Maintaining a Safe Blood Supply in an Era of Emerging Pathogens.

Coming shortly after outbreaks of dengue and chikungunya virus in related locations, the recent outbreak of Zika virus in the southern part of the western hemisphere is yet another reminder that infectious pathogens continue to emerge rapidly and can adversely affect public health, including the safety of the blood supply. In response to Zika virus, public health measures that rely largely on donor deferral and sourcing of blood from non-outbreak areas until a blood donor screening test becomes available have been implemented to address the safety of the blood supply in the United States. However, a more universal approach to ensuring blood safety in the setting of rapidly emerging infectious diseases is needed.

Facilitating Antibacterial Drug Development in a Time of Great Need.

The continued development of new antibacterial drugs is critical to meet patient and public health needs. In this editorial, authors from the US Food and Drug Administration and European Medicines Agency reflect on the role of public-private partnerships and the development of clinical trials networks as agents to guide and perform quality studies of antibacterial drugs.

Pandemic diseases preparedness and response in the age of COVID-19-a symposium report.

For years, experts have warned that a global pandemic was only a matter of time. Indeed, over the past two decades, several outbreaks and pandemics, from SARS to Ebola, have tested our ability to respond to a disease threat and provided the opportunity to refine our preparedness systems. However, when a novel coronavirus with human-to-human transmissibility emerged in China in 2019, many of these systems were found lacking. From international disputes over data and resources to individual disagreements over the effectiveness of facemasks, the COVID-19 pandemic has revealed several vulnerabilities. As of early November 2020, the WHO has confirmed over 46 million cases and 1.2 million deaths worldwide. While the world will likely be reeling from the effects of COVID-19 for months, and perhaps years, to come, one key question must be asked, How can we do better next time? This report summarizes views of experts from around the world on how lessons from past pandemics have shaped our current disease preparedness and response efforts, and how the COVID-19 pandemic may offer an opportunity to reinvent public health and healthcare systems to be more robust the next time a major challenge appears.

The public's role in COVID-19 vaccination: Human-centered recommendations to enhance pandemic vaccine awareness, access, and acceptance in the United States.

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.

Healthcare epidemiology: the current status of planning for pandemic influenza and implications for health care planning in the United States.

The United States needs to be better prepared for a large-scale medical catastrophe, be it a natural disaster, a bioterrorism act, or a pandemic. There are substantial planning efforts now devoted to responding to an influenza pandemic. Here, we review these efforts and identify some harsh realities: (1) the US health care system is private, competitive, broke, and at capacity, so that any demand for surge cannot be met with existing economic resources, hospital beds, manpower, or supplies; (2) the emphasis placed on the development and rapid production of an effective vaccine is excellent, but the effort is underfunded to meet global demand; (3) and the Centers for Disease Control and Prevention's community mitigation measures, such as the use nonpharmacological and social interventions (e.g., use of face masks or respirators, social distancing, and closure of schools), lack validation and could have substantial indirect and unintended consequences. Finally, international collaborations are essential for disease surveillance and to assure investigator access to influenza strains, equitable vaccine distribution, and availability of critical supplies from offshore sources.

Removing barriers to global pandemic influenza vaccination.

This article clarifies the regulatory issues surrounding influenza pandemic vaccine for the larger policy community and describes the need for regulatory harmonization. Vaccination would save lives in an influenza pandemic, but a lack of global manufacturing capacity will leave most of the world without access to vaccine. Capacity can be expanded if governments harmonize their regulatory policies. This article details the regulatory approaches taken by the United States, the European Union, and Japan for pandemic vaccine development, three regions that produce the majority of the world's seasonal influenza vaccine. They should quickly converge on regulatory requirements, intellectual property considerations, the use of recombinant DNA techniques for vaccine production, and technical issues about the composition of pandemic vaccine.

Ebola Virus Disease: Therapeutic and Potential Preventative Opportunities.

The 2014 Ebola virus disease (EVD) epidemic in West Africa was unprecedented in its geographical distribution, scale, and toll on public health infrastructure. Standard public health measures were rapidly overwhelmed, and many projections on outbreak progression through the region were dire. At the beginning of the outbreak there were no treatments or vaccines that had been shown to be safe and effective for treating or preventing EVD, limiting health care providers to offer supportive care under extremely challenging circumstances and at great risk to themselves. Over time, however, drugs and vaccines in the development pipeline were prioritized based on all available research data and were moved forward for evaluation in clinical trials to demonstrate safety and efficacy. The armamentarium against EVD eventually included biologics such as monoclonal antibodies, convalescent plasma, and vaccines as well as small molecule therapeutics such as small interfering RNAs and nucleoside analogs. This article provides a high-level overview of the interventions and prophylactics considered for use in the outbreak and discusses the challenges faced when attempting to deploy investigational countermeasures in the midst of an evolving epidemic.

Anthrax countermeasures: current status and future needs.

The U.S. government does not yet have the range of medical countermeasures needed to protect its citizens from anthrax and other potential bioweapons. In the event of an anthrax attack, treatment interventions in addition to antibiotics would be needed so that very ill patients can be treated and clean-up crews can be better protected, especially if an engineered strain is used. This article describes specific anthrax countermeasures that are in development, barriers to development, and potential mechanisms the government could use to accelerate the movement of these countermeasures through the pipeline. A key challenge will be to encourage the transition of promising leads from basic research to the product development stage, when they may qualify for BioShield funds.

Navigating the storm: report and recommendations from the Atlantic Storm exercise.

Atlantic Storm was a tabletop exercise simulating a series of bioterrorism attacks on the transatlantic community. The exercise occurred on January 14, 2005, in Washington, DC, and was organized and convened by the Center for Biosecurity of UPMC, the Center for Transatlantic Relations of Johns Hopkins University, and the Transatlantic Biosecurity Network. Atlantic Storm portrayed a summit meeting of presidents, prime ministers, and other international leaders from both sides of the Atlantic Ocean in which they responded to a campaign of bioterrorist attacks in several countries. The summit principals, who were all current or former senior government leaders, were challenged to address issues such as attaining situational awareness in the wake of a bioattack, coping with scarcity of critical medical resources such as vaccine, deciding how to manage the movement of people across borders, and communicating with their publics. Atlantic Storm illustrated that much might be done in advance to minimize the illness and death, as well as the social, economic, and political disruption, that could be caused by an international epidemic, be it natural or the result of a bioterrorist attack. These lessons are especially timely given the growing concerns over the possibility of an avian influenza pandemic that would require an international response. However, international leaders cannot create the necessary response systems in the midst of a crisis. Medical, public health, and diplomatic response systems and critical medical resources (e.g., medicines and vaccines) must be in place before a bioattack occurs or a pandemic emerges.

Management of anthrax.

From 3 October 2001 through 16 November 2001, in the United States, there were 18 confirmed cases of inhalational and cutaneous anthrax, an additional 4 suspected cases of cutaneous anthrax, and 5 deaths due to inhalational anthrax. Although the number of cases was relatively small, this experience brought bioterrorism and its potential to sharp focus as thousands of people began receiving prophylactic antibiotics after possible exposure to anthrax spores. These events have resulted in a substantial impact on the health care system, including the rewriting of pneumonia guidelines, new emphasis on identification of microbial etiology, substantial infusion of funds for bioterrorism-related research, and a sudden mandate for regional disaster and public health planning. This article provides clinicians with clinically relevant information about the diagnosis and management of anthrax.