Influenza Pandemic: Challenges Remain in Preparedness
Published: 2005-05-26T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Vaccine shortages and distribution problems during the 2004-2005 influenza season raised concerns about the nation's ability to respond to a worldwide influenza epidemic--or influenza pandemic--which many experts believe to be inevitable. Some experts believe that the next pandemic could be spawned by the recurring avian influenza in Asia. If avian influenza strains directly infect humans and acquire the ability to be readily transmitted between people, a pandemic could occur. Modeling studies suggest that its effect in the United States could be severe, with one estimate from the Centers for Disease Control and Prevention (CDC) ranging from 89,000 to 207,000 deaths and from 38 million to 89 million illnesses. GAO was asked to discuss surveillance systems in place to identify and monitor an influenza pandemic and concerns about preparedness for and response to an influenza pandemic. This testimony is based on GAO's 2004 report on disease surveillance; reports and testimony on influenza outbreaks, influenza vaccine supply, and pandemic planning that GAO has issued since October 2000; and work GAO has done in May 2005 to update key information.
section_title: What GAO Found
paragraphs: Federal public health officials plan to rely on the nation's existing influenza surveillance system and enhancements to identify an influenza pandemic. CDC currently collaborates with multiple public health partners, including the World Health Organization (WHO), to obtain data that provide national and international pictures of influenza activity. Federal public health officials and health care organizations have undertaken several initiatives that are intended to enhance influenza surveillance capabilities. While some of these initiatives are focused more generally on increasing preparedness for bioterrorism and other emerging infectious disease health threats, others have been undertaken in preparation for an influenza pandemic. For example, in response to concerns over the past few years about the potential for avian influenza to become the next influenza pandemic, CDC implemented an initiative in cooperation with WHO to improve influenza surveillance in Asia. CDC has also implemented initiatives to improve the communications systems it uses to collect and disseminate surveillance information. In addition, CDC, the Department of Agriculture, and the Food and Drug Administration have made efforts to enhance their coordination of surveillance efforts for diseases that arise in animals and can be transferred to humans, such as SARS and certain strains of influenza with the potential to become pandemic. While public health officials have undertaken several initiatives to enhance influenza surveillance capabilities, challenges remain with regard to other aspects of preparedness for and response to an influenza pandemic. In particular, the Department of Health and Human Services (HHS) has not finalized planning for an influenza pandemic. In 2000, GAO recommended that HHS complete the national plan for responding to an influenza pandemic, but the plan has been in draft format since August 2004. Absent a completed federal plan, key questions about the federal role in the purchase, distribution, and administration of vaccines and antiviral drugs during a pandemic remain unanswered. Other challenges with regard to preparedness for and response to an influenza pandemic exist across the public and private sectors, including challenges in ensuring an adequate and timely influenza vaccine and antiviral supply; addressing regulatory, privacy, and procedural issues surrounding measures to control the spread of disease, for example, across national borders; and resolving issues related to an insufficient hospital and health workforce capacity for responding to a large-scale outbreak such as an influenza pandemic.

section_title: Letter
paragraphs: I am pleased to be here today as you discuss issues regarding the nation’s  preparedness to respond to a worldwide influenza epidemic, or influenza  pandemic. The emergence of new diseases such as severe acute  respiratory syndrome (SARS) has raised concerns about our ability to  respond to other infectious disease outbreaks such as an influenza  pandemic, which many experts believe to be inevitable. Vaccine shortages  and distribution problems during the 2004-2005 influenza season add to  these concerns.
Influenza pandemics arise periodically but unpredictably from a major  genetic change in the virus that results in a new strain. Some experts  believe that the next pandemic could be spawned by the recurring avian  influenza in Asia. As of May 19, 2005, 97 people, mostly young and  otherwise healthy, have been confirmed by the World Health Organization  (WHO) to have been infected with avian influenza since 2003, and 53 of  them have died. Recent studies suggest that avian influenza strains are  increasingly capable of causing severe disease in humans and suggest that  these strains have become endemic in some wild birds. If these avian  influenza strains directly infect humans and acquire the ability to be  readily transmitted between people, a pandemic could occur.
While the severity of the next pandemic cannot be predicted, modeling  studies suggest that its effect in the United States could be severe. The  Centers for Disease Control and Prevention (CDC) estimates that if a  “medium-level” influenza pandemic were to occur in the United States, in  the absence of any control measures (e.g., vaccination and drugs), it could  cause 89,000 to 207,000 deaths, 314,000 to 734,000 hospitalizations, 18  million to 42 million outpatient visits, and another 20 million to 47 million  cases of the illness. From 15 percent to 35 percent of the U.S. population  could be affected by an influenza pandemic, with associated costs ranging  from $71 billion to $167 billion.
You asked us to provide our perspective on the nation’s ability to conduct  disease surveillance for an influenza pandemic, as well as the public  health system’s preparedness for an influenza pandemic. In this testimony,  I will discuss (1) surveillance systems in place to identify and monitor an  influenza pandemic and (2) challenges in preparedness and response to an  influenza pandemic.
My testimony today is based largely on our 2004 report on disease  surveillance as well as reports and testimony on influenza outbreaks,  influenza vaccine supply, pandemic planning, and the SARS outbreak that  we have issued since October 2000 and work we have conducted to  update key information. Our prior work on disease surveillance and  influenza pandemics included analysis of information provided by multiple  federal departments and agencies, including the Department of Health and  Human Services (HHS)—specifically from CDC and the Food and Drug  Administration (FDA)—and the Departments of Agriculture, Defense, and  Homeland Security, as well as interviews with officials of those  departments and agencies. We also interviewed public health department  officials from 11 states, vaccine manufacturers, and vaccine distributors  and surveyed physician group practices. To learn about pandemic  planning efforts, we interviewed HHS officials in the National Vaccine  Program Office and reviewed HHS’s August 2004 draft “Pandemic  Influenza Preparedness and Response Plan.” Our prior work on the SARS  outbreak included analysis of information provided by U.S. agencies,  WHO, and Asian governments, as well as interviews with officials from  those entities. We also conducted fieldwork on SARS in Beijing; Hong  Kong; Guangdong Province, China; and Taipei, Taiwan. In May 2005, we  updated our information to include issues that arose during the 2004-2005  influenza season and to verify the current status of HHS efforts on  surveillance, planning, and preparedness activities. We conducted all of  our work in accordance with generally accepted government auditing  standards.
In summary, federal public health officials plan to rely on the nation’s  existing influenza surveillance system and enhancements to identify an  influenza pandemic. CDC currently collaborates with multiple public  health partners, including WHO, to obtain data that provide national and  international pictures of influenza activity. Federal public health officials  and health care organizations have undertaken several initiatives that are  intended to enhance influenza surveillance capabilities. While some of  these initiatives are focused more generally on increasing preparedness  for bioterrorism and other emerging infectious disease health threats,  others were undertaken in preparation for an influenza pandemic. For  example, in response to concerns over the past few years about the  potential for avian influenza to become the next influenza pandemic, CDC  implemented an initiative in cooperation with WHO to improve influenza  surveillance in Asia. CDC has also implemented initiatives to improve the  communications systems it uses to collect and disseminate surveillance  information. In addition, CDC, USDA, and FDA have made efforts to  enhance their coordination of surveillance efforts for diseases that arise in  animals and can be transferred to humans, such as SARS and certain  strains of influenza with the potential to become pandemic.
While public health officials have undertaken several initiatives to enhance  influenza surveillance capabilities, challenges remain with regard to other  aspects of preparedness for and response to an influenza pandemic. In  particular, HHS has not finalized planning for an influenza pandemic. In  2000, we recommended that HHS complete the national plan for  responding to an influenza pandemic, but the plan has been in draft format  since August 2004. Absent a completed federal plan, key questions about  the federal role in the purchase, distribution, and administration of  vaccines and antiviral drugs during a pandemic remain unanswered. Other  challenges with regard to preparedness for and response to an influenza  pandemic exist across the public and private sectors, including challenges  in ensuring an adequate and timely influenza vaccine and antiviral supply;  addressing regulatory, privacy, and procedural issues surrounding  measures to control the spread of disease, for example, across national  borders; and resolving issues related to an insufficient hospital and health  workforce capacity for responding to a large-scale outbreak such as an  influenza pandemic.
subsections: section_title: Background
paragraphs: To be prepared for major public health threats such as an influenza  pandemic, public health agencies need several basic capabilities, including  disease surveillance systems. Specifically, to detect cases of pandemic  influenza, especially before they develop into widespread outbreaks, local,  state, and federal public health officials as well as international  organizations collect, analyze, and share information related to cases of  the disease. When effective, surveillance can facilitate timely action to  control outbreaks and promote informed allocation of resources to meet  changing disease conditions.
subsections: section_title: Influenza
paragraphs: Influenza is more severe than some other viral respiratory infections, such  as the common cold. Most people who get influenza recover completely in  1 to 2 weeks, but some develop serious and potentially life-threatening  medical complications, such as pneumonia. People aged 65 and older,  people of any age with chronic medical conditions, children younger than  2 years, and pregnant women are more likely than other people to develop  severe complications from influenza. Influenza and pneumonia rank as the  fifth leading cause of death among persons aged 65 and older.
Influenza viruses undergo minor but continuous genetic changes from year  to year. Almost every year, an influenza virus causes acute respiratory  disease in epidemic proportions somewhere in the world. Vaccination is  the primary method for preventing influenza and its more severe  complications. Influenza vaccine is produced and administered annually to  provide protection against particular influenza strains expected to be  prevalent that year. Influenza vaccine takes several months to produce.  Deciding which viral strains to include in the annual influenza vaccine  depends on data collected from domestic and international surveillance  systems that identify prevalent strains and characterize their effect on  human health. FDA decides which strains to include in the vaccine and  also licenses and regulates the manufacturers that produce the vaccine.
HHS has limited authority, however, to directly control influenza vaccine  production and distribution.
FDA has approved four antiviral medications (amantadine, rimantadine,  oseltamivir, and zanamivir) for prevention and treatment of influenza.  However, influenza virus strains can become resistant to one or more of  these drugs, and so they may not always be effective.
section_title: Disease Surveillance and Response
paragraphs: In the United States, responsibility for disease surveillance is shared— involving health care providers; more than 3,000 local health departments,  including county, city, and tribal health departments; 59 state and  territorial health departments; more than 180,000 public and private  laboratories; and public health officials from multiple federal departments  and agencies.
States, through the use of their state and local health departments, have  principal responsibility for protecting the public’s health and therefore  take the lead in conducting disease surveillance and supporting response  efforts. According to the Institute of Medicine (IOM), most states require  health care providers to report any unusual illnesses or deaths—especially  those for which a cause cannot be readily established. Generally, local  health departments are responsible for conducting initial investigations  into reports of infectious diseases. Laboratory personnel test clinical and  environmental samples for possible exposures and identification of  illnesses. Epidemiologists in health departments use disease surveillance  systems to detect clusters of suspicious symptoms or diseases in order to  facilitate early detection and treatment. Local and state health  departments monitor disease trends. Local health departments are also  responsible for sharing information they obtain from providers or other  sources with their state departments of health. State health departments  are responsible for collecting surveillance information—which they share  on a voluntary basis with CDC and others—from across their state and for  coordinating investigations and response efforts. Public health officials  provide needed information to the clinical community and the public.
At the federal level, several departments and agencies are involved in  disease surveillance and response. For example,    HHS has primary responsibility for coordinating the nation’s response to  public health emergencies. As part of its mission, the department has a  role in planning to prepare for and respond to an influenza pandemic. One  action the department has taken is the development of a draft national  pandemic influenza plan, titled “Pandemic Influenza Preparedness and  Response Plan.”
CDC is charged with protecting the nation’s public health by directing  efforts to prevent and control diseases and responding to public health  emergencies. It has primary responsibility for conducting national disease  surveillance and developing epidemiological and laboratory tools to  enhance disease surveillance. CDC also provides an array of technical and  financial support for state infectious disease surveillance efforts. In  addition, CDC participates in international disease and laboratory  surveillance sponsored by WHO.
FDA is responsible for ensuring that new vaccines and drugs are safe and  effective and for conducting research on diagnostic tools and treatment of  disease outbreaks. The agency also regulates and licenses vaccines and  antiviral agents through the Center for Biologics Evaluation and Research  and the Center for Drug Evaluation and Research, respectively. FDA also  develops influenza viral reference strains and reagents and makes them  available to manufacturers for vaccine development and evaluation.
The Department of Defense (DOD) contributes to global disease  surveillance, training, research, and response to emerging infectious  disease threats. DOD maintains the DOD Influenza Surveillance Program,  a laboratory-based surveillance program. DOD maintains multiple sites  throughout the world that serve as sentinels for disease outbreaks, where  it collects and analyzes viral specimens.
The Department of Agriculture (USDA) is responsible for protecting and  improving the health and marketability of animals and animal products by  preventing, controlling, and eliminating animal diseases. USDA undertakes  disease surveillance and response activities to protect U.S. livestock,  ensure the safety of international trade, and contribute to the national  zoonotic disease surveillance effort.
The United States is a member of WHO, which is responsible for  coordinating international disease surveillance and response efforts. An  agency of the United Nations, WHO administers the International Health  Regulations, which outline WHO’s role and the responsibility of member  countries and regions in preventing the global spread of infectious  diseases. WHO also helps marshal resources from its members to control  outbreaks within individual countries or regions. In addition, WHO works  with national governments to improve their surveillance capacities  through—for example—assessing and redesigning national surveillance  strategies, offering training in epidemiologic and laboratory techniques,  and emphasizing more efficient communication systems.
section_title: Existing Influenza Surveillance System and Enhancements Would Be Used to Identify an Influenza Pandemic
paragraphs: Surveillance is a key component in planning for an influenza pandemic,  and federal public health officials plan to rely on the nation’s existing  annual influenza surveillance system and enhancements to identify an  influenza pandemic. Federal public health officials have undertaken  several initiatives that are intended to enhance influenza surveillance  capabilities. These initiatives have been undertaken both through  programs specific to influenza as well as through programs focused more  generally on increasing preparedness for bioterrorism and other emerging  infectious disease health threats. Federal officials have implemented and  expanded syndromic surveillance systems in order to detect outbreaks  more quickly, but there are concerns that these systems are costly to run  and still largely untested. Federal officials have also implemented  initiatives designed to improve public health communications and have  undertaken initiatives intended to improve the coordination of zoonotic  surveillance efforts.
subsections: section_title: Systems Are in Place to Routinely Monitor for Influenza
paragraphs: Current U.S. surveillance for identifying annual influenza outbreaks as  well as an influenza pandemic involves multiple public health partners at  all levels of government and relies on several data sources. At the federal  level, CDC’s Influenza Branch leads the national influenza surveillance  effort, monitoring disease and viral trends using data submitted each week  from October through May. These surveillance data are collected at the  local and state levels and voluntarily submitted to CDC. Data submitted on  influenza activity in the United States include data from more than 120  laboratories and 2,000 health care providers and mortality reports from  122 cities. In addition, influenza data are collected from all 50 state health  departments and the health departments in the District of Columbia and  New York City. CDC also receives data that are specifically focused on  influenza in pediatric patients. When the data are used collectively, they  provide a national picture of influenza activity. Specifically, they allow  CDC to (1) identify when and where influenza activity is occurring,   (2) determine what strains of the influenza virus are in circulation,   (3) detect changes in the influenza virus, (4) monitor influenza-related  illnesses, and (5) measure the impact influenza is having on deaths in the  United States.
DOD also plays a role in national and international influenza surveillance.  Specifically, DOD’s Influenza Surveillance Program, under the direction of  the Air Force, collects viral specimens from its active duty personnel and  their dependents at military facilities around the world. DOD’s program  also sends specimens to CDC for further analysis and contributes to the  determination of which viral strains FDA includes in the nation’s annual  influenza vaccine. Internationally, DOD provides viral specimens to WHO  and assists in identifying emerging influenza strains.
In countries throughout the world, infectious disease surveillance is a  national responsibility, but WHO assists its members’ efforts through its  Global Influenza Surveillance Network. WHO’s Network is composed of  112 institutions, called National Influenza Centres, from 83 countries.  Collectively, these Centres monitor influenza activity and annually gather  more than 175,000 viral specimens for analysis from patients with  influenza-like illnesses throughout the world. Selected influenza isolates— an estimated 2,000 viruses—may also be sent to one of four WHO  Collaborating Centres for further, more specific genetic analysis. The  additional analysis conducted by the WHO Collaborating Centers is used  for the annual WHO recommendations on which strains to include in the  influenza vaccine for the northern and southern hemispheres. In addition  to making recommendations on the components of the influenza vaccine,  this Global Influenza Surveillance Network also serves as a global alert  mechanism for the emergence of influenza viruses with pandemic  potential.
section_title: Federal Agencies Have Undertaken Initiatives to Enhance Influenza Surveillance
paragraphs: CDC has undertaken several initiatives that are intended to enhance  influenza surveillance capabilities in preparation for an influenza  pandemic. CDC works with its international partners to improve global  surveillance for influenza. For example, CDC participates in international  disease and laboratory surveillance sponsored by WHO. Also, when  concerns were raised over recent influenza seasons that the avian  influenza A (H5N1) could become the next influenza pandemic, CDC led a  variety of efforts with its international partners to plan for and address  threats of increased influenza activity worldwide. For example, CDC  worked collaboratively with WHO to conduct investigations of avian  influenza A in Vietnam and to provide laboratory testing. CDC also  provided training assistance and has implemented an initiative to improve  influenza surveillance in Asia.
CDC also supports several domestic initiatives to improve surveillance  capabilities for influenza. For example, CDC supports enhanced influenza  surveillance activities through its Epidemiology and Laboratory Capacity  (ELC) Grants. Established in 1997, this program provides funding to state  and local influenza programs. Grants have steadily increased from the first  awards in 1997, when less than $100,000 was provided to five states  through August 2004, with funding totaling more than $2 million being  given to about 47 states or major metropolitan areas. States and cities  receiving ELC-influenza funding are encouraged to achieve three  highlighted influenza epidemiology and laboratory surveillance capacities:  sentinel physician surveillance, viral isolation and subtyping, and year- round surveillance. Each state targets funding to meet one or more of  these three priorities and uses funding for support of improvements that  include the assignment or hiring of an influenza coordinator, recruitment  of sentinel physicians to collect influenza specimens and report influenza- like illness to the state, laboratory infrastructure enhancements to  increase influenza testing capabilities for viral isolation and subtyping, and  expansion of influenza surveillance activities to year-round.
In an effort to enhance the ability to detect infectious disease outbreaks,  particularly in their early stages, federal funding has supported state  efforts to implement numerous syndromic surveillance systems. These  systems collect information on syndromes from a variety of sources. For  example, the National Retail Data Monitor (NRDM) collects data from  retail sources instead of hospitals. As of February 2004, NRDM collected  sales data from about 19,000 stores, including pharmacies, in order to  monitor sales patterns in such items as over-the-counter influenza  medications for signs of a developing infectious disease outbreak.
CDC is taking steps to enhance its two public health communications  systems, the Health Alert Network (HAN) and the Epidemic Information  Exchange (Epi-X), which are used in disease surveillance and response  efforts. For example, CDC is working to increase the number of HAN  participants who receive assistance with their communication capacities.  In addition, following reports of human deaths from avian influenza A in  Vietnam in August 2004, CDC issued a HAN message reiterating criteria for  domestic surveillance, diagnostic evaluation, and infection control  precautions. CDC also issued detailed laboratory testing procedures for  avian influenza through HAN. Similarly, CDC has expanded Epi-X by  giving officials at other federal agencies and departments, such as DOD,  the ability to use the system. CDC is also adding users to Epi-X from local  health departments, giving access to CDC staff in other countries, and  making the system available to Field Epidemiology Training Programs  (FETP) located in 21 countries. Finally, CDC is facilitating Epi-X’s  interface with other data sources by allowing users to access the Global  Public Health Intelligence Network (GPHIN), the system that searches  Web-based media for information on infectious disease outbreaks  worldwide.
In addition to the efforts to enhance communication systems, federal  public health officials also have enhanced federal coordination for  zoonotic disease surveillance and expanded training programs. According  to CDC, nearly 70 percent of emerging infectious disease episodes during  the past 10 years have been zoonotic diseases. Moreover, recent outbreaks  of human disease caused by avian influenza strains in Asia and Europe  highlight the potential for new strains to be introduced into the  population. Surveillance for zoonotic diseases requires collaboration  between animal and human disease specialists. CDC, USDA, and FDA have  made efforts to enhance their coordination of zoonotic disease  surveillance. For example, CDC and UDSA are working with two national  laboratory associations to add veterinary diagnostic laboratories to the  Laboratory Response Network (LRN). As of May 2004, 10 veterinary  laboratories had been added to LRN, and CDC officials told us that they  had plans to add more veterinary laboratories in the future. In addition,  CDC officials told us the agency has appointed a staff person whose  responsibility, in part, is to assist in finding ways to enhance zoonotic  disease coordination efforts among federal agencies and departments and  with other organizations. This person is helping CDC develop a working  group of officials from CDC, USDA, and FDA to coordinate zoonotic  disease surveillance. According to CDC officials, the goal of this working  group is to explore ways to link existing surveillance systems to better  coordinate and integrate surveillance for wildlife, domestic animal, and  human diseases. CDC officials also said that the agency is exploring the  feasibility of a pilot project to demonstrate this proposed integrated  zoonotic disease surveillance system. In addition, USDA officials told us  that they hired 23 wildlife biologists in fall 2003 to coordinate disease  surveillance, monitoring, and management activities among USDA, CDC,  states, and other federal agencies. While each of these initiatives is  intended to enhance the surveillance of zoonotic diseases, each is still in  the planning stage or the very early stages of implementation.
USDA also conducts influenza surveillance in domestic animals.  Coordination with USDA is important because a pandemic strain is likely  to arise from genetic mixing of animal and human influenza viruses.  Recent outbreaks in domestic poultry in Asia and Europe associated with  cases of human disease highlight the importance of coordinating  surveillance activities. Surveillance for influenza viruses in poultry in the  United States has increased substantially since the outbreak of highly  pathogenic avian influenza (HPAI) in Pennsylvania and surrounding states  in 1983 and 1984. However, individual states are generally responsible for  the development and implementation of surveillance programs that are  consistent with the size and complexity of the resident poultry industry.
section_title: Despite Efforts by Federal Officials, Challenges Remain regarding Preparedness for and Response to an Influenza Pandemic
paragraphs: Challenges regarding the nation’s preparedness for and response to an  influenza pandemic remain. Specifically, our prior work has found that  although CDC participated in an interagency working group that  developed the U.S. plan for pandemic preparedness that was posted for  public comment in August 2004, as of May 23, 2005, the plan had not been  finalized. Further, we found that the draft plan does not address certain  critical issues, including how vaccine for an influenza pandemic will be  purchased, distributed, and administered; how population groups will be  prioritized for vaccination; what quarantine authorities or travel  restrictions may need to be invoked; and how federal resources should be  deployed. At the state level, we found that most hospitals across the  country lack the capacity to respond to large-scale infectious disease  outbreaks.
subsections: section_title: HHS’s Pandemic Influenza Plan Remains in Draft and Leaves Many Important Issues Unresolved
paragraphs: In August 2004, HHS released its national pandemic influenza plan for  comment. The draft “Pandemic Influenza Preparedness and Response  Plan” describes HHS’s role in coordinating a national response to an  influenza pandemic and provides guidance and tools to promote pandemic  preparedness planning and coordination at the federal, state, and local  levels, including both the public and the private sectors. However, as of  May 23, 2005, this document remained in draft form. Further, although the  plan is comprehensive in scope, it leaves many important decisions  unresolved about the purchase, distribution, and administration of  vaccines. For example, some decisions yet to be made include determining  the public- versus private-sector roles in the purchase and distribution of  pandemic influenza vaccines; the division of responsibility between the  federal government and the states for vaccine distribution; and how  population groups will be prioritized and targeted to receive limited  supplies of vaccines. Until these key decisions are made, public health  officials at all levels may find it difficult to plan for an influenza pandemic,  and the timeliness and adequacy of response efforts may be compromised.
The draft plan does not establish a definitive federal role in the purchase  and distribution of vaccines during an influenza pandemic. Instead, HHS  provides options for vaccine purchase and distribution that include public- sector purchase and distribution of all pandemic influenza vaccine; a  mixed public-private system where public-sector supply may be targeted  to specific priority groups; and maintenance of the current largely private  system. In its draft plan, HHS does not recommend a specific alternative.
Furthermore, the draft plan delegates to the states responsibility for  distribution of vaccine. The lack of a clearly defined federal role in  distribution complicates pandemic planning for the states. Furthermore,  among the current state pandemic influenza plans, there is no consistency  in terms of their procurement and distribution of vaccine and the relative  role of the federal government. Approximately half of the states handle  procurement and distribution of the annual influenza vaccine through the  state health agency. The remainder either operate through a third-party  contractor for distribution to providers or use a combination of these two  approaches.
section_title: Challenges Persist in Ensuring an Adequate and Timely Influenza Vaccine Supply
paragraphs: Challenges persist in ensuring an adequate and timely influenza vaccine  supply. The number of producers remains limited, and the potential for  manufacturing problems such as those experienced during the 2004-2005  influenza season is still present. When one manufacturer’s production is  affected, providers who order vaccine from that manufacturer can  experience shortages, while providers who receive supplies from another  manufacturer may have all the vaccine they need. The allocation plan CDC  developed for this past season’s shortage was dependent upon voluntary  compliance by the private sector and individuals to forgo vaccination.  Most annual influenza vaccine distribution and administration are  accomplished within the private sector, with relatively small amounts of  vaccine purchased and distributed by CDC or by state and local health  departments. In the United States, 85 percent of vaccine doses are  purchased by the private sector, such as private physicians and  pharmacies. HHS has not yet determined how influenza vaccine will be  distributed and administered during an influenza pandemic.
There are many issues surrounding the production of influenza vaccine,  which will only become exacerbated during an influenza pandemic.  Vaccines, which are considered the first line of defense to prevent or  reduce influenza-related illness and death, may be unavailable or in short  supply. Producing the vaccine is a complex process that involves growing  viruses in millions of fertilized chicken eggs. Experience has shown that  the vaccine production cycle takes at least 6 to 8 months after a virus  strain has been identified, and vaccines for some influenza strains have  been difficult to mass-produce, causing further delay. The lengthy process  for developing a vaccine may mean that a vaccine would not be available  during the initial stages of a pandemic.
Vaccine shortages during the 2004-2005 influenza season have highlighted  the fragility of the influenza vaccine market and the need for its expansion  and stabilization. Currently, only two manufacturers are licensed to sell  their vaccine in the United States. Maintaining an influenza vaccine  supply is critically important for protecting the public’s health and  improving our preparedness for an influenza pandemic. As a result,  according to CDC officials, the agency plans to alleviate the impact of next  year’s influenza season by taking aggressive steps to ensure an expanded  influenza supply to protect the nation. To this end, the agency’s fiscal year  2006 budget request includes an increase of $30 million for CDC to enter  into guaranteed purchase contracts with vaccine manufacturers to ensure  the production of bulk monovalent influenza vaccine. If supplies fall short,  this bulk product can be turned into a finished trivalent influenza vaccine  product for annual distribution. If supplies are sufficient, the bulk vaccine  can be held until the following year’s influenza season and developed into  vaccines if the circulating strains remain the same. In addition, according  to CDC, this guarantee will help to expand the influenza market by  providing an incentive to manufacturers to expand capacity and possibly  encourage additional manufacturers to enter the market. In addition, the  fiscal year 2006 budget request includes an increase of $20 million to  support influenza vaccine purchase activities.
Even if sufficient quantities of the vaccine are produced in time, vaccines  against various strains differ in their ability to produce the immune  response necessary to provide effective protection against the disease.  Studies show that it is uncertain how effective a vaccine will be in  preventing or controlling the spread of a pandemic influenza virus.
section_title: Challenges Persist in Ensuring an Adequate Supply of Antiviral Drugs
paragraphs: Early in an influenza pandemic, especially before a vaccine is available or  during a period of limited vaccine supply, use of antiviral drugs may have a  significant effect. Specifically, antiviral drugs can help prevent or mitigate  the number of influenza-related deaths until an influenza vaccine becomes  available. They can be used against all strains of pandemic influenza and  have immediate availability as both a prophylactic to prevent illness and as  a treatment if administered within 48 hours of the onset of symptoms.  According to HHS, analysis is ongoing to define optimal antiviral use  strategies, potential health impacts, and cost-effectiveness of antiviral  drugs in the setting of a pandemic.
The United States has a limited supply of influenza antiviral medications  stored for an influenza pandemic. HHS officials expect the amount  produced will be below demand during a pandemic. This assumption,  supported by drug manufacturers, is based on the fact that current  production levels of antiviral drugs are set in response to current demand,  whereas demand in a pandemic is expected to increase significantly if  vaccines are unavailable. In addition, the production of antiviral  medications cannot be rapidly expanded and involves a long production  process. Moreover, sometimes influenza virus strains can become resistant  to one or more of the four approved influenza antiviral drugs, and thus the  drugs may not always work. For example, the influenza A (H5N1) viruses  identified in human patients in Asia in 2004 and 2005 have been resistant  to two of the four antiviral drugs, amantadine and rimantadine.
section_title: Implementation of Control Measures to Prevent Spread of Pandemic Influenza Presents Difficulties
paragraphs: Another challenge in responding to an influenza pandemic involves  implementing certain control measures to prevent the spread of the  disease. These control measures—case identification and contact tracing,  transmission control, and exposure management—are well-established  and have proved effective in both health care and community settings.  However, federal attempts to limit the spread of SARS into the United  States by advising passengers who traveled to infected countries faced  multiple obstacles. For example, due to airline concerns over authority  and privacy, as well as procedural constraints, CDC was unable to obtain  passenger contact information it needed to trace travelers. Although HHS  has statutory authority to prevent the introduction, transmission, or  spread of communicable diseases from foreign countries into the United  States, HHS regulations implementing the statute do not specifically  provide for HHS to obtain passenger manifests or other passenger contact  information from airlines and shipping companies for disease outbreak  control purposes.
section_title: Most Hospitals Lack the Capacity to Respond to Large-Scale Infectious Disease Outbreaks
paragraphs: A challenge identified during the SARS outbreak that may also affect  response efforts during an influenza pandemic is lack of sufficient hospital  and workforce capacity. This lack could be exacerbated during an  influenza pandemic, compared to other natural disasters, such as a  tornado or hurricane, or an intentional release of a bioterrorist agent,  because it is likely that a pandemic would result in both widespread and  sustained effects.
Public health officials we spoke with said a large-scale outbreak, such as  an influenza pandemic, could strain the available capacity of hospitals by  requiring entire hospital sections (along with their staff) to be used as  isolation facilities. As we have reported earlier, most states lack “surge  capacity,” that is, the capacity to respond to the large influx of patients  that could occur during a large public health emergency. For example,  few states reported that they had the capacity to evaluate, diagnose, and  treat 500 or more patients involved in a single incident. In addition, few  states reported having the capacity to rapidly establish clinics to immunize  or provide treatment to large numbers of patients. Moreover, a shortage in  workforce could increase during an influenza pandemic because higher  disease rates could result in high rates of absenteeism among health care  workers who are likely to be at increased risk of exposure and illness.
section_title: Concluding Observations
paragraphs: There are a number of systems in place to identify influenza outbreaks  abroad, to alert us to a pandemic, and these systems generally appear to  be working well. HHS has taken important steps to enhance surveillance  and to fund initiatives for preparedness and response, including steps to  increase the vaccine supply.
However, important challenges remain in our preparedness to respond,  should an influenza pandemic occur in the United States. The steps HHS is  taking to address vaccine production capacity and stockpiling of antiviral  drugs may not be in place in time to fill the current gaps in preparedness  should an influenza pandemic occur in the next several years. As we  learned in the 2004-2005 influenza season, problems affecting even a single  manufacturer can produce major shortages. Once a pandemic influenza  strain is identified, a vaccine will take many months to produce, and our  current stockpile of antiviral drugs is insufficient to meet the likely  demand. Pandemic influenza would have major impacts on the ability of  communities to respond, businesses to function, and public safety to be  maintained when communities across the country are simultaneously  impacted and hospital capacity is overwhelmed.
Since 2000, we have been urging the department to complete its pandemic  plan. A draft plan was issued in August 2004, with a 60-day period for  public comment, but as of this week, the plan had not been finalized. It is  important for the federal government and the states to work through  issues such as how vaccine will be purchased, distributed, and  administered, how population groups will be prioritized for vaccination,  what quarantine authorities or travel restrictions may need to be invoked,  and how federal resources should be deployed before we are in a time of  crisis.
Mr. Chairman, this concludes my prepared statement. I would be happy to  respond to any questions you or other Members of the Subcommittee may  have at this time.
section_title: Contact and Staff Acknowledgments
paragraphs: For further information about this testimony, please contact Marcia  Crosse at (202) 512-7119. Gloria E. Taylor, Gay Hee Lee, Elizabeth T.  Morrison, and Roseanne Price made key contributions to this statement.
section_title: Related GAO Products
paragraphs: Emergng Infecious Diseases: Revew of Sate and Federal Disease  Surveillance Effors. GAO-04-877. Washington, D.C.: September 30, 2004. t nectous Disease Preparedness: Federal Chalenges in Responding to I f i Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28,  2004.
Emergng Infecious Diseases: Asian SARS Outbreak Challenged  I tnernational and Natonal Responses. GAO-04-564. Washington, D.C.: i April 28, 2004.
Publc Heath Preparedness: Response Capac y mproving, bu Much  t Remains to Be Accomp shed. GAO-04-458T. Washington, D.C.:   February 12, 2004.
Infectious Diseases: Gaps Remain in Survei ance Capabil ies o State and  Local Agences. GAO-03-1176T. Washington, D.C.: September 24, 2003. i Severe Acute Respiraory Syndrome: Estabished Infectious Dsease  Control Measures Helped Contain Spread, But a Large-Scale Resurgence  May Pose Challenges. GAO-03-1058T. Washington, D.C.: July 30, 2003.
SARS Outbreak: Improvemens to Pub c Health Capacity Are Needed for Responding o Bioerrorism and Emergng Infectous Diseases. GAO-03-tti 769T. Washington, D.C.: May 7, 2003.
Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have  Improved Pub c HealhResponse Capacty, but Gaps Reman. GAO-03-t  liii 654T. Washington, D.C.: April 9, 2003.
Global Healh: Chalenges in Improving Infectious Disease Surve ance  Systems. GAO-01-722. Washington, D.C.: August 31, 2001.
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future  Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001.
Flu Vaccne: Supply Probems Heighen Need o Ensure Access for High Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.  nluenza Pandemic: Pan Needed for Federal and State Response. GAO- I f 01-4. Washington, D.C.: October 27, 2000.  l West Nile Virus Outbreak: Lessons for Pubic Healh Preparedness.  GAO/HEHS-00-180. Washington, D.C.: September 11, 2000.
Global Health: Framework for Infectious Disease Surveillance.  GAO/NSIAD-00-205R. Washington, D.C.: July 20, 2000.
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