Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
Published: 2008-09-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The emergence of the H5N1 avian influenza virus (also known as "bird flu") has raised concerns that it or another virus might mutate into a virulent strain that could lead to an influenza pandemic. Experts predict that a severe pandemic could overwhelm the nation's health care system, requiring the rationing of limited resources. GAO was asked to provide information on the progress of the Department of Health and Human Services's (HHS) plans for responding to a pandemic, including analyzing how HHS plans to (1) use pharmaceutical interventions to treat infected individuals and protect the critical workforce and (2) use nonpharmaceutical interventions to slow the spread of disease. To conduct this work, GAO reviewed government documents and scientific literature, and interviewed HHS officials, state and local public health officials, and subject-matter experts on pandemic response.
section_title: What GAO Found
paragraphs: HHS plans to make existing federal stockpiles of pharmaceutical interventions available for distribution once a pandemic begins. These interventions would include antivirals, which are drugs to prevent or reduce the severity of infection, and pre-pandemic vaccines, which are vaccines produced prior to a pandemic and developed from influenza strains that have the potential to cause a pandemic. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in the Strategic National Stockpile and in jurisdictional stockpiles. According to HHS, these public sector stockpiles are intended to be used primarily for the treatment of individuals sick with influenza. HHS intends to oversee the distribution and administration of pre-pandemic vaccine to individuals identified as members of the critical workforce. Members of the critical workforce--estimated to be about 20 million--include workers in sectors that are considered necessary to keep society functioning, such as health care and law enforcement personnel. HHS's strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine--a vaccine specific to the pandemic-causing strain--becomes widely available. HHS anticipates that initial batches of a pandemic vaccine may not be available until 20 to 23 weeks after the start of the pandemic. As batches of the pandemic vaccine become available, HHS plans for state and local jurisdictions to provide it to members of targeted groups based on factors such as occupation and age, instead of making it available to the general public. HHS faces challenges implementing its strategy for using pharmaceutical interventions during a pandemic, including the lack of vaccine manufacturing capacity in the United States. HHS is currently making large investments to expand domestic vaccine manufacturing capacity. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions, such as isolation of sick individuals and voluntary home quarantine of those exposed to the pandemic strain. To assist state and local jurisdictions with implementing nonpharmaceutical interventions, HHS has developed guidance that describes the department's "community mitigation framework." The framework involves the early initiation of multiple nonpharmaceutical interventions, each of which is expected to be partially effective and to be maintained consistently throughout a pandemic. HHS faces difficulties, including helping jurisdictions develop ways to ensure community compliance. HHS is investing in several initiatives to increase the nation's knowledge about the general use and effectiveness of nonpharmaceutical interventions. The findings from this research will be used to update existing guidance.

section_title: Letter
paragraphs: The emergence of the H5N1 avian influenza virus (also known as “bird  flu”) has raised concerns that it or another influenza virus might mutate  into a novel and virulent strain that could lead to a human influenza  pandemic that would pose a grave threat to global public health.  Pandemics occur when an influenza strain to which humans have little or  no immunity begins to cause serious illness and spreads easily from  person to person. In the United States alone, at least 675,000 people died  during the 1918-19 pandemic, the deadliest pandemic in the twentieth  century. The Department of Health and Human Services (HHS) has  estimated that a pandemic similar to the severe 1918-19 pandemic would  sicken 90 million people in the United States (30 percent of the  population), of whom nearly 10 million would require hospitalization and  almost 2 million would die. Given that as of 2005 there were  approximately 950,000 staffed hospital beds in the United States, HHS’s  estimates indicate that the effects of a severe pandemic would far exceed  the capacity of U.S. hospitals.
HHS has made substantial progress in its preparedness for pandemic  influenza. For example, since 2000, we had been urging HHS to complete  its pandemic plan. HHS released the HHS Pandemic Influenza Plan in  November 2005. (See app. I for summaries of select federal pandemic  documents.) We recently reported that HHS has improved its influenza  surveillance and diagnostic testing capabilities. Prompted by concerns  regarding H5N1, HHS and its international partner organizations have  increased efforts to enhance animal and human surveillance systems  overseas. Additionally, in February 2006, the Food and Drug  Administration (FDA)—an agency within HHS—approved a diagnostic test  developed by the Centers for Disease Control and Prevention (CDC)— another agency within HHS—that recognizes H5 influenza viruses within   4 hours of testing; it previously would have taken 2 to 3 days.
Despite this progress, a severe pandemic would pose formidable  challenges to the federal government’s efforts to minimize damage to the  public’s health and the nation’s economy. The single most important  pharmaceutical intervention during a pandemic—a pandemic vaccine that  is well-matched to the pandemic-causing strain—will not be available in  large quantities in the initial stages of a pandemic. Other pharmaceutical  interventions, such as antivirals and pre-pandemic vaccines (possibly less  effective vaccines produced prior to the pandemic and based on strains  experts believe may cause a pandemic) are also expected to be in limited  supply and unavailable to the population at large. In addition, although  the ability to quickly increase the number of health care providers, called  surge capacity, will be vital for treating the potentially large numbers of  infected individuals, efforts to do so must overcome existing shortages of  health care workers in the United States. Similarly, because they are  rarely used on a large scale, the effectiveness of large-scale  implementation of nonpharmaceutical interventions, including closing  schools and voluntary home quarantine, is uncertain. In addition,  throughout the initial stages of a pandemic, crucial information—such as  when and where to access medical care, and how to reduce the chances of  infection—will need to be communicated to the public in a way that does  not incite panic.
Given these obstacles and the possible risk that the best-made plans may  still be ineffective in a severe pandemic, the federal government is taking  steps to prepare the nation for a potential pandemic in hopes of lessening  its overall impact. The National Response Framework charges the  Secretary of the Department of Homeland Security (DHS) with  responsibility for overall management and federal coordination of  domestic incidents when needed, the Federal Emergency Management  Agency (FEMA) Administrator with responsibility as principal advisor to  the President regarding emergency management, and the Secretary of HHS  with responsibility for public health and medical response. On November  2, 2005, the Secretary of HHS released the HHS Pandemic Influenza Plan,  which provides HHS’s plans for responding to a pandemic. The document  also provides pandemic response guidance to officials in state and local  jurisdictions and to health care facility officials. Since then, HHS has  released five updates regarding the department’s preparedness efforts and  has released its Pandemic Influenza Implementation Plan. Despite these  efforts, influenza and public health preparedness experts have raised  concerns about the adequacy of HHS’s plans and guidance to state and  local officials and to health care facility officials.
Because of your interest in pandemic preparedness, we are providing  information on the progress of HHS’s plans and its guidance to state and  local officials, and to health care facility officials, for responding to a  pandemic outbreak. The focus of our work is on 4 key components taken  from 5 of the 11 response elements critical for preparedness as described  in the HHS Pandemic Influenza Plan (see table 5 in app. I for a list of all  the response elements). Three components that we examined— pharmaceutical interventions (vaccines and antivirals), surge capacity of  health care providers, and public communications—have repeatedly been  found to need improvement by GAO and outside experts. In prior work,  we reported on potential problems with pharmaceutical interventions  during a pandemic, including vaccine shortages and the need for  identifying target groups in advance. Health care provider shortages,  including nurses and physicians, have been reported for many years by  GAO. We reported that during the anthrax incidents of 2001, the media  and the general public looked to CDC as the source for health-related  information. However, CDC was not always able to successfully convey  the information that it had. We also reported on the significance of  communicating clearly on response efforts during a pandemic. The fourth  component we focus on in our work—guidance for nonpharmaceutical  interventions—is based on limited scientific evidence.
Specifically, for this report we analyzed how HHS plans to (1) use  pharmaceutical interventions for treatment of infected individuals and to  protect the critical workforce, (2) improve surge capacity of health care  providers, (3) prepare state and local authorities to use  nonpharmaceutical interventions for slowing the spread of disease, and  (4) prepare to communicate with the public during a pandemic.
To determine how HHS plans to implement the four key components, we  reviewed government documents related to a pandemic response. (See  app. I for a description of each document.) In addition, to learn more  about the elements needed for an effective public health emergency  response, we reviewed related reports issued by GAO and HHS agencies,  independent studies (including those from the Institute of Medicine,  Congressional Research Service, and World Health Organization), and  peer-reviewed journals. We interviewed officials from HHS offices,  including the Office of the Assistant Secretary for Preparedness and  Response, Office of the Assistant Secretary for Public Affairs, CDC,  National Vaccine Program Office, National Institutes of Health, Agency for  Healthcare Research and Quality, Health Resources and Services  Administration, and FDA to learn more about their planning efforts. In  addition, we interviewed state and local public health officials and  members of the National Association of County and City Health Officials  and the Association of State and Territorial Health Officials. We also  interviewed officials from the American Hospital Association, American  Medical Association, American Society For Microbiology, Council of State  and Territorial Epidemiologists, Infectious Diseases Society of America,  and Association of Public Health Laboratories. We also interviewed  subject-matter experts to get their perspectives on HHS’s planning efforts.  We participated in relevant public meetings on pandemic preparedness,  such as those sponsored by the Institute of Medicine, to gain knowledge of  new scientific evidence on the effectiveness of planning efforts.
U.S. pandemic preparedness work is an ongoing process. The data in this  report were last updated on August 2008. However, changes have  continued to occur since completion of our data collection, and this report  may not reflect all these changes. We conducted our work from April 2006  through September 2008 in accordance with generally accepted  government auditing standards.
subsections: section_title: Background
paragraphs: Pandemics occur when an influenza virus mutates into a novel strain that  is highly transmissible among humans, leading to outbreaks worldwide.  Because there is little or no pre-existing immunity in the population, the  strain is highly pathogenic, thus causing disease among those who become  infected. Infected individuals may be capable of transmitting the virus  strain for 1 to 2 days before developing symptoms. Pandemics arise  periodically but unpredictably and can cause successive waves of disease  lasting for up to 3 years.
In recent years, the H5N1 strain and other strains of the influenza virus  have emerged or re-emerged. Experts are concerned because of  similarities between the H5N1 strain and the H1N1 strain, which caused  the 1918-19 pandemic. For example, research suggests that both the H5N1  and H1N1 strains prompt an over-reaction of the inflammatory response in  humans, causing rapid and severe damage to the lungs. Although the H5N1  strain has not been easily transmitted among humans, influenza experts  believe that H5N1 or another new influenza strain may eventually mutate  to become highly transmissible.
subsections: section_title: Pharmaceutical Interventions during a Pandemic
paragraphs: Pharmaceutical interventions available during a pandemic include  vaccines and antivirals. Pharmaceutical interventions are the primary  methods used to prevent the spread of disease as well as to reduce  morbidity and mortality caused by the influenza virus. See table 1.
Vaccination is the primary method for preventing infection with the  influenza virus. Vaccines reduce the severity of disease or provide  immunity by causing the body to produce protective antibodies to fight off  a particular virus strain. In order for a vaccine to be most effective, it  needs to be well-matched to a particular strain of the influenza virus so  that the antibodies formed in response to the vaccine protect against that  strain. However, existing strains of the influenza virus can mutate into new  strains; in part, this is why a new vaccine is created each year for the  upcoming influenza season. Much of what is known about the anticipated  effectiveness of a pandemic vaccine is based on evidence from the annual  seasonal vaccine.
During a pandemic, it may be necessary to use a vaccine that was  developed prior to a pandemic and therefore may not be well-matched to  the pandemic-causing strain. This vaccine, called a pre-pandemic vaccine,  is developed using an influenza strain that experts believe is likely to  cause the next pandemic. Research exploring the use of a pre-pandemic  vaccine based on strains of the H5N1 virus suggests that it may provide  some protection against serious illness and death. In contrast, a  pandemic vaccine would be developed against an identified pandemic- causing strain and would likely provide better protection against the  pandemic strain.
It is likely that seasonal influenza vaccine manufacturers will produce the  vaccine used during a pandemic. However, for the 2007-08 influenza  season, only five vaccine manufacturers were licensed to produce  seasonal influenza vaccine for the United States and only one  manufacturer produced its vaccine from start to finish in facilities within  U.S. borders. We also recently reported that experts are concerned that  countries without domestic manufacturing capacity will not have access to  vaccine in the event of a pandemic if the countries with manufacturing  capacity prohibit the export of pandemic vaccine until their own needs are  met.
Antivirals can reduce symptoms and help prevent the spread of influenza  by suppressing the growth of the influenza virus. Unlike the immune  response triggered by a vaccine, antivirals target the virus itself. For  example, some antivirals interfere with the virus’s ability to attach to cells,  thereby preventing infection of human cells. Antivirals also differ from  vaccines in that they do not need to be reformulated to match a specific  influenza strain in order to be effective. In addition, antivirals can be  manufactured and stockpiled in advance, making them potentially  available at the beginning of a pandemic. HHS currently maintains a  stockpile of antivirals in the SNS.
However, as we have previously reported, there are limitations associated  with relying on antivirals during a pandemic. For example, the  effectiveness of antivirals during seasonal influenza has been limited if  they are used more than 48 hours after the onset of symptoms in an  infected individual. For prophylactic use against seasonal influenza in  healthy individuals, antivirals may not be as effective if they are not taken  throughout the entire time an outbreak is present in a community. Some  influenza strains have become resistant to the antivirals currently  approved for prevention and treatment, and thus, the antivirals may not  always be effective in preventing disease. In addition, antivirals, like  vaccines, take several months to produce, and the lead time needed to  scale up production capacity may make it difficult to meet any large-scale,  unanticipated demand immediately. As we recently reported, current  antiviral production capacity is inadequate to meet expected demand  during a pandemic. Further, antivirals can be expensive to stockpile and  difficult to administer, depending on the form in which they are given. For  example, Tamiflu is given as a capsule or liquid and is relatively easy to  administer, whereas, Relenza, is more difficult to administer because it is a  powder that must be inhaled using a special device.
Since 2000, we and others have reported that federal, state, and local  officials need to have information on target groups that have priority for  receiving pharmaceutical interventions to know how, where, and to whom  to distribute the interventions. We reported that having established target  groups is particularly crucial in times of limited supply, such as during a  pandemic, when a lack of specific guidance makes it difficult for federal,  state, and local officials to plan. For example, in a prior report, we noted  that health officials in one state did not know exactly how many  individuals were considered a priority for receiving a vaccine. In that  case we found that it took state officials nearly a month to compile data on  high-risk individuals, to decide how many doses of vaccine were needed in  local areas, and to receive and ship vaccine to counties. State and local  officials rely on federal guidance when making decisions on which groups  should be targeted first for vaccination. For example, in a prior report on  the 2004-05 influenza season, when the United States lost approximately  half of its seasonal vaccine supply because of manufacturing difficulties,  we found that CDC quickly revised its recommendations on who should be  prioritized for vaccine. CDC’s changes decreased the targeted population  from approximately 188 million to 98 million. State and local officials we  spoke with for this report told us that they quickly adopted CDC’s revised  recommendations.
section_title: Surge Capacity of Health Care Providers
paragraphs: Since the terrorist attacks on September 11, 2001, public health  departments and hospitals have been considered vital elements of  emergency preparedness and response efforts. Surge capacity in public  health departments and hospitals will be critical to pandemic response  given the large number of people expected to require medical care. During  a pandemic, hospitals will need to provide care for influenza patients as  well as continue providing care for other patients.
A pandemic will put a severe strain on the health care system, which  already is easily overwhelmed by seasonal influenza outbreaks. Seasonal  influenza results in more than 200,000 hospital admissions and 36,000  deaths in the United States every year, and hospitals were stretched to  capacity in some past seasonal influenza outbreaks. A severe pandemic  would overwhelm hospitals in the United States. For example, using HHS’s  planning assumptions, authors of one study estimated that influenza  patients would need the equivalent of 191 percent of available staffed non- ICU beds and 461 percent of available staffed ICU beds.
A pandemic would occur in the context of existing health care provider  shortages. Shortages of health care providers, including physicians and  nurses, have been reported for many years by GAO and others. For  example, the Association of American Medical Colleges recently released a  report summarizing studies issued by 15 states between 2000 and 2007  regarding physician shortages in the United States. That report found that  many of these states reported shortages of physicians in specialties such  as primary care, cardiology, and endocrinology. Similarly, a recent survey  of chief executive officers by the American Hospital Association found  that as of December 2006, hospitals across the country reported having an  estimated 116,000 registered nurse vacancies. That survey also found that  nearly half of emergency departments are operating at or above capacity.
Partly in response to these workforce shortages, Congress passed the  Pandemic and All-Hazards Preparedness Act (PAHPA) in December 2006.  Among other things, the law requires the Secretary of HHS by 2009 to  identify strategies to recruit, retain, and protect the public health  workforce from workplace exposures during public health emergencies,  which would include pandemics. In addition, PAHPA established the  Office of the Assistant Secretary for Preparedness and Response to  coordinate activities between HHS and other federal departments,  agencies, and offices and state and local officials responsible for  emergency preparedness.
section_title: Nonpharmaceutical Interventions
paragraphs: Nonpharmaceutical interventions are measures used to reduce the impact  of a communitywide infectious disease outbreak without the use of  pharmaceuticals. Examples of nonpharmaceutical interventions include  isolation, quarantine, social distancing, and infection control (see table 2).
Slowing the spread of disease during a pandemic will be particularly  important given anticipated shortages of pharmaceutical interventions and  the expectation that a severe pandemic will overwhelm the health care  system. Experts have suggested that nonpharmaceutical interventions can  help the health care system by reducing the anticipated influx of patients  by limiting the rate of disease transmission (see fig. 1).
In the past, nonpharmaceutical interventions have been used in some  cases to successfully slow the spread of infectious disease outbreaks. For  example, during the 1918-19 pandemic, local public health officials relied  on nonpharmaceutical interventions—including rules forbidding  overcrowding in streetcars and bans on public gatherings—to slow the  spread of disease. More recently, during the global outbreak of severe  acute respiratory syndrome (SARS) in 2003, nonpharmaceutical  interventions were also implemented to slow the spread of disease. For  example, we reported that nonpharmaceutical interventions, such as  closing two hospitals to new admissions, appeared to be useful in  Canada’s management of the SARS outbreak.
section_title: Communication with the Public
paragraphs: Public health emergencies such as the SARS outbreak in 2003 and the  anthrax incidents in 2001 have demonstrated that communication with the  public about a public health emergency by federal officials is a critical  component of national preparedness. In July 2003, we reported that  effective communication between health care providers and the public  reinforced the need to adhere to infectious disease control measures and  that rapid and frequent communications regarding SARS helped slow its  spread. In addition, in October 2003, we reported that the media and the  public looked to CDC as the source for health-related information during  the anthrax incidents, but that CDC was not always able to successfully  convey the information that it had.
As with the SARS outbreak and anthrax incidents, a pandemic will  generate immediate, intense, and sustained demand for information. The  public will want information quickly about the risks and status of the  pandemic, what they can do to stay healthy, what is being done by the  government to protect them, and where to go for medical services. Very  technical points and sensitive political issues will need to be explained to  the general public. If accurate and consistent information is not available  and disseminated in a timely and efficient manner, rumors, myths, and  misinformation may lead to unnecessary public anxiety and could result in  mistrust of, and noncompliance with, the public health and medical  measures that are recommended to save lives.
section_title: HHS Plans to Make Federal Stockpiles of Pharmaceuticals Accessible to State and Local Jurisdictions, but Faces Challenges with Implementation
paragraphs: Once a pandemic begins, HHS plans to make accessible to state and local  jurisdictions federal stockpiles of antivirals and pre-pandemic vaccine  until a pandemic vaccine becomes widely available. According to HHS,  public-sector stockpiles of antivirals are intended to be used primarily for  the treatment of sick individuals. HHS intends to oversee the distribution  and administration of federally owned pre-pandemic vaccine to individuals  identified as members of the critical workforce; that is, workers in sectors  that are necessary for society to continue functioning. HHS also plans to  provide jurisdictions with doses of the pandemic vaccine as they become  available. HHS recommends that state and local jurisdictions follow its list  of targeted groups in administering the pandemic vaccine. However, HHS  faces challenges with implementing its strategy for using pharmaceutical  interventions, such as the lack of vaccine manufacturing capacity within  U.S. borders and the length of time experts anticipate will be needed to  manufacture a pandemic vaccine. Additionally, we and others have  reported since 2000 how problems can arise if potential target groups are  not established in advance. In 2008, HHS released guidance on prioritizing  target groups for pandemic vaccine and draft guidance on antiviral use  during a pandemic. HHS has not yet released draft guidance for public  comment on prioritizing target groups for pre-pandemic vaccine.
subsections: section_title: HHS Plans to Distribute Antivirals from the SNS to Jurisdictions and Is Relying on Additional Stockpiles to Supplement These Drugs
paragraphs: Until a pandemic vaccine becomes widely available, one part of HHS’s  strategy for using pharmaceutical interventions involves distributing  antivirals in the SNS to state and local jurisdictions. HHS has established a  national goal of stockpiling 75 million treatment courses of antivirals in  public-sector stockpiles—meaning those in the SNS and in jurisdictional  stockpiles. As of May 2008, HHS had stockpiled 44 million courses of  antivirals for treatment in the SNS and is subsidizing the purchase of   31 million treatment courses by state and local jurisdictions for storage in  their own stockpiles. As of May 2008, state and local jurisdictions had  collectively stockpiled nearly 22 million treatment courses of antivirals.
Of the federally stockpiled antivirals, HHS has reserved 6 million courses  for containment of an initial outbreak. For example, these 6 million  courses may be used to respond to initial outbreaks abroad and parts of  the United States experiencing the earliest cases. Officials told us that  after the department distributes these initial 6 million courses of antivirals,  it plans to deliver the remaining antivirals in the SNS to all jurisdictions  simultaneously for treatment of individuals sick with influenza. According  to HHS’s guidance, state and local jurisdictions will receive their  allotments of antivirals on a per-capita basis and should prepare to receive  their share of antivirals when a pandemic begins, either in the United  States or overseas. According to HHS officials, the decision to release  antivirals from the SNS will be made by the Secretary of HHS in  conjunction with the Director of CDC. HHS officials estimate that it will  take between 7 days and 1 month for all antivirals to be distributed to  jurisdictions. HHS officials also told us that they have conducted several  exercises to test HHS’s plan to distribute antivirals to these jurisdictions  during a pandemic. Antivirals from the SNS will be delivered to one  location within each jurisdiction. According to HHS officials, state and  local jurisdictions will distribute both the SNS antivirals and antivirals  stored in their own stockpiles throughout their respective areas using  pandemic-specific distribution plans.
HHS officials told us that the stockpiles of antivirals owned by state and  local jurisdictions will provide the jurisdictions with more immediate  access to the drugs during the initial stages of a pandemic. Because these  stockpiles will be entirely under each jurisdiction’s control, officials there  may choose to use some of these antivirals as prophylaxis—as proposed in  HHS’s draft guidance on antiviral use during a pandemic—in an attempt to  slow the spread of the pandemic by providing them to healthy individuals  who have been exposed to the pandemic-causing strain. However, to  ensure that stockpiles are not rapidly depleted, HHS currently  recommends that jurisdictions use antivirals only for treatment. HHS also  advises jurisdictions to begin deploying their respective antiviral  stockpiles immediately when a pandemic has been confirmed.
In June 2008, HHS released draft guidance for the use of antivirals during a  pandemic in the Federal Register for public comment. The draft guidance  is consistent with HHS’s previous recommendation that public-sector  stockpiles be used primarily for treatment of individuals sick with  influenza. In its draft guidance, HHS also acknowledged that more  antivirals will be needed than will be available in public-sector stockpiles  particularly if antivirals are used for prophylaxis. HHS proposes in its draft  guidance that the private sector stockpile 110 million additional courses.  HHS also suggests that antivirals in the private-sector stockpile be targeted  for prophylactic use for health care and emergency services personnel,  and in some circumstances, for persons with compromised immune  systems as well as those living in group settings. The purchasing,  allocation, and distribution of private-sector stockpiles would be the  responsibility of the owner of those stockpiles.
section_title: HHS Intends to Make Available Federally Owned Pre-Pandemic Vaccine to Protect the Critical Workforce
paragraphs: HHS’s strategy also involves releasing federally owned pre-pandemic  vaccine to specific locations in state and local jurisdictions for  administration when it has been determined that sustained transmission of  the pandemic virus has occurred. HHS intends to oversee distribution and  administration of pre-pandemic to members of the critical workforce  identified by a federal interagency group—the National Infrastructure  Advisory Council. Workers considered critical consist of those necessary  to maintain national or homeland security, economic survival, and the  public health and welfare. These employees include emergency service  providers, such as law enforcement, banking and financing personnel, and  health care providers. The National Infrastructure Advisory Council  estimates that the critical workforce includes about 20 million people.  HHS has a goal of stockpiling enough pre-pandemic vaccine to cover this  group. As of May 2008, HHS had purchased and stockpiled enough pre- pandemic vaccine for about 13 million people. HHS’s strategy for using  pre-pandemic vaccine is to keep society functioning until a pandemic  vaccine becomes widely available.
State and local jurisdictions will receive allotments of pre-pandemic  vaccine on a per-capita basis. According to HHS officials, stockpiles of  pre-pandemic vaccine will be released for simultaneous distribution to  selected sites in each jurisdiction. Currently, each vaccine manufacturer  stores the doses of pre-pandemic vaccine that it produces. According to  HHS, each manufacturer is assigned to supply this vaccine to certain  jurisdictions using its established distribution channels. HHS officials also  told us that they have a longer-term plan to distribute vaccine using a  single distributor, based on CDC’s Vaccine Management Business  Improvement Project. According to HHS officials, this centralized  distribution system would be incorporated with its existing Vaccine  Ordering and Distribution System, which allows for federal tracking of  vaccine distribution. HHS anticipates having a centralized distribution  system in place around 2010. HHS officials told us that utilizing this type of  system would be beneficial during the early stages of a pandemic, when it  is expected that maintaining central control of and securing vaccine will  be a high priority.
section_title: HHS Plans to Distribute Pandemic Vaccine As It Becomes Available for Vaccination of Target Groups
paragraphs: HHS plans to provide pandemic vaccine as it becomes available to state  and local jurisdictions for use among target groups. HHS has developed  guidance for the prioritization system for administration of the pandemic  vaccine. HHS has divided the entire U.S. population into four broad  categories—homeland and national security, health care and community  support services, critical infrastructure, and the general population. Within  each category, groups are clustered into five tiers that correspond to the  vaccination priority—or target group—for that specific category. (See  table 3 for target groups for a severe pandemic.) These targeted groups  were derived through consideration of four vaccination program  objectives: (1) protecting those who are essential to the pandemic  response and provide care for persons who are ill; (2) protecting those  who maintain essential community services; (3) protecting children; and  (4) protecting workers who are at greater risk of infection because of their  job. In its guidance, HHS also proposed that not all targeted groups be  vaccinated in every pandemic, depending on the severity of the  pandemic. For a less severe pandemic, for example, individuals in tiers 2  and 3 in the category of critical infrastructure would not be targeted for  vaccination. HHS also noted that the guidance will need to be reassessed  periodically before a pandemic occurs to consider factors such as changes  in vaccine production capacity. During a pandemic, guidance will also be  modified based on additional factors that will not be known until a  pandemic occurs, including the characteristics of pandemic illness.
HHS officials told us that should a pandemic occur in the near future,  pandemic vaccine will likely be distributed from vaccine manufacturers  directly to state and local jurisdictions using the same distribution systems  the manufacturers regularly use for seasonal influenza vaccine. As with  pre-pandemic vaccine, HHS anticipates that eventually multiple  manufacturers will produce pandemic vaccine. However, it anticipates  utilizing a single, centralized distributor. HHS expects to have a centralized  distribution system in place around 2010.
section_title: HHS Faces Challenges with Implementing Its Strategy for Using Pharmaceutical Interventions
paragraphs: HHS faces three challenges with implementing its strategy for using  pharmaceutical interventions during a pandemic. The first challenge is  associated with uncertainties about the effectiveness and clinical  outcomes of the pharmaceutical interventions. For example, the  uncertainty concerning which influenza strain will cause the next  pandemic raises the possibility that the pre-pandemic vaccine currently  being developed will not offer protection against the pandemic strain.  Also, because the actual pandemic-causing strain has not yet surfaced,  researchers can only estimate what amount of vaccine will actually be  needed to stimulate a sufficient human immune response. Similarly, the  appropriate dosage of antivirals or the exact length of the treatment  course needed to make them effective will not be known until the actual  pandemic-causing strain emerges. Further, the ability of influenza viruses  to develop resistance to antivirals also raises questions about their  effectiveness. In 2005, a group of global experts on antivirals noted that  studies have suggested that different strains of the H5N1 avian influenza  virus have developed resistance to different antivirals.
There is also the potential for adverse outcomes that may result from  large-scale administration of a newly developed vaccine, such as what  occurred during the “swine flu” outbreak of 1976. The government’s  success in vaccinating large numbers of the public with the swine flu  vaccine was negated by the development of Guillain-Barré syndrome  among hundreds of immunized individuals, leading to several deaths.  This adverse event only became apparent when the vaccine had been  administered to large numbers of people.
A second challenge concerns difficulties with the production of  pharmaceutical interventions, particularly vaccines. The United States  lacks vaccine manufacturing capacity; for example, we found that for the  2007-08 influenza season only one influenza vaccine manufacturer had its  production processes entirely within U.S. borders. Additionally, in 2007 we  found that the lack of U.S. vaccine manufacturing capacity is cause for  concern among experts because it is possible that countries without  domestic manufacturing capacity will not have access to vaccine in the  event of a pandemic if the countries with domestic manufacturing capacity  prohibit the export of the pandemic vaccine until their own needs are  met.
According to HHS, exacerbating the lack of manufacturing capacity is the  length of time experts anticipate will be needed to manufacture a  pandemic vaccine. HHS estimates that it may take as long as 20 to   23 weeks after the start of the pandemic for the first doses of pandemic  vaccine to become available. Figure 2 shows how pharmaceutical  manufacturers would proceed to develop and produce pandemic vaccine  as well as when initial batches of vaccine are likely to become available.
In response to this lack of manufacturing capacity, HHS has established  the long-term goal of domestically producing enough pandemic vaccine for  300 million people within 6 months of having a reference strain of the  pandemic virus. HHS expects to reach this level of manufacturing capacity  around 2010. The department is currently making large investments in  domestic vaccine manufacturing capacity for this purpose. (See app. II for  a description of these investments.) HHS is doing this in part by  supporting vaccine research with contracts that require manufacturers to  establish vaccine-producing facilities within U.S. borders. Through these  contracts, one U.S. facility has expanded its manufacturing capacity and is  expected to double its existing capacity by 2009 and triple its capacity by  2011. A second facility was recently established in the United States and is  expected to manufacture a licensed product in 2010. HHS officials told us  there had also been progress in expanding domestic manufacturing  capacity for antivirals.
The third challenge HHS faces involves difficulties in stockpiling and  distributing pharmaceutical interventions. The high costs of purchasing  and storing antivirals calls into question HHS’s plan to rely on state and  local jurisdictions to acquire and store their own stockpiles of antivirals.  For example, officials from one state we spoke with told us that the state  was facing financial difficulty in determining how it will purchase its share  of antivirals and in identifying and paying for adequate storage space. HHS  officials have acknowledged that the cost of purchasing antivirals is high,  but have also noted that the contract price HHS has negotiated for state  and local jurisdictions is better than the retail price. No federal funding  has been made available to aid state and local jurisdictions in building and  maintaining storage capacity. In addition, should a pandemic occur in the  near future, HHS plans to utilize multiple distributors for pre-pandemic  and pandemic vaccines, allowing manufacturers to use existing processes  with which they are familiar. However, HHS acknowledged that this  process also has multiple weaknesses. For example, the current  distribution plan requires extensive coordination between HHS and  multiple manufacturers and distributors. It also requires that states and  local jurisdictions manage vaccine shipments from multiple sources,  which may complicate receipt and storage activities. In response, HHS is  planning to centralize its distribution system through a single distributor.
section_title: HHS Has Made Progress on Revising Guidance for Target Groups for Use of Pandemic Vaccine, but Has Not Finalized Guidance for Using Pre-Pandemic Vaccine and Antivirals
paragraphs: HHS has made progress on revising its 2005 guidance to state and local  jurisdictions for identifying target groups for the use of pandemic vaccine,  but has not finalized guidance for using antivirals and pre-pandemic  vaccine. Since 2000, GAO and others have reported on the importance of  having pre-established target groups for pharmaceutical interventions to  avoid problems deciding who should receive these interventions. In  addition, during times of shortage, state and local public health officials  look to the federal government for guidance, including when making  decisions on which groups should be targeted for prioritization. For  example, during the seasonal influenza vaccine shortage of 2004-05, state  and local officials immediately adopted the revised guidance on who  should be targeted for vaccination as recommended by CDC. State and  local public health officials and others have stressed that federal guidance  on target groups is needed to aid in their pandemic planning efforts.
HHS first published target groups for pandemic vaccine and antivirals in  the HHS Pandemic Influenza Plan in November 2005. These initial  groups were identified to support a goal of reducing morbidity and  mortality among those at greatest risk for developing complications from  influenza, such as the elderly. Since the publication of the HHS Pandemic  Influenza Plan, there has been wide recognition that other factors should  be considered, such as protecting those critical workers needed to keep  society functioning, including health care and law enforcement personnel.  In addition, recent expansion in the production of antivirals has increased  the amount available. Thus, HHS, in consultation with other federal  agencies, was tasked by the National Strategy for Pandemic Influenza  Implementation Plan and the HHS Pandemic Influenza Implementation  Plan to revise the groups outlined in the HHS Pandemic Influenza Plan.  In July 2008, HHS released guidance on prioritizing target groups for  pandemic vaccine. HHS released draft guidance for public comment in the  Federal Register on how antivirals may be used during a pandemic in June  2008.
However, HHS has not yet released draft guidance identifying target  groups for pre-pandemic vaccine. HHS officials told us they are working  on draft guidance for pre-pandemic vaccine in collaboration with other  federal agencies, such as DHS. According to officials, target groups for  pre-pandemic vaccine are likely to resemble those for pandemic vaccine,  but with more of a focus on the critical workforce rather than on the  general population. HHS officials said a tiered structure, such as that used  for the pandemic vaccine, would only be needed if a pandemic occurs  before HHS has reached its goal of stockpiling enough doses for 20 million  people.
section_title: HHS Efforts to Improve Surge Capacity of Health Care Providers Will Be Challenged during a Pandemic
paragraphs: HHS has initiated efforts to improve the surge capacity of health care  providers, but these efforts will be challenged during a severe pandemic.  Surge capacity of health care providers will be hindered by existing  shortages of health care providers and by the potentially high absentee  rates of providers during a pandemic. Inadequate staffing of health care  facilities will be likely, and the ability to deliver health care consistent with  established standards of care may be compromised. HHS’s efforts include  plans to supplement the number of health care providers with medical and  nursing students. Given the uncertain effectiveness of efforts to increase  surge capacity, HHS has developed guidance to assist health care facilities  in planning for altered standards of care; that is, for providing care while  allocating scarce equipment, supplies, and personnel in a way that saves  the largest number of lives in mass casualty events, such as pandemics.
subsections: section_title: Surge Capacity during a Pandemic Will Be Hindered by the Potentially High Absentee Rate of Health Care Workers
paragraphs: In a severe pandemic, existing health-care provider shortages would  worsen as health care providers become infected through exposure to  infected patients or reach exhaustion because of longer working hours.  The federal government assumes absenteeism among all workers,  including health care providers, could be as high as 40 percent. During  the 2003 SARS outbreak (a disease that has a high mortality rate and poses  a high risk for health care workers similar to a pandemic), health care  workers accounted for more than 20 percent of the infected cases. During  the epidemics in Toronto and Hong Kong, 51 percent and between   28 percent and 50 percent, respectively, of health care providers who  treated SARS patients became infected with the SARS virus.
Studies have shown that during extreme public health emergencies, such  as a pandemic, some health care workers may be unable or unwilling to  report to work. For example, a survey of public health department  workers, including communicable disease staff, nurses, and physicians, at  three public health departments in Maryland found that approximately   46 percent would be likely not to report to work during a pandemic  outbreak. Similarly, in a survey of hospital personnel, including doctors  and nurses, only half responded that they would be willing to report to  work during a pandemic. Those who said they may be unlikely to report to  work cited fear of contracting an illness as the reason. These potential  workforce shortages during a pandemic will affect care for all patients, not  just those with influenza.
section_title: HHS’s Efforts to Improve Surge Capacity during a Pandemic Will Face Challenges
paragraphs: HHS has initiated many efforts to increase the number of health care  workers during a public health emergency by supplementing the  workforce with federal response teams and by encouraging mutual aid  between states. However, HHS faces challenges in improving surge  capacity during a severe pandemic because of the widespread effects of a  pandemic and the existing shortages of health care providers.
subsections: section_title: HHS’s Plans for Surge Capacity of Health Care Providers during a Pandemic
paragraphs: HHS has planned four types of efforts to improve surge capacity during a  pandemic. First, the HHS Pandemic Influenza Plan recommends that  health care facilities use personnel available locally to increase the  number of health care providers during emergencies. These  recommendations include using trainees (such as medical and nursing  students), patients’ family members, and retired health care providers to  provide support for essential patient care at times of severe staffing  shortages. The plan recommends that hospital clinical administrators take  on patient care responsibilities and that facilities recruit health care  providers from other medical settings, such as medical offices and day  surgery centers, to assist with patient care in the hospital setting.  Additionally, the plan recommends that health care providers be cross- trained to provide support for essential patient care at times of severe  staffing shortages. To assist with this effort, HHS’s Agency for Healthcare  Research and Quality has developed a video to help train health care  workers who are not respiratory care specialists to provide basic  respiratory care and ventilator management to adult patients during mass  casualty events. In addition, the HHS Pandemic Influenza Plan  recommends deployment of federal medical responders, such as members  of the National Disaster Medical System, during the early stages of a  pandemic to supplement the number of health care providers.
Second, the HHS Pandemic Influenza Plan encourages state and territory  officials to use the Emergency System for Advance Registration of  Volunteer Health Professionals program, which enables state and territory  officials to quickly identify licensed volunteer professionals to work in  areas with shortages. This program is state-based systems that provide  advanced registration and the credentialing information of clinicians  needed to augment health care facilities during a declared emergency. The  program enables the sharing of pre-registered health care professionals  across state lines. According to HHS, as of February 2008, 40 state and  territorial jurisdictions had begun to implement the program; all states and  territories are required to have this program fully operational by August  2008.
Third, HHS has advised state officials to incorporate the Emergency  Management Assistance Compact (EMAC) in their plans as another  vehicle for obtaining medical assistance during a pandemic. Once a  governor declares a state of emergency, a state can request that EMAC  address its need for resources, such as health care providers. EMAC  personnel will find states that have health care providers who can be  deployed across state lines. EMAC was established in 1996 and is  administered by the National Emergency Management Association. All 50  states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands  have enacted legislation providing authority to join EMAC.
Fourth, HHS encourages state and local officials to use other mechanisms  to expand surge capacity of health care providers for providing care to  less severely ill patients during a pandemic. These mechanisms would  encourage home care of less severely ill patients and include “telehealth”  (also known as “telemedicine”), which allows health care providers in  hospitals to care for and monitor patients at home with the use of  electronic information and telecommunications technologies; and call  centers (similar to nurse advice lines), which will allow patients at home  to contact health care providers in hospitals in order to obtain medical  advice regarding home care.
section_title: Challenges to Efforts to Increase Surge Capacity during the Initial Outbreak of a Pandemic
paragraphs: HHS faces several challenges in its efforts to increase surge capacity of  health care providers during a pandemic. There are concerns that the use  of untrained personnel may reduce the capacity of trained health care  providers to deliver needed care. For example, officials from one  professional association told us that using such individuals would require  training and supervision, which would actually increase the workload of  the health care facilities’ staff. They also told us that cross-training  personnel to provide support for essential patient care during a mass  casualty event may be infeasible because health care providers will be  busy caring for patients in their own areas of expertise. Cross-training of  health care providers needs to be done in advance, but this may be  infeasible because it would take providers away from their daily patient- care responsibilities, and this may be difficult to do given current  workforce shortages.
Furthermore, health care providers from other areas may not be available  for deployment in a severe pandemic. Members of response teams, such as  those of the National Disaster Medical System, already have full-time jobs  in health care. Therefore, these teams would not necessarily add to the  nation’s overall number of health care providers who would be available to  treat influenza patients. We were told by HHS and FEMA officials that the  National Disaster Medical System response teams will not likely be  deployed during a pandemic outbreak because of the widespread nature of  a pandemic and the need for those responders in their own regions.  Similarly, while the EMACs make it easier for health care providers to  work in states other than those in which they are licensed, given the  widespread nature of pandemics, health care providers likely will be  needed in their own home regions.
section_title: HHS Has Issued Guidance Regarding Implementation of Altered Standards of Care to Be Used If There Is Inadequate Staffing of Health Care Facilities
paragraphs: During a severe pandemic, inadequate staffing of health care facilities will  be likely despite efforts to improve surge capacity. Thus, the ability to  deliver health care consistent with established standards of care for all  patients may be compromised. HHS officials told us they believe that  decisions on the allocation of scarce resources—such as equipment,  supplies and personnel—are best made at the local level. Therefore, the  HHS Pandemic Influenza Implementation Plan recommends that health  care facilities plan ahead for providing altered standards of care; that is,  for providing care while allocating scarce resources in a way that saves the  largest number of lives in mass casualty events. With altered standards of  care, instead of treating the sickest or most injured patients first, health  care providers would identify and treat patients who have a critical need  for treatment and would be likely to survive. Complicating conditions,  such as an underlying chronic disease that may impact an individual’s  ability to survive, would be considered in the decision-making process.  Resources being used by current patients, such as those recovering from  surgery, would also become part of the overall resource allocation  decisions and might be re-allocated to patients with a more critical need  for treatment and a higher likelihood to survive. Altered standards of care  would be implemented on a temporary basis. Once the event wanes and  more resources become available, provision of health care would return to  established standards of care used in normal situations.
HHS has issued two guidance documents, Altered Standards of Care in  Mass Casualty Events and Mass Medical Care with Scarce Resources: A  Community Planning Guide, to assist health care facilities to plan for  providing altered standards of care. Altered Standards of Care in Mass  Casualty Events provides health care facilities guiding principles for  developing altered standards of care. Additionally, it includes a discussion  of the authority to activate the use of altered standards of care and the  associated legal and regulatory issues, including the possible need for  liability protection for health care providers and facilities. Mass Medical  Care with Scarce Resources expands on the Altered Standards of Care in  Mass Casualty Events report. It provides a discussion of the  circumstances that communities would face as a result of a mass casualty  event, approaches and strategies that could be used to provide the most  appropriate standards of care possible under the circumstances, examples  of tools and resources available to help state and local officials in their  planning process, ethical considerations in planning for a mass casualty  event, and a pandemic case study.
section_title: Long-Term Efforts to Increase the Number and Enhance the Preparedness Level of Health Care Providers
paragraphs: PAHPA calls for HHS’s Assistant Secretary for Preparedness and Response  to lead and coordinate HHS emergency preparedness and response  activities. Accordingly, the Assistant Secretary is engaged in efforts to  increase the number and enhance the preparedness level of health care  providers for public health emergencies. As part of this effort, HHS  officials told us that they have begun to examine issues related to  recruitment, retention, and protection of the public health workforce with  the goal of identifying strategies to overcome workforce shortages. In  addition, to encourage health professionals to enter employment in a state  or local public health agency, PAHPA authorizes HHS to award grants to  states to assist in operating public health workforce loan repayment  programs for individuals who serve in health professional shortage areas  or in areas at high risk of a public health emergency.
PAHPA also authorized HHS to develop Centers of Public Health  Preparedness at accredited schools of public health. HHS intends that  these centers will help to train and educate health professionals to prepare  for and respond to public health emergencies, including a pandemic. As  part of this effort, CDC will develop core emergency preparedness and  response curriculums, identify performance goals, and develop health  systems research projects. HHS has already incorporated standardized  benchmarks and performance measures into existing grant programs.
section_title: HHS Has Provided Guidance to Help State and Local Jurisdictions Overcome Difficulties with Implementing Nonpharmaceutical Interventions
paragraphs: HHS will rely on state and local jurisdictions to utilize nonpharmaceutical  interventions to help slow the spread of disease and to lessen the burden  on the nation’s health care system until a pandemic vaccine is widely  available. HHS has developed guidance and is investing in research on the  general use and effectiveness of nonpharmaceutical interventions, thereby  helping jurisdictions make more informed decisions. According to HHS,  the findings from this research will be used to update existing guidance.  However, HHS faces difficulties in helping state and local jurisdictions  overcome implementation challenges, such as identifying steps for  ensuring community compliance.
subsections: section_title: HHS Will Rely on State and Local Jurisdictions to Utilize Nonpharmaceutical Interventions to Help Slow the Spread of Disease
paragraphs: The authority to implement nonpharmaceutical interventions—such as  decisions on school closures—to slow the spread of disease and lessen the  burden on the nation’s health care system until a pandemic vaccine is  available rests with state and local jurisdictions. To assist state and local  authorities with their current planning efforts for using nonpharmaceutical  interventions, HHS published a guidance document in February 2007—the  Interim Pre-pandemic Planning Guidance: Community Strategy for  Pandemic Influenza Mitigation in the United States – Early, Targeted,  Layered Use of Nonpharmaceutical Interventions. HHS officials told us  that the recommendations in the guidance are for pre-pandemic  contingency planning and are intended to provide state and local  jurisdictions with a conceptual framework to guide their planning. In this  guidance, HHS introduces its “community mitigation framework” that is  based upon a targeted, layered strategy involving the direct application of  multiple, partially-effective nonpharmaceutical interventions, initiated  early and maintained consistently throughout a pandemic. Specifically,  HHS’s guidance describes four interventions: (1) isolation (either at home  or in a health care setting) and treatment (as appropriate) with antivirals  of all individuals with confirmed or probable infections; (2) voluntary  home quarantine of members of households exposed to the disease and  consideration of combining this intervention with antivirals, provided  sufficient amounts are available and can readily be distributed; (3) school  closures (including public and private schools as well as colleges and  universities) accompanied by closures of other public settings   (e.g., shopping malls and movie theaters) to prevent out-of-school social  contacts; and (4) adult social distancing to reduce contact among adults in  the community and workplace.
HHS officials and other experts have acknowledged the significance of  implementing certain nonpharmaceutical interventions in order to  maximize the available public health benefit while minimizing adverse  secondary effects of the interventions. Thus, HHS recommends that state  and local jurisdictions consider the severity of the pandemic when making  decisions about how to respond to the outbreak. For example, for a less  severe pandemic, HHS recommends voluntary home isolation of sick  individuals, but generally does not recommend measures that may be  more burdensome, such as voluntary quarantine of exposed household  members, school closures, and adult social distancing. HHS recommends  that state and local jurisdictions implement those additional measures and  others in a more severe pandemic.
Department officials and experts have also stressed the importance of  balancing the need to intervene early enough for nonpharmaceutical  measures to be effective, while at the same time not causing unnecessary  hardship by implementing them too early. HHS and other federal agencies  released guidance in March 2008—the Federal Guidance to Assist States  in Improving State-Level Pandemic Influenza Operating Plans—that  included information to assist state and local jurisdictions in determining  when to implement certain nonpharmaceutical interventions. For  example, this guidance recommends implementing voluntary quarantine  and administering antivirals to individuals exposed to the pandemic virus  when a case of novel influenza is detected in an area, including before  sustained human-to-human transmission has been established.
Once a pandemic is underway, HHS anticipates providing technical  assistance to state and local jurisdictions on the implementation of  nonpharmaceutical interventions. This technical assistance would include  assessing the specific epidemiological characteristics of the pandemic,  such as how the pandemic-causing strain is transmitted, and consulting  with state and local jurisdictions on the effectiveness of the  nonpharmaceutical interventions that had been implemented. Because it is  not possible to accurately predict the severity of a pandemic, HHS officials  told us the recommendations in the guidance may change significantly  during an actual pandemic, based on data HHS gathered from providing  technical assistance as well as from data from initial outbreak  investigations or from routine surveillance systems.
subsections: section_title: HHS’s Guidance on Nonpharmaceutical Interventions Is Based on Inconclusive Scientific Evidence
paragraphs: HHS officials acknowledge that the recommendations in its guidance are  not specific because the scientific evidence on the use and effectiveness of  nonpharmaceutical interventions is limited, and therefore inconclusive.  The research to date using mathematical modeling and analysis of  historical data of past pandemics suggests that utilizing multiple  nonpharmaceutical interventions simultaneously and early in a pandemic  may aid in slowing disease transmission. For example, historical studies  of the 1918-19 pandemic describe how some cities reduced death rates by  successfully implementing multiple nonpharmaceutical interventions,  including social distancing, mandated mask wearing, and case isolation.  However, because of incomplete historical records, researchers are not  able to determine precisely, where, when, and for how long these  interventions were implemented.
HHS has supported several research initiatives to establish a stronger  evidence base concerning the implementation and effectiveness of  nonpharmaceutical interventions, thereby helping jurisdictions to make  more informed decisions. For example, in October 2006, HHS awarded  $5.2 million to support eight research projects on topics ranging from the  role hand hygiene can play in reducing disease transmission to examining  upper respiratory infections in families. According to HHS, the findings  from this research will be used to update existing guidance. HHS and other  experts have stressed the need for additional research to, for example,  better inform the assumptions used in mathematical models. HHS listed  other key areas for further research in its guidance, such as understanding  fundamental questions regarding influenza transmission and the potential  psychosocial effects of certain nonpharmaceutical interventions, such as  prolonged voluntary home quarantine and social distancing.
section_title: HHS Faces Difficulties in Assisting State and Local Jurisdictions to Overcome Implementation Challenges
paragraphs: HHS faces difficulties in helping state and local jurisdictions implement  nonpharmaceutical interventions. First, as HHS acknowledged in its  guidance, there is the potential for state and local jurisdictions to  implement these interventions in an uncoordinated, untimely, and  inconsistent manner, thereby dramatically reducing their effectiveness.  For example, if one jurisdiction implements a voluntary quarantine of sick  individuals and a neighboring jurisdiction does not, the overall movement  of sick individuals in the area may not be sufficiently reduced. HHS hopes  that state and local jurisdictions will follow its guidance and act in  concert, but HHS cannot compel jurisdictions to do so.
Second, HHS faces the challenge of helping state and local jurisdictions  identify specific thresholds for implementing and ending  nonpharmaceutical interventions, such as at what point to close schools.  The Federal Guidance to Assist States in Improving State-Level  Pandemic Influenza Operating Plans provides general guidance to state  and local jurisdictions on when to consider beginning to implement  nonpharmaceutical interventions. However, this guidance does not  provide details on when to implement specific interventions. For example,  the guidance recommends state and local officials begin to consider  closing schools when transmission of a pandemic virus occurs, but does  not identify a specific absentee rate at which officials should take action.  Experts have noted that determining specific triggers is difficult, partly  because the data currently available are imperfect and sparse, requiring  decision-makers to make assumptions regarding the transmission rate of  the pandemic-causing strain as well as the effects of other community  behaviors during the pandemic. In addition, state and local officials  generally do not have the capabilities to collect the data that federal  authorities will need to develop specific triggers during an actual  pandemic. For example, one local official noted that one method of  determining specific community triggers would be to use prevalence rates,  which measure the percentage of the population infected with disease.  However, state and local areas do not have surveillance systems capable  of providing this level of detail in real-time.
Third, HHS faces the challenge of helping state and local jurisdictions  convince residents to comply with its requests regarding  nonpharmaceutical interventions. This task is especially difficult because  restrictions on public activities to combat a pandemic may need to be in  place for several months. During the 1918-19 pandemic,  nonpharmaceutical interventions were implemented for 2 to 8 weeks.  However, researchers have suggested that such interventions would need  to be implemented for a longer period for a future pandemic in order to  prevent another increase in transmission after the interventions are  discontinued. In the 1918-19 pandemic, nonpharmaceutical interventions  were lifted. In some cases, the public became fatigued with the  interventions, leading to public opposition and noncompliance when  authorities found it necessary to reimpose the restrictions.
A fourth challenge HHS faces is that these restrictions may have negative  impacts on the nation’s economy and on the financial well-being of  individual households. For example, nonpharmaceutical interventions may  exacerbate worker absenteeism as parents stay home to care for their  children when schools are closed. This could eventually result in  disruptions in the provision of essential services, such as law enforcement.  Similarly, lengthy nonpharmaceutical interventions could financially strain  individuals and families. For example, while an HHS-sponsored study on  public perceptions regarding a pandemic found a generally high  willingness to comply with public health recommendations, it also found a  decrease in reported ability to comply with recommended measures when  financial constraints were considered. Thus, 57 percent of respondents  said they would have problems complying with recommended measures  because of financial difficulties if they had to be out of work for 1 month,  with 76 percent reporting problems if they had to miss 3 months.
A fifth challenge for HHS is the lack of trust by U.S. citizens of federal  government public health authorities. A recent study found that only   40 percent of the U.S. population would trust federal government public  health authorities as a source for accurate information. The authors of  this study assert that this lack of trust may have been exacerbated by the  public’s negative perceptions of the government’s response to Hurricane  Katrina in 2005 and that the U.S. population may now be less willing to  cooperate with some public health requirements in the future, including  isolation of sick individuals.
section_title: HHS Is Developing Messages and Procedures for Communicating to the Public during a Pandemic but Challenges Remain
paragraphs: HHS has made progress by establishing roles, responsibilities, and  procedures for communicating messages to the general public during a  pandemic. HHS has also developed pandemic educational materials to  communicate messages to the general public before and during a  pandemic and has identified ways to disseminate these materials. In  addition, HHS has engaged the general public on pandemic issues to better  understand public perceptions and knowledge. Nonetheless,  communicating sensitive and complex issues to the general public during  a pandemic will be challenging.
subsections: section_title: Roles, Responsibilities, and Procedures Have Been Established for How HHS Plans to Communicate with the General Public about a Pandemic
paragraphs: HHS has assigned roles and responsibilities, and developed procedures,  for how HHS plans to communicate with the general public about a  pandemic. Under the National Response Framework, HHS is the lead  federal agency for public health and medical services, and as such, HHS is  the federal agency responsible for communicating with the general public  about the public health and medical aspects of a pandemic before and  during an outbreak. In addition, the HHS Pandemic Influenza Plan  identified activities that should be undertaken to prepare HHS to  communicate with the general public before and during a pandemic.
In November 2006, HHS completed the U.S. Department of Health and  Human Services Pandemic Influenza Communications Plan which lays  out detailed roles, responsibilities, and procedures to guide HHS  communications with the general public. For example, this plan assigned  HHS’s Office of the Assistant Secretary for Public Affairs responsibility for  coordinating pandemic health messages across all HHS agencies and with  state and local communications staff in order to ensure that all HHS  agencies work closely together to make public statements that are timely,  consistent, and accurate.
HHS has named spokespersons within HHS to deliver messages to the  public before and during an outbreak. HHS has trained federal, state,  local, and private sector public affairs officials to communicate with the  general public about a pandemic. The Crisis and Emergency Risk  Communication training modules developed by HHS clarify the role of  spokespersons, describe the psychology of communicating during a crisis,  and provide best practices for working with the media during a crisis. HHS  has held 10 Crisis and Emergency Risk Communication training sessions  for nearly 500 senior federal officials and public affairs staff, and 11  regional training sessions for approximately 900 state and local leaders.  Two additional trainings are scheduled in 2008. HHS also held Crisis and  Emergency Risk Communication training sessions in June 2007 for Red  Cross leaders and in January 2007 for stakeholders. Nearly 900 training  sites participated in these sessions via the Internet.
During a pandemic, the HHS communications effort will operate out of its  Emergency Communications Center. The center’s capabilities include  originating or accessing video feeds, news conferencing, posting mass  electronic mailings, responding to media telephone inquiries, receiving,  vetting, and clearing messages to be released by HHS. HHS will use a  departmental public affairs conference line to provide telephone  connections for public affairs staff throughout the department. These  phone connections will allow HHS public affairs personnel to work from  dispersed sites during the crisis, coordinate messages, receive guidance or  direction, and provide information to those needing it. The DHS National  Incident Communications Conference Line will also be used by HHS to  exchange information with other federal agencies.
In addition, the Office of the Assistant Secretary for Public Affairs  conducts media outreach to strengthen the relationship between the  media and HHS and to support pandemic planning and education. Periodic  briefings are scheduled between senior department officials, including the  HHS Secretary, and members of the press. For example, in early 2007 HHS  held a series of roundtable discussions on pandemics with the major  broadcast and cable television networks, wire services, and bloggers to  raise awareness of pandemics; the secretaries of HHS and Department of  Agriculture participated. HHS press-office staff members also talk to the  media regularly to answer questions and provide updates on pandemic  planning and related issues. In January 2007, HHS began holding a series  of tabletop exercises with key media leaders and senior government  officials in six major cities to facilitate effective communication to help  insure the timely dissemination of accurate information to the general  public through the use of media outlets during a pandemic.
section_title: HHS Has Developed Pandemic Educational Materials to Communicate Messages to the General Public before and during a Pandemic
paragraphs: HHS has developed and disseminated educational materials for  communicating critical information to the general public and is in the  process of developing additional materials. HHS has identified some of the  critical information that the general public will require during a pandemic  and has developed message maps—communications tools used to help  organize complex information—to convey that information in a concise  format before an outbreak. HHS has developed 82 message maps. HHS’s  message maps are each designed to distill three primary, easily understood  messages on issues such as the differences between avian influenza,  pandemic influenza, and seasonal influenza, as well as what HHS is doing  to prepare for a pandemic. Each of these primary messages has three  supporting messages that can be used as appropriate to provide context  for the issue being mapped. HHS message maps take the form of a series  of questions and answers and are made public so that spokespersons from  across the government or from private organizations can use the maps to  convey accurate and consistent background information to their  constituents before an outbreak. Table 4 shows an example of an HHS  message map.
HHS has several means of disseminating information regarding a  pandemic. HHS manages www.pandemicflu.gov, the official U.S.  government Web site for disseminating information on pandemics to the  public before and during a pandemic. The Web site is updated with new  information as it becomes available and provides the public, public health  and emergency preparedness officials, government and business leaders,  school systems, and local communities with comprehensive  governmentwide information on a pandemic. In addition, HHS will use a  variety of other information systems to distribute pandemic information  including telephone hotlines, such as 1-800-CDC-INFO; educational  sessions through teleconferencing, such as the Clinician Outreach and  Communication Activity to which the public can call-in; satellite  informational broadcasts; and radio and television public service  announcements.
HHS has developed public service announcements for use on television  and radio that urge the general public to learn about and prepare for a  pandemic and has created an archive of materials—video footage, posters,  and fact sheets—for conveying key pandemic messages to the general  public. HHS also has developed planning checklists for specific  audiences—such as medical providers, schools, and businesses—to raise  awareness and to assist these audiences in preparing for a pandemic. For  example, the planning checklists identify issues that should be considered,  such as storing additional infection control supplies (such as hand  cleansing products and tissues); establishing pandemic-specific policies,  procedures, and roles and responsibilities; planning to maintain continuity  of operations; coordinating activities with local stakeholders; practicing  infection control; and developing communications plans.
section_title: Despite HHS’s Preparations, Communicating with the General Public during a Pandemic Will Be Challenging
paragraphs: HHS officials told us that communicating messages to the general public  during a pandemic will be challenging despite the department’s  preparations. The first challenge is that a pandemic will create an  immediate, intense, and sustained demand for information from both the  general public and the groups to whom the public will be turning for  information, such as the media and health care community. In addition,  the general public will likely turn to numerous sources other than HHS for  information, including other federal agencies, state and local authorities,  the media, health care providers, the Internet, hotlines, employers, peers,  family, and community leaders. HHS will not be able to ensure that  messages delivered to the general public by non-HHS entities are  coordinated and consistent with HHS messages, and the communications  may cause confuse the general public.
A second challenge concerns the public’s reception to HHS’s  communications. HHS has found a low level of public understanding on  pandemic issues, some unwillingness to comply under certain  circumstances with the messages that HHS plans to deliver, and anxiety  over particular messages (such as why pre-pandemic vaccines and some  antivirals will not be made available to the general public). For example, a  nationally representative survey on pandemic issues found that 58 percent  of the general public in the United States did not know what a pandemic  is. The survey also found that the public is less willing or is unable to  follow some of the recommendations that HHS plans to communicate  during a pandemic. For example, HHS plans to recommend that sick  individuals who do not require hospital care observe voluntary home  isolation and treatment; however, 24 percent of the people surveyed said  that they did not have someone to take care of them in their homes. The  same study also found that 35 percent of respondents would go to work if  requested by their employer even if public health officials recommended  that people stay at home during a pandemic.
Furthermore, HHS tabletop exercises have identified several issues that  will prove challenging when communicating with the public during a  pandemic, particularly the sensitivity of certain messages, the use of  specialized public health terms in the messages, and the inadequacy of  HHS message maps to address the complexity of the issues being  communicated. Discussions during these tabletop exercises will help HHS  to develop plans to resolve these identified challenges. For example,  HHS’s messages will have to communicate clearly the difference between  specialized terms such as isolation and quarantine, and the meaning of the  phrase “altered standards of care.” Because of the complexity of the issues  in its message maps, HHS plans to develop additional educational  materials to distribute to the public before a pandemic in order to make  these complexities more comprehensible.
section_title: Conclusions
paragraphs: Although HHS has made progress in identifying issues that need to be  addressed and in funding research and vaccine production, significant  challenges remain, many of which are beyond HHS’s control or which  cannot be quickly addressed. Such challenges include coping with the  potentially high absentee rate among health care providers during a  pandemic and the length of time it will take to develop a pandemic vaccine  once the virus is identified. One important activity, however, that is within  HHS’s control that HHS could address before a pandemic is finalizing the  guidance on how limited pharmaceutical interventions should be used  during a pandemic.
A severe pandemic, such as that of 1918-19, has the potential to result in  widespread illness and death and is expected to overwhelm the nation’s  ability to respond. According to HHS, initial batches of the most effective  protective measure—a pandemic vaccine—may take as long as 20 to   23 weeks after the start of the pandemic to become available. Although the  federal government has provided some guidance, final decisionmaking will  fall on state and local officials who will have to decide how to allocate  pharmaceutical interventions and whom interventions should go to first,  and when.
HHS, in consultation with other federal agencies, has been tasked with  revising guidance to assist state and local jurisdictions in identifying  groups that should be considered a priority for receiving limited  pharmaceutical interventions. In 2008, HHS released guidance on  prioritizing target groups for pandemic vaccine and draft guidance for  public comment on how antivirals may be used during a pandemic.  However, HHS has not yet released draft guidance for public comment on  prioritizing target groups for pre-pandemic vaccine. We and others have  reported since 2000 how problems related to pandemic planning—such as  those problems with the distribution and administration of pharmaceutical  interventions—can arise if target groups are not established in advance.  This lack of essential information could slow the initial response at the  state and local levels and complicate the general public’s understanding of  the necessity for rationing these interventions. Additionally, the general  public should continue to be engaged in the process of priority setting, as  public participation is an essential component for acceptance of tough  decisions that will be required unless and until greater capacity or a  universal vaccine can be developed.
section_title: Recommendation for Executive Action
paragraphs: To improve the nation’s preparedness for a pandemic, we are  recommending that the Secretary of HHS expeditiously finalize guidance  to assist state and local jurisdictions to determine how to effectively use  limited supplies of antivirals and pre-pandemic vaccine in a pandemic,  including prioritizing target groups for pre-pandemic vaccine.
section_title: Agency Comments and Our Evaluation
paragraphs: HHS provided written comments on a draft of this report which we have  reproduced in appendix III. HHS also provided technical comments, which  we have incorporated as appropriate.
In its comments, HHS noted that it has taken and plans to take additional  actions related to our recommendation since we provided the draft report  to the department for its review. HHS indicated that the final guidance for  pandemic vaccine allocation was released on July 23, 2008, and that this  guidance describes the groups who should be targeted and prioritized for  receiving pandemic vaccine. HHS also indicated that the department  released draft guidance on how antivirals may be used during a pandemic  in June 2008, and that HHS will release for public comment proposed draft  guidance on pre-pandemic vaccine allocation in the near future. We  updated the text of the report to reflect these developments. We also  revised the wording of our recommendation in light of HHS’s comment  that HHS recommends that antivirals in public-sector stockpiles should be  used primarily for the treatment of individuals sick with influenza. We first  identified the need for finalized guidance on how limited pharmaceutical  interventions should be used during a pandemic, including target groups  where appropriate, in 2000. We believe that finalizing guidance on the use  of pharmaceutical interventions will be crucial for responding to a  pandemic outbreak and that the necessary guidance documents should be  finalized as soon as possible.
Throughout its comments, HHS described aspects of its pandemic  preparedness activities that it believed could be presented more clearly in  our report and presented additional details about its activities. We have  revised the language in the report to reflect HHS’s comments where it was  necessary. In particular, we revised our discussion of pharmaceutical  interventions to clarify our presentation of the three types of  pharmaceuticals and how pre-pandemic vaccine will be distributed and  administered during a pandemic. We also revised the report to reflect  HHS’s objection to our statement that the use of antivirals early in a  pandemic could slow the spread of the pandemic. HHS commented that  the magnitude of the impact of pharmaceuticals on pandemic spread is  uncertain given “…limited countermeasure supplies, unclear  effectivenesss, and operational challenges…”
Many of HHS’s comments addressed the scope of the department’s actions  in relation to the responsibilities of states and local jurisdictions. For  example, HHS noted that it will directly oversee the administration of pre- pandemic vaccine to members of the critical workforce, rather than fully  delegate that task. For antivirals, HHS agreed that states are free to  administer antivirals in their own stockpiles to anyone they like, but also  noted that state plans have been reviewed by CDC to ensure that the plans  reflect the national recommendation to use antivirals primarily for  treatment of individuals sick with influenza. Thirdly, HHS emphasized that  health care personnel surge capacity in a pandemic is a local  responsibility. Although the 2005 HHS Pandemic Influenza Plan  recommends deployment of federal medical responders to supplement the  number of health care providers, HHS noted that the federal government  does not have adequate health care personnel to provide surge capacity.  On that topic, HHS also noted that its planning documents for allocating  scarce health care resources were intended as “…planning documents for  consideration by communities, not for the purposes of establishing  definitive standards.”
Finally, HHS proposed alternate terms for some of the concepts in our  report (we have noted these instances in the report). For example, HHS  disagreed with our use of the term “altered standards of care” and said  that the more appropriate term is “standards of care appropriate to the  situation.” Because we believe that “altered standards of care” is an  accurate description of what may happen as the result of the allocation of  scarce health care resources in a pandemic emergency and because HHS  used this phrase in its guidance to state and local jurisdictions, we did not  make this change.
We are sending copies of this report to the Secretary of HHS and to  interested congressional committees. We will also make copies available  to others on request. In addition, the report will be available at no charge  on GAO’s Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please contact me  at (202) 512-7114 or CrosseM@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this report. GAO staff who made major contributions to this report are  listed in appendix IV.
section_title: Appendix I: Summaries of Select Federal Documents Relevant for Preparing for and Responding to Influenza Pandemic
paragraphs: The National Response Framework lays out, in part, the manner in which  the federal government responds to domestic incidents. The plan is a  guide for an all-hazards response, categorizing the types of federal  assistance into specific emergency support functions. Primary and  supporting agencies are listed for each emergency support function.  “Emergency Support Function #8 – Public Health and Medical Services  Annex” of the National Response Framework directs the Department of  Health and Human Services (HHS) to provide support as the primary  agency, with 16 other agencies, including the Departments of Homeland  Security and Agriculture.
The National Response Framework replaced the National Response Plan  in March 2008, which, in turn, replaced the Federal Response Plan in April  2005. The Federal Response Plan, originally drafted in 1992 and revised in  1999, established the process and structure for the federal government’s  provision of assistance in response to any major disaster or emergency  declared under the Robert T. Stafford Disaster Relief and Emergency  Assistance Act (Stafford Act). The purpose of the Stafford Act is “to  provide an orderly and continuing means of assistance by the federal  government to state and local governments in carrying out their  responsibilities to alleviate the suffering and damage which result” from  disasters and emergencies.
National Strategy for Pandemic Influenza  On November 1, 2005, the President of the United States released the  National Strategy for Pandemic Influenza, which provides a framework  for future planning efforts for how the country will prepare for, detect, and  respond to an influenza pandemic. The strategy reflects the federal  government’s approach to the pandemic threat and is based on three main  types of activities: (1) preparedness and communication, (2) surveillance  and detection, and (3) response and containment.
National Strategy for Pandemic Influenza Implementation Plan  On May 3, 2006, the President of the United States released the National  Strategy for Pandemic Influenza Implementation Plan, which further  clarifies the roles and responsibilities of governmental and  nongovernmental entities—including federal, state, local, and tribal  authorities and regional, national, and international stakeholders—and  provides preparedness guidance for all segments of society. This plan  addresses the following topics: U.S. government planning and response;  international efforts and transportation and borders; protecting human  health; protecting animal health; law enforcement, public safety, and  security; and institutional considerations. The federal government has  identified approximately 300 action items to address the threat of a  pandemic. These items include 199 action items led or co-led by HHS. As  stated in the plan’s preface, the plan will be reviewed on a continuous  basis and revised as appropriate to reflect changes in the understanding of  the threat and the development of new technologies.
Since the release of the implementation plan, the Homeland Security  Council released the National Strategy for Pandemic Influenza  Implementation Plan One Year Summary on July 17, 2007. This  document summarizes the federal government’s efforts to prepare for an  influenza pandemic.
Because HHS has primary responsibility for coordinating the nation’s  response to public health emergencies under “Emergency Support  Function #8,” the department has developed the HHS Pandemic Influenza  Plan. The first part of this plan provides HHS’s strategic plan for dealing  with an influenza pandemic. This includes information on  recommendations on the use of vaccines and antivirals, legal authorities,  key HHS activities, HHS research activities, and international partnerships  on avian and pandemic influenza. Preparing for and responding to a  pandemic will not be purely a federal responsibility; it will primarily be a  local response. And because a pandemic is likely to occur in multiple areas  simultaneously, resources cannot be geographically shifted as is often  done with other emergencies; every community will need to rely on its  own planning and resources to respond to the outbreak. Therefore, the  second part of the HHS Pandemic Influenza Plan consists of 11  supplements that provide guidance to state and local officials on response  elements necessary for preparation for a pandemic (see table 5).
The third part of the plan, which details the critical actions items for  which HHS has the lead as described in the National Strategy for  Pandemic Influenza Implementation Plan, was produced as a separate  plan—the Pandemic Influenza Implementation Plan—and was released  in November 2006. The Pandemic Influenza Implementation Plan also  includes a second part that contains the HHS agencies’ operational plans.
The HHS Pandemic Influenza Plan will be reviewed on a continuous  basis and revised as appropriate to reflect changes in the understanding of  the threat and new technologies. HHS has released five updates regarding  the progress of the department’s preparedness efforts on March 13, 2006;  June 29, 2006; November 13, 2006; July 18, 2007; and March 17, 2008,  respectively.
Homeland Security Presidential Directive-21: Public Health and  Medical Preparedness  On October 18, 2007, the President of the United States released the  Homeland Security Presidential Directive-21: Public Health and Medical  Preparedness, which provides a strategy for protecting the health of the  U.S. population against all disasters, including a pandemic. This directive  describes four critical components of public health and medical  preparedness: biosurveillance, countermeasure distribution (including  pharmaceuticals), mass casualty care, and community resilience. All four  critical components will include coordination of efforts at the federal,  state, and local levels, as well as with private sector, public health, and  medical disaster response resources.
Guidance on Allocating and Targeting Pandemic Influenza Vaccine  On July 23, 2008, HHS, in coordination with DHS, released the Guidance  on Allocating and Targeting Pandemic Influenza Vaccine. This guidance  provides a framework to state and local jurisdictions on how to allocate  limited supplies of pandemic vaccine to targeted groups, with the goal of  providing this vaccine to all who choose to receive it. According to the  guidance, groups targeted for vaccination varies depending on the severity  of the pandemic.
section_title: Appendix II: HHS Activities for Acquiring Pharmaceutical Interventions for an Influenza Pandemic within the United States
paragraphs: According to HHS officials, it is important to have a stockpile of  pharmaceutical interventions, when possible, for use during the early  stages of a pandemic. HHS allotted portions of its total fiscal year 2006  appropriation for pandemic-related purposes—$5.683 billion—to the  acquisition and development of pharmaceutical interventions.  Specifically, approximately $1.1 billion was targeted for investment in  antivirals and approximately $3.2 billion was dedicated for vaccines. HHS  has also established goals for amounts of pharmaceutical interventions to  be stockpiled nationally (see table 6).
HHS has invested millions of dollars into the stockpiling of antivirals to  achieve its two goals for antivirals. Table 7 summarizes the approximate  number of courses stockpiled as of May 2008. In addition, in March 2006,  HHS allotted $200 million dollars to the development of additional  antivirals, and in January 2007, the department awarded a 4-year contract  of about $103 million for further development of the new antiviral  peramivir.
HHS has also awarded contracts to purchase pre-pandemic vaccines from  manufacturers to add to the federal stockpile. See table 8 for HHS’s efforts  to stockpile pre-pandemic vaccines. HHS officials told us that the greatest  challenge to preparing for an influenza pandemic and implementing its  plans for using pharmaceutical interventions is the lack of vaccine  manufacturing capacity within the United States. We found in prior work  that the lack of U.S. vaccine manufacturing capacity is cause for concern  among experts because it is possible that countries without domestic  manufacturing capacity will not have access to vaccines in the event of a  pandemic if the countries with domestic manufacturing capacity prohibit  the export of the pandemic vaccine until their own needs are met.
Table 9 describes other HHS initiatives to establish domestic  manufacturing infrastructure for vaccine production.
Other HHS activities to enhance domestic vaccine manufacturing capacity  include investing in vaccine development and research. For example, HHS  has invested over $1 billion in development of a cell-based approach to  influenza vaccine manufacturing, which it claims will modernize the  current egg-based production process (see table 10). The current  manufacturing process uses chicken eggs, and egg-based vaccines can  easily become contaminated. Cell-based technology does not have these  sterility issues and allows for faster development and greater production  capacity. Although cell-based vaccine production has been used for other  vaccines, it has not been approved for use in developing influenza  vaccines. However, according to HHS, it anticipates that a licensed cell- based influenza vaccine will be manufactured in 2010. Also, in January  2007, HHS awarded contracts totaling approximately $133 million to  vaccine manufacturers for development of pre-pandemic vaccines,  containing adjuvants—substances that may be added to a vaccine to  increase the body’s immune response, thereby necessitating a lower dose  of vaccine.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: In addition to the contact named above, Martin T. Gahart, Assistant  Director; George Bogart; Cathleen Hamann; Gay Hee Lee; and Deborah J.  Miller made key contributions to this report.
section_title: Related GAO Products
paragraphs: Influenza Pandemic: Federal Agencies Should Continue to Assist States  to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.:  June 19, 2008.
Emergency Preparedness: States Are Planning for Medical Surge, but  Could Benefit from Shared Guidance for Allocating Scarce Medical  Resources. GAO-08-668. Washington, D.C.: June 13, 2008.
Influenza Pandemic: Efforts Under Way to Address Constraints on  Using Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92.  Washington, D.C.: December 21, 2007.
Influenza Pandemic: Opportunities Exist to Address Critical  Infrastructure Protection Challenges That Require Federal and Private  Sector Coordination. GAO-08-36. Washington, D.C.: October 31, 2007.
Influenza Vaccine: Issues Related to Production, Distribution, and  Public Health Messages. GAO-08-27. Washington, D.C.: October 31, 2007.
Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer  Federal Leadership Roles and an Effective National Strategy.   GAO-07-781. Washington, D.C.: August 14, 2007.
Emergency Management Assistance Compact: Enhancing EMAC’s  Collaborative and Administrative Capacity Should Improve National  Disaster Response. GAO-07-854. Washington, D.C.: June 29, 2007.
Influenza Pandemic: DOD Combatant Commands’ Preparedness Efforts  Could Benefit from More Clearly Defined Roles, Resources, and Risk  Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007.
Influenza Pandemic: Efforts to Forestall Onset Are Under Way;  Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604.  Washington, D.C.: June 20, 2007.
Emergency Management: Most School Districts Have Developed  Emergency Management Plans, but Would Benefit from Additional  Federal Guidance. GAO-07-609. Washington, D.C.: June 12, 2007.
Avian Influenza: USDA Has Taken Important Steps to Prepare for  Outbreaks, but Better Planning Could Improve Response. GAO-07-652.  Washington, D.C.: June 11, 2007.
The Federal Workforce: Additional Steps Needed to Take Advantage of  Federal Executive Boards’ Ability to Contribute to Emergency  Operations. GAO-07-515. Washington, D.C.: May 4, 2007.
Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but  Accountability, Funding, and Communications Need to be Clearer and  Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21,  2006.
Influenza Pandemic: Applying Lessons Learned from the 2004-05  Influenza Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4,  2005.
Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for  Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response.   GAO-05-863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.  Washington, D.C.: May 26, 2005.
Infectious Disease Preparedness: Federal Challenges in Responding to  Influenza Outbreak. GAO-04-1100T. Washington, D.C.: September 28,  2004.
Bioterrorism: Public Health Response to Anthrax Incidents of 2001.  GAO-04-152. Washington, D.C.: October 15, 2003.
Infectious Diseases: Gaps Remain in Surveillance Capabilities of State  and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003.
SARS Outbreak: Improvements to Public Health Capacity Are Needed for  Responding to Bioterrorism and Emerging Infectious Diseases.   GAO-03-769T. Washington, D.C.: May 7, 2003.
Bioterrorism: Preparedness Varied across State and Local Jurisdictions.  GAO-03-373. Washington, D.C.: April 7, 2003.
Hospital Emergency Departments: Crowded Conditions Vary among  Hospitals and Communities. GAO-03-460. Washington, D.C.: March 14,  2003.
Nursing Workforce: Emerging Nurse Shortages Due to Multiple Factors.  GAO-01-944. Washington. D.C.: July 10, 2001.
Nursing Workforce: Recruitment and Retention of Nurses and Nurse  Aides Is a Growing Concern. GAO-01-750T. Washington, D.C.: May 17,  2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High- Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.