Publications

In this case study, we describe a well-resourced private school in New York City that implemented COVID-19mitigation measures based on public health expert guidance and the lessons learned from this process

Biomanufacturing practitioners and researchers describe the norms that should govern the growing, global field, to include safety, security, sustainability, and social responsibility. These ‘4S Principles’ should be broadly adopted so that the future of the field may provide the greatest benefits to society.

The Model State Indoor Air Quality Act (MSIAQA)¹ developed in collaboration with national advisors adopts science-based regulatory standards, such as testing, enhanced air filtration, system maintenance, and ventilation, to advance the public’s health and increase occupant productivity—ensuring that public indoor environments provide healthy air to breathe.

Improving indoor air quality (IAQ) will diminish routine exposure to airborne diseases,^1,2 limit outbreaks or epidemics,³ and lower risks of noninfectious respiratory conditions like asthma that affect the health of millions each year.⁴ Improving IAQ is also cost-effective. Proper ventilation and filtration in crowded public indoor settings can significantly reduce the costs of illness at a benefit-cost ratio ranging from 3:1 to 100:1,⁵ exceeding similar ratios for most other public health interventions.⁶

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.

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.

When health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and what the evidence tells us. This evidence can help clarify the virus’s evolutionary path. But regardless of the origins of the virus, there are steps the global community can take to reduce future pandemic threats.

Following the 2001 end to negotiations on a legally binding protocol, states parties to the 1972 Biological and Toxin Weapons Convention (BWC) developed entrenched positions about the necessity of treaty verification, hindering progress on treaty aims. The study described in this article was designed to facilitate dialogue on verification-related issues outside the context of those positions, using the term “assurance” to represent the degree of certainty that states parties are meeting their treaty obligations. From August 2020 to July 2021, the researchers conducted 36 interviews—16 with state-party delegations and 20 with independent experts, representing 20 countries. They performed mixed-methods analysis on the interviews, including quantitative metrics on qualitative interview content. Interviewees’ views on verification, compliance, and related concepts varied widely. Future efforts by states parties to achieve common understanding on these topics could facilitate concrete progress. While no single mechanism is sufficient to achieve verification or assess compliance, packages of mechanisms could increase assurance. Interviewees expressed general support for implementing assurance mechanisms, even in the absence of a comprehensive, legally binding protocol or verification regime, even among states parties for which that is the primary goal. Avenues to increase assurance among BWC stakeholders merit further discussion in the current intersessional program.

In response to a series of biosafety incidents in 2014, the White House directed two high-level expert committees to analyze biosafety and biosecurity in U.S. laboratories and make recommendations for work with select agents and toxins. Overall, they recommended 33 actions to address areas related to national biosafety, including promoting a culture of responsibility, oversight, outreach and education, applied biosafety research, incident reporting, material accountability, inspection processes, regulations and guidelines, and determining the necessary number of high-containment laboratories in the United States.

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.
 

After a biological incident—whether it is natural, deliberate, accidental, or undetermined—there is an imperative to investigate and identify the cause of the incident, and attribute who, if anyone, is responsible. The ability to attribute responsibility for a biological incident (bioattribution) helps to ensure that the deliberate use of biological weapons may be fully prosecuted and those responsible are held accountable. Bioattribution capabilities may also serve as a deterrent for use of biological weapons. Such a capability is the result of an attribution investigation that integrates multiple data sources, including information collected by law enforcement and public health officials, intelligence information, and technical information about the biological agent and other biological and environmental samples collected. The process is complicated; it relies on technical methodology and social systems (ie, the ability to get samples and to have a trusted process) to produce the technical information and sampling for attribution. It is important to routinely evaluate the state of the science available for bioattribution to ensure that investigations may leverage state-of-the-art technology and that efforts are being made to overcome technical challenges.

Recent calls to establish a global project registry before releasing any gene-drive-modified organisms (GDOs) have suggested a registry could be valuable to coordinate research, collect data to monitor and evaluate potential ecological impacts, and facilitate transparent communication with community stakeholders and the general public. Here, we report the results of a multidisciplinary expert workshop on GDO registries convened on 8–9 December 2020 involving 70 participants from 14 countries. Participants had expertise in gene drive design, conservation and population modeling, social science, stakeholder engagement, governance and regulation, international policy, and vector control; they represented 45 organizations, spanning national and local governmental agencies, international organizations, nonprofit organizations, universities, and district offices overseeing local vector control. The workshop aimed to gather perspectives on a central question: “In what ways could a gene-drive project registry both contribute to and detract from the fair development, testing and use of GDOs?” We specifically queried the perceived purpose of a registry, the information that would need to be included, and the perceived value of a registry. Three primary findings emerged from the discussion: first, many participants agreed a registry could serve a coordinating function for multidisciplinary and multisector work activities; second, doing so may require different design elements, depending on the target end-user group and intended purpose for that group; and third, these different information requirements lead to concerns about information sharing via a registry, suggesting potential obstacles to achieving transparency through such a mechanism. We conclude that any development of a gene-drive project registry requires careful and inclusive deliberation, including with potential end-users, to ensure that registry design is optimal.

The Johns Hopkins Center for Health Security hosted a meeting, “National Strategy for Improving Indoor Air Quality,” in Washington, DC, on September 8, 2022. The meeting featured a keynote speaker and four expert panels focused on the importance of indoor air quality (IAQ), challenges to providing healthy indoor air across the United States, international perspectives and strategies for healthy air improvements, and catalyzing needed science and technology innovation in the IAQ field. Dr. Ashish Jha, White House COVID-19 Response Coordinator, opened the meeting by reiterating the importance of IAQ to the Biden-Harris Administration. 

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.

This study examined the feasibility of creating a new nongovernmental health security research policy center in Asia, how such a center might benefit the advancement of policies promoting health security, and where such a center might be located. Health security policy encompasses numerous aspects of global health, including emerging infectious diseases, epidemics, medical and public health preparedness and response, deliberate and accidental biological threats, risk management related to advanced life science research and other biosecurity issues, and reduction of global catastrophic biological risks (GCBRs). GCBRs are 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.¹ If unchecked, GCBRs could lead to great suffering, loss of life, and sustained damage to national governments, international relationships, economies, societal stability, or global security.

On April 8, 2022, the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health convened a virtual, not-for-attribution meeting to solicit expert input on the US Department of Defense’s (DoD) first Biodefense Posture Review (BPR). US Secretary of Defense Lloyd J. Austin III called for a comprehensive BPR in a November 2021 memo concerning the DoD’s biodefense vision. In the memo, Secretary Austin points out the critical roles DoD played in the COVID-19 response, both within the Department and as part of the broader whole-of-government response. After-action reviews of these vital contributions highlighted areas for improvement in DoD’s preparedness and response. Therefore, Secretary Austin directed a whole-of-department review to efficiently and robustly assess the DoD’s capabilities and modernize its strategies for biodefense.

The COVID-19 pandemic has brought forth a number of biotechnological advances to enhance the public's health: new diagnostic tests, mRNA vaccines, and new antiviral medications. Biotechnology is also being used to address global challenges like climate change, food insecurity, and building the bioeconomy, which directly or indirectly improve public health. Gene drives are one such biotechnology. They are genetically engineered systems that can alter the inheritance patterns in a host species, such as a mosquito, so that a greater percentage of its progeny inherit a specific desired trait. Research and investments in biotechnology have been used to reduce arthropod-borne infectious diseases, such as malaria and Zika, and to manage or eliminate invasive species.² Funding thus far has been adequate. For example, Target Malaria, a global consortium of researchers developing a gene drive to decrease the burden of malaria, has an average of US$11.5 million per year in funding.³ Although no gene drive has been released into the environment yet, technologies with similar attributes have been released in field trials, notably by Oxitec in Florida.⁴

On February 8 and 9, 2022, the Johns Hopkins Center for Health Security co-hosted a virtual dialogue session with the Regional Centre for Biotechnology of the Department of Biotechnology in the Indian Ministry of Science and Technology. The meeting focused on successes, challenges, opportunities, and lessons learned in the COVID-19 responses in India and the United States, and how COVID-19 responses can continue while also preparing for future health security crises.

The dialogue focused on COVID-19 developments that occurred since the last meeting in January 2021. Discussions centered around national response efforts, mass vaccination, surveillance approaches, causes and biosecurity implications of COVID-19 misinformation and disinformation, synthetic biological risks, global biosecurity governance, and the need for future collaboration among countries and within the scientific community.

The meeting convened senior thought leaders, scientists, public health practitioners, and medical experts from the United States and India. In accordance with the dialogue format, participants offered insights based on personal expertise and did not represent the government of either country in an official capacity.

Scientists have explored gene drive technologies with the aim of controlling vector-borne diseases, including malaria, which killed an estimated 386,000 people in 2019.¹ Gene drives are genetic modifications that can be used to create populations where a particular gene is passed from a parent organism to its offspring at a higher rate than would be expected under natural inheritance conditions.² For example, mosquitoes that transmit malaria may be modified with a gene drive so that surviving offspring inherit and spread a gene that inhibits or alters the mosquitoes' infection potential. The drive would spread over subsequent generations, resulting in limited malaria transmission. Other gene drive strategies are designed to dramatically reduce the population of the carrying organism, such as a mosquito. Due to the broad-acting and potentially irreversible nature of these tools, current regulations may not be sufficient to mitigate the unique risks posed by gene drive technologies.³

This article describes what is known about the origin of SARS-CoV-2, with implications for policy, biological research and public-health surveillance. Theories about the origin include a natural emergence; a laboratory accident with a naturally harvested strain; an accident with a naturally harvested strain modified in a laboratory; and the deliberate creation of a biological weapon. While available scientific evidence points to a natural zoonotic event as the origin of SARS-CoV-2, this paper recommends specific steps governments and scientific institutions should take to address uncertainties about the origin of the COVID-19 pandemic, as well as to make all potential causes for a pandemic less likely to produce one in the future. Immediate steps include promoting international scientific collaboration, addressing scientific misinformation and disinformation, fully implementing ‘One Health’ and reining in the illegal wildlife trade.