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Department of Health and Human ServicesPandemic Influenza Preparedness and Response PlanExecutive Summary - Draft August 2004 Comments on this plan should be forwarded to: National Vaccine Program Office e-mail: pandemicinfluenza@osophs.dhhs.gov Executive Summary An influenza pandemic has a greater potential to cause rapid increases in death and illness than virtually any other natural health threat. Planning and preparedness before the next pandemic strikes – the inter-pandemic period – is critical for an effective response. This Draft Pandemic Influenza Preparedness and Response Plan describes a coordinated strategy to prepare for and respond to an influenza pandemic. It also provides guidance to state and local health departments and the health care system to enhance planning and preparedness at the levels where the primary response activities in the U.S. will be implemented. Influenza causes seasonal epidemics of disease resulting in an average of 36,000 deaths each year. A pandemic – or global epidemic – occurs when there is a major change in the influenza virus so that most or all of the world’s population has never been exposed previously and is thus vulnerable to the virus. Three pandemics occurred during the 20th century, the most severe of which, in 1918, caused over 500,000 U.S. deaths and more than 20 million deaths worldwide. Recent outbreaks of human disease caused by avian influenza strains in Asia and Europe highlight the potential of new strains to be introduced into the population. Recent studies suggest that avian strains are becoming more capable of causing severe disease in humans and that these strains have become endemic in some wild birds. If these strains reassort with human influenza viruses such that they can be effectively transmitted between people, a pandemic can occur. Characteristics of an influenza pandemic that must be considered in preparedness and response planning include: 1) simultaneous impacts in communities across the U.S., limiting the ability of any jurisdiction to provide support and assistance to other areas; 2) an overwhelming burden of ill persons requiring hospitalization or outpatient medical care; 3) likely shortages and delays in the availability of vaccines and antiviral drugs; 4) disruption of national and community infrastructures including transportation, commerce, utilities and public safety; and 5) global spread of infection with outbreaks throughout the world. The Department of Health and Human Services (HHS) continues to make progress in preparing to effectively respond to an influenza pandemic. This has been done through programs specific for influenza and those focused more generally on increasing preparedness for bioterrorism and other emerging infectious disease health threats. Substantial resources have been allocated to assure and expand influenza vaccine production capacity; increase influenza vaccination use; stockpile influenza antiviral drugs in the Strategic National Stockpile (SNS); enhance U.S. and global disease detection and surveillance infrastructures; expand influenza-related research; support public health planning and laboratory; and improve health care system readiness at the community level. Additional preparation is also ongoing in several critical areas. Vaccination is the primary strategy to reduce the impact of a pandemic but the time required currently to develop a vaccine and the limited U.S. influenza vaccine production capacity represent barriers to optimal prevention. Enhancing existing U.S. and global influenza surveillance networks can lead to earlier detection of a pandemic virus or one with pandemic potential. Virus identification and the generation of seed viruses for vaccine production is a critical first step for influenza vaccine development. In addition to expanding the number of global surveillance sites and extending existing sentinel surveillance sites to perform surveillance throughout the year, there has been a concomitant enhancement of laboratory capacity to identify and subtype influenza strains. Vaccine research and development can be accelerated during the inter-pandemic period by preparing and testing candidate vaccines for influenza strains that have pandemic potential, conducting research that will guide optimal vaccine formulation and schedule, and assessing techniques that can enhance manufacturing yields using current and prospective production methods. Plans are in place to increase U.S. influenza vaccine manufacturing capacity through a partnership with industry to assure that vaccine can be produced at any time throughout the year. This includes increasing the demand for annual influenza vaccine by the Centers for Medicaid and Medicare Services (CMS) and the Centers for Disease Control and Prevention (CDC), which will have the dual benefits of improving annual influenza prevention and control by strengthening the vaccine delivery system, and expanding manufacturing capacity to meet this increased demand -- and also promoting the diversification of existing vaccine production with technology that is amenable to rapid expansion to meet vaccine needs in a pandemic. Enhanced planning by the public and private health care sectors to assure the ability to distribute vaccine, targeting available supply to priority groups, and monitoring vaccine effectiveness and adverse events also are critical to meet pandemic response goals. Early in a pandemic, especially before vaccine is available or during a period of limited supply, use of other interventions may have a significant effect. For example, antiviral drugs are effective as therapy against susceptible influenza virus strains when used early in infection and can also prevent infection (prophylaxis). In 2003, the antiviral drug oseltamivir was added to the SNS. Analysis is ongoing to define optimal antiviral use strategies, potential health impacts, and cost-effectiveness of antiviral drugs in the setting of a pandemic. Results of these analyses will contribute to decisions regarding the appropriate type and quantity of antiviral drugs to maintain in the SNS. Planning by public and private health care organizations is needed to assure effective use of available drugs, whether from a national stockpile, state stockpiles or in private sector inventories. Implementing infection control strategies to decrease the global and community spread of infection, while not changing the overall magnitude of a pandemic, may reduce the number of people infected early in the course of the outbreak, before vaccines are available for prevention. Travel advisories and precautions, screening persons arriving from affected areas, closing schools and restricting public gatherings, and quarantine of exposed persons may be important strategies for reducing transmission. The application of these interventions will be guided by the evolving epidemiologic pattern of the pandemic. Planning by state and local health departments and by the health care system and coordination between the two is critical to assure effective implementation of response activities and delivery of quality medical care in the context of increased demand for services. Guidance included in this plan and from other organizations, as well as technical assistance and funding are available to facilitate planning. Coordination in planning and consistency in implementation with other emergency response plans, such as those for bioterrorist threats and SARS can improve efficiency and effectiveness. In addition, other public health emergency programs such as the Heath Resources and Services Administration (HRSA) Hospital Preparedness Program and the CDC Public Health Preparedness and Response Cooperative Agreements are providing states with resources to strengthen their ability to respond to bioterror attacks, infectious diseases and natural disaster. For example, initiatives and funding being provided by HRSA will help states improve coordination of health care services and emergency response capacity and facilitate preparedness for influenza, smallpox, SARS, as well as other public health emergencies. In FY 04, HHS introduced a cross-cutting critical benchmark for state pandemic influenza preparedness planning as part of the Department’s awards to states to improve hospitals’ response to bioterrorism and other diseases. The goal of this planning activity is to assure implementation of an effective response including the delivery of quality medical care in the context of the anticipated increased demand for services in a pandemic (www.hhs.gov/asphep/FY04benchmarks.html). Completing pandemic preparedness and response plans and testing them in tabletop and field exercises are key next steps. All totaled since Sept. 11, 2001, HHS has invested more than $3.7 billion in strengthening the Nation’s public health infrastructure. Preparedness for an influenza pandemic is coordinated in the office of the Assistant Secretary for Health, HHS. Response activities will be coordinated by the Assistant Secretary for Public Health Emergency Preparedness, on behalf of the Secretary in close coordination with the Department of Homeland Security as stipulated in HSPD#5. Other federal agencies will play critical roles as well. Pandemic influenza response activities are outlined by pandemic phase, a classification system developed by the World Health Organization (WHO) in 1999. Phase 0, the inter-pandemic phase, is divided into 4 levels: Phase 0, Level 0 (0.0; with no recognized human infections caused by a novel influenza strain; Phase 0, Level 1 (0.1; (“new virus alert”) with a case of human infection caused by a novel strain; Phase 0, Level 2 (0.2; with two or more human cases but no documented person-to-person transmission and unclear ability to cause outbreaks; and phase 0,level 3 (0.3; (“pandemic alert”) with person-to-person spread in the community and an outbreak in one country lasting for more than two weeks. Progression from a new virus alert to a pandemic alert will be accompanied by response activities that include intensified U.S. and global surveillance; investigation of the virology and epidemiology of the novel influenza strain including collaboration with international partners on containment; vaccine development and clinical testing leading toward licensure of a pandemic vaccine; coordination with health departments and activation of local plans, and implementation of the communications plan which includes education of health care providers and the public. Pandemic Phase 1 occurs with confirmation that the novel influenza virus is causing outbreaks in one country, has spread to others, and disease patterns indicate that serious morbidity and mortality are likely to occur. In Phase 2, outbreaks and epidemics occur in multiple countries with global disease spread. Response activities during these phases depend, in part, on the extent of disease internationally and in the U.S. Community-level interventions and travel restrictions may decrease disease spread. Once vaccine becomes available, immunization programs will begin. At this phase, antiviral prophylaxis and therapy targeted to maximize impact, local coordination of hospital and outpatient medical care and triage, and activation of emergency response plans to preserve community services also will occur. Federal agencies and personnel will support response activities, monitor vaccine effectiveness and adverse events following vaccination and antiviral drug use, conduct surveillance to track disease burden, and disseminate information. Widespread pandemic disease, as with annual influenza outbreaks, is likely to be seasonal. Thus, Phase 3 signals the end of the first pandemic wave and may be followed by a second seasonal wave in Phase 4. A pandemic will end, Phase 5, as population immunity to the pandemic strain becomes high due to disease or vaccination, the virus changes, and/or another influenza strain becomes predominant. Phase 3 activities include recovery, assessment and refinement of response strategies, ongoing vaccine production and vaccination and restocking supplies such as antiviral drugs. Greater vaccine availability, experience with and improved strategies for a pandemic response, and increased immunity to the pandemic strain should decrease the impact of the second pandemic wave. Synopsis A. Purposes of the Pandemic Influenza Preparedness and Response Plan To define and recommend preparedness activities that should be undertaken before a pandemic that will enhance the effectiveness of a pandemic response. To describe federal coordination of a pandemic response and collaboration with state and local levels including definition of roles, responsibilities, and actions. To describe interventions that should be implemented as components of an effective influenza pandemic response. To guide health departments and the health care system in the development of state and local pandemic influenza preparedness and response plans. To provide technical information on which recommendations for preparedness and response are based. B. Components of the Pandemic Influenza Preparedness and Response Plan The Plan includes this core section and twelve annexes. The core plan describes coordination and decision making at the national level; provides an overview of key issues for preparedness and response; and outlines action steps to be taken at the national, state, and local levels before and during a pandemic. Annexs 1 and 2 provide information to health departments and private sector organizations to assist them in developing state and local pandemic influenza preparedness and response plans. Annexes 3-12 contain technical information about specific preparedness and response components. They include a description of influenza disease and pandemics; surveillance; vaccine development and production; vaccine use strategies; antiviral medication use strategies; strategies to decrease transmission of influenza; communications; research; observations and lessons learned from the 1976 swine influenza program; and comparisons between planning for an influenza pandemic and Severe Acute Respiratory Syndrome (SARS) outbreaks. C. Pandemic Plan Development Process The first national pandemic influenza plan was developed in 1978, shortly after the swine influenza cases and vaccination campaign in 1976. In 1993, a U.S. Working Group on Influenza Pandemic Preparedness and Emergency Response was formed to draft an updated national plan. This group included representatives from the HHS agencies (CDC, FDA, NIH, HRSA and others) and coordinated by the National Vaccine Program Office (NVPO). Comments and input on specific issues included in the plan has been obtained from a wide range of groups in the public and private sectors; and from other pandemic influenza preparedness plans (see weblinks) or planning guides (such as the Association of State and Territorial Health Officials [ASTHO]). Recent developments that have influenced the influenza pandemic planning process include experience gained through planning for bioterrorist events and other health emergencies such as the international response to SARS and the national responses to anthrax cases and the implementation of a the US smallpox vaccination program. Ongoing enhancements in public health and communications infrastructure and development of new technologies, for example in vaccine development and production, are likely to influence portions of the plan. Therefore, it is envisioned that the Plan will be an evergreen document, which will be modified as new developments warrant. Supporting materials (such as educational materials, fact sheets, question and answer documents, etc.) will be added to the Plan or modified as needed. D. Goals of a Pandemic Response Limit morbidity and mortality of influenza and its complications during a pandemic. Decrease social disruption and economic loss. E. Key Pandemic Preparedness and Response Principles Detect novel influenza strains through clinical and virologic surveillance of human and animal influenza disease. Global surveillance networks identify circulating influenza strains informing recommendations for annual influenza vaccines in the U.S. and around the world. Surveillance also has identified novel strains that have caused outbreaks among domestic animals and persons in several countries. Given the speed with which infection may spread globally via international travel, effective international surveillance to identify persons who have influenza illness coupled with laboratory testing to determine the infecting strain is a critical early warning system for potential pandemics. Effective U.S. surveillance systems also are fundamental in the detection of influenza disease and the causative strains, and to monitor the burden of morbidity and mortality. Rapidly develop, evaluate, and license vaccines against the pandemic strain and produce them in sufficient quantity to protect the population. The production timeline of the annual influenza vaccine. The time from identification of a new influenza strain to production, licensure, and distribution- is approximately six to eight months In contrast to the protracted timelines in the development, licensure and use of other vaccines, the accelerated timeline for the annual influenza vaccine reflects active collaboration and coordination of the World Health Organization, HHS agencies and influenza vaccine manufacturers. Use of new molecular techniques to develop high-yield vaccine reference strains (the “seed” viruses that will be prepared by public sector labs and provided to vaccine manufacturers) and production of monovalent vaccine containing only the pandemic strain could shorten the timeline to initial availability of a pandemic vaccine. Currently, three manufacturers produce influenza vaccine that is licensed for the U.S. market, two with all or part of the production process located in the U.S. The amount of pandemic influenza vaccine produced depends on the physical capacity of the manufacturing facilities, the growth characteristics of the pandemic virus in embryonated chicken eggs used for vaccine production, and the amount of influenza virus protein that is included in each dose to achieve optimal protection. The number of available doses also is limited by manufacturing capacity for filling and labeling vials or syringes. In 2004, HHS worked with industry to assure year-round supply of eggs for vaccine production. In addition HHS is supporting the expansion of production capacity and diversification of influenza manufacturing technology, particularly the development of influenza vaccines made in cell culture. Implement a vaccination program that rapidly administers vaccine to priority groups and monitors vaccine effectiveness and safety. In contrast to the childhood immunization program, the distribution and administration of influenza vaccine during the annual seasonal epidemic occurs largely through the private sector. In a pandemic, vaccine supply levels will change over time. When a pandemic first strikes vaccine will likely not be ready for distribution. Because of this, antiviral drug therapy and preventive use in those not infected (prophylaxis), quality medical care, and interventions to decrease exposure and/or transmission of infection will be important approaches to decrease the disease burden and potentially the spread of the pandemic until vaccine becomes available. Vaccine will require six to eight months to produce. Once the first lots of vaccine are available, there is likely to be much greater demand than supply. Vaccine will need to be first be targeted to priority groups that will be defined on the basis of several factors. These may include the risk of occupational infections/transmission (e.g., health care workers); the responsibilities of certain occupations in providing essential public health safety services; impact of the circulating pandemic virus on various age groups; and heightened risks for persons with specific conditions. Although the priority groups for annual influenza vaccination will provide some guidance for vaccine priority-setting for a pandemic, the risk profile for a pandemic strain and the priorities for vaccination may differ substantially and therefore will need to be guided by the epidemiologic pattern of the pandemic as it unfolds. Later in the pandemic, vaccine supply will approximate demand, and vaccination of the full at-risk population can occur. Given the time required for vaccine development and vaccine production capacity, shortages may exist throughout the first pandemic wave. In recent years when influenza vaccine was delayed or in short supply for annual influenza epidemics, many persons were vaccinated who were not in recommended priority groups, vaccine distribution was inequitable, and a gray market developed in response to increased demand, with high prices being paid for some vaccine doses. During a pandemic, increased demand for vaccine could exacerbate these problems. Several options exist for purchase and distribution of influenza vaccine during a pandemic. The Federal government could purchase all available pandemic influenza vaccine with pro rata distribution to state and local health departments; there could be a mixed system of Federal and private sector purchase; or the current, primarily private system could be utilized. It should be noted that the Federal government already finances a substantial portion of influenza vaccine, including that purchased for eligible children under the Vaccines for Children (VFC) program and reimbursement for doses administered to persons 65 years old or older under the Medicare Modernization Act. In a mixed system with public and private vaccine supply, the proportion in each sector may change as target groups and available vaccine supply change during the course of a pandemic response. The range of options is currently being considered by HHS. Determine the susceptibility of the pandemic strain to existing influenza antiviral drugs and target use of available supplies; avoid inappropriate use to limit the development of antiviral resistance and ensure that this limited resource is used effectively. The objective of antiviral prophylaxis is to prevent influenza illness. Prophylaxis would need to continue throughout the period of exposure in a community. The objective of treatment is to decrease the consequences of infection. For optimal impact, treatment needs to be started as soon as possible and within 48 hours of the onset of illness. Two classes of drugs are used to prevent and treat influenza infections. Adamantines (amantadine and rimantadine) are effective as prophylaxis and have been shown to decrease the duration of illness when used for treatment of susceptible viruses. However, resistance often develops during therapy. The adamantines are available from proprietary and generic manufacturers. Neuraminidase inhibitors (NI; oseltamivir and zanamivir) also are effective for prophylaxis and treatment of susceptible strains. New data suggests that NI treatment can decrease complications such as pneumonia and bronchitis, and decrease hospitalizations. The development of antiviral resistance, to date, has been uncommon. The NIs are produced by European manufacturers. The U.S. supply of NIs is limited as demand for these drugs during annual influenza outbreaks is low. Zanamivir supply is limited in the U.S. The available supply of influenza antiviral medications is limited and production cannot be rapidly expanded: there are few manufacturers and these drugs have a long production process. In 2003, oseltamivir was added to the SNS. Analysis is ongoing to define optimal antiviral use strategies, potential health impacts, and cost-effectiveness of antiviral drugs in the setting of a pandemic. Results of these analyses will contribute to decisions regarding the appropriate antiviral drugs to maintain in the SNS. Planning by public and private health care organizations is needed to assure effective use of available drugs, whether from a national stockpile, state stockpiles or the private sector. Developing guidelines and educating physicians, nurses, and other health care workers before and during the pandemic will be important to promote effective use of these agents in the private sector. Implement measures to decrease the spread of disease internationally and within the U.S. guided by the epidemiology of the pandemic. Infection control in hospitals and long-term care facilities prevents the spread of infection among high-risk populations and health care workers. Because influenza strains that cause annual outbreaks are effectively transmitted between people and can be transmitted by people who are infected but appear well, efforts to prevent their introduction into the U.S. or decrease transmission in the community have limited effectiveness. If a novel influenza strain that is not as efficiently spread between people causes outbreaks in other countries or the U.S., measures such as screening travelers from affected areas, limiting public gatherings, closing schools, and/or quarantine of exposed persons could slow the spread of disease. Decisions regarding use of these measures will need to be based on their effectiveness and the epidemiology of the pandemic. Assist state and local governments and the health care system with preparedness planning in order to provide optimal medical care and maintain essential community services. An influenza pandemic will place a substantial burden on inpatient and outpatient health care services. Because of the increased risk of exposure to pandemic virus in health care settings, illness and absenteeism among health care workers in the context of increased demand will further strain the ability to provide quality care. In addition to a limited number of hospital beds and staff shortages, equipment and supplies may be in short supply. The disruptions in the health care system that result from a pandemic may also have an impact on blood donation and supply. Planning by local health departments and the health care system is important to address potential shortages. Strategies to increase hospital bed availability include deferring elective procedures, more stringent triage for admission, and earlier discharge with follow-up by home health care personnel. Local coordination can help direct patients to hospitals with available beds and distribute resources to sites where they are needed. Health care facilities may need to be established in non-traditional sites to help address temporary surge needs. Specific challenges in these settings such as infection control must be addressed. Not all ill persons will require hospital care but many may need other support services. These include home health care, delivery of prescription drugs, and meals. Local planning is needed to address the delivery of these and essential community functions such as police, fire, and utility service. Communicate effectively with the public, health care providers, community leaders, and the media. Informing health care providers and the public about influenza disease and the course of the pandemic, the ability to treat mild illness at home, the availability of vaccine, and priority groups for earlier vaccination will be important to ensure appropriate use of medical resources and avoid possible panic or overwhelming of vaccine delivery sites. Effective communication with community leaders and the media also is important to maintain public awareness, avoid social disruption, and provide information on evolving pandemic response activities. F. Coordination of a Pandemic Response An influenza pandemic will represent a national health emergency requiring coordination of response activities. As outlined in Homeland Security Presidential Directive 5 (http://www.fema.gov/pdf/reg-ii/hspd_5.pdf), the Department of Homeland Security (DHS) has primary responsibility for coordinating domestic incident management and will coordinate all nonmedical support and response actions across all federal departments and agencies. HHS will coordinate the overall public health and medical emergency response efforts across all federal departments and agencies. Authorities exist under the Public Health Service Act for the HHS Secretary to declare a public health emergency and to coordinate response functions. In addition, the President can declare an emergency activating the Federal Response Plan, in accordance with the Stafford Act, under which HHS has lead authority for Emergency Support Function #8 (ESF8) HHS response activities will be coordinated in the Office of the Assistant Secretary for Public Health Emergency Preparedness in collaboration with the Office of the Assistant Secretary for Public Health and Science and will be directed through the Secretary’s Command Center. The Command Center will maintain communication with HHS agency emergency operations centers and with other Departments. HHS agencies will coordinate activities in their areas of expertise. Chartered advisory committees will provide recommendations and advice. Expert reviews and guidance also may be obtained from committees established by the National Academy of Sciences, Institute of Medicine or in other forms. G. Preparedness Activities During the inter-pandemic period many activities can be pursued to assure that the government is as prepared as possible for a pandemic. These include: Expand manufacturing capacity for influenza vaccine, develop surge capacity for a pandemic vaccine production, and assess potential approaches to optimize vaccine dose, and diversify manufacturing. Strengthen global surveillance – human and veterinary – leading to earlier detection of novel influenza strains that infect humans, cause severe disease and are capable of person-to-person transmission such that they have a high probability of international spread and assess the susceptibility of the pandemic virus to antiviral drugs. Enhanced surveillance infrastructure also will strengthen detection of other respiratory pathogens – as occurred with SARS. In addition to coordination between HHS and USDA, building and strengthening a global veterinary surveillance network will complement the existing clinical laboratory network organized by WHO. Strengthen U.S. surveillance by expanding to year-round surveillance for influenza disease and the viral strains that cause it. Develop hospital-based surveillance for severe respiratory illness (e.g., influenza and other infectious agents) and identify methods to rapidly expand the current sentinel physician surveillance system during an influenza pandemic or other health emergency. Conduct research to better understand the pathogenic and transmission potential of novel influenza viruses in order to improve predictions about the strains that could trigger an outbreak that could lead to a pandemic. To shorten the timeline to vaccine availability in a pandemic, develop collections (libraries) of novel influenza strains that may cause a pandemic; prepare reagents to diagnose infection and evaluate candidate vaccines; and develop high-growth reference strains that can be used for vaccine production. For selected novel influenza strains, develop investigational vaccine lots and perform clinical studies to evaluate immunogenicity, safety, and whether one or two doses are needed for protection. In the determination of the optimal vaccine dose, studies should also be performed to assess whether adding an adjuvant – a substance to enhance the immune response to vaccination – or alternative vaccine administration approaches will lead to improved protection and/or the ability to protect more people with the available amount of vaccine virus and effectively expand the vaccine supply. Conduct research to develop new influenza vaccines that are highly efficacious, are easier to administer, or that are directed against a constant portion of the influenza virus and thus sidestepping the need to develop a new vaccine every year to match the predominant viral strains that are most likely to cause disease. With this approach it may be possible to create an influenza vaccine stockpile in the future. Continue efforts to expand annual influenza vaccine use and provide appropriate incentives to strengthen the vaccine delivery system, increase vaccine use and acceptance by the public, and to manufacturers to increase overall capacity. Improve capacity to monitor influenza vaccine effectiveness and to track vaccine distribution and coverage. Periodically assess the appropriateness of the types and quantities of antiviral drugs included in the SNS. Promote planning and provide guidance to groups that will have the lead role in a pandemic response such as state and local health departments, the public and private health care organizations, and emergency response groups; and review, test and revise the plans, as needed. Evaluate the potential impacts of interventions to decrease transmission of infection such as travel advisories, school closings, limiting public gatherings, and quarantine and isolation. Develop materials for various audiences that will inform and educate them about influenza and pandemic influenza. |
Last revised: August 27, 2004
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