Influenza Pandemic: Challenges in Preparedness and Response
Published: 2005-06-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Shortages of influenza vaccine in the 2004-05 and previous influenza seasons and mounting concern about recent avian influenza activity in Asia have raised concern about the nation's preparedness to deal with a worldwide influenza epidemic, or influenza pandemic. Although the extent of such a pandemic cannot be predicted, according to the Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), it has been estimated that in the absence of any control measures such as vaccination or antiviral drugs, a "medium-level" influenza pandemic could kill up to 207,000 people in the United States, affect from 15 to 35 percent of the U.S. population, and generate associated costs ranging from $71 billion to $167 billion in the United States. GAO was asked to discuss the challenges the nation faces in responding to the threat of an influenza pandemic, including the lessons learned from previous annual influenza seasons that can be applied to its preparedness and overall ability to respond to a pandemic. This testimony is based on GAO reports and testimony issued since 2000 on influenza vaccine supply, pandemic planning, emergency preparedness, and emerging infectious diseases and on current work examining the influenza vaccine shortage in the United States for the 2004-05 influenza season.
section_title: What GAO Found
paragraphs: The nation faces multiple challenges to prepare for and respond to an influenza pandemic. First, key questions about the federal role in purchasing and distributing vaccines during a pandemic remain, and clear guidance on potential priority groups is lacking in HHS's current draft of its pandemic preparedness plan. For example, the draft plan does not establish the actions the federal government would take to purchase or distribute vaccine during an influenza pandemic. In addition, as was highlighted in the nation's recent experience responding to the unexpected influenza vaccine shortage for the 2004-05 influenza season, clear communication of the nation's response plan will be a major challenge. During the 2004-05 influenza season, state health officials reported that mixed messages created confusion. For example, CDC advised vaccination for persons aged 65 and older, and at the same time a state advised vaccination for persons aged 50 and older. Further challenges include ensuring an adequate and timely supply of influenza vaccine and antiviral drugs, which can help prevent or mitigate the number of influenza-related deaths. Particularly given the length of time needed to produce vaccines, influenza vaccine may be unavailable or in short supply and might not be widely available during the initial states of a pandemic. Finally, the lack of sufficient hospital and health care workforce capacity to respond to an infectious disease outbreak may also affect response efforts during an influenza pandemic. Public health officials we spoke with said that 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.

section_title: Letter
paragraphs: I am pleased to be here today as you discuss the nation’s preparedness to  respond to a worldwide influenza epidemic—known as a pandemic.  Shortages of influenza vaccine in the 2004–05 and previous annual  influenza seasons, as well as mounting concern about recent avian  influenza activity in Asia, have raised concern about the nation’s  preparedness to deal with a pandemic. Pandemic influenza, which arises  periodically but unpredictably from a major genetic change in the  influenza virus, can lead to worldwide disease and death. Although the  extent of the next pandemic cannot be predicted, modeling studies suggest  that its effect in the United States could be severe. According to the  Centers for Disease Control and Prevention (CDC), it has been estimated  that in the absence of any control measures such as vaccination and drugs,  a “medium-level” influenza pandemic in the United States could kill 89,000  to 207,000 people, affect from 15 to 35 percent of the U.S. population, and  generate associated costs ranging from $71 billion to $167 billion. In the  event of a pandemic, the nation will likely experience a vaccine shortage.  The nation’s experience responding to the unexpected shortage of annual  influenza vaccine during the 2004–05 influenza season—in which public  health officials sought to match available vaccine supply with demand— underscores the challenges that federal, state, and local entities would  need to meet in the event of a pandemic. In addition, our recent work has  highlighted other challenges in responding to pandemic influenza.
You asked us to provide our perspective on the nation’s preparedness for  responding to an influenza pandemic, including the lessons learned from  previous annual influenza seasons that would be applicable to pandemic  preparedness. In this testimony, I will discuss challenges we identified  related to (1) planning for the purchase and distribution of influenza  vaccine, including defining priority groups to be vaccinated;   (2) communicating information about the situation and the response plan  clearly and effectively among health officials, providers, and the public;   (3) ensuring an adequate supply of vaccine and antiviral drugs; and   (4) addressing hospital and workforce capacity to respond to large-scale  outbreaks of infectious disease, including pandemic influenza.
My testimony today is based on reports and testimony on influenza  vaccine supply, pandemic planning, emergency preparedness, and  emerging infectious diseases that we have issued since October 2000 and  on a review in progress for this committee on actions taken and lessons  learned at federal, state, and local levels to ensure that high-risk  individuals had access to vaccine during the 2004–05 influenza vaccine  shortage. Our prior work includes analysis of information provided by and  interviews with officials in the Department of Health and Human Services  (HHS), specifically from CDC, the Food and Drug Administration (FDA),  and the National Vaccine Program Office. We also interviewed public  health department officials, vaccine manufacturers, and vaccine  distributors; surveyed physician group practices; and reviewed HHS’s  August 2004 draft Pandemc nfuenza Preparedness and Response Pan.  l Since March 2005 we have reviewed documents and interviewed officials  from HHS, CDC, and the National Vaccine Program Office; national  organizations, including the Association of State and Territorial Health  Officials; organizations that conduct mass immunization clinics; a major  vaccine manufacturer; and a large purchaser of influenza vaccine. We also  conducted site visits at a judgmental sample of states and localities.  We  conducted our work in accordance with generally accepted government  auditing standards. CDC and the National Vaccine Program Office  provided comments on the facts contained in this statement, and we made  changes as appropriate.
In summary, the nation faces multiple challenges to prepare for and  respond to an influenza pandemic. First, key questions remain about the  federal role in purchasing and distributing vaccines during a pandemic,  and clear guidance on potential priority groups is lacking in HHS’s current  draft of its pandemic preparedness plan. In addition, as highlighted by the  nation’s recent experience responding to the unexpected influenza vaccine  shortage for the 2004–05 influenza season, clear communication of the  nation’s response plan will be a major challenge. Further challenges  include ensuring an adequate and timely supply of influenza vaccine and  antiviral drugs, which can help prevent or mitigate the number of  influenza-related deaths. Finally, the lack of sufficient hospital and health  care workforce capacity to respond to an infectious disease outbreak may  also affect response efforts during an influenza pandemic.
subsections: section_title: Background
paragraphs: Influenza is more severe than some other viral respiratory infections, such  as the common cold. Most people who contract 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 generally more likely than  others to develop severe complications from influenza.
Vaccination is the primary method for preventing influenza and its more  severe complications. Produced in a complex process that involves  growing viruses in millions of fertilized chicken eggs, influenza vaccine is  administered annually to provide protection against particular influenza  strains expected to be prevalent that year. Experience has shown that  vaccine production generally takes 6 or more months after a virus strain  has been identified; vaccines for certain influenza strains have been  difficult to mass-produce. After vaccination, it takes about 2 weeks for the  body to produce the antibodies that protect against infection. According to  CDC recommendations, the optimal time for vaccination is October  through November, because the annual influenza season typically does not  peak until January or February. Thus, in most years vaccination in  December or later can still be beneficial.
At present, two vaccine types are recommended for protection against  influenza in the United States: an inactivated virus vaccine injected into  muscle and a live virus vaccine administered as a nasal spray. The  injectable vaccine—which represents the large majority of influenza  vaccine administered in this country—can be used to immunize healthy  individuals and those at highest risk for complications, including those  with chronic illness and those aged 65 and older, but the nasal spray  vaccine is currently approved for use only among healthy individuals aged  5 to 49 years who are not pregnant. Vaccine manufacture and purchase  take place largely within the private sector: for the 2004–05 influenza  season, two companies (one producing the injectable vaccine and one  producing the nasal spray) manufactured vaccine for the U.S. market.
Although vaccination is the primary strategy for protecting individuals  who are at greatest risk of serious complications and death from influenza,  antiviral drugs can also contribute to the treatment and prevention of  influenza. Four antiviral drugs have been approved for treatment. If taken  within 2 days after symptoms begin, these drugs can reduce symptoms and  make someone with influenza less contagious to others. Three of the four  antiviral drugs are also approved for prevention; according to CDC, they  are about 70 to 90 percent effective for preventing illness in healthy adults.
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 the planning needed to prepare for and respond to an influenza  pandemic. One action the department has taken is to develop a draft  national pandemic influenza plan, titled Pandemc In uenza Preparedness i fl and Response Pan, which was released in August 2004 for a 60-day l comment period. Within HHS, CDC is the principal agency for protecting  the nation’s health and safety. CDC’s activities include efforts to prevent  and control diseases and to respond to public health emergencies. CDC  and its Advisory Committee on Immunization Practices (ACIP)  recommend which population groups should be targeted for vaccination  each year and, when vaccine supply allows, recommends that any person  who wishes to decrease his or her risk of influenza-like illness be  vaccinated. FDA, another HHS agency, also plays a role in preparing for  the annual influenza season and for a potential pandemic. FDA is  responsible for ensuring that new vaccines and drugs are safe and  effective. The agency also regulates and licenses vaccines and antiviral  agents.
HHS has limited authority to control vaccine production and distribution  directly; influenza vaccine supply and marketing are largely in the hands of  the private sector. Although the Public Health Service Act authorizes the  Secretary of HHS to “take such action as may be appropriate” to respond  to a public health emergency, as determined and declared by the  Secretary, it is not clear whether or to what extent the Secretary could  directly influence the manufacture or distribution of influenza vaccine to  respond to an influenza pandemic. The appropriateness of the Secretary’s  response would depend on the nature of the public health emergency, for  example on the available evidence relating to a pandemic. According to a  senior HHS official involved in HHS emergency preparedness activities,  manufacturers of vaccine for the U.S. market have agreed in principle to  switch to production of pandemic influenza vaccine should the need arise  and proper compensation and indemnification be provided; therefore, he  said, it would probably be unnecessary for the federal government to  nationalize vaccine production, although the federal government has the  legal authority to do so if circumstances warrant it.
For the 2004–05 influenza season, CDC estimated as late as September  2004 that about 100 million doses of vaccine would be available for the  U.S. market. CDC and ACIP recommended vaccination for about   185 million people, including roughly 85 million people at high risk for  complications. On October 5, 2004, however, one manufacturer  announced that it could not provide its expected production of   46–48 million doses—roughly half of the U.S. supply of expected vaccine.
Because a large proportion of vaccine produced by the other major  manufacturer of injectable vaccine had already been shipped before  October 5, 2004, about 25 million doses of injectable vaccine for high-risk  individuals and others, and about 1 million doses of the nasal spray  vaccine for healthy people, were available after the announcement to be  distributed to Americans who wanted an influenza vaccination.
Preparing for and responding to an influenza pandemic differ in several  respects from preparing for and responding to a typical influenza season.  For example, past influenza pandemics have affected healthy young adults  who are not typically at high risk for complications associated with  influenza, and a pandemic could result in an overwhelming burden of ill  persons requiring hospitalization or outpatient medical care. In addition,  the demand for vaccine may be greater in a pandemic.
section_title: Planning for Purchase and Distribution of Vaccine and Defining Priority Groups
paragraphs: Challenges remain in planning for purchase and distribution of vaccine  and defining priority groups in the event of a pandemic. HHS has not  finalized planning for an influenza pandemic, leaving unanswered  questions about the nation’s ability to prepare for and respond to such an  outbreak. For the past 5 years, we have been urging HHS to complete its  pandemic influenza plan. The document remains in draft form, although  federal officials said in June 2005 that an update of the plan is being  completed and is expected to be available in summer 2005. Key questions  about the federal role in purchasing and distributing vaccines during a  pandemic remain, and clear guidance on potential groups that would likely  have priority for vaccination is lacking in the current draft plan.
One challenge is that the draft pandemic plan does not establish the  actions the federal government would take to purchase or distribute  vaccine during an influenza pandemic. Rather, it describes options for  vaccine purchase and distribution, which include public-sector purchase  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. The draft plan does not  specifically recommend any of these options. According to the draft plan,  the federal government’s role may change over the course of a pandemic,  with greater federal involvement early, when vaccine is in short supply.  Noting that several uncertainties make planning vaccination strategies  difficult, the draft plan states that national, state, and local planning needs  to address possible contingencies, so that appropriate strategies are in  place for whichever situation arises.
If public-sector vaccine purchase is an option, establishing the funding  sources, authority, or processes to do so quickly may be needed. During  the 2004–05 shortage, some state health officials reported problems with  states’ ability, with regard to both funding and the administrative process,  to purchase influenza vaccine. For example, during the effort to  redistribute vaccine to locations of greatest need, the state of Minnesota  tried to sell its available vaccine to other states seeking additional vaccine  for their high-risk populations. According to federal and state health  officials, however, certain states lacked the funding or authority under  state law to purchase the vaccine when Minnesota offered it. In response  to problems encountered during the 2004–05 shortage, the Association of  Immunization Managers proposed in 2005 that federal funds be set aside  for emergency purchase of vaccine by public health agencies and that cost  not be a barrier in acquiring vaccine to distribute to the public.
Although an influenza pandemic may differ from an annual influenza  season, experience during the 2004–05 shortage illustrates the importance  of having a distribution plan in place ahead of time to prevent delays when  timing is critical:    Collaborating with stakeholders to create a workable distribution  plan is time consuming. After the October 5, 2004, announcement of the  sharp reduction in influenza vaccine supply, CDC began working with the  sole remaining manufacturer of injectable vaccine on plans to distribute  this manufacturer’s remaining supply to providers across the country. The  plan had two phases and benefited from voluntary compliance by the  manufacturer to share proprietary information to help identify geographic  areas of greatest need for vaccine. The first phase, which began in October  2004, filled or partially filled orders from certain provider types, including  state and local public health departments and long-term care facilities. The  second phase, which began in November 2004, used a formula to  apportion the remaining doses across the states according to each state’s  estimated percentage of the national unmet need. States could then  allocate doses from their apportionment to providers and facilities, which  would purchase the vaccine through a participating distributor. The state  ordering process under the second phase continued through mid-January.  Health officials in several states commented on the late availability of this  vaccine; officials in one state, for example, remarked that the phase two  vaccine was “too much, too late.”
Identifying priority groups in local populations also takes time.
Federal, state, and local officials need to have information on the  population of the priority groups and the locations where they can be  vaccinated to know how, where, and to whom to distribute vaccine in the  event of an influenza pandemic. During the 2004–05 influenza season,  federal officials developed a distribution plan to allocate a limited amount  of vaccine, but the states also had to determine how much vaccine was  needed and where to distribute it within their own borders. For example,  state health officials in Florida did not know exactly how many high-risk  individuals needed vaccination, so they surveyed long-term care facilities  and private providers to estimate the amount of vaccine needed to cover  high-risk populations. It took nearly a month for state officials to compile  the results of the surveys, to decide how many doses needed to be  distributed to local areas, and to receive and ship vaccine to the counties.
Distributing the vaccine to a state or locality is not the same as  administering the vaccine to an individual. Once vaccine has been  distributed to a state or local agency, individuals living in those areas still  need to be vaccinated. Vaccinating a large number of people is  challenging, particularly when demand exceeds available supply. For  example, during the 2004–05 influenza season, many places giving  vaccinations right after the shortage was announced were overwhelmed  with individuals wanting to be vaccinated. Certain local public health  departments in California, including the Santa Clara County Public Health  Department, provided chairs and extra water for people waiting in long  lines outdoors in warm weather. Fear of a more virulent pandemic  influenza strain could exacerbate such scenarios. A number of states  reported that they did not have the capacity to immunize large numbers of  people and partnered with other organizations to increase their capacity.  For example, in 2004–05, according to state health officials in Florida,  county health departments, including those in Orange and Broward  Counties, worked with a national home health organization to immunize  high-risk individuals by holding mass immunization clinics and setting up  clinics in providers’ offices to help administer available vaccine quickly.  Other locations, including the local health department in Portland, Maine,  held lotteries for available vaccine; according to local health officials,  however, administrative time was required to arrange and publicize the  lottery.
HHS’s draft pandemic plan does not define priority groups for vaccination,  although the plan states that HHS is developing an initial list of suggested  priority groups and soliciting public comment on the list. The draft plan  instructs the states to define priority groups for early vaccination and  indicates that as information about virus severity becomes available,  recommendations will be formulated at the national level. According to  the plan, setting priorities will be iterative, tied to vaccine availability and  the pandemic’s progression. Without agreed-upon identification of  potential priority groups in advance, however, problems can arise. During  the 2004–05 season, for example, CDC and ACIP acted quickly on   October 5, 2004, to narrow the priority groups for available vaccine, giving  the narrowed groups equal importance. In some places, however, there  was not enough available vaccine to cover everyone in these narrowed  priority groups, so states set their own priorities among these groups.  Maine, for example, excluded health care workers from the state’s early  priority groups because state officials estimated that there was not enough  vaccine to cover everyone in CDC and ACIP’s priority groups.
section_title: Communicating Information about the Situation and Response Plan Clearly and Effectively
paragraphs: Another challenge in responding to a pandemic will be to clearly  communicate information about the situation and the nation’s response  plans to public health officials, providers, and the public. Experience  during the 2004–05 vaccine shortage illustrates the critical role  communication plays when information about vaccine supply is unclear.
Communicating a consistent message and clearly explaining any  apparent inconsistencies. In a pandemic, clear communication on who  should be vaccinated will be important, particularly if the priority  population differs from those targeted for annual influenza vaccination, or  if the priority groups in one area of the country differ from those in others.  During the 2004–05 influenza season, health officials in Minnesota  reported that some confusion resulted when the state determined that  vaccine was sufficient to meet demand among the state’s narrower priority  groups and made vaccine available to other groups, such as healthy  individuals aged 50–64 years, earlier than recommended by CDC. Health  officials in California reported a similar situation. State health officials  pointed out that in mid-December, local radio stations in California were  running two public service announcements—one from CDC advising those  65 and older to be vaccinated and one from the California Department of  Health Services advising those 50 and older to be vaccinated. State  officials emphasized that these mixed messages created confusion.
Communicating information from a primary source. Having a primary  and timely source of information will be important in a pandemic. In the   2004–05 influenza season, individuals seeking vaccine could have found  themselves in a communication loop that provided no answers. For  example, CDC advised people seeking influenza vaccine to contact their  local public health department; in some cases however, individuals calling  the local public health department would be told to call their primary care  provider, and when they called their primary care provider, they would be  told to call their local public health department. This lack of a reliable  source of information led to confusion and possibly to high-risk  individuals’ giving up and not receiving the protection of an annual  influenza vaccination.
Recognizing that different communication mechanisms are  important and require resources. Another challenge in communicating  plans in the event of a pandemic will be to ensure that the communication  mechanisms used reach all affected populations. During the 2004–05  influenza season, public health officials reported the importance of  different methods of communication. For example, officials from the  Seattle–King County Public Health Department in Washington State  reported that it was important to have a hotline as well as information  posted on a Web site, because some seniors calling Seattle–King County’s  hotline reported that they did not have access to the Internet. According to  state and local health officials, however, maintaining these communication  mechanisms took time and strained personnel resources. In Minnesota, for  example, to supplement state employees, the state health department  asked public health nursing students to volunteer to staff the state’s  influenza vaccine hotline.
Educating health care providers and the public about all available  vaccines. For the 2004–05 season, approximately 3 million doses of nasal  spray vaccine were ultimately available for vaccinating healthy individuals  aged 5–49 years who were not pregnant, including some individuals (such  as health care workers in this age group and household contacts of  children younger than 6 months) in the priority groups defined by CDC  and ACIP, yet some of these individuals were reluctant to use this vaccine  because they feared that the live virus in the nasal spray could be  transmitted to others. State health officials in Maine, for example, reported  that the state purchased about 1,500 doses of the nasal spray vaccine for  their emergency medical service personnel and health care workers, yet  administered only 500 doses.
section_title: Ensuring Supply of Influenza Vaccine and Antiviral Drugs
paragraphs: Challenges in ensuring an adequate and timely supply of influenza vaccine  and antiviral drugs—which can help prevent or mitigate the number of  influenza-related deaths until an pandemic influenza vaccine becomes  available—may be exacerbated during an influenza pandemic. Particularly  given the time needed to produce vaccines, influenza vaccine may be  unavailable or in short supply and may not be widely available during the  initial stages of a pandemic. According to CDC, maintaining an abundant  annual influenza vaccine supply is critically important for protecting the  public’s health and improving our preparedness for an influenza pandemic.  The shortages of influenza vaccine in 2004–05 and previous seasons have  highlighted the fragility of the influenza vaccine market and the need for  its expansion and stabilization.
In its budget request for fiscal year 2006, CDC reports that it plans to take  steps to ensure an expanded influenza vaccine supply. The agency’s fiscal  year 2006 budget request includes $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 finished vaccines if the bulk products maintain their  potency and the circulating strains remain the same. According to CDC,  this guarantee will help expand the influenza market by providing an  incentive to manufacturers to expand capacity and possibly encourage  additional manufacturers to enter the market. In addition, CDC’s fiscal  year 2006 budget request includes an increase of $20 million to support  influenza vaccine purchase activities.
In the event of a pandemic, before a vaccine is available or during a period  of limited vaccine supply, use of antiviral drugs could have a significant  effect. Antiviral drugs can be used against all strains of pandemic influenza  and, because they can be manufactured and stored before they are needed,  could be available both to prevent illness and, if administered within   48 hours after symptoms begin, to treat it. Like vaccine, antiviral drugs  take several months to produce from raw materials, and according to one  antiviral drug manufacturer, the lead time needed to scale up production  capacity and build stockpiles may make it difficult to meet any large-scale,  unanticipated demand immediately. HHS’ National Vaccine Program Office  also reported that in a pandemic, the manufacturing capacity and supply  of antiviral drugs is likely to be less than the global demand. For these  reasons, the National Vaccine Program Office reported that analysis is  under way to determine optimal strategies for antiviral drug use when  supplies are suboptimal; the office also noted that antiviral drugs have  been included in the national stockpile. HHS has purchased more than   7 million doses of antiviral drugs for the national stockpile.
Nevertheless, this stockpile is limited, and it is unclear how much will be  available in the event of a pandemic, given existing production capacity.  Moreover, some 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 avian influenza virus strain (H5N1)  identified in human patients in Asia in 2004 and 2005 has been resistant to  two of four existing antiviral drugs.
section_title: Hospital and Workforce Capacity to Respond to Large- Scale Infectious Disease Outbreaks
paragraphs: The lack of sufficient hospital and workforce capacity is another challenge  that may affect response efforts during an influenza pandemic. The lack of  sufficient capacity could be more severe during an influenza pandemic  compared with other natural disasters, such as a tornado or hurricane, or  with an intentional release of a bioterrorist agent because it is likely that a  pandemic would result in widespread and sustained effects. Public health  officials we spoke with said that 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. In addition, most states lack surge capacity—the ability  to respond to the large influx of patients that occurs during a public health  emergency. For example, few states reported having 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 treat large numbers of patients. Moreover,  shortages in the health care workforce could occur during an influenza  pandemic because higher disease rates could result in high rates of  absenteeism among workers who are likely to be at increased risk of  exposure and illness or who may need to care for ill family members.
section_title: Concluding Observations
paragraphs: Important challenges remain in the nation’s preparedness and response  should an influenza pandemic occur in the United States. As we learned in  the 2004–05 influenza season, when vaccine supply, relative to demand, is  limited, planning and effective communication are critical to ensure timely  delivery of vaccine to those who need it. HHS’s current draft plan lacks  some key information for planning our nation’s response to a pandemic. It  is important for the federal government and the states to work through  critical issues—such as how vaccine will be purchased, distributed, and  administered; which population groups are likely to have priority for  vaccination; what communication strategies are most effective; and how  to address issues related to vaccine and antiviral supply and hospital and  workforce capacity—before we are in a time of crisis. Although HHS  contends that agency flexibility is needed during a pandemic, until key  federal 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.
Mr. Chairman, this concludes my prepared statement. I would be happy to  respond to any questions you or other Members of the Committee may  have at this time.
section_title: GAO Contact and Staff Acknowledgments
paragraphs: For further information about this testimony, please contact Marcia  Crosse at (202) 512-7119. Jennifer Major, Nick Larson, Gay Hee Lee, Kim  Yamane, George Bogart, and Ellen W. Chu made key contributions to this  statement.
section_title: Related GAO Products
paragraphs: nluenza Pandemic: Challenges Reman in Preparedness. GAO-05-760T.
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Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges.  GAO-05-177T. Washington, D.C.: November 18, 2004.
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.
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Bioterrorism: Preparedness Vared across Stae and Local Jurisdictions.  GAO-03-373. Washington, D.C.: April 7, 2003.
Global Healh: Chalenges in Improving Infectious Disease Surve ance  Systems. GAO-01-722. Washington, D.C.: August 31, 2001.  ill 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.
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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