The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic.

The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products. EUAs proved vital for the first group of COVID-19 vaccines, including the temporary pause of one vaccine while emergency safety issues were evaluated. Although this review on the EUA is primarily focused on the USA, distinctions were made with other jurisdictions such as Europe and Canada with respect to the emergency authorizations of the vaccines. Finally, we discuss some important differences following EUA and formal new drug/vaccine application (NDA/BLA) approvals.

The psychology of protecting the UK public against external threat: COVID-19 and the Blitz compared.

The COVID-19 pandemic and the World War 2 aerial bombing campaign against the UK between 1939 and 1945 both exposed the civilian population to a sustained threat. Risk, whether from exposure to viral load or the density of the bombing, led to a range of protective measures and behavioural regulations being implemented. The V1 and V2 missiles used in summer and autumn, 1944, functioned as a second wave of bombing, arriving after people believed the danger had passed. Adherence to lockdown and a reluctance to return to work after the lifting of lockdown during the COVID-19 pandemic in the UK were mirrored in the preference for using home-based bomb shelters during the air raids. Heightened sensitivity to risk, or a so-called deep shelter mentality, did not materialise even during the second wave of bomb attacks and some deep bomb shelters were closed because of low occupancy. The most popular protective measures were those that reflected people's preferences, and not necessarily those that provided the greatest safety. As with the COVID-19 pandemic, the public drove government policy as much as they followed it.

How to Surge to Face the SARS-CoV-2 Outbreak: Lessons Learned From Lombardy, Italy.

Italy is fighting against one of the worst medical emergency since the 1918 Spanish Flu. Pressure on the hospitals is tremendous. As for official data on March 14th: 8372 admitted in hospitals, 1518 in intensive care units, 1441 deaths (175 more than the day before). Unfortunately, hospitals are not prepared: even where a plan for massive influx of patients is present, it usually focuses on sudden onset disaster trauma victims (the most probable case scenario), and it has not been tested, validated, or propagated to the staff. Despite this, the All Hazards Approach for management of major incidents and disasters is still valid and the "4S" theory (staff, stuff, structure, systems) for surge capacity can be guidance to respond to this disaster.

Progress in Public Health Emergency Preparedness-United States, 2001-2016.

OBJECTIVES: To evaluate the Public Health Emergency Preparedness (PHEP) program's progress toward meeting public health preparedness capability standards in state, local, and territorial health departments. METHODS: All 62 PHEP awardees completed the Centers for Disease Control and Prevention's self-administered PHEP Impact Assessment as part of program review measuring public health preparedness capability before September 11, 2001 (9/11), and in 2014. We collected additional self-reported capability self-assessments from 2016. We analyzed trends in congressional funding for public health preparedness from 2001 to 2016. RESULTS: Before 9/11, most PHEP awardees reported limited preparedness capabilities, but considerable progress was reported by 2016. The number of jurisdictions reporting established capability functions within the countermeasures and mitigation domain had the largest increase, almost 200%, by 2014. However, more than 20% of jurisdictions still reported underdeveloped coordination between the health system and public health agencies in 2016. Challenges and barriers to building PHEP capabilities included lack of trained personnel, plans, and sustained resources. CONCLUSIONS: Considerable progress in public health preparedness capability was observed from before 9/11 to 2016. Support, sustainment, and advancement of public health preparedness capability is critical to ensure a strong public health infrastructure.

A comparative assessment of major international disasters: the need for exposure assessment, systematic emergency preparedness, and lifetime health care.

BACKGROUND: The disasters at Seveso, Three Mile Island, Bhopal, Chernobyl, the World Trade Center (WTC) and Fukushima had historic health and economic sequelae for large populations of workers, responders and community members. METHODS: Comparative data from these events were collected to derive indications for future preparedness. Information from the primary sources and a literature review addressed: i) exposure assessment; ii) exposed populations; iii) health surveillance; iv) follow-up and research outputs; v) observed physical and mental health effects; vi) treatment and benefits; and vii) outreach activities. RESULTS: Exposure assessment was conducted in Seveso, Chernobyl and Fukushima, although none benefited from a timely or systematic strategy, yielding immediate and sequential measurements after the disaster. Identification of exposed subjects was overall underestimated. Health surveillance, treatment and follow-up research were implemented in Seveso, Chernobyl, Fukushima, and at the WTC, mostly focusing on the workers and responders, and to a lesser extent on residents. Exposure-related physical and mental health consequences were identified, indicating the need for a long-term health care of the affected populations. Fukushima has generated the largest scientific output so far, followed by the WTCHP and Chernobyl. Benefits programs and active outreach figured prominently in only the WTC Health Program. The analysis of these programs yielded the following lessons: 1) Know who was there; 2) Have public health input to the disaster response; 3) Collect health and needs data rapidly; 4) Take care of the affected; 5) Emergency preparedness; 6) Data driven, needs assessment, advocacy. CONCLUSIONS: Given the long-lasting health consequences of natural and man-made disasters, health surveillance and treatment programs are critical for management of health conditions, and emergency preparedness plans are needed to prevent or minimize the impact of future threats.

La Sanidad Militar como herramienta de la Diplomacia Médica / Military Health System as a Tool of Medical Diplomacy

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Deployable, portable, and temporary hospitals; one state's experiences through the years.

This article will review the use of temporary hospitals to augment the healthcare system as one solution for dealing with a surge of patients related to war, pandemic disease outbreaks, or natural disaster. The experiences highlighted in this article are those of North Carolina (NC) over the past 150 years, with a special focus on the need following the September 11, 2001 (9/11) attacks. It will also discuss the development of a temporary hospital system from concept to deployment, highlight recent developments, emphasize the need to learn from past experiences, and offer potential solutions for assuring program sustainability. Historically, when a particular situation called for a temporary hospital, one was created, but it was usually specific for the event and then dismantled. As with the case with many historical events, the details of the 9/11 attacks will fade into memory, and there is a concern that the impetus which created the current temporary hospital program may fade, as well. By developing a broader and more comprehensive approach to disaster responses through all-hazards preparedness, it is reasonable to learn from these past experiences, improve the understanding of current threats, and develop a long-term strategy to sustain these resources for future disaster medical needs.

Emergency managers as community change agents: an expanded vision of the profession.

Reflecting the historical evolution of attack preparedness, technological failures, and so-called natural disaster events, the profession of emergency management confronts new challenges today. In part, these reflect important cultural differences among stakeholder groups, especially local emergency managers. homeland security personnel, and those focused on public health threats and business continuity. An expanded and more strategic vision of the profession is required wherein fundamental assumption sets are placed into broader contexts. Contrary to the drift experienced in the US during the past decade, a major paradigm shift is required reflecting new orientations and program priorities.

From biodefence to biosecurity: the Obama administration's strategy for countering biological threats.

The Seventh Review Conference of the Biological Weapons Convention (BWC), the first international treaty to outlaw an entire class of weapons, was held in Geneva in December 2011. On 7 December, Secretary of State Hillary Clinton became the highest-ranking US government official to address a BWC meeting. Secretary Clinton told the assembled delegation that 'we view the risk of bioweapons attack as both a serious national security challenge and a foreign policy priority'. At the same time, she warned that a large-scale disease outbreak 'could cripple an already fragile global economy'. Secretary Clinton's speech reflected a new understanding that the range of biological threats to international security has expanded from state-sponsored biological warfare programmes to include biological terrorism, dual-use research and naturally occurring infectious diseases such as pandemics. Recognizing these changes, President Barack Obama released a new national strategy for countering biological threats in 2009. This strategy represents a shift in thinking away from the George W. Bush administration's focus on biodefence, which emphasized preparing for and responding to biological weapon attacks, to the concept of biosecurity, which includes measures to prevent, prepare for and respond to naturally occurring and man-made biological threats. The Obama administration's biosecurity strategy seeks to reduce the global risk of naturally occurring and deliberate disease outbreaks through prevention, international cooperation, and maximizing synergies between health and security. The biosecurity strategy is closely aligned with the Obama administration's broader approach to foreign policy, which emphasizes the pragmatic use of smart power, multilateralism and engagement to further the national interest. This article describes the Obama administration's biosecurity strategy; highlights elements of continuity and change from the policies of the Bush administration; discusses how it fits into Obama's broader foreign policy agenda; and analyses critical issues that will have to be addressed in order to implement the strategy successfully.

Horror and hope: (re)presenting militarised children in global North-South relations.

This article examines the (re)presentations of militarised children in contemporary global politics. In particular, it looks at the iconic image of the 21st century's child soldier, the subject of which is constructed as a menacing yet pitiable product of the so-called new wars of the global South. Yet this familiar image is a small, one-dimensional and selective (re)presentation of the issues facing children who are associated with conflict and militarism. In this sense it is a problematic focal point for analysing the insecurity and human rights of children in and around conflict. Instead, this article argues that the image of the child soldier asserts an important influence in its effect upon global North-South relations. It demonstrates how the image of the child soldier can assist in constructing knowledge about the global South, and the global North's obligations to it, either through programmes of humanitarianism, or through war.

Reintegrating young combatants: do child-centred approaches leave children­and adults­behind?

This article uses recent experience in Angola to demonstrate that young fighters were not adequately or effectively assisted after war ended in 2002. The government's framework excluded children from accessing formal disarmament, demobilisation and reintegration (DDR) programmes, and its subsequent attempts to target children have largely failed. More critically the case of Angola calls into question the broader effectiveness and appropriateness of child-centred DDR. First, such targeting is inappropriate to distinct post-conflict contexts and constructs a 'template child' asserted to be more vulnerable and deserving than adult ex-combatants, which does little to further the reintegration of either group, or the rights of the child in a conflict context. Second, child-centred reintegration efforts tend to deny children agency as actors in their own reintegration. Third, such efforts contribute to the normalisation of a much larger ideational and structural flaw of post-conflict peace building, wherein 'success' is construed as the reintegration of large numbers of beneficiaries back into the poverty and marginalisation that contributed to conflict in the first place.

Historical review of sports policy in rural China (1949-2008).

The rural population in China remains in the majority, and has traditionally played a key role in the development of China. This paper outlines the rhetoric of, and the material changes in the development of rural sports policy in the period since 1949. In effect this represents the largest single programmatic attempt to develop a rural sports policy, and it is one which reflects and contributes to the changing ideology of the state in China. The article explores the historical context of the unfolding of rural sports policy, the rationales provided by state and party leaders and representatives, and the rhetoric employed in supporting such policy direction. The development of policy is described as falling into three periods. From 1949 to 1977 the emphasis was on developing policies to promote labour production and national defence. This was succeeded by a period from 1978 to 2001 in which the major focus was on promoting a culturally positive environment (the construction of a 'spiritual civilization'), while in the period 2002 -08 the concern was with promoting equity and reducing the gap between urban and rural life quality. These developing rationales have sought in a variety of ways to address the major imbalances that exist in Chinese society between urban and rural, Eastern and Western China, and sports policy has thus became a significant tool in China's modernization agenda in the rural context.