Publications

The US/EU collaboration on health and health security issues has been steadily productive for years. Whether it was working together to support the World Health Organization, standing up the Global Health Security Agenda (GHSA) in 2014, or responding to the Ebola crisis in West Africa in 2014, health security problems have been in existence long before the COVID-19 pandemic, and fruitful cooperation between the US and EU has helped minimize threats and advance health. In the last four years, however, the US has stepped away from international cooperation on health security issues with the EU as well as other partners.

Recent advances have allowed the genomes of the severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) – the causative agent of COVID-19 – to be sequenced within hours or days of a case being identified. As a result, for the first time, genomic sequencing in real time has been able to inform the public health response to a pandemic. Metagenomic sequencing was fundamental to the detection and characterization of the novel pathogen. Early sharing of SARS-CoV-2 genome sequences allowed molecular diagnostic assays to be developed rapidly, which improved global preparedness, and contributed to the design of countermeasures. Rapid, large-scale virus genome sequencing is contributing to understanding the dynamics of viral epidemics and to evaluating the efficacy of control measures. Increased recognition that viral genome sequencing can contribute to improving public health is driving more laboratories to invest in this area. However, the cost and work involved in gene sequencing are substantial, and laboratories need to have a clear idea of the expected public health returns on this investment. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing activities now and in the future.

While there is consensus for the use of personal protective equipment and other measures for the prevention of transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk situations, such as aerosol-generating medical procedures, there is a divergence of opinion and enthusiasm for measures such as social distancing, cloth masks, and other recommendations in low-risk situations. The insights of epidemiologist Geoffrey Rose¹ on sick and high-risk populations may be helpful. In its simplest form, his concept can be explained as follows: the high-risk subpopulation—such as elderly people with preexisting cardiac or pulmonary conditions—may contribute a lesser share to the outcome (eg, infection, death) than a low-risk subpopulation would. This is simply because of the sheer larger number of persons in the low-risk subpopulation. Consider, for example, a population of 1,000 persons, with 100 in a high-risk subpopulation and 900 in a low-risk subpopulation, and a rate of infection 4 times as high in the high-risk subpopulation as in the low-risk subpopulation; their rates of infection are 20% and 5%, respectively. In this hypothetical scenario, the high-risk subpopulation contributes 20 cases to the outcome compared to 45 cases from the low-risk subpopulation.

Hospitals across the United States must take immediate action to save lives and fairly allocate limited resources by implementing crisis standards of care (CSC).

Hospitals are experiencing large surges in COVID-19 patients, and intensive care units are already over capacity in many areas. In response, hospitals are canceling admissions and procedures, augmenting staffing, transferring patients, even establishing and operating alternate care sites. But these actions may not be enough. There will come a point in the crisis when these adaptations cannot compensate for the overwhelming caseload. At this point, hospitals must shift to crisis standards of care. This means making unprecedented and agonizing decisions under great uncertainty in order to do the most good possible with limited resources. The tools and publications on this page are intended to help health care providers and public officials plan for the implementation of CSC.

This document was authored by Dan Hanfling, John Hick, Rick Hunt, and Eric Toner, drawing on evidence-based reports from the Institute of Medicine (now National Academy of Medicine).

The COVID-19 pandemic, in the words of Tedros Adhanom Ghebreyesus, the director general of the World Health Organization (WHO), “is a once-in-a-century health crisis.” Indeed, the last public health emergency to wreak such havoc was the great influenza pandemic that began in 1918, which sickened about a third of the world’s population and killed at least 50 million people. But because global conditions are becoming increasingly hospitable to viral spread, the current pandemic is unlikely to be the last one the world faces this century. It may not even be the worst.

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.

Antibody tests for detecting past infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have many uses for public health decision making, but demand has largely come from individual consumers. This review focuses on the individual relevance of antibody tests: their accuracy in detecting prior infection, what past SARS-CoV-2 infection can currently infer about future immunity or possible medical sequelae, and the potential future importance of antibody tests for vaccine selection and medical screening. Given uncertainty about the antibody tests (quality, accuracy level, positive predictive value) and what those tests might indicate immunologically (durability of antibodies and necessity for protection from reinfection), seropositive test results should not be used to inform individual decision making, and antibody testing should remain a tool of public health at this time.

In 2019, the US Centers for Disease Control and Prevention (CDC) reported the largest number of measles cases since 1992. Thirty-one states reported a total of 1282 cases.1 Rising measles incidence increases the likelihood that state and local health departments across the US will have to respond to an outbreak of this disease in the future.

Given the social and economic upheavals caused by the COVID-19 pandemic, political leaders, health officials, and members of the public are eager for solutions. One of the most promising, if they can be successfully developed, is vaccines. While the technological development of such countermeasures is currently underway, a key social gap remains. Past experience in routine and crisis contexts demonstrates that uptake of vaccines is more complicated than simply making the technology available. Vaccine uptake, and especially the widespread acceptance of vaccines, is a social endeavor that requires consideration of human factors. To provide a starting place for this critical component of a future COVID-19 vaccination campaign in the United States, the 23-person Working Group on Readying Populations for COVID-19 Vaccines was formed. One outcome of this group is a synthesis of the major challenges and opportunities associated with a future COVID-19 vaccination campaign and empirically-informed recommendations to advance public understanding of, access to, and acceptance of vaccines that protect against SARS-CoV-2. While not inclusive of all possible steps than could or should be done to facilitate COVID-19 vaccination, the working group believes that the recommendations provided are essential for a successful vaccination program.

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.

For many children in the United States, the 2020 school year is beginning online, presenting a difficult set of challenges to keep kids learning. The importance of schools goes far beyond the academic benefits of in-person instruction. Schools provide meals, access to health services, and a safe space for students to develop social and emotional skills. Prolonged school closures can jeopardize access to these resources, particularly for the most vulnerable students. School closures also affect parents and guardians. More than 41 million adults were a care provider for a child under the age of 18 in the United States in 2018. During the Covid-19 pandemic, the care of children for many of these adults has collided with work. A survey of working parents in May and June by Northeastern University reported that 13% of the 2,557 participants had to reduce their working hours or leave work entirely to compensate for the loss of childcare availability due to school and childcare closures. Those still working reported an average of eight working hours of the week lost to childcare needs.

Infectious disease outbreaks pose major threats to human health and security. Countries with robust capacities for preventing, detecting and responding to outbreaks can avert many of the social, political, economic and health system costs of such crises. The Global Health Security Index (GHS Index)—the first comprehensive assessment and benchmarking of health security and related capabilities across 195 countries—recently found that no country is sufficiently prepared for epidemics or pandemics. The GHS Index can help health security stakeholders identify areas of weakness, as well as opportunities to collaborate across sectors, collectively strengthen health systems and achieve shared public health goals. Some scholars have recently offered constructive critiques of the GHS Index’s approach to scoring and ranking countries; its weighting of select indicators; its emphasis on transparency; its focus on biosecurity and biosafety capacities; and divergence between select country scores and corresponding COVID-19-associated caseloads, morbidity, and mortality. Here, we (1) describe the practical value of the GHS Index; (2) present potential use cases to help policymakers and practitioners maximise the utility of the tool; (3) discuss the importance of scoring and ranking; (4) describe the robust methodology underpinning country scores and ranks; (5) highlight the GHS Index’s emphasis on transparency and (6) articulate caveats for users wishing to use GHS Index data in health security research, policymaking and practice.

The Global Forum on Scientific Advances Important to the Biological Weapons Convention facilitates engagement between scientists performing cutting-edge research and States Parties delegations to the Biological Weapons Convention (BWC). The Global Forum helps the delegates become familiar with some of the rapid advances in the biological and related sciences that affect the treaty and its implementation, and it demonstrates to scientists the role of the BWC in shaping the governance of these technologies. Our efforts to inform BWC delegations on emerging and future biology and biotechnology capabilities supplement an existing portfolio of programs—including the BWC Meetings of Experts and regional science and technology workshops hosted by the InterAcademy Partnership—that work collectively to help States Parties identify and evaluate potential biological threats and develop mechanisms to allow the BWC to remain adaptive to these new capabilities. Additionally, the Global Forum supports efforts, such as model codes of conduct, to foster a culture of responsibility among the scientific community that enables researchers to pursue advanced and revolutionary capabilities while simultaneously encouraging them to account for potential risks and mitigate those effects.

This year, the Global Forum was cosponsored by the Johns Hopkins Center for Health Security and the United Nations Office for Disarmament Affairs (UNODA). The formal involvement of UNODA and the BWC Implementation Support Unit highlights the importance of addressing emerging science and technology in the context of the BWC and the commitment to facilitating engagement between scientists and policymakers to identify and understand emerging biological capabilities and risks.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of novel coronavirus disease 2019 (COVID-19), has caused more than 961,000 known deaths1 since it was reported to the World Health Organization on December 31, 2019. Determining the origin of the pandemic coronavirus is of great importance, not only to understand the mechanics of how the virus replicates and spreads but also to anticipate and prevent additional viruses from becoming future health security crises. If an origin can be found for SARS-CoV-2, steps can then be taken to prevent a similar pathway for other viruses to lead to a pandemic. For that reason, it is the responsibility of the scientific community to review and analyze data relating to the origin of SARS-CoV-2.

The coronavirus disease 2019 (COVID-19) pandemic may have caught governments by surprise, but medical and public health communities have long warned of the potential for a high-consequence pandemic. Most recently, in September 2019, a report by the independent Global Preparedness Monitoring Board urged political leaders to take steps in their countries to improve preparedness for such events.1 One month later, the Global Health Security (GHS) Index, a framework for benchmarking health security in 195 countries, found that no country was fully prepared for a major health emergency.2 The Index identified serious weaknesses in many countries that could undermine their ability to respond to a pandemic, but it did not anticipate the poor response to the pandemic by high-scoring countries such as the US where major gaps in federal leadership resulted in a failure to mobilize the country’s substantial capacity.

We report key epidemiologic parameter estimates for coronavirus disease identified in peer-reviewed publications, preprint articles, and online reports. Range estimates for incubation period were 1.8–6.9 days, serial interval 4.0–7.5 days, and doubling time 2.3–7.4 days. The effective reproductive number varied widely, with reductions attributable to interventions. Case burden and infection fatality ratios increased with patient age. Implementation of combined interventions could reduce cases and delay epidemic peak up to 1 month. These parameters for transmission, disease severity, and intervention effectiveness are critical for guiding policy decisions. Estimates will likely change as new information becomes available.

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 world's attention has been drawn to the pace and progress of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) research, as scientists around the world race to better understand the virus and develop therapies and vaccines. While the fruits of this research cannot come soon enough, progress would not be possible were it not for profound advances in biotechnology in the past decade. The progress extends far beyond medical interventions and research tools, it also encompasses advances in agriculture, biological replacements for petroleum chemistry, and a myriad of novel biological products—from spider silk to laboratory grown meats to organic construction materials.^1-3 These myriad endeavors and innovations are part of the “bioeconomy,” which is defined as the economic activity that comes from bio-based feedstock (such as agricultural and forestry biomass), products or materials (like biofuels and chemicals), and processes that contribute sustainable solutions to resolving issues in areas such as food, energy, health, and the environment.^4,5,6 Strategies for developing and supporting national bioeconomies encompass diverse fields, including energy, agriculture, medicine, manufacturing, industrial chemistry, pharmaceuticals, and defense.

An important factor in growing the US bioeconomy is recruiting and training its future workforce. Other science, technology, engineering, and math (STEM) fields have relied on diverse educational opportunities for recruitment, including prestigious high school and collegiate competitions. For genetic engineering and synthetic biology, there are very few competitions; they include the Biodesign Competition and the much larger and scientifically focused International Genetically Engineered Machine (iGEM) competition. iGEM, run by an independent nonprofit organization, is often cited as a measure of progress in developing the synthetic biology workforce. Starting in 2021, iGEM will move its main competitive event, the “Giant Jamboree,” from its long-standing home in Boston to Paris, which is likely to negatively affect participation by the US team. In this article, we describe the value of iGEM to the bioeconomy and its upcoming challenges through a review of available literature, observation of the iGEM Jamboree, and interviews with 10 US-based iGEM team coaches. The coaches expressed positive views about the iGEM process for their students in providing a hands-on biotechnology experience, but they were concerned about the funding US students received to participate in iGEM compared with teams from other countries. They were also concerned that the relocation to Paris would negatively affect or preclude their participation. Possible options to continue the benefits of experiential learning in synthetic biology are discussed, including alternative funding for iGEM teams through a grant process and the need for additional biology competitions.

Since its first appearance in the United States in February 2020, novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 3.77 million and killed over 140,000 people in the United States (as of July 20, 2020).¹ Responses to the virus, including closing venues where person-to-person spread was likely (eg, schools, churches, businesses) and requiring the use of masks and physical distancing measures when person-to-person contact could not be avoided, reduced the spread of SARS-CoV-2. At the same time, these protective actions have also radically transformed social life and upended national and household economies.^2,3 As the health crisis continues and pandemic fatigue starts to take hold, political leaders, health officials, and the general public are anxiously searching for solutions.