequences of pandemics, to begin preparing the system of global manufacturing for future pandemics. The following insights and recommendations are taken from our interviews with leading experts and our own analysis.

Biology can be misused, and the risk of this causing widespread harm increases in step with the rapid march of technological progress. A key security challenge involves attribution: determining, in the wake of a human-caused biological event, who was responsible. Recent scientific developments have demonstrated a capability for detecting whether an organism involved in such an event has been genetically modified and, if modified, to infer from its genetic sequence its likely lab of origin. We believe this technique could be developed into powerful forensic tools to aid the attribution of outbreaks caused by genetically engineered pathogens, and thus protect against the potential misuse of synthetic biology.

Since its recognition as a pandemic in early 2020, novel coronavirus disease 2019 (COVID-19) has touched nearly every corner of US society. However, some populations and environments have been affected far more severely than others. Vulnerable populations—especially those subject to structural racism, discrimination due to disability, and financial insecurity—tend also to be particularly susceptible to the economic consequences of and severe disease and death from COVID-19. In addition, the institutions, industries, and systems that are fundamentally important to our lives and our democracy have, in some cases, become places where severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads readily if allowed to gain a foothold. In these places, it can be difficult to prevent the introduction of the virus or control the spread of SARS-CoV-2 once it is introduced.

In The Lancet, Denis Y Logunov and colleagues from the N F Gamaleya Research Institute of Epidemiology and Microbiology in Russia present findings from two phase 1/2, non-randomised, open-label studies of a heterologous, replication-deficient, recombinant adenovirus vector-based vaccine in both frozen and lyophilised formulations. The researchers enrolled 76 healthy adult volunteers (aged 18–60 years) into the two studies (38 people in each study); 53 (70%) participants were men and 23 (30%) were women. The primary outcome measures of the studies were safety and immunogenicity (antigen-specific humoral immunity). In phase 1 of each three-arm study, two groups of nine volunteers received one dose of either recombinant adenovirus type 26 (rAd26) vector or recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S), in lyophilised or frozen form. In phase 2, another group of 20 healthy adult volunteers in each study received sequential doses of rAd26-S followed by rAd5-S of one of the two formulations. Adverse events were mostly mild, with the most common adverse events being pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Adverse events occurred at similar frequency for each vaccine vector, with each formulation, and after each dose. Serious adverse events did not arise in this small cohort. Both formulations of the vaccine were immunogenic in all participants, inducing neutralising humoral and cell-mediated responses. In phase 2, 85% of participants had detectable antibodies at 14 days after the priming dose, rising to 100% by day 21, with substantial titre rises after the boosting dose.

The COVID-19 pandemic will continue for the foreseeable future, but widespread vaccination could hasten its end. At least 165 candidate vaccines for the SARS CoV-2 virus are in development around the world and there is hope that one or more of these candidates will soon be shown to be sufficiently safe and effective to achieve emergency use authorization in the United States. When a vaccine has been authorized for use, it will initially be in limited supply. During this period of scarcity, a plan is needed for how to allocate and distribute the limited supply—which groups should be prioritized to receive the vaccine first and which groups can wait until later. This difficult and potentially contentious topic is being actively discussed in the United States by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) and the National Academy of Medicine (NAM), as well as globally at the World Health Organization (WHO) and elsewhere. The purpose of this report is to offer an additional ethics framework for use in making decisions about allocation of SARS-CoV-2 vaccine during this initial period of scarcity in the United States and make related suggestions about vaccine distribution. Our approach takes into account considerations of medical risk, public health, ethics and equity, economic impact, and logistics. We note where our approach aligns or differs from the 2018 CDC guidance for vaccine allocation in a severe influenza pandemic, which is the most recent pandemic vaccine guidance from the US government.

The impact of the COVID-19 pandemic in the United States has been profound. Despite initial declines in cases in May 2020 following implementation of stringent stay-at-home orders, cases are resurging in most states. The number of deaths has been rising in many states, with hospitalization rates for COVID-19 now again matching or exceeding numbers seen at the peak in New York City in March and April. Hospitals are under pressure or approaching a crisis in many places around the country. This resurgence is stressing many sectors of society, from businesses to education to health care. Unlike many countries in the world, the United States is not currently on course to get control of this epidemic. It’s time to reset.

This brief report describes concrete policy actions at the federal, state, and local levels that are needed to get control of the COVID-19 pandemic in the United States.

Before an infectious disease outbreak of any size can be addressed and before illness can be treated, it must be first be identified through the diagnosis of cases. Diagnostic testing is a mainstay of not only clinical medicine but also epidemiologic investigation. Limitations surrounding access to diagnostic testing have dominated much of the current response to COVID-19 and highlight the need to have more rapid, convenient, and equitable access to testing. Looking ahead, through the increasing diffusion of health technology to consumers and patients, it is becoming more feasible for diagnostic testing to be placed in the hands of the patient. Such tests when used to diagnose infectious disease, and coupled to information technology, could have a transformative benefit for future pandemic response.

The Johns Hopkins Center for Health Security conducted this study to develop an expert assessment of the promise and challenges posed by at home infectious diagnostic technologies. A major aim of this study is to inform pandemic preparedness activities that rely on diagnostic technologies and determine how at home approaches can integrate with and augment the existing diagnostic paradigm.

This document describes the value of serosurveys (antibody studies) for SARS-CoV-2 infections, the different methods by which they can be performed, and the resources required to produce actionable information. It provides recommendations for the US government and states for performing these studies and deriving value from them.

Globally, institutions of higher education are facing unprecedented challenges related to Coronavirus Disease (COVID-19). The resulting academic, financial, ethical, and operational questions are complex and high-stakes. The COVID-19 pandemic may represent an inflection point, fundamentally altering how we work, socialize, and learn. The authors of this toolkit collectively believe that our institutions need near-term tools to ensure continuity through this pandemic as well as methods for rethinking the basic assumptions and values of their institutions.

This operational toolkit has been developed to help business owners who are considering reopening or expanding their operations to determine their establishments’ risk of transmission of COVID-19 and how to reduce it.

As displayed in the figure below, the Operational Toolkit consists of 3 parts: an instruction manual; a business risk worksheet; and an assessment calculator.

As some governments begin to lift strict public health measures and move into the next phase of their outbreaks of COVID-19, local, state, and federal authorities are planning for the gradual reopening of businesses and resumption of economic activity. While planning for a staged approach to business resumption must be coordinated by local, state, and federal authorities, individual organizations should start planning for how they will restart or expand their operations so that modification and mitigation measures will already be in place when work can resume and the new ”business as usual” can commence.

This operational toolkit allows business leaders to work through a 4-stage process to obtain an overall risk score for their business and to identify considerations for reducing both operational and individual level risks posed by COVID-19. The overall score represents the inherent risk of exposure to COVID-19 that may occur in a business and possible changes to daily operations and policies that can lower the inherent risk of exposure. This toolkit is intended to provide businesses with a starting point in their planning to reopen or expand their operations by identifying their risk levels for contributing to the spread of COVID-19 and providing them with a list of mitigation measures to implement that will increase the safety of their employees, clients, customers, and community. 

The 3 parts of the Operational Toolkit include:

1. An Instruction Manual (PDF)
   Instructions that explain how to complete the 4-stage Business Risk Worksheet and Assessment Calculator.
    
2. A Business Risk Worksheet (PDF)
   A 4-stage step-by-step worksheet for you to report and understand your business’s overall risk of spreading COVID-19 and how your business operations can be made safer.
    
3. An Assessment Calculator (XLSX)
   An Excel spreadsheet you will fill out to receive a calculated risk score and a modification score.

The COVID-19 (COVID) pandemic has led to unprecedented action and innovation in the US healthcare system; at the same time, it has presented extraordinary challenges and risks. Through dramatic augmentation of surge capacity, deferral of other services, and implementation of crisis standards of care, hospitals in many locations have been able to absorb the blow of the first peak of COVID cases and continue to provide lifesaving care to both COVID patients and others with life-threatening emergencies. But many communities are just beginning to experience the full force of the pandemic, and in every location, the healthcare response to COVID has come at a very dear price. Healthcare facilities have sustained huge financial losses, and healthcare workers’ health and well-being have been put at high risk. New standard operating procedures and work processes have been improvised, and many old lessons have had to be relearned.