Pandemics and Epidemics

From the document: "The U.S. Army estimates that if a severe infectious disease pandemic were to occur today, the number of U.S. fatalities could be almost twice the total number of battlefield fatalities in all of America's wars since the American Revolution in 1776. A pandemic occurs when an infectious agent emerges that can be efficiently transmitted between humans and has crossed international borders. DOD's day-to-day functioning and the military's readiness and operations abroad could be impaired if a large percentage of its personnel are sick or absent, and DOD's assistance to civil authorities might be limited. House Report 114-102 included a provision for GAO (Government Accountability Office) to assess DOD's planning and coordination to support civil authorities during a pandemic. This report assesses the extent to which (1) DOD has guidance and plans for supporting civil authorities in the event of a domestic outbreak of a pandemic disease and (2) HHS (Health and Human Services) and DHS have plans to respond to a pandemic if DOD support capabilities are limited, and they have mechanisms to coordinate their pandemic preparedness and response. GAO reviewed agency pandemic guidance and plans, interagency coordination mechanisms, and pandemic-related exercises and after-action reports"

"Multiple pandemics, numerous outbreaks, thousands of lives lost and billions of dollars of national income wiped out -- all since the turn of this century, in barely 17 years -- and yet the world's investments in pandemic preparedness and response remain woefully inadequate. […] Every expert commentary and every analysis in recent years tells us that the costs of inaction are immense. And yet, as the havoc caused by the last outbreak turns into a fading memory, we become complacent and relegate the case for investing in preparedness on a back burner, only to bring it to the forefront when the next outbreak occurs. […] Investing in health security through financing preparedness is a highly cost effective way to protect lives and safeguard livelihoods and communities. Whether measured in human lives saved or economic disruption avoided, the return on investments in pandemic preparedness is extraordinarily high. Moreover, many of the capabilities and much of the infrastructure required for pandemic preparedness also support efforts to fight endemic diseases and counter the threat of antimicrobial resistance. Taken together, the recommendations of the International Working Group set out in this report represent a pathway towards achieving the goal of universal health security, whilst strengthening health systems and helping ensure delivery of the Sustainable Development Goals."

"The 2010 Department of Homeland Security (DHS) Quadrennial Homeland Security Review states 'ultimately Homeland Security is about effectively managing risks to the Nation's security.' With risk defined as the likelihood and consequences of potential unwanted events, managing risks from naturally-occurring, accidental, or deliberate biological events such as emerging infectious disease or bioterrorism is difficult to accomplish through activities that attempt to reduce these events' likelihood of occurrence. Although much is being done to prevent these types of events, such events could and do still occur. Instead, activities that mitigate these risks largely focus on reducing, managing, or limiting the consequences of biological events once they begin to occur. Surveillance plays an import role in early detection of such events, allowing an early response, limiting the spread and effects of such events. Doing this effectively requires the earliest possible warning that an event is occurring, as well as continuing shared situational awareness throughout the event, to enable effective decision making regarding what actions should be taken. The mission of the National Biosurveillance Integration Center (NBIC) is fundamentally about the integration of biosurveillance information to enable early warning and shared situational awareness, and disseminate it to the appropriate people in a timely fashion. The National Biosurveillance Integration Center Strategic Plan first provides an overview of national biosurveillance in general, as well as current NBIC activities and operations, then outlines the goals and objectives required to achieve the NBIC's mission over the next five years. These strategic goals, objectives, and activities represent a balance of efforts that enable early warning and shared situational awareness through information ingestion and analysis; synthesis of existing government, private non-governmental, open-source, and classified information; and innovating advanced analytics and models, all in collaboration with federal partners and state, local, territorial, tribal, private, and international stakeholders. NBIC's goals and objectives outlined in this plan include these stakeholders and will be measured for success against specific milestones developed in collaboration with them."

"The 'National Strategy for Biosurveillance' sets forth the United States Government approach to strengthen our national biosurveillance enterprise and describes a core set of functions critical to this Strategy's success.The approach builds on existing biosurveillance concepts and capabilities in seeking to enable more rapid detection, knowledge, and characterization of human, animal, or plant disease activity to enhance incident situational awareness.At the same time, this Strategy outlines an approach that is more selective and deliberate in its intent. The Strategy defines biosurveillance as the process of gathering, integrating, interpreting, and communicating essential information related to all-hazards threats or disease activity affecting human, animal, or plant health to achieve early detection and warning, contribute to overall situational awareness of the health aspects of an incident, and to enable better decisionmaking at all levels. […] This Strategy articulates an overarching goal supported by core functions.It also includes guiding principles that provide a foundation for biosurveillance activities and specific enablers to achieve a well-integrated, national biosurveillance enterprise.Through a deliberate emphasis on the identified core functions and enabling focus areas, the aim is to enhance the Nation's ability to detect, track, investigate, and navigate incidents affecting human, animal, and plant health, thereby better protecting the safety, well being, and security of the American people. The Guiding Principles serve as the Strategy foundation and inform biosurveillance efforts. The Core Functions focus and prioritize our biosurveillance efforts. The crosscutting Enablers are aimed at facilitating the successful implementation of our Strategy."

Public Law 113-5 is "[an] Act to reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes."

From the Executive Summary, "The United States Department of Health and Human Services (HHS) Secretary, through the Assistant Secretary for Preparedness and Response (ASPR), directs activities related to the nation's public health and health preparedness, as well as assuring appropriate national response capability such as medical countermeasures. The National Biodefense Science Board (NBSB) was tasked with providing guidelines and recommendations for a coordinated strategy to assure the nation's biosurveillance capacity as it contributes to situational awareness of issues potentially and actually impacting the public's health. A 'biosurveillance' system includes programs, policies, procedures, workforce, and technology related to biosurveillance for human health. Biosurveillance is an important component of public health and healthcare situational awareness but would not in itself include other components of situational awareness such as inventory and resource management. Biosurveillance is, however, connected to the public health and healthcare response component of situational awareness by ensuring the most optimal and informed decision making to thereby assure our national health security"

"Between December 2014 and June 2015, the United States experienced its largest highly pathogenic avian influenza (HPAI) outbreak--and most serious animal health disease incident--in history. This plan was updated in August 2015 to reflect immediate changes required based on those events. Soon thereafter, in January 2016, there was an HPAI/low pathogenicity avian influenza (LPAI) outbreak in Indiana. This version of the 'USDA APHIS [United States Department of Agriculture, Animal and Plant Health Inspection Services] HPAI Response Plan: The Red Book (Updated May 2017)' reflects the knowledge and lessons learned during both of these outbreaks, as well as in the recent HPAI/LPAI incident in 2017. Additionally, this version incorporates changes made in related Foreign Animal Disease Preparedness and Response Plan (FAD PReP) materials."

"The U.S. poultry industry is experiencing a severe outbreak of highly-pathogenic avian influenza (HPAI). The U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS) has reported 223 cases of HPAI in domestic flocks in 15 states. With the start of summer, the finding of new cases slowed. The last reported new case was in Iowa on June 17, 2015. More than 48 million chickens, turkeys, and other poultry have been euthanized to stem the spread of the disease. Cases have been caused by several highly pathogenic H5 avian influenza (AI) strains that result in substantial mortality in domestic poultry. Turkey and egg-laying hen farms in Minnesota and Iowa have been hardest hit. Commercial broiler farms have not been affected to date. According to the Centers for Disease Control and Prevention (CDC), no infections in humans have been associated with the HPAI outbreak, and the public health risk is low. […] It is believed that an HPAI outbreak is likely to occur again in the fall when wild birds begin their migrations through the four flyways. This may result in more spread of AI, possibly in the poultry-producing eastern and southeastern regions untouched by the current outbreak. APHIS and the poultry industry are taking lessons from the current outbreak to prepare for the fall. USDA is developing a vaccine to be available for manufacture if the agency decides to adopt a vaccination policy to manage any future outbreak. APHIS and the poultry industry are reassessing biosecurity, indemnity payment formulas, and other measures that aim to improve the containment and elimination process."

From About This Document: "On 31 December 2019, WHO [World Health Organization] was alerted to a cluster of pneumonia patients in Wuhan City, Hubei Province of China. One week later, on 7 January 2020, Chinese authorities confirmed that they had identified a novel (new) coronavirus as the cause of the pneumonia (figure 1). The proposed interim name of the virus is 2019-nCoV. [...] This strategic preparedness and response plan outlines the public health measures that the international community stands ready to provide to support all countries to prepare for and respond to 2019-nCoV. The document takes what we have learned so far about the virus and translates that knowledge into strategic action that can guide the efforts of all national and international partners when developing context-specific national and regional operational plans."

From the Document: "On December 31, 2019, the World Health Organization (WHO) was informed of a cluster of pneumonia cases in Wuhan, China. Illnesses have since been linked to a previously unidentified strain of coronavirus, designated 2019 novel Coronavirus, or 2019-nCoV. To date, thousands have been infected, mostly in China, and over 100 have died. The disease has spread to several other countries, including the United States. As the scope of the epidemic widened in China, the U.S. Centers for Disease Control and Prevention (CDC) stated on January 27, 2020, that 'the immediate health risk from the new virus to the general American public is low currently.' With the situation rapidly changing, both WHO and CDC post frequent updates."

This Centers for Disease Control and Prevention (CDC) webpage includes information and resources on the Novel Coronavirus. The webpage includes the following sections: "Overview of Novel Coronavirus"; "Update, Case Definitions, & Guidance"; "Photos"; "Related Materials"; and "Updates".

From the Overview: "The 'COVID-19 [Coronavirus Disease 19] Pandemic Operational Guidance: All-Hazards Incident Response and Recovery' provides actionable guidance for SLTT [state, local, tribal, and territorial] officials to prepare for response and recovery operations amidst the COVID-19 pandemic. While FEMA is releasing this in advance of the 2021 Atlantic and Pacific hurricane seasons and the peak Western wildfire season, the planning considerations outlined here are applicable to any disaster operation in the COVID-19 environment, including no-notice incidents, spring flooding, tropical cyclones, severe weather, and other all-hazard incidents. This document highlights how FEMA has adapted to operating in the COVID-19 pandemic environment, but to the greatest extent possible, the foundational emergency management concepts remain unchanged."

From the Purpose: "The purpose of this document is to provide a practical guide for the UNCTs [UN Country Teams] and partners to develop a CPRP [Country Preparedness and Response Plan] to immediately support national governments to prepare for and respond to COVID-19 [coronavirus disease 2019]. The initial CPRP should be developed for a 3-month period from 1 February to 30 April in alignment with the SPRP [Strategic Preparedness and Response Plan]. Subsequent CPRPs will be developed based on the evolving situation and needs. This guide outlines the priority steps and actions to be included in the CPRP across the major areas of the public health preparedness and response: [1] Country-level coordination, planning, and monitoring; [2] Risk communication and community engagement; [3] Surveillance, rapid-response teams, and case investigation; [4] Points of entry; [5] National laboratories; [6] Infection prevention and control; [7] Case management; [8] Operations support and logistics. This guide does not supersede existing national guidance and plans. Rather, this guide should be used to rapidly adapt existing relevant national plans, including NAPHS [ National Action Plans for Health Security] and PIPPs [Pandemic Influenza Preparedness Plans], and focus the support of the international community."

From the Executive Summary: "We can and will beat COVID-19 [coronavirus disease 2019]. America deserves a response to the COVID-19 pandemic that is driven by science, data, and public health -- not politics. Through the release of the National Strategy for the COVID-19 Response and Pandemic Preparedness, the United States is initiating a coordinated pandemic response that not only improves the effectiveness of our fight against COVID-19, but also helps restore trust, accountability and a sense of common purpose in our response to the pandemic. [...] The National Strategy provides a roadmap to guide America out of the worst public health crisis in a century. It outlines an actionable plan across the federal government to address the COVID-19 pandemic[.]"

From the Background: "This report discusses selected actions taken by the federal government to quell the introduction and spread of 2019-nCoV [2019 Novel Coronavirus] in the United States. The HHS [U.S. Department of Health and Human Services] Secretary has taken several specific actions to address the 2019-nCoV threat. While some of these actions are based in generally applicable authorities of the Secretary, other authorities may be contingent upon the Secretary or another federal official making a determination or declaration, specific to that authority, regarding the existence of a public health emergency or threat. Each of the actions taken by the Secretary, its statutory basis, and any distinct declarations and determinations supporting the action is presented in this report."

From the Document: "The United States has confirmed cases of individuals who have a severe acute respiratory illness caused by a novel (new) coronavirus ('2019-nCoV') ('the virus') first detected in Wuhan, Hubei Province, People's Republic of China ('China'). The virus was discovered in China in December 2019. As of January 31, 2020, Chinese health officials have reported approximately 10,000 confirmed cases of 2019-nCoV in China, more than the number of confirmed cases of Severe Acute Respiratory Syndrome (SARS) during its 2003 outbreak. An additional 114 cases have been confirmed across 22 other countries; in several of these cases, the infected individuals had not visited China. More than 200 people have died from the virus, all in China."

From the Goal and Objectives: "The overall goal of the Joint Mission was to rapidly inform national (China) and international planning on next steps in the response to the ongoing outbreak of the novel coronavirus disease (COVID-19 ) and on next steps in readiness and preparedness for geographic areas not yet affected. The major objectives of the Joint Mission were as follows: [1] To enhance understanding of the evolving COVID-19 outbreak in China and the nature and impact of ongoing containment measures; [2] To share knowledge on COVID-19 response and preparedness measures being implemented in countries affected by or at risk of importations of COVID-19; [3] To generate recommendations for adjusting COVID-19 containment and response measures in China and internationally; and [4] To establish priorities for a collaborative programme of work, research and development to address critical gaps in knowledge and response and readiness tools and activities."

"During 2014--2016, CDC, working with U.S. and international partners, mounted a concerted response to end the unprecedented epidemic of Ebola virus disease (Ebola) in West Africa. CDC's response, which was the largest in the agency's history, was directed simultaneously at controlling the epidemic in West Africa and strengthening preparedness for Ebola in the United States. Although experience in responding to approximately 20 Ebola outbreaks since 1976 had provided CDC and other international responders an understanding of the disease and how to stop its spread, the epidemic in West Africa presented new and formidable challenges. The initial response was slow and complicated for several reasons, including wide geographic spread of cases, poor public health and societal infrastructure, sociodemographic factors, local unfamiliarity with Ebola, and distrust of government and health care workers. In the United States, widespread public alarm erupted after Ebola cases were diagnosed in Dallas, Texas, and New York City, New York. CDC, in collaboration with its U.S. and international counterparts, applied proven public health strategies as well as innovative new approaches to help control the Ebola epidemic in West Africa and strengthen public health readiness in the United States. Lessons learned include the recognition that West African and other countries need effective systems to detect and stop infectious disease threats, the need for stronger international surge capacity for times when countries are overwhelmed by an outbreak, and the importance of improving infection prevention and control in health care settings."

This testimony compilation is from the October 24, 2014 hearing, "Ebola Crisis: Coordination of a Multi-Agency Response," before the U.S. House Committee on Oversight & Government Reform. From the statement of Dr. Nicole Lurie: "I appreciate the opportunity to talk to you today about the aggressive steps that HHS [Health and Human Services] and other Federal Agencies have taken since the first cases of Ebola were identified in West Africa. By all accounts, the spread of this deadly disease in West Africa is unprecedented and we continue to work diligently, as part of the global community, to support the response and make necessary preparations in this country." Statements, letters, and materials submitted for the record include those of the following: Nicole Lurie, Michael Lumpkin, James Lariviere, John Roth, Deborah Burger, and Rabih Torbay.

"On September 16, 2014, President Obama announced a major increase in the U.S. response to the current Ebola outbreak in West Africa. The Department of Defense (DOD) submitted requests to Congress to make excess Overseas Contingency Operations funds appropriated for FY2014 available to support this effort. The requested funds would be used to provide humanitarian assistance, including: (1) transportation of DOD and non-DOD personnel and supplies; (2) coordination of delivery of supplies from both DOD and non-DOD sources such as isolation units, personnel protective equipment, and medical supplies; (3) construction of 17 planned Ebola treatment units; and, (4) training and education in support of sanitation and mortuary affairs functions to limit the spread of the Ebola outbreak. DOD officials have stated that DOD personnel will not provide direct medical care to Ebola victims, but that non-governmental organizations are submitting proposals to the World Health Organization and other entities to provide health care workers."

"To capture critical lessons from the Ebola epidemic of 2014--2016, the U.S. Department of Health and Human Services (HHS) asked CNA to convene an independent panel of public health, healthcare, emergency response, and communication experts to review the Department's international and domestic responses. This report summarizes the Independent Panel's assessment of HHS's challenges--and, where appropriate, challenges facing the broader U.S. government--and presents recommendations for addressing future urgent public health threats. The Ebola epidemic that began in West Africa was a seminal event for the global public health response community. The epidemic crystalized the importance of national disease surveillance capacities and timely multilateral coordination. The World Health Organization (WHO) and others acknowledge that investments must be made in the ability of countries to detect, report, and respond to urgent public health threats, and that reforms are needed to strengthen WHO's role as the worldwide protector of health."

"The battle against SARS [Severe Acute Respiratory Syndrome] is not yet over in Hong Kong and elsewhere in the world. At the 54th annual conference of the World Health Organisation's regional committee for the Western Pacific region held in September 2003 in Manila, Dr Lee Jong-wook, Director-General of the World Health Organisation (WHO), said, 'We have to prepare on the assumption that this (SARS) will come back.' We will only win the battle if the Government and all sectors of the community take part in the fight. The HKSAR [Hong Kong Special Administrative Region] Government has already put in place a comprehensive strategy to guard against SARS. Various sectors and trades have also implemented preventive measures and are on full alert. We will remain vigilant and oversee the community's collective effort to ensure that a high level of preparedness is maintained on all fronts. Within the Government, the Health, Welfare and Food Bureau will ensure readiness of all Government departments and the Hospital Authority by conducting checks and keeping track of the progress in the implementation of necessary measures."

"SARS [severe acute respiratory syndrome] showed that Ontario's public health system is broken and needs to be fixed. Despite the extraordinary efforts of many dedicated individuals and the strength of many local public health units, the overall system proved woefully inadequate. SARS showed Ontario's central public health system to be unprepared, fragmented, poorly led, uncoordinated, inadequately resourced, professionally impoverished, and generally incapable of discharging its mandate. The SARS crisis exposed deep fault lines in the structure and capacity of Ontario's public health system. Having regard to these problems, Ontario was fortunate that SARS was ultimately contained without widespread community transmission or further hospital spread, sickness and death. SARS was contained only by the heroic efforts of dedicated front line health care and public health workers and the assistance of extraordinary managers and medical advisors. They did so with little assistance from the central provincial public health system that should have been there to help them. These problems need urgently to be fixed."

"This second interim report deals with legislation to strengthen the 'Health Protection and Promotion Act' and to enact emergency powers for public health disasters like SARS [Severe Acute Respiratory Syndrome] or flu pandemics. It is produced now to respond to current government plans for further amendments to the 'Health Protection and Promotion Act and radical changes to the Emergency Management Act'. The recommendations in this second report are interim, not final or exhaustive. The report touches only on those issues subjected already to sufficient discussion between the government and the health community to make them ripe for action."

From the opening statement of Tom Davis: "The SARS [Severe Acute Respiratory Syndrome] threat is the first challenge to our Nation's health network capabilities. It provides us with a chance to evaluate existing procedures and safeguards. SARS has brought fear and confusion to everyone's lives, particularly international travelers, airline crews and health care workers. Currently there is no known cure and the disease is easily communicable. In a precautionary effort to prevent further spread of the disease, President Bush signed an Executive order on Friday, April 4, authorizing the use of quarantine if necessary. The President's unprecedented actions prove how serious the threat of SARS epidemic is to our country. SARS is believed to have originated in China in the fall of 2002. It has since spread to 17 countries. As of today there have been over 2,600 SARS cases reported worldwide, with 98 deaths. In the United States the number of cases continues to rise. Today this country has approximately 148 suspected cases in 30 different States, with the highest concentrations in New York and California. Fortunately, no deaths have been reported. We've actually seen two suspected cases of SARS nearby in northern Virginia. I'm pleased that we'll hear testimony from the director of the Loudoun County Health Department, who is responsible for the treatment of a SARS patient in early February." Statements, letters, and materials submitted for the record include those of the following: Janet Heinrich, Tommy G. Thompson, Lacy Clay, Tom Davis, David Goodfriend, and Margaret Hamburg.

In April 2009, a novel influenza virus began to spread around the world. The World Health Organization (WHO) refers to the virus as Influenza A(H1N1). The U.S. Centers for Disease Control and Prevention (CDC) and other Administration officials refer to it as 2009 H1N1 flu. Throughout this report, the virus is referred to as H1N1. Although H1N1 does not appear to be as lethal as H5N1 avian influenza, which reemerged in 2005, the virus is slightly more lethal than seasonal flu and it continues to spread. Researchers are not yet clear to what extent H1N1 transmission will continue spread or how virulent the virus will be ultimately. […] Investments that the United States and other stakeholders have made to prepare for a possible influenza pandemic, and to monitor the spread of other infectious diseases, have been applied to the most recent global response to H1N1. While health experts have made considerable gains against the disease, questions remain. Some health experts are concerned that poorer countries may not yet have the capacity to sufficiently monitor and respond to H1N1. Others warn that H1N1 transmission might accelerate in winter months. Questions still remain about whether the disease can change or reassort, particularly should outbreaks in countries simultaneously contending with H5N1 bird flu cases occur (such as Egypt, Vietnam, and Indonesia)."

"On June 11, the World Health Organization (WHO) raised the level of influenza pandemic alert to phase 6, which indicates the start of an actual pandemic. This change reflects the spread of the influenza A(H1N1) virus, not its severity. Although currently the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, this experience could change. This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues."

From the opening statement of Bennie G. Thompson: The committee is meeting today to receive testimony on 'Beyond Readiness: An Examination of the Current Status and Future Outlook of the National Response to Pandemic Influenza.' [...] The good news is that a vaccine is currently under development, and over the last 4 years, Congress has provided approximately $8.6 billion for pandemic planning efforts. But unfortunately, despite this amount of funding, according to GAO [Government Accountability Office] there are still major gaps in pandemic planning and preparedness efforts. Among the major gaps is the failure to plan for additional bed space and medical supplies. Additionally, GAO determined that leadership roles and responsibilities for an influenza pandemic need to be further clarified, tested, and exercised. Given this country's recent experience with disasters, it is hard to believe that there are those who underestimate the importance of plans and drills. [...] Finally, we need to understand that the emergency preparedness and response community and the health care community have always shared resources during crises and disasters. These formal and informal partnerships may be strained during a pandemic. Increased drills and exercises will strengthen these relationships, decrease uncertainty, and improve response and recovery. Statements, letters, and materials submitted for the record include those of the following: Bennie G. Thompson, Peter T. King, Paul C. Broun, Stephen F. Lynch, Jane Holl Lute, William Corr, Bernice Steinhardt, Colleen M. Kelley, Richard G. Muth, and Thomas A. Farley.

"During the past decade, the 53 Member States of the WHO [World Health Organization] European Region, 31 of which are part of the European Union/European Economic Area, invested considerably in pandemic preparedness. This came in the wake of global threats posed by (re-)emerging diseases such as avian influenza A(H5N1) and A(H7N9), the SARS outbreak of 2003, and the outbreak of MERS (Middle East respiratory syndrome) which began in 2012. Adequate preparedness is also a national obligation under the International Health Regulations (2005) and the EU Decision on serious cross-border threats to health (No 1082/2013/EU). The first pandemic since 1968 occurred in 2009, caused by a new strain of influenza A(H1N1) of swine origin. The virus spread rapidly around the globe and caused only mild disease in the majority of cases. However, severe disease and deaths occurred in a significant number of people, mostly in the same groups that are at risk of complications due to seasonal influenza infection, but also in other risk groups and even in previously healthy individuals. It has been estimated that in the first year of the pandemic between 151 000 and 475 000 deaths worldwide were attributable to influenza. Healthcare services, particularly critical care units, were often stretched to their limits, and early recognition and treatment of severe disease could be life-saving. The 2009 pandemic tested national plans, and in the aftermath many countries and international organisations evaluated their preparedness and response activities. European countries, particularly in the western part of the Region, were generally better prepared for the 2009 pandemic than most countries. But when confronted with a milder pandemic than was expected, even the better prepared countries experienced gaps in their surveillance and healthcare systems. Their planning assumptions were not flexible enough, they faced difficult communications and logistics issues with respect to pandemic vaccines, and often failed to establish effective communication lines with front-line healthcare responders."

"This report is intended to stimulate discussion within HHS, with other federal departments and across relevant organizations--both governmental and non-governmental--about how to build upon the successful elements of the response and concretely address areas that warrant improvement. […] Discussions, accompanied by careful analysis of scientific evidence, can inform concrete actions to improve pandemic and all-hazards preparedness. This report represents an early step in a multifaceted improvement process that will require continued participation by the public, and health and preparedness officials at all levels, both public and private. […] The 2009 H1N1 influenza pandemic, which was declared by the World Health Organization (WHO) in June 2009 and officially ended in August 2010, provided an important test of our nation's preparedness activities and our ability to respond and adapt to a large-scale, protracted public health emergency with the potential for enormous health consequences. […] It is appropriate for the Department of Health and Human Services (HHS) to step back and examine which aspects of our preparedness and response worked well and which did not, as well as which elements of our preparedness were not stressed in our response to the 2009 H1N1 pandemic, but could be in a very severe pandemic as experienced in 1918."

"A new influenza strain, influenza A (H5N1), is spreading through bird populations across Asia, Africa, and Europe, infecting domesticated birds, including ducks and chickens, and long-range migratory birds. In response to this threat, the President issued the National Strategy for Pandemic Influenza on November 1, 2005. The Strategy outlines the coordinated Federal Government effort to prepare for pandemic influenza. This Implementation Plan for the National Strategy for Pandemic Influenza further clarifies the roles and responsibilities of governmental and non-governmental entities, including Federal, State, local, and tribal authorities and regional, national, and international stakeholders, and provides preparedness guidance for all segments of society. It also provides guidance for families and individuals to ensure appropriate personal protection. The Implementation Plan represents a comprehensive effort by the Federal Government to identify the critical steps that must be taken immediately and over the coming months and years to address the threat of an influenza pandemic. It assigns specific responsibilities to Departments and Agencies across the Federal Government, and includes measures of progress and timelines for implementation to ensure that we meet our preparedness objectives. This Plan will be revised over time. The pandemic threat is constantly evolving, as is our level of preparedness."

"Pandemic (H1N1) 2009 was the first public health emergency of international concern (PHEIC) declared under the International Health Regulations (2005) [IHR (2005)] and the first influenza pandemic in more than 40 years. Canada, Mexico, and the United States recognize that the risk of another pandemic has not diminished and that the world faces an ongoing threat posed by the emergence and spread of influenza viruses with the potential to cause a human influenza pandemic. The three countries continue to work together to strengthen their preparedness in anticipation of a highly contagious influenza virus or other pandemic either originating in or spread to this continent. […] The 'North American Plan for Animal and Pandemic Influenza' (NAPAPI) retains the key elements of the 2007 version, while incorporating the lessons learned from the North American response to Pandemic (H1N1) 2009, including recognizing that a pandemic influenza virus may emerge in our region and expanding the focus on animal influenza viruses to incorporate both avian and non-avian species. The NAPAPI outlines how the three countries intend to strengthen their emergency response capacities as well as our trilateral and cross-sectoral collaborations and capabilities in order to assist each other and ensure a faster and more coordinated response to future outbreaks of animal influenza or an influenza pandemic. [… ] In brief, the NAPAPI is a comprehensive cross-sectoral regional health security framework developed mainly with the input of the health, agriculture, security, and foreign affairs sectors to protect against, control and provide a public health response to animal and pandemic influenza in North America, while avoiding unnecessary interference with international travel and trade."

From the opening statement of Yvette D. Clarke: "The Homeland Security Committee has long been concerned with the state of our preparedness to deal with pandemics. Today, our subcommittee turns its attention to the Federal response to the reemerging threat of pandemic influenza. Over the weekend, President Obama declared a National emergency with respect to the 2009 H1N1 influenza pandemic. This action underscored the gravity of the situation. Although we went into this pandemic better prepared than we had been in the past, we were not fully prepared to meet the pandemic when it started this year. Going into this pandemic, we knew that, No. 1, our early warning and detection systems were inadequate; No. 2, some key planning activities were incomplete; No. 3, we didn't have a good approach to provide health care under pandemic conditions; and, No. 4, our levels of preparedness for pandemic influenza were unclear. Unfortunately, our failure to develop these systems, activities, and policies cost us during the response. For instance, the pandemic started in North America, the one place we were not looking for it. We did not have an early warning. The alarm sounded only when people started to die. We did not have the luxury of time to observe the virus before the pandemic started; and, to the surprise of the community, the virus turned out to be H1N1, not the H5N1 virus that causes avian influenza." Statements, letters, and materials submitted for the record include those of the following: Yvette D. Clark, Daniel E. Lungren, Bennie G. Thompson, Laura Richardson, Alexander Garza, Nicole Lurie, Richard Serino, and Marcy Forman.

From the opening statement of Sherrod Brown: "Domestically we are seeing increases in cases of swine flu. As of this afternoon, the Centers for Disease Control was reporting 91 laboratory-confirmed cases of the swine flu in 10 States, including 1 case in my State of Ohio. This morning it was reported that an infant in Texas died from this flu, the first confirmed fatality in the United States. [...] Today, virtually all cases outside of Mexico have been mild and sporadic but geographically widespread, suggesting that more cases will likely emerge. For these reasons, it is important that Congress examine what efforts are currently being undertaken to ensure the safety of our citizens now and what actions are being taken going forward to limit the spread of this virus and to prevent future outbreaks. To date CDC [Centers for Disease Control and Prevention] and the Department of Homeland Security have taken aggressive and proactive steps to respond to this outbreak and protect our Nation's public health. CDC's Division of the Strategic National Stockpile has already released one-quarter of its antiviral drugs, Tamiflu and Relenza, personal protective equipment, and respiratory protection devices to help States with confirmed cases of swine flu respond to the outbreak." Statements, letters, and materials submitted for the record include those of the following: Sherrod Brown, Michael B. Enzi, Christopher J. Dodd, Richard Burr, Barbara A. Mikulski, Richard E. Besser, Anthony Fauci, John McCain, Robert P. Casey, Pat Roberts, Jack Reed, Jeff Merkley, Ted Kennedy, and Patty Murray.

The Morbidity and Mortality Weekly Report (MMWR) Series is prepared by the Centers for Disease Control and Prevention (CDC). [It] is the agency's primary vehicle for scientific publication of timely, reliable, authoritative, accurate, objective, and useful public health information and recommendations. This issue of MMWR contains the "Updated Preparedness and Response Framework for Influenza Pandemics". From the summary: "'This updated framework can be used for influenza pandemic planning and serves as recommendations for risk assessment, decision-making, and action in the United States. The updated framework replaces the U.S. federal government stages from the 2006 implementation plan for the National Strategy for Pandemic Influenza (US Homeland Security Council. National strategy for pandemic influenza: implementation plan. Washington, DC: US Homeland Security Council; 2006. [...] The six intervals of the updated framework are as follows: 1) investigation of cases of novel influenza, 2) recognition of increased potential for ongoing transmission, 3) initiation of a pandemic wave, 4) acceleration of a pandemic wave, 5) deceleration of a pandemic wave, and 6) preparation for future pandemic waves. The following eight domains are used to organize response efforts within each interval: incident management, surveillance and epidemiology, laboratory, community mitigation, medical care and countermeasures, vaccine, risk communications, and state/local coordination.'"

"Viral hepatitis remains a silent epidemic in the United States. Most of the 3.5--5.3 million Americans living with viral hepatitis do not know that they are infected, placing them at greater risk for severe, even fatal, complications from the disease and increasing the likelihood that they will spread the virus to others. Viral hepatitis can persist undetected for many years before manifesting as chronic liver disease, cirrhosis (scarring of the liver) or even liver cancer. As a result, viral hepatitis is a leading infectious cause of death and claims the lives of 12,000--18,000 Americans each year. It is the leading cause of liver cancer and the most common reason for liver transplantation. In 2007, deaths due to viral hepatitis outpaced deaths due to HIV. Despite these facts, awareness of viral hepatitis remains very low in the general public and among at risk populations. Even health care providers can lack knowledge and awareness about these infections. […] In May 2013, reflecting on their progress to date and encouraged by emerging opportunities for even greater progress resulting from the promise of emerging hepatitis C treatments as well as the expansion of access to viral hepatitis prevention, care, and treatment offered by the Affordable Care Act, the partners agreed to propel these efforts further by renewing the Action Plan for another 3 years by outlining specific actions for 2014--2016. Nonfederal stakeholders were strongly supportive of this renewal effort and played a critical role in providing input into the process. All agreed that the updated plan should explicitly embrace the vital contributions of both federal and nonfederal stakeholders in achieving the national goals for the prevention, diagnosis, care, and treatment of viral hepatitis in the United States."

"Millions of Americans from all walks of life are at-risk for or living with viral hepatitis. An estimated 3.5 million people are living with hepatitis C (HCV), the most-common type of viral hepatitis. An estimated 850,000 people are living with hepatitis B virus(HBV). Viral hepatitis is a silent and deadly disease. Hepatitis B and C often have no symptoms. So, many people do not know that they have the virus. Meanwhile, the virus is damaging their liver and they remain at risk for transmitting the virus to others. We are losing ground in the battle against viral hepatitis. Hepatitis C kills more Americans than all 60 other reportable infectious diseases. New cases of hepatitis have increased because of the opioid epidemic that is gripping communities across the United States. New hepatitis C infections increased more than 250% between 2010 and 2014. After decades of declines in hepatitis B cases, progress on hepatitis B prevention has stalled and in some areas new cases have increased."

"In 2005, the U.S. Department of Health and Human Services (HHS) developed the HHS Pandemic Influenza Plan to prevent, control, and mitigate the effects of influenza viruses that pose high risk to humans. Influenza viruses, of which there are many types, can cause rapid, widespread disease and death. Pandemic influenza outbreaks in the 20th Century alone left tens of millions of people dead in their wake and cost hundreds of billions of dollars in lost lives, wages, productivity and economic devastation. Influenza viruses with pandemic potential require the rapid development, production and availability of medical countermeasures (MCMs) such as vaccines, diagnostics and antiviral drugs to mitigate the impact of the pandemic, as well as additional preparedness and response efforts beyond medical countermeasures. HHS has made substantial progress in pandemic influenza preparedness since the 2005 Plan was released. In the current document, HHS reviews that progress, highlighting both the successes and remaining gaps in our preparedness and response activities for pandemic influenza. Most significantly, HHS efforts in pandemic influenza preparedness now are closely aligned with seasonal influenza activities, harnessing expanded surveillance, laboratory, vaccine, and antiviral drug resistance monitoring capacity. These activities are linked to efforts to communicate protective measures to the public and to help the health care system manage the demands of seasonal and potential pandemic influenza. Research across all these areas, and increased global capacity to diagnose and type the influenza viruses encountered outside the United States, contribute to domestic preparedness against pandemic influenza."

"Viral hepatitis poses a serious threat to the health of millions of Americans from all walks of life. The release of the first Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis in 2011 marked the beginning of a coordinated national response to viral hepatitis in the United States. In the five years since that time, federal and nonfederal stakeholder efforts have evolved and advanced in response to the growing threat of viral hepatitis to the health of Americans. Despite this progress, viral hepatitis remains a serious threat to the health of Americans. The number of new hepatitis C virus (HCV) infections has increased rapidly, prior progress in reducing new hepatitis B virus (HBV) infections has stalled, and hepatitis-related deaths have increased. We are missing key opportunities to prevent transmission, diagnose and treat infections, prevent serious disease, and - in many cases - cure people. [...] We have the knowledge and tools to save lives and win the fight against viral hepatitis. This National Viral Hepatitis Action Plan for 2017-2020 (Action Plan) uses this knowledge and these tools to prevent new infections, improve the lives of people living with viral hepatitis, and chart a course toward elimination of these public health threats. We can do so by aligning goals and sharing strategies among key partners, engaging stakeholders across all sectors, leveraging important advances, confronting challenges, and prioritizing our efforts to reach the populations most impacted."

From the statement of Henry Johnson: "A few important facts that I want the committee to be aware of. First, two-thirds of Americans infected with hepatitis are unaware of their infection, leaving them unable to take action to protect their health and the health of others. Second, the only dedicated Federal funding for hepatitis is $19.3 million per year for the CDC. This is not enough and pales in comparison to funding for other infectious diseases. Considering these two facts, it is clear that the Federal Government has failed in its response to hepatitis, and I am hopeful that this hearing can bring about a period where this trend is reversed." Statements, letters, and materials submitted for the record include those of the following: Howard Koh, Randy Mayer, Rolf Joachim Benirshke, Anh Cao, Bill Cassidy, Gerald E. Connolly, Mike Honda, Darrell E. Issa, Howard K. Koh, Jeffrey Levi, Randy Mayer, Michael Ninburg, Jackie Speier, and Edolphus Towns.

"Zika virus disease can cause adverse pregnancy and neurological outcomes. Given this ongoing threat, GAO [Government Accountability Office] was asked to evaluate progress made and challenges faced by federal agencies in responding to the Zika virus outbreak in the United States. GAO examined (1) information on what is known and not known about the epidemiology of the Zika virus, and any challenges with conducting surveillance and epidemiological studies, (2) characteristics of different diagnostic tests authorized during the outbreak, challenges test manufacturers and users faced, and the extent to which FDA and CDC [Centers for Disease Control and Prevention] followed their own communication guidance, and (3) the strengths and limitations of available mosquito control methods, and challenges federal agencies face supporting these efforts. GAO reviewed literature and agency documentation, and interviewed federal and state officials about the Zika virus and the U.S. response. GAO also convened an expert meeting with the assistance of the National Academy of Sciences to discuss various issues surrounding the response to the Zika virus. [...] GAO is making five recommendations to FDA and CDC, including that CDC establish a transparent process for providing test manufacturers access to diagnostic tests and FDA and CDC provide information to help ensure that users of diagnostic tests can compare performance. Agencies agreed with four recommendations but raised some concerns with the fifth. GAO has addressed these concerns in the report."

"This resource is focused on the comprehensive health needs of infants and children affected by Zika Virus (ZIKV). It is intended as a planning resource for states and communities as they develop a coordinated response to meet the immediate and long term needs of infants and children affected by ZIKV, and their families. The resource guide applies a system of care approach and builds on existing Federal and State services and programs for supporting children with special health care needs (CSHCN). This information will assist states and communities in effectively leveraging and integrating existing programs and assessing programmatic flexibilities to augment their systems of care to address ZIKV. Readers should be aware that the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have published guidelines regarding screening, assessment, and management of newborns and infants with in utero ZIKV exposure. The Department of Health and Human Services also has developed resources regarding care for non-pregnant women and men of reproductive age, and for pregnant women in the context of ZIKV. This resource guide references these guidelines and other expert sources. This resource guide should be viewed as a companion emergency preparedness and public health document, and will be updated as the evidence, guidelines, and information on ZIKV evolves."

This is the May 25, 2016 hearing on "Science of Zika: The DNA of an Epidemic," held before the House Committee on Science, Space, and Technology. From the opening statement of Lamar Smith: "Today, we will examine the state of science in the most recent battle in the war against mosquito-borne disease: the Zika virus. While for most people Zika causes only mild illness, the Centers for Disease Control and Prevention have found that there is a link between Zika infection during a woman's pregnancy and severe birth defects. For some adults there could also be serious neurological impacts." Statements, letters, and materials submitted for the record include those of the following: Kacey Ernst, Daniel Neafsey, Steven Presley, and Hadyn Parry.

"This plan outlines the operational response activities for the U.S. Government (USG) if confirmed local transmission or widespread transmission of Zika virus disease occurs in the United States (including the tribal areas, territories and affiliated Pacific Islands) and the President determines enhanced Federal government unity of effort is required. Planning is based on the HHS Zika Virus Disease Domestic Preparedness and Response Goals and Objectives, the CDC Zika Virus Action Plan, the CDC Interim Response Plan and the (Draft) Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans. This document is designed to complement and not repeat the actions already outlined in these foundational documents."

"The purpose of this document is to describe the Centers for Disease Control and Prevention (CDC) response plan for locally acquired cases of Zika virus infection in the continental United States and Hawaii. Zika virus is spread to people primarily through the bite of an infected Aedes aegypti or Aedes albopictus mosquito. The response activities outlined in this plan are based on currently available knowledge about Zika virus and its transmission, and these activities may change as more is learned about Zika virus infection. Most of the plan focuses on response activities that would occur after locally acquired Zika virus transmission has been identified. CDC also is committed to responding to travel-associated and sexually transmitted Zika virus infections reported in the United States (US) before detection of locally transmitted cases of Zika virus infection."