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.

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.

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.

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.

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.

Meeting the challenges of medical countermeasure development.

Despite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three-pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures - and the systems to deliver them - and the requisite support of all stakeholders, including national leadership.

Scientists urge DHS to improve Bioterrorism Risk Assessment.

In 2006, the Department of Homeland Security (DHS) completed its first Bioterrorism Risk Assessment (BTRA), intended to be the foundation for DHS's subsequent biennial risk assessments mandated by Homeland Security Presidential Directive 10 (HSPD-10). At the request of DHS, the National Research Council established the Committee on Methodological Improvements to the Department of Homeland Security's Biological Agent Risk Analysis to provide an independent, scientific peer review of the BTRA. The Committee found a number of shortcomings in the BTRA, including a failure to consider terrorists as intelligent adversaries in their models, unnecessary complexity in threat and consequence modeling and simulations, and a lack of focus on risk management. The Committee unanimously concluded that an improved BTRA is needed to provide a more credible foundation for risk-informed decision making.

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.