    Influenza Vaccine: Shortages in 2004-05 Season Underscore Need
    for Better Preparation (30-SEP-05, GAO-05-984).

    In early October 2004, the nation lost about half its expected
    influenza vaccine supply when one of two major manufacturers
    announced it would not release any vaccine for the 2004-05 season
    because of potential contamination. The Centers for Disease
    Control and Prevention (CDC) had earlier recommended vaccination
    for 188 million individuals, including those at high risk of
    severe complications from influenza (such as seniors and those
    with chronic conditions), and other groups (such as their close
    contacts). Although health officials took actions to distribute
    the limited supply of influenza vaccine, reports persisted of
    high-risk individuals and others in priority groups who could not
    find a vaccination, including those who were turned away and
    never returned when supplies became available. Such reports
    raised questions about the adequacy of U.S. preparedness to
    respond to significant vaccine shortages. GAO was asked to
    examine actions taken at federal, state, and local levels to
    ensure that high-risk individuals had access to influenza vaccine
    during the shortage, including any lessons learned.
    -------------------------Indexing Terms-------------------------
    REPORTNUM:   GAO-05-984
        ACCNO:   A38837
      TITLE:     Influenza Vaccine: Shortages in 2004-05 Season Underscore
    Need for Better Preparation
         DATE:   09/30/2005
      SUBJECT:   Community health services
    	     Contingency plans
    	     Emergency preparedness
    	     Health care planning
    	     Influenza
    	     Health care services
    	     Health hazards
    	     Health resources utilization
    	     Health services administration
    	     Immunization programs
    	     Immunization services
    	     Infectious diseases
    	     Intergovernmental relations
    	     Lessons learned
    	     Policy evaluation
    	     Strategic planning

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    GAO-05-984

         * Results in Brief
         * Background
         * Health Officials Took Steps to Vaccinate High-Risk Individua
         * Federal and State Officials Took Quick Actions
         * Public Health Officials Acted to Distribute Remaining Vaccin
              * CDC Devised a Plan to Distribute the Limited Supply of Influ
              * Federal, State, and Local Actions Limited Vaccine to High-Ri
         * Public Health Officials Used Multiple Communication Strategi
         * Late-Season Actions Aimed to Boost Supply and Demand
              * Planning, Timely Action, and Communication Are Key to an Eff
         * Lesson Learned: Limited Contingency Planning Slows Response
         * Lesson Learned: Unless Expedited, Actions to Boost Supply Ar
         * Lesson Learned: Effective Response Requires Communication to
              * Concluding Observations
              * Agency Comments
         * Appendix I: Comments from the Department of Health and Human
         * Appendix II: GAO Contact and Staff Acknowledgments
              * GAO Contact
              * Acknowledgments
         * Related GAO Products
         * Order by Mail or Phone

    Report to Congressional Committees

    United States Government Accountability Office

    GAO

    September 2005

    INFLUENZA VACCINE

    Shortages in 2004-05 Season Underscore Need for Better Preparation

    Influenza Vaccine Shortage Influenza Vaccine Shortage Influenza Vaccine
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    GAO-05-984

    Contents

    Letter 1

    Results in Brief 3
    Background 5
    Health Officials Took Steps to Vaccinate High-Risk Individuals and Others
    in Priority Groups 10
    Planning, Timely Action, and Communication Are Key to an Effective
    Response 23
    Concluding Observations 32
    Agency Comments 33
    Appendix I Comments from the Department of Health and Human Services 35
    Appendix II GAO Contact and Staff Acknowledgments 37
    Related GAO Products 38

    Tables

    Table 1: Groups Recommended for Influenza Vaccination, Before and After
    October 5, 2004 13
    Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan 16
    Table 3: Communication Methods Used by Various Health Departments to
    Disseminate Influenza Information 21

    Figures

    Figure 1: Influenza Vaccine Cycle 6
    Figure 2: Influenza Vaccine Production and Distribution 8
    Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage 11
    Figure 4: Phase II of CDC's Influenza Vaccine Distribution Plan 17
    Figure 5: Influenza Vaccination Rates for Selected Priority Groups 24

    Abbreviations

    ACIP Advisory Committee on Immunization Practices CDC Centers for Disease
    Control and Prevention FDA Food and Drug Administration HHS Department of
    Health and Human Services

    This is a work of the U.S. government and is not subject to copyright
    protection in the United States. It may be reproduced and distributed in
    its entirety without further permission from GAO. However, because this
    work may contain copyrighted images or other material, permission from the
    copyright holder may be necessary if you wish to reproduce this material
    separately.

    United States Government Accountability Office

    Washington, DC 20548

    September 30, 2005

    The Honorable Tom Davis Chairman The Honorable Henry A. Waxman Ranking
    Minority Member Committee on Government Reform House of Representatives

    The Honorable Susan M. Collins Chairman Committee on Homeland Security and
    Governmental Affairs United States Senate

    As the traditional influenza vaccination period started in fall 2004, the
    nation faced the unexpected loss of nearly half its projected vaccine
    supply. One of the two major manufacturers of influenza vaccine for the
    United States warned in late August 2004 that deliveries would be delayed
    because a small quantity of its vaccine failed sterility tests. On October
    5, 2004, the manufacturer announced that because of potential
    contamination, it would be unable to release any vaccine for the U.S.
    market. The Department of Health and Human Services (HHS) had expected
    that this manufacturer would produce about 47 million doses-close to half
    of the 100 million doses estimated for the 2004-05 influenza season.1
    Before the October 5 announcement, HHS's Centers for Disease Control and
    Prevention (CDC) and its Advisory Committee on Immunization Practices
    (ACIP) had recommended that those at high risk of severe complications
    from influenza and those in other priority groups-such as health care
    workers and those aged 50-64 years-receive an influenza vaccination.2
    After the announcement, with no other U.S.-licensed manufacturers able to
    replace the large amount of lost vaccine on such short notice, concerns
    arose about the effects of the loss, especially on those most vulnerable
    to complications from influenza.

    1See Centers for Disease Control and Prevention, "Supplemental
    Recommendations about Timing of Influenza Vaccination, 2004-05 Season,"
    Morbidity and Mortality Weekly Report, vol. 53, no. 37 (2004): 878-879.

    2ACIP makes recommendations to CDC, and CDC generally adopts them; we
    refer to such recommendations as CDC recommendations. Although CDC
    estimates published in October 2004 show about 188 million people in
    high-risk and other priority groups, not everyone in these groups receives
    a vaccination each year. According to CDC, the prior maximum number of
    doses distributed was approximately 83.1 million. Thus CDC estimated that
    an expected 100 million doses of vaccine would be sufficient to meet
    demand for the 2004-05 influenza season.

    Media reports of long lines of seniors waiting hours for a chance at a
    vaccination, of others at high risk who could not find a vaccination, and
    of individuals turned away who never returned when supplies became
    available fueled worries that the nation was not adequately prepared to
    respond to the significant vaccine shortage or to an influenza pandemic (a
    widespread or worldwide influenza epidemic). Notwithstanding these
    concerns, CDC's postseason data indicate that 2004-05 vaccination rates
    among certain high-risk groups such as seniors approached historical
    rates.3

    You observed that the 2004-05 influenza vaccine shortage was the most
    severe in recent history and that lessons learned from this season would
    enable the nation to better deal with a similar situation in the future.
    This report examines the response to the 2004-05 shortage and identifies
    the lessons. We address the following questions:

               1. What actions were taken at federal, state, and local levels to
               ensure that high-risk individuals had access to influenza vaccine
               during the 2004-05 shortage?
               2. What were the lessons learned from the strategies implemented
               at the federal, state, and local levels to ensure that high-risk
               individuals had access to influenza vaccine?

    To address these objectives, we reviewed documents and interviewed
    officials from (1) CDC and HHS's National Vaccine Program Office; (2)
    national organizations, including the Association of State and Territorial
    Health Officials, the Association of Immunization Managers, and the
    National Association of County and City Health Officials;4 (3)
    organizations that conduct mass immunization clinics; (4) sanofi pasteur,5
    the remaining major manufacturer of influenza vaccine available for people
    at high risk of influenza-related complications; and (5) Kaiser
    Permanente, a health system that is a large purchaser of influenza
    vaccine. We also conducted site visits to a judgmental sample of states
    (California, Florida, Maine, Minnesota, and Washington) and localities
    (San Diego and San Francisco, California; Miami-Dade County, Florida;
    Portland, Maine; Stearns County, Minnesota; and Seattle-King County,
    Washington). We selected these states and localities to reflect a mix of
    geographic locations, population size, and vaccination success rates.6 In
    each state, we reviewed documents and interviewed officials from public
    health agencies, professional associations, and provider organizations. We
    also interviewed local representatives of home health organizations that
    conduct mass immunizations and representatives of the Minnesota Multistate
    Contracting Alliance for Pharmacy, which arranges purchase of vaccines for
    use in 43 states. We conducted our work in accordance with generally
    accepted government auditing standards from March through September 2005.

    3See Centers for Disease Control and Prevention, "Estimated Influenza
    Vaccination Coverage among Adults and Children, United States, September
    1, 2004-January 31, 2005," Morbidity and Mortality Weekly Report, vol. 54,
    no. 12 (2005): 304-307.

                                    Results in Brief

    Upon learning that nearly one-half of the projected vaccine supply would
    be unavailable for the 2004-05 influenza season, federal, state, and local
    health officials took several actions to help ensure that those at high
    risk of severe influenza-related complications had access to available
    vaccine. These efforts prompted federal revision of the recommendations on
    who should be vaccinated, so that vaccine could be directed to those at
    high risk and to other priority groups. Federal, state, and local actions
    also focused on distributing vaccine to priority groups, using a number of
    communication strategies to keep providers and the public informed about
    the shortage. CDC, for example, developed and implemented a complex plan
    to distribute vaccine to providers serving priority groups across the
    states. Late in the influenza vaccination period-from mid-December through
    January-health officials took various actions to increase vaccine
    availability and attempted to distribute vaccine across the wider
    population by broadening recommendations on who should be vaccinated.

    4Members of the Association of State and Territorial Health Officials
    include the chief health officials representing state and territorial
    public health agencies. Members of the Association of Immunization
    Managers include immunization program directors from state health
    departments, U.S. territories, and selected cities. Members of the
    National Association of County and City Health Officials include
    representatives from local public health agencies. In addition to
    officials from these associations, we interviewed some association
    members.

    5Aventis Pasteur became sanofi pasteur (spelled without capital letters)
    in January 2005.

    6We selected our sites on the basis of CDC's Behavioral Risk Factor
    Surveillance System survey data (state-level data) on the percentage of
    adults in priority groups for 2004-05 who reported receiving an influenza
    vaccination during the traditional fall vaccination period
    (September-November 2004).

    A number of lessons emerged from federal, state, and local responses to
    the 2004-05 influenza vaccine shortage, some specific to that season's
    shortage, others with wider ramifications for potential future shortages
    or a public health emergency. The primary lessons fall into three broad,
    interrelated categories: planning, timely action, and communication.

               o  Limited contingency planning slows response. At the start of
               the traditional fall vaccination period, CDC did not have a
               contingency plan specifically designed to respond to a severe
               influenza vaccine shortage. The lack of such a plan led to delays
               and uncertainty on the part of many state and local entities on
               how best to ensure access to vaccine during the shortage by
               individuals at high risk and others in priority groups.
               Nevertheless, some state and local entities used strategies that
               enabled them to respond relatively efficiently. For example, a
               number of states used existing emergency preparedness plans and
               issued emergency health directives to improve priority groups'
               access to vaccine during the shortage. Some public health
               departments also facilitated the administration of vaccine in an
               orderly fashion when demand was highest, including scheduling
               vaccinations by appointment and holding lotteries.
               o  Unless expedited, actions to boost available supply may have
               little effect. Although federal agencies attempted to boost
               influenza vaccine supply, their efforts came too late in what
               turned out to be a relatively moderate influenza season. For
               example, HHS officials purchased vaccine that was not licensed for
               the U.S. market, but the purchases occurred in December 2004 and
               January 2005, by which time demand had already waned. Similarly,
               state officials reported that CDC's attempt to expand availability
               to other children and to adults of the vaccine purchased for its
               Vaccines for Children program came after demand for vaccine had
               dropped.
               o  Effective response requires communication that is both clear
               and consistent. Although CDC quickly communicated with nonfederal
               agencies, providers, and the public throughout the changing
               environment of the 2004-05 influenza season, communication was not
               always coordinated among these entities, and inconsistent messages
               did occur, contributing to delays and confusion and ultimately
               resulting in a late-season vaccine surplus. For example, in
               California, state officials in mid-December were advising
               vaccinations for those aged 50 years and older, while CDC was
               simultaneously recommending vaccinations only for those aged 65
               years and older. In addition, although a national campaign
               communicated the early-season messages to step aside in favor of
               those in priority groups, the campaign did not include a message
               to come back later when more vaccine became available. In certain
               locations, individuals seeking vaccination found themselves in a
               communication loop if they tried to follow CDC's advice to contact
               their local public health department for vaccine availability:
               when they did so, they were told to call their primary care
               provider, but when they called their primary care provider, they
               were told to call their local public health department.
               Furthermore, public education about the various forms of vaccine
               fell short. For example, despite the availability of a nasal spray
               vaccine for healthy individuals aged 5-49 years who were not
               pregnant, inadequate education about the vaccine contributed to
               the reluctance of some individuals to use it.

               After the 2004-05 influenza season, CDC reviewed its response to
               the vaccine shortage and took a number of steps, including issuing
               interim guidelines in August 2005 to assist in responding to
               possible future shortages.

               We provided a draft of this report to HHS, and pertinent sections
               to the states and localities we visited and to sanofi pasteur, for
               their review. HHS concurred with our finding that contingency
               planning is important and indicated that further actions, such as
               approval of additional influenza vaccines for the U.S. market,
               were under way. HHS, states, localities, and sanofi pasteur
               provided technical comments, which we incorporated as appropriate.
               HHS's written comments appear in appendix I.

               Influenza is characterized by cough, fever, headache, and other
               symptoms and is more severe than some 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. On average each year in the United States, more
               than 36,000 individuals die and more than 200,000 are hospitalized
               from influenza and related complications. People aged 65 years and
               older, people of any age with chronic medical conditions, children
               younger than 2 years of age, and pregnant women are generally more
               likely than others to develop severe influenza-related
               complications.

               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, and
               vaccines for certain influenza strains have been difficult to
               mass-produce. After vaccination, the body takes about 2 weeks to
               produce the antibodies that protect against infection. According
               to CDC, 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 (see fig. 1). If
               supplies permit, CDC recommends a vaccination for anyone who wants
               one. Because circulating influenza strains change, a new vaccine
               is created each year. For this reason, and because immunity
               declines over time, CDC recommends a new influenza vaccination
               every year for high-risk individuals and other priority groups,
               including close contacts of those at high risk.

                                       Background

    Figure 1: Influenza Vaccine Cycle

    aThe influenza season varies from year to year, generally beginning in
    late October and peaking in January or February.

    Two types of vaccine are recommended for protection against influenza in
    the United States: (1) an inactivated virus vaccine injected into muscle
    and (2) a live virus vaccine administered as a nasal spray. The injectable
    vaccine-which represents the large majority (over 95 percent) of influenza
    vaccine administered in this country-can be used to immunize healthy
    individuals and those at high risk of severe complications, including
    those with chronic illness and those aged 65 years and older. The nasal
    spray vaccine, in contrast, is currently approved for use only among
    healthy individuals aged 5-49 years who are not pregnant. 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 the disease.7

    In a typical year, manufacturers make influenza vaccine available before
    the optimal fall vaccination season. For the 2003-04 influenza season, two
    manufacturers-one with production facilities in the United States (sanofi
    pasteur) and one with production facilities in the United Kingdom
    (Chiron)-produced about 83 million doses of injectable vaccine, which
    represented about 96 percent of the U.S. vaccine supply. A third U.S.
    manufacturer (MedImmune) produced the nasal spray vaccine. According to
    CDC, MedImmune produced about 3 million doses of the nasal spray vaccine,
    or about 4 percent of the overall influenza vaccine supply, for the
    2003-04 season.

    Influenza vaccine production and distribution are largely private-sector
    activities. Manufacturers sell influenza vaccine to resellers (such as
    medical supply distributors and pharmacies), to federal agencies and state
    and local public health departments, or directly to providers (see fig.
    2). Individuals can obtain an influenza vaccination at a number of places,
    including physicians' offices, public health clinics, nursing homes, and
    nonmedical locations such as workplaces or retail outlets. Millions of
    individuals receive influenza vaccinations through mass immunization
    campaigns in these nonmedical settings, where organizations such as
    visiting nurse agencies under contract administer the vaccine.

    7Four antiviral drugs have been approved for treatment. If taken within 2
    days of illness, these drugs can reduce symptoms and make someone with
    influenza less contagious to others.

    Figure 2: Influenza Vaccine Production and Distribution

    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.8 In the event that the Secretary of HHS determines
    and declares a public health emergency, the Public Health Service Act
    authorizes the Secretary to "take such action as may be appropriate" to
    respond.9

    8FDA has limited authority to prohibit the resale of prescription drugs,
    including influenza vaccine that has been purchased by health care
    entities such as public or private hospitals. This authority does not
    extend to resale of the vaccine for emergency medical reasons. The term
    "health care entity" does not include wholesale distributors.

    Within HHS, CDC is one of the agencies that help protect the nation's
    health and safety. CDC's activities include efforts to prevent and control
    diseases and to respond to public health emergencies. ACIP, after
    consulting with CDC, makes recommendations on which population groups
    should be targeted for vaccination. CDC also administers a number of
    programs to help make vaccines, including influenza vaccine, affordable
    for low-income and other populations. For example, under CDC's Vaccines
    for Children program, vaccines are provided free of charge for certain
    children 18 years of age or younger, including those who are
    Medicaid-eligible, uninsured, or underinsured (that is, their insurance
    does not include vaccinations). CDC also reserves stockpiles of certain
    vaccines. For the 2004-05 influenza season, CDC contracted with vaccine
    manufacturers to supply influenza vaccine for a national stockpile for the
    first time. The agency originally contracted for 4.5 million doses,
    including 2 million doses from Chiron, which were therefore not available.
    CDC also maintains stockpiles of antiviral medications that can alleviate
    influenza symptoms and reduce contagion in those who contract the disease.

    Other organizations within HHS that are involved with immunization
    activities include the National Vaccine Program Office, which is
    responsible for coordinating and ensuring collaboration among the many
    federal agencies involved in vaccine and immunization activities, and the
    Food and Drug Administration (FDA), which in approving and regulating the
    use of vaccines and drugs, including antiviral medications, is responsible
    for ensuring that they are safe and effective. In addition to federal
    agencies, state and local health departments are often the first
    responders in situations affecting public health.

    Initially for the 2004-05 influenza season, CDC in May 2004 recommended
    that about 188 million Americans receive a vaccination-about 85 million at
    high risk of severe complications and about 103 million in other priority
    groups, such as people in close contact with high-risk individuals,
    healthy people aged 50-64 years, and health care workers.10 CDC also
    suggested that, depending on the availability of vaccine, other
    individuals who should receive a vaccination include (1) any person who
    wished to reduce the likelihood of contracting influenza, (2) individuals
    who provide essential community services, and (3) students and others in
    institutional settings. Although Chiron had announced that it was
    experiencing production problems in August 2004, according to CDC, the
    manufacturer had assured the agency that the production issues were being
    resolved. Subsequently, on September 24, 2004, CDC reiterated its
    recommendation that 188 million individuals in high-risk and other groups
    be vaccinated as vaccine became available. CDC also recommended that
    anyone wanting to reduce the risk of contracting influenza be vaccinated.
    Not everyone in these high-risk and priority groups, however, receives a
    vaccination each year. Among health care workers, for example, about 40
    percent received a vaccination in the 2002-03 and 2003-04 seasons,
    according to one CDC survey. Similarly, about 66 percent of individuals
    aged 65 years and older reported receiving influenza vaccination in the
    2002-03 and 2003-04 influenza seasons, according to CDC estimates.11

    9According to the act, to declare a public health emergency, the Secretary
    must determine that (1) a disease or disorder presents a public health
    emergency, or (2) a public health emergency, including significant
    outbreaks of infectious disease or bioterrorist attacks, otherwise exists.
    Public Health Improvement Act, Pub. L. No. 106-505, S: 102, 114 Stat.
    2314, 2315 (2002) (adding S:319 to the Public Health Service Act)
    (codified at 42 U.S.C. S: 247d).

      Health Officials Took Steps to Vaccinate High-Risk Individuals and Others in
                                    Priority Groups

    After the October 5, 2004, announcement of the sharp reduction in expected
    influenza vaccine supply, federal, state, and local health officials took
    steps to help ensure that those at high risk of severe complications from
    infection had access to influenza vaccine. For example, health officials
    quickly revised vaccination recommendations so that the remaining supply
    could be targeted to those in priority groups comprising those at high
    risk, certain health care workers, and household contacts of children
    younger than 6 months of age. Other efforts focused on distributing
    vaccine to priority groups and on keeping providers and the public updated
    as to vaccine availability. Finally, late in the influenza vaccination
    period-from mid-December through January-health officials' actions focused
    on further augmenting the vaccine supply and, once supply increased, on
    encouraging vaccination for anyone remaining in the priority groups and
    for others who had earlier deferred vaccination (see fig. 3).

    10CDC recommended vaccination for people aged 50-64 years to raise the low
    vaccination rates among people with high-risk conditions in this age
    group. Further, people in this age group without high-risk conditions also
    benefit from lower influenza rates, fewer medical visits, and less
    medication. See Centers for Disease Control and Prevention, "Prevention
    and Control of Influenza: Recommendations of the Advisory Committee on
    Immunization Practices," Morbidity and Mortality Weekly Report, vol. 53,
    RR-6 (2004): 1-40.

    11See Centers for Disease Control and Prevention, "Estimated Influenza
    Vaccination Coverage among Adults and Children, United States, September
    1, 2004-January 31, 2005," Morbidity and Mortality Weekly Report, vol. 54,
    no. 12 (2005): 304-307.

    Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage

    aCDC actions broadening recommendations on who should be vaccinated
    applied only in locations where state and local health officials judged
    vaccine supply to be adequate.

    Federal and State Officials Took Quick Actions

    Several responses by public health officials took place within hours or
    days of the public announcement that a severe shortage of influenza
    vaccine was imminent.

               o  Federal and state health officials redefined priority groups
               for influenza vaccination. CDC immediately redefined the groups
               recommended to receive vaccine in 2004-05 for protection against
               influenza and its complications and issued revised recommendations
               on October 5, 2004. These revised recommendations focused on
               priority groups that included high-risk individuals, health care
               workers involved in direct patient care, and household contacts of
               children younger than 6 months of age. CDC's revised
               recommendations decreased the number of people in groups
               recommended for vaccination from about 188 million to about 98
               million (see table 1).12 At the same time, CDC also asked people
               not in these priority groups to forgo or defer vaccination. State
               and local health officials we met with reported having quickly
               adopted CDC's revised recommendations. Some health departments,
               however, found that they did not have enough vaccine to cover
               everyone in CDC's priority groups and therefore subdivided CDC's
               priority groups. For example, in Maine, all health care workers
               were initially excluded from the state's priority groups, although
               later, Maine health officials recommended vaccination for
               particular types of health care workers, such as those working in
               intensive care units and emergency departments, if local vaccine
               supply allowed.

    12On October 5, 2004, CDC issued interim recommendations for influenza
    vaccination during the 2004-05 season, which took precedence over earlier
    recommendations. The season's priority groups for vaccination with
    injectable influenza vaccine were considered to be of equal importance.
    See Centers for Disease Control and Prevention, "Interim Influenza
    Vaccination Recommendations, 2004-05 Influenza Season," Morbidity and
    Mortality Weekly Report, vol. 53, no. 39 (2004): 923-924.

    Table 1: Groups Recommended for Influenza Vaccination, Before and After
    October 5, 2004

                                                Population             October 5,
                                               (millions)a May 2004b,c      2004c
    High-risk groups
    People aged 65 years and older                 35.6
    Adults and children with chronic               39.4
    illness
    Pregnant women                                  4.0
    All children aged 6-23 months                   5.9
    Other priority groups
    Health care workers aged 64 years and           7.0
    younger
    People aged 2-64 years who are                 69.5
    household contacts of high-risk
    individualsd
    People aged 2-64 years who are
    household contacts of children younger
    than 6 monthsd                                  6.3
    Healthy people aged 50-64 years who are
    not household contacts of high-risk
    individuals                                    20.1
    Totals                                                    187.8       98.2

    Source: CDC.

    Note: Check marks denote priority groups recommended by CDC, at the time
    shown, for vaccination.

    aBased on July 1, 2002, population estimates, U.S. Census Bureau.

    bCDC suggested that, depending on vaccine availability, anyone wishing to
    reduce the likelihood of contracting influenza, individuals who provide
    essential community services, and students and others in institutional
    settings also be vaccinated.

    cCDC suggested that residents of nursing homes and long-term-care
    facilities, and children 6 months-18 years old receiving chronic aspirin
    therapy, also be vaccinated.

    dThese groups belonged to a single category in CDC's May 2004
    recommendations.

               o  HHS collaborated with manufacturers to temporarily halt further
               distribution of injectable influenza vaccine and to ramp up
               production of nasal spray vaccine. At the request of CDC, sanofi
               pasteur, the sole remaining manufacturer of injectable influenza
               vaccine for the U.S. market, voluntarily suspended further
               distribution of the approximately 25 million doses it had not yet
               shipped on October 5, 2004, until the week of October 11, 2004,
               when CDC completed its assessment of the situation. Distribution
               was temporarily halted because CDC needed time to devise a plan to
               better target vaccine distribution to providers serving
               individuals in the priority groups. HHS officials also worked with
               MedImmune, the maker of the nasal spray vaccine, to increase its
               production for the 2004-05 influenza season from about 1 million
               doses to a total of 3 million doses.

               o  Federal officials evaluated foreign sources of influenza
               vaccine and assessed the federal stockpile of antiviral
               medications. On October 11, 2004, HHS convened an interagency
               team, comprising officials from HHS's Office of the Secretary,
               CDC, FDA, and others, to devise a plan to import influenza vaccine
               not licensed for the U.S. market from foreign manufacturers; this
               vaccine could be administered in the United States under an
               investigational new drug protocol.13 Around the same time, FDA
               quickly authorized the redistribution of vaccine among hospitals
               and other health entities to alleviate shortages.14 HHS also
               assessed its stockpile of antiviral medications that could be used
               to prevent or treat influenza and began the process of purchasing
               more. According to HHS officials, by December 2004 the federal
               government purchased and stockpiled enough antiviral medicines to
               treat more than 7 million people.
               o  State and local health departments used existing emergency
               plans and incident command systems. Some state and local health
               departments used their emergency preparedness plans and incident
               command systems (the organizational systems set up specifically to
               handle the coordinated response to emergency situations) during
               the influenza vaccine shortage. The five state health departments
               and two of the local health departments we visited used their
               incident command systems to help manage shortage-related
               activities, and three of the state health departments reported
               using their emergency plans. In addition, officials from the
               Florida Health Care Association, an organization representing
               long-term-care providers in that state, reported using certain
               elements in their disaster planning guide, which includes plans
               for disasters like hurricanes or bioterrorism.
               o  Federal and state officials took measures against price
               gouging. Around the time (October 13, 2004) that one Florida-based
               distributor was sued by that state for selling influenza vaccine
               at significantly inflated prices,15 several states began issuing
               warnings that all suspected cases of price gouging by vaccine
               distributors and providers would be reported to the states'
               attorneys general for further investigation and possible
               prosecution. In support of states' efforts to curtail the
               overpricing of limited influenza vaccine, CDC began collecting
               reports of price gouging and shared the information with the
               National Association of Attorneys General and state prosecutors.
               On October 14, 2004, the Secretary of HHS sent a letter to the
               attorney general of each state, urging thorough investigation of
               reports of price gouging, and on October 22, 2004, HHS filed a
               "friend of the court" brief in support of the Florida lawsuit.

               Beginning in mid-October, federal, state, and local public health
               officials acted to distribute the remaining 25 million doses of
               injectable influenza vaccine across the states and directed the
               limited amount of available injectable vaccine to those in
               priority groups. State and local public health departments also
               took steps to help ensure that vaccine was distributed to those
               within their jurisdictions who were in priority groups.

               In October and November, working with representatives from
               national public health organizations and sanofi pasteur, CDC
               developed a plan to distribute sanofi pasteur's unshipped vaccine.
               The plan consisted of two overlapping phases and was aided by the
               manufacturer's voluntary sharing of proprietary information to
               help identify geographic areas in greatest need of vaccine.

               Phase I, which began the week of October 11, 2004, consisted of
               filling orders that were clearly identifiable as public-sector
               orders and orders, such as those from long-term-care facilities,
               that had been placed with sanofi pasteur. Orders selected for full
               or partial filling included those that could be immediately
               identified as placed by the Department of Veterans Affairs, the
               Indian Health Service, long-term-care facilities and hospitals,
               and others (see table 2). Filling these orders distributed
               approximately 13 million doses of vaccine over a 6-8 week period.

               Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan

               Source: CDC.

               Phase II, which was announced by CDC on November 9, 2004,
               consisted of distributing approximately 12 million doses: about 3
               million doses for some of the remaining public-sector orders from
               phase I and about 9 million doses across the states according to a
               formula based on each state's percentage of the estimated
               nationwide unmet need.16 CDC calculated a state's unmet need by
               taking the total estimated number of individuals in priority
               groups in the state and subtracting the total number of doses that
               had been delivered before and during phase I. To help state health
               officials identify the regions within their states needing vaccine
               from phase II distribution, CDC developed an Internet-based
               program called the Flu Vaccine Finder on its secure data
               network.17 The program allowed state health officials to view,
               county by county, a list of vaccine orders shipped by sanofi
               pasteur to various types of customers, such as pediatricians and
               hospitals. Officials could then allocate vaccine available to
               their state under phase II to providers within their state that
               needed, but had not yet received, vaccine (see fig. 4). According
               to CDC officials, the agency understood that not all of the phase
               II doses would be ready to ship to states at once, so orders were
               partially filled and shipped in waves. Furthermore, the formula
               for determining each state's allocation was imperfect, according
               to CDC, resulting in some states' having more vaccine than needed
               to cover demand from those in priority groups and other states'
               having too little. In response, CDC reallocated vaccine available
               for ordering by states in December 2004. In addition, some states
               found it necessary to redistribute vaccine within their own
               borders, or they attempted to purchase or sell vaccine to other
               states to best align supply and demand at local levels. States
               could begin ordering their vaccine allotments through the secure
               data network on November 17, 2004, and ordering continued through
               mid-January.

               Figure 4: Phase II of CDC's Influenza Vaccine Distribution Plan

               Note: Not all states (for example, Minnesota and Maine) chose to
               order vaccine through phase II of CDC's influenza vaccine
               distribution plan.

               Public health officials at all levels implemented various
               strategies to help ensure that their vaccine supplies were
               targeted to high-risk individuals and others in priority groups.

               o  Emergency directives issued. To help support providers in
               vaccinating only those individuals in CDC's priority groups, a
               number of states, such as California and Florida, issued emergency
               public health directives requiring health care providers to limit
               influenza vaccination to people in priority groups and to refrain
               from vaccinating individuals not in CDC's priority groups.18 Some
               of these directives, including those of the District of Columbia
               and Michigan, explicitly stated that providers failing to comply
               with these directives could face penalties, such as fines or
               imprisonment. But some states chose not to issue emergency
               directives. For example, Minnesota state health officials reported
               that they had such strong voluntary compliance and cooperation
               from the state's provider community that they decided it was not
               necessary to post a directive mandating compliance.
               o  Surveys conducted of providers and long-term-care facilities.
               During mid-October, working with national professional
               organizations, CDC conducted a survey of long-term-care facilities
               to identify those that had placed orders with Chiron. A number of
               health departments, including six we visited, had also surveyed
               long-term-care facilities, and at least two, Minnesota and
               Seattle-King County in Washington State, completed their surveys
               before CDC began administering its version. In addition, many
               state health departments, including three we visited, surveyed
               providers about vaccine availability and the need for covering
               those in priority groups. In an effort to assess the degree of the
               vaccine supply shortage, for example, Minnesota public health
               officials developed and administered a survey to identify how much
               influenza vaccine was available in each of its 92 local public
               health jurisdictions, not knowing before the shortage which
               providers had ordered vaccine from Chiron or which ones had
               ordered from sanofi pasteur.
               o  Vaccine transferred among states. Because CDC's distribution
               plan was based in part on estimated need for vaccine, some states
               received more than enough to cover demand from their priority
               groups, and some states received too little. To redistribute
               vaccine to locations that needed vaccine to meet demand from
               priority groups, a state could attempt to sell its available
               vaccine to another state. According to the Association of State
               and Territorial Officials, Nebraska shipped some vaccine to other
               states when its own demand was met. Minnesota state health
               officials also reported offering to sell available vaccine to
               other states. At the same time, states without enough vaccine,
               such as Maryland, tried to obtain it from another.
               o  Partnerships established with the private sector. To augment
               state and local vaccine supply, public health departments looked
               to the private sector for help. A number of state and local health
               departments we talked with reported facilitating redistribution or
               acting as brokers for donations of vaccine that had been purchased
               by large employers for employee vaccination campaigns before the
               shortage. According to health officials in Washington, for
               example, one large employer donated about 700 doses of influenza
               vaccine to the health department in Seattle-King County, which was
               then able to supply local nursing homes. Certain states and
               localities partnered with for-profit and not-for-profit home
               health organizations, which held mass immunization clinics and set
               up clinics in providers' offices to help administer the vaccine
               quickly. For example, the Visiting Nurses Association of Southern
               Maine held a mass immunization clinic on a local college campus.
               These organizations followed CDC's recommendations for vaccinating
               priority groups by screening potential vaccine recipients.
               o  Crowding alleviated through appointments and lotteries. In an
               effort to control crowding, health officials in some localities
               created vaccination appointments for individuals who were at high
               risk or in another priority group. When available supplies were
               insufficient to cover every qualified person who wanted a
               vaccination, some health departments held lotteries for available
               vaccine. The local public health department in Portland, Maine,
               for example, held a lottery for the small amount of vaccine it had
               received before the shortage plus the several hundred doses
               donated by an area medical center and the state department of
               health. To register for the lottery, people had to show they
               belonged to a priority group by supplying a note from their
               provider.

               Throughout the 2004-05 influenza vaccine shortage, federal, state,
               and local health officials used a variety of communication
               mechanisms to keep health officials, providers, and the public
               updated about vaccine availability and about the various
               strategies for distribution to providers and the public. At the
               federal level, CDC held frequent press conferences beginning in
               early October 2004. At these events, the agency updated the public
               on current efforts and recommendations, and it asked people who
               did not belong to a priority group to step aside and defer
               vaccination so that those in the priority groups would have
               access. CDC also conducted biweekly conference calls with
               representatives from various national health organizations to
               update them and obtain their feedback on distribution efforts.19
               According to CDC officials, state and local health officials could
               generally access the minutes from these discussions the following
               day on CDC's Health Alert Network.20 CDC also used this network to
               send advisories and updates on the influenza vaccine situation,
               beginning on October 5, 2004, and continuing through the end of
               January. The majority of the state health officials we met with
               reported receiving key information about the shortage from this
               network; the information was then forwarded to local health
               officials, hospitals, and medical associations that, in turn,
               passed the information on to providers.

               State and local health officials we met with also reported using
               various communication methods to relay national guidance, along
               with state and local guidance, and information about vaccine
               availability. These communication methods included mass e-mails
               and faxes; public education campaigns for influenza prevention;
               the media, including television, radio, and newspapers; telephone
               hotlines; and Web sites (see table 3).

    13FDA requires the submission of an investigational new drug application
    before the initial entry of an unapproved drug-including vaccines licensed
    for use in other countries-into human studies in the United States. This
    investigational new drug application includes a description of the vaccine
    and its method of manufacture, and results of previously conducted quality
    control and toxicology testing.

    14Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act allows such
    entities to sell, purchase, or trade a drug or vaccine or offer to sell,
    purchase, or trade a drug or vaccine for emergency medical reasons. On
    October 9, 2004, CDC issued a statement noting that "anticipated shortages
    of influenza vaccine this influenza season constitute emergency medical
    reasons."

    15Florida v. ASAP Meds. Inc., No. 04-16032(09) (Fla. Cir. Ct. filed Oct.
    13, 2004) (settlement agreement filed May 19, 2005).

    Public Health Officials Acted to Distribute Remaining Vaccine

      CDC Devised a Plan to Distribute the Limited Supply of Influenza to High-Risk
      Individuals and to Others in Priority Groups

                                                             Percentage of orders
    Provider type                                                       filled
    Department of Veterans Affairs                                         100
    Indian Health Service                                                  100
    Long-term-care facilities and hospitals                                100
    Providers who care for children (Vaccines for
    Children program providers, office-based
    pediatricians)                                                         100
    Community immunization providers                                        75
    Visiting Nurses Association of America                                  50
    Department of Defense                                                   50
    Office-based primary care providers                                     50
    State and local public health departments                               50

    16To determine the number of individuals in priority groups in each state,
    CDC used U.S. Census data and available data from the National Health
    Interview Survey for each of the groups.

    17The secure data network is an ongoing project sponsored by CDC that
    allows CDC field staff, researchers, and public health partners to
    securely exchange confidential, proprietary, or sensitive data over the
    Internet.

      Federal, State, and Local Actions Limited Vaccine to High-Risk Individuals and
      Others in Priority Groups

    18During the 2004-05 influenza season, the Association of State and
    Territorial Health Officials reported that 15 states and the District of
    Columbia issued emergency public health directives.

    Public Health Officials Used Multiple Communication Strategies to Impart Key
    Information

    19National health organizations included the Association of State and
    Territorial Health Officials, National Association of County and City
    Health Officials, Council of State and Territorial Epidemiologists, and
    Association of Public Health Laboratories.

    20The Health Alert Network is an early-warning and response system
    operated by CDC, which is designed to ensure that state and local health
    departments, as well as other federal agencies and departments, have
    timely access to emerging health information.

    Table 3: Communication Methods Used by Various Health Departments to
    Disseminate Influenza Information

                                                Public
                                               education
                      Mass   Health  Provider  campaign
                    e-mails,  Alert  education (posters,   Media   Telephone Web
                     faxes   Network campaign   flyers)  publicity  hotline  site
    California
    State health
    agency
    San Diego
    San
    Francisco
    Florida
    State health
    agency
    Miami-Dade
    County
    Maine
    State health
    agency
    Portland
    Minnesota
    State health
    agency
    Stearns
    County
    Washington
    State health
    agency
    Seattle-King
    County

    Source: GAO.

    Late-Season Actions Aimed to Boost Supply and Demand

    At the latest part of the influenza vaccination period, from mid-December
    2004 through January 2005, federal and state health officials took several
    actions intended to further augment the vaccine supply and make vaccine
    more accessible. Four areas were addressed: broadened recommendations for
    groups to be vaccinated, modifications to the Vaccines for Children
    program, purchase of foreign-made vaccine, and release of the federal
    stockpile of influenza vaccine.

               o  CDC and states broadened the priority groups for influenza
               vaccination. On December 17, 2004, CDC announced broadened
               vaccination recommendations to include those aged 50-64 years and
               household contacts of high-risk individuals in locations where
               state and local health officials judged vaccine supply to be
               adequate. CDC's broadened recommendations became effective January
               3, 2005, allowing extra time for vaccination of individuals in the
               original priority groups and time for state and local health
               departments to prepare for increased requests for vaccine.21 As of
               January 3, 2005, however, according to information from the
               Association of State and Territorial Health Officials, 20 states
               had already expanded vaccination recommendations: 13 specified the
               additional groups identified by CDC, and 7 lifted all vaccination
               restrictions, allowing anyone wanting a vaccination to get one.22
               On January 27, 2005, CDC endorsed states' efforts to broaden
               vaccination recommendations to include all people wanting
               influenza immunization in states and localities where vaccine
               supply was sufficient to do so. Before that date, according to
               association officials, 27 states had already expanded
               recommendations to include everyone, although a few states waited
               longer to expand recommendations.
               o  CDC made vaccine from the Vaccines for Children program more
               widely available.23 CDC's ACIP passed a resolution for CDC's
               Vaccines for Children program, effective December 17, 2004, that
               expanded the groups of children eligible to receive the program's
               influenza vaccine to include program-eligible children outside of
               CDC's priority groups who were household contacts of people in
               high-risk groups. Later, on January 27, 2005, CDC authorized
               limited amounts of influenza vaccine from the Vaccines for
               Children program and held by the states to be transferred to state
               health departments for nonprogram use where the demand among
               program-eligible children had already been met. Public providers
               that had a reserve of program vaccine after vaccinating their
               program-eligible children could then use this vaccine for adults
               and children who were not eligible for the Vaccines for Children
               program.
               o  HHS purchased foreign-manufactured influenza vaccine for the
               U.S. market. After efforts initiated in early October to develop a
               plan to obtain foreign-made influenza vaccine that was not
               licensed for the U.S. market and make it available under an
               investigational new drug protocol, HHS in December 2004 purchased
               about 1.2 million doses from one manufacturer in Germany and, in
               January 2005, purchased about 250,000 doses from another
               manufacturer in Switzerland. CDC could then make this vaccine
               available to those states and localities wanting additional
               vaccine to alleviate shortages. According to HHS officials,
               however, none of the additional doses were used in the 2004-05
               influenza season.
               o  CDC made stockpiled vaccine available to providers. On January
               27, 2005, after the production of 3.1 million late-season doses
               designated for CDC's stockpile of influenza vaccine,24 CDC
               announced that that it would make this vaccine available to sanofi
               pasteur, which, in turn, could market and sell the vaccine to
               public and private providers and then replenish CDC's stockpile.
               This strategy allowed providers to order influenza vaccine
               directly from the manufacturer or a distributor, rather than go
               through state or local health departments. Providers who purchased
               these stockpiled doses would also be allowed to return unused
               vaccine for a credit and would have to pay only shipping costs for
               returned vaccine.

               Although the actions taken to address the influenza vaccine
               shortage helped achieve vaccination rates approaching past levels
               for certain priority groups (see fig. 5), a number of lessons
               emerged from federal, state, and local responses to the 2004-05
               influenza shortage. Some lessons were specific to that season's
               shortage, and others have wider ramifications for potential future
               shortages or a pandemic. The primary lessons can be grouped into
               three broad, interrelated categories: planning, timely action, and
               communication.

               Figure 5: Influenza Vaccination Rates for Selected Priority Groups

               Before October 5, 2004, CDC lacked a contingency plan specifically
               designed to respond to a scenario involving a severe influenza
               vaccine shortage at the start of the traditional fall vaccination
               period; the absence of a plan led to a delay in response. Faced
               with the unanticipated shortfall in the amount of influenza
               vaccine expected to be available for the 2004-05 influenza season,
               CDC revised recommendations and worked with sanofi pasteur to
               begin assessing available supply and to create a distribution plan
               for the remaining vaccine. Developing and implementing this plan
               took time and led to delays in response and some confusion at the
               state and local levels, particularly right after Chiron's October
               5, 2004, announcement. Public health officials in all five states
               we visited remarked that although phase I of CDC's redistribution
               plan quickly and effectively distributed some vaccine to public
               and private providers serving priority groups, the vaccine
               available in phase II of CDC's redistribution plan was too much,
               too late. Phase II ordering began on November 17, 2004, and
               continued into January 2005, but several weeks could elapse after
               orders were placed until vaccine was delivered. According to state
               and local public health officials we interviewed, by the time the
               vaccine was delivered through a cumbersome distribution process,
               demand for the vaccine had substantially waned, and public and
               private providers were left to redistribute the excess. The phase
               II distribution problem was compounded for state and local health
               officials because CDC restricted access to its secure data network
               to two people per state. This narrow restriction left several
               state and local public health officials, according to those we
               interviewed, without vital information about the supply or demand
               for vaccine.

               Our work showed that four areas of planning are particularly
               important for enhancing preparedness before a similar situation in
               the future: (1) defining the responsibilities of federal, state,
               and local officials; (2) using emergency preparedness plans and
               emergency health directives; (3) distinguishing between demand and
               need; and (4) identifying mechanisms for distributing and
               administering vaccine.

               o  Better defining responsibilities of federal, state, and local
               officials can minimize confusion. During the 2004-05 vaccine
               shortage, CDC worked with national organizations representing
               states and localities to coordinate roles and responsibilities.
               Several public health officials we spoke with reported that CDC
               effectively worked with sanofi pasteur and national organizations
               representing state and local health officials to coordinate
               responsibilities shortly after Chiron's announcement. Despite
               these efforts, however, problems occurred. For example, to
               identify national demand for vaccine, federal, state, and local
               health officials surveyed providers in states and localities to
               assess existing supply and additional need. CDC worked with
               national professional associations to survey long-term-care
               providers throughout the country to determine if seniors had
               adequate access to vaccine. Maine and other states, however, also
               surveyed their long-term-care providers to make the identical
               determination. This duplication of effort expended additional
               resources, burdened some long-term-care providers in the states,
               and created confusion.
               o  Emergency preparedness plans and emergency health directives
               help coordinate local response. State and local health officials
               in several locations we visited reported that using existing
               emergency plans or incident command centers helped coordinate
               effective local response to the vaccine shortage. For example,
               public health officials from Seattle-King County said that using
               the county's incident command system played a vital role in
               coordinating an effective and timely local response and in
               communicating a clear message to the public and providers. In
               addition, according to public health officials, emergency public
               health directives helped ensure access to vaccine by supporting
               providers in enforcing CDC's recommendations and in helping to
               prevent price gouging in those states whose directives addressed
               price gouging. Certain officials we spoke with, however, reported
               that although plans and directives helped, improvements were still
               needed. Some health officials indicated that as a result of the
               past influenza season, they were revising state and local
               preparedness plans or modifying command center protocols to
               prepare for future emergency situations. For example, in Maine,
               after experiences during the 2004-05 influenza season, state
               officials recognized the need to speed completion of their
               pandemic influenza preparedness plan. In addition, they said the
               vaccine shortage experience helped identify which officials should
               attend which meetings during a crisis to ensure the right people
               have the right information.
               o  Distinguishing between demand and need for vaccine can improve
               distribution. In discussing the adequacy of vaccine supplies,
               public health officials make a distinction between demand and need
               for vaccine by a high-risk group. In this context, demand is the
               number of high-risk individuals who want to receive an influenza
               vaccination, and need is the total number of high-risk individuals
               in an area or region, regardless of whether they want to receive a
               vaccination. Because some individuals in high-risk groups are
               unlikely to be vaccinated, estimating vaccine amounts on the basis
               of total need, rather than demand, can overstate the amount that
               will likely be used in any given location. Differentiating between
               demand and need would have helped states avoid substantially over-
               or underordering vaccine from CDC or a manufacturer. California
               state officials said that differentiating between demand and need
               earlier in the season could have reduced delays and confusion
               during the shortage. Certain states and localities we visited had
               taken time before the season to address contingencies for vaccine
               supply fluctuations. For example, Minnesota state officials used
               experiences in previous influenza seasons to build a state
               influenza plan that educated providers and local public health
               officials about the difference between demand and need. According
               to state officials, communicating this difference to local
               providers and health officials helped more accurately identify how
               much vaccine was in demand throughout the state.
               o  The distribution and administration of vaccine can be
               facilitated. One mechanism used in a majority of the states and
               localities we visited was building partnerships between public and
               private sectors. This mechanism was effective in both the
               distribution and the administration of vaccine. In San Diego
               County, California, for example, local health officials worked
               with a coalition of partners in public health, private businesses,
               and nonprofit groups throughout the county. In addition, several
               states and localities also partnered with other organizations,
               including home health organizations, to increase their capacity to
               administer vaccine to large numbers of people. For example, public
               health officials, including those in California and Florida,
               worked with national home health organizations to quickly immunize
               those in high-risk and other priority groups by holding mass
               immunization clinics. Other mechanisms we identified, aimed mainly
               at addressing the challenge of administering a limited amount of
               vaccine, included scheduling appointments and holding lotteries.
               In Stearns County, Minnesota, for example, public health officials
               worked with private providers to implement a system of vaccination
               by appointment. Rather than standing in long lines for
               vaccination, individuals with appointments went to a clinic during
               a given time slot. Public health officials in Portland, Maine,
               emphasized the effectiveness of holding a lottery as a way to
               equitably administer limited amounts of vaccine to people and as
               an alternative to having large crowds show up for a limited number
               of doses.

               After the 2004-05 influenza season, CDC officials developed
               lessons learned from their experiences, including lessons on the
               importance of contingency planning and defining which groups have
               higher priority in the event of a vaccine shortage. In August
               2005, CDC issued interim guidelines to assist state and other
               immunization programs in planning for and dealing with an
               influenza vaccine shortage during the 2005-06 season.25 Also in
               August 2005, CDC published potential priority groups for
               vaccination in the event of a shortage. Because the total vaccine
               supply for the 2005-06 influenza season was not then known,
               however, CDC did not recommend setting priorities for injectable
               vaccine at that time.26 On September 2, 2005, CDC published
               priority recommendations for use of injectable vaccine through
               October 24, 2005.27

               During the 2004-05 influenza vaccine shortage, federal, state, and
               local officials needed to continually adapt to changing vaccine
               supply and demand, to make decisions, and to take action quickly.
               The actions they took after the traditional fall vaccination
               period, however, came too late to boost supply while demand was
               still high. These actions included making available
               foreign-manufactured vaccine that was not licensed for the U.S.
               market, expanding availability of vaccine from the Vaccines for
               Children program, and releasing vaccine reserved for the federal
               stockpile.

               HHS's decision to purchase influenza vaccine not licensed for the
               U.S. market and to make it available under an investigational new
               drug protocol was too late to mitigate the shortage's effects
               because of when such vaccines became available and because of
               cumbersome administrative requirements. Soon after Chiron's
               October 5, 2005, announcement, HHS started looking into foreign
               vaccine that was licensed for use in other countries but not in
               the United States. Nonetheless, by the time HHS purchased this
               vaccine in December 2004 and January 2005, there was little demand
               for it. CDC officials acknowledged that one lesson learned from
               experience in 2004-05 was that use of foreign-licensed vaccine
               under an investigational new drug protocol during the influenza
               season requires that vaccine be shipped no later than the
               beginning of October. Further, recipients of such vaccines may be
               required to sign a consent form and follow up with a health care
               worker after vaccination-steps that, according to health officials
               we interviewed in several states, would be too cumbersome to
               administer and could dampen public enthusiasm for being
               vaccinated. Although about 1.5 million doses of this vaccine
               became available, none were used because demand had fallen, and
               injectable vaccine licensed for the U.S. market was still
               available.

               CDC's December 2004 and January 2005 implementation of decisions
               to make vaccine from the Vaccines for Children program more widely
               available was not timely and lacked flexibility. CDC explored
               options to use program vaccine to vaccinate three groups of
               people-children eligible for the Vaccines for Children program but
               not in a priority group, children not eligible for the program,
               and adults-but only in geographic areas where the needs of
               eligible children in high-risk groups had been met.28 But by the
               time CDC determined that demand from eligible children had been
               met and announced that it was taking steps to make more program
               vaccine available for others, many states' demand for additional
               vaccine had dropped. Because vaccine purchased under the Vaccines
               for Children program became available for nonprogram use so late,
               some states reported they were unable to vaccinate all their
               state's children in CDC's priority groups. In other states,
               vaccine purchased under the program remained unused after all
               program-eligible children were vaccinated, but completing the
               process to transfer the unused vaccine delayed some states from
               administering the remaining vaccine to individuals not eligible
               for Vaccines for Children. Since CDC expanded program vaccine
               availability too late, vaccine purchased under the Vaccines for
               Children program ultimately went unused. As a result, CDC is
               surveying epidemiologists, state health officials, and
               immunization managers on lessons learned to connect activities to
               outcomes, such as releasing program vaccine to increase
               immunization rates. Further, state health officials we interviewed
               reported that administrative difficulties in making vaccine
               available to a broader population hindered its ready use during
               the shortage. According to state health officials in California
               and Washington, if broadening Vaccines for Children eligibility
               had been more flexible and allowed more efficient transfer of
               vaccine to those not in the program, vaccine could have been made
               available sooner and more widely to people in priority groups.

               CDC's decision to release influenza vaccine produced for its
               national stockpile was also ineffective because the action came
               too late. The majority of doses reserved for the stockpile were
               not delivered until January 2005 because CDC wanted doses produced
               earlier in the season to be available to fill state orders. By the
               time the stockpiled doses were released back to the manufacturer
               for purchase by providers and others in January, national demand
               had shrunk. Of the 3.1 million doses of injectable vaccine
               released from the stockpile in January 2005, only approximately
               115,000 were ordered. Without exception, state health officials in
               the five states we visited reported that this vaccine became
               available too late in the season to be useful.

               Finally, certain states faced barriers when trying to buy
               available influenza vaccine from other states, preventing timely
               redistribution. During the 2004-05 shortage, some state health
               officials reported problems with their ability-both in paying for
               vaccine and in administering the transfer process-to purchase
               influenza vaccine. For example, 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
               flexibility 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, eliminating cost as a barrier
               in acquiring vaccine to distribute to the public.

               While part of the lesson learned about communication was positive,
               some aspects of this lesson pointed to need for improvement.
               Positives can be seen, for example, in the extent of CDC's
               communication. During the 2004-05 shortage, CDC communicated
               regularly through a variety of media as the situation evolved.
               Officials from most states and localities we talked with reported
               that CDC played an active role in communicating information
               despite a changing environment. Several state and local officials
               we spoke with said that biweekly conference calls were effective
               in providing updates and coordinating responsibilities. The state
               health officer from Alabama, for instance, noted the frequency and
               quality of the communications that CDC put forth during the
               influenza season.

               Despite these positives, when examining the 2004-05 influenza
               season, state and local officials identified areas of
               communication to improve for future seasons. During our visits to
               states and localities, we found four particularly important
               communication issues. These issues included maintaining
               consistency of communications to avert confusion, understanding
               the importance of changing messages under changing circumstances,
               using diverse media to reach diverse audiences, and educating
               providers and the public about prevention alternatives.

               o  Consistency among federal, state, and local communications is
               critical for averting confusion. Health officials in Minnesota,
               for example, reported that some confusion resulted when the state
               determined that the influenza vaccine supply was sufficient to
               meet demand and therefore made vaccine available to other groups,
               such as healthy individuals aged 50-64 years, earlier than
               recommended by CDC. Similarly, health officials in California
               reported that in mid-December, local radio stations in the state
               were running two public service announcements-one from CDC
               advising those aged 65 years and older to be vaccinated, and one
               from the California Department of Health Services advising those
               aged 50 years and older to be vaccinated. They emphasized that
               these mixed messages created confusion. In addition, some
               individuals seeking influenza vaccine in other regions 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
               were told to call their primary care provider, and when they
               called their primary care provider, they were told to call their
               local public health department. This inconsistency in information
               from authoritative sources led to confusion and possibly to
               high-risk individuals' giving up and not receiving an influenza
               vaccination.29
               o  Modifying messages to respond to changing circumstances can
               prevent unintended consequences. Beginning in October, CDC
               communicated a message asking individuals who were not in a
               high-risk group or another priority group to forgo or defer
               vaccination, or to step aside, so that that those in priority
               groups could have access to available vaccine. According to CDC,
               this message resulted in an estimated 17.5 million individuals who
               specifically deferred vaccination to save vaccine for those in the
               priority groups. Public health officials we interviewed, however,
               lamented the fact that this nationwide effort did not also include
               a message to individuals who did step aside to check back with
               their providers or to seek an influenza vaccination later in the
               season. State and local officials suggested that CDC should have
               had a message to step aside until a certain estimated date, when
               more vaccine would be available and demand from individuals in the
               narrowed CDC priority groups would ease. These officials noted
               that many people in priority groups, including those aged 65 years
               and older who should have been vaccinated, stepped aside. These
               officials also said that they were concerned about other
               individuals, particularly those aged 50-64 years, who were not
               vaccinated during the moderate 2004-05 influenza season and, as a
               result, might think vaccination was not important enough to seek
               in future seasons.
               o  Using diverse media helps reach diverse audiences. During the
               2004-05 influenza season, public health officials reported the
               importance of using a variety of communication methods to help
               ensure that messages reached as many individuals as possible. For
               example, officials from the health department in Seattle-King
               County, Washington, reported that it was important to have a
               telephone 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. Further,
               public health officials in Miami-Dade County in Florida said that
               bilingual radio advertisements promoting influenza vaccine for
               those in priority groups helped increase the effectiveness of
               local efforts to raise vaccination rates.

               o  Education is important in alerting providers and the public
               about prevention alternatives. Educating health care providers and
               the public about all available influenza vaccines and forms of
               prevention may increase the number of vaccinated individuals and
               also reduce the spread of influenza. Experience with the nasal
               spray vaccine in 2004-05 illustrates the importance of education.
               Approximately 3 million doses of nasal spray vaccine were
               ultimately available during the season for vaccinating healthy
               individuals.30 According to public health officials we
               interviewed, however, some individuals were reluctant to use this
               vaccine because they feared that the vaccine was too new and
               untested or 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 500 doses were
               administered. Further, public health officials we interviewed said
               that education about all available forms of prevention, including
               the use of antiviral medications and good hygiene practices, can
               help reduce the spread of influenza.31

               According to CDC officials, as part of preparations for the
               2005-06 influenza season, the agency developed a draft
               communication plan-separate from the interim guidelines issued to
               states-from lessons learned, which includes messages for
               responding to the fluctuations in supply and demand anticipated
               throughout the season. As of August 2005, CDC officials said that
               this plan will remain in draft form because tactics will be
               changed and updated as circumstances change.

               Aided by a relatively moderate influenza season, efforts to
               mitigate the sudden and unexpected shortage of influenza vaccine
               for the 2004-05 season were largely successful, although the
               season was not without problems. Lacking a preseason plan to
               address a significant shortfall after the beginning of the
               traditional fall vaccination period, the federal government
               reacted to the shortage and its aftereffects as they unfolded
               throughout the season. This lack of preseason planning created
               confusion and delays during the optimal fall influenza vaccination
               window, when state and local public health agencies and health
               care providers most needed vaccine to protect individuals at high
               risk of severe complications. Conversely, federal efforts to boost
               supply late in the season had little effect, because demand fell
               off sharply in December and January, and vaccine became available
               too late. In some instances, uncoordinated communication from
               federal to state and local jurisdictions, and to providers and the
               general public, contributed to confusion, frustration, and
               individuals' failure to seek or receive an influenza vaccination.
               Drawing from experiences during the 2004-05 shortage, CDC has
               taken a number of steps, including issuing interim guidelines in
               August 2005, to assist in responding to possible future shortages.
               It is too early, however, to assess the effectiveness of these
               efforts in coordinating actions of federal, state, and local
               health agencies and others who play a part in the annual influenza
               vaccination process.

               In commenting on a draft of this report, HHS noted that the draft
               summarized in detail the activities undertaken by CDC and its
               public- and private-sector partners to deal with the influenza
               vaccine shortage of 2004-05, and the agency concurred with our
               finding that contingency planning will greatly improve response
               efforts. The agency also provided details on other actions, such
               as approval of additional influenza vaccines for the U.S. market,
               that were under way. HHS also agreed that adjustments to
               vaccination recommendations and vaccine supply ideally should
               occur earlier in the influenza season, but such adjustments cannot
               always be implemented in a shortage year. HHS's written comments
               appear in appendix I.

               As arranged with your office, unless you publicly announce the
               contents of this report earlier, we plan no further distribution
               of it until 30 days after its issue date. At that time, we will
               send copies of this report to the Secretary of HHS, the Directors
               of CDC and the National Vaccine Program Office, and other
               interested parties. We will also make copies available to others
               upon request. In addition, the report will be available at no
               charge on the GAO Web site at http://www.gao.gov .

               If you or your staff members have any questions, please contact me
               at (202) 512-7119 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 members who made major
               contributions to this report are listed in appendix II.

               Marcia Crosse Director, Health Care

               Marcia Crosse, (202) 512-7119 or crossem@gao.gov

               In addition to the contact named above, Kim Yamane, Assistant
               Director; George Bogart; Ellen W. Chu; Nicholas Larson; Jennifer
               Major; Terry Saiki; and Stan Stenersen made key contributions to
               this report.

               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.

               Flu Vaccine: Recent Supply Shortages Underscore Ongoing
               Challenges. GAO-05-177T . Washington, D.C.: November 18, 2004.

               Infectious Disease Preparedness: Federal Challenges in Responding
               to Influenza Outbreaks. GAO-04-1100T . Washington, D.C.: September
               28, 2004.

               Public Health Preparedness: Response Capacity Improving, but Much
               Remains to Be Accomplished. GAO-04-458T . Washington, D.C.:
               February 12, 2004.

               Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts
               Have Improved Public Health Response Capacity, but Gaps Remain.
               GAO-03-654T . Washington, D.C.: April 9, 2003.

               Bioterrorism: Preparedness Varied across State and Local
               Jurisdictions. GAO-03-373 . Washington, D.C.: April 7, 2003.

               Flu Vaccine: Steps Are Needed to Better Prepare for Possible
               Future Shortages. GAO-01-786T . Washington, D.C.: May 30, 2001.

               Flu Vaccine: Supply Problems Heighten Need to Ensure Access for
               High-Risk People. GAO-01-624 . Washington, D.C.: May 15, 2001.

               Flu Pandemic: Plan Needed for Federal and State Response. GAO-01-4
               . Washington, D.C.: October 27, 2000.

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    21See Centers for Disease Control and Prevention, "Updated Interim
    Influenza Vaccination Recommendations, 2004-05 Influenza Season,"
    Morbidity and Mortality Weekly Report, vol. 53, no. 50 (2004): 1183-1184.

    22By December 15, 2004, nine states had begun offering influenza vaccine
    to people aged 50 years and older and to household contacts of high-risk
    individuals.

    23In November 2004, CDC provided guidance for providers to borrow
    influenza vaccine from the Vaccines for Children program, to immunize
    children ineligible for the program, if, among other things, the providers
    anticipated being able to replace the borrowed doses in the near term.

      Planning, Timely Action, and Communication Are Key to an Effective Response

    24Before Chiron's announcement, CDC had planned to establish a stockpile
    of approximately 4.5 million doses of injectable influenza vaccine
    purchased from both Chiron and sanofi pasteur. The primary purpose of the
    planned stockpile was to meet late-season, unmet pediatric demand.

    Lesson Learned: Limited Contingency Planning Slows Response

    Lesson Learned: Unless Expedited, Actions to Boost Supply Are Likely to Have
    Little Effect

    25CDC indicated that it had assembled a team in December 2004 to begin
    contingency planning for the 2005-06 influenza season. See Centers for
    Disease Control and Prevention, "Interim Guideline: Planning for a
    Possible U.S. Influenza Vaccine Shortage, 2005-06 Season," August 4, 2005,
    http://www.cdc.gov/flu/professionals/vaccination/pdf /vaccshortguide.pdf
    (downloaded on Aug. 24, 2005).

    26See Centers for Disease Control and Prevention, "Tiered Use of
    Inactivated Influenza Vaccine in the Event of a Vaccine Shortage,"
    Morbidity and Mortality Weekly Report, vol. 54, no. 30 (2005): 749-750.

    27See Centers for Disease Control and Prevention, "Update: Influenza
    Vaccine Supply and Recommendations for Prioritization during 2005-06
    Influenza Season," Morbidity and Mortality Weekly Report, vol. 54, no. 34
    (2005): 850.

    28CDC indicated that because the Vaccines for Children program is an
    entitlement, moving too rapidly to release vaccine to ineligible people
    may risk denying vaccine to children for whom the law requires
    availability.

    Lesson Learned: Effective Response Requires Communication to Be Both Clear and
    Consistent

    29According to data collected during December 1-11, 2004, on self-reported
    vaccination during September 1 through November 30, 2004, among adults in
    priority groups who had not yet received influenza vaccine, about 23
    percent reported that they attempted to obtain a vaccination but could
    not. See Centers for Disease Control and Prevention, "Estimated Influenza
    Vaccination Coverage among Adults and Children-United States, September
    1-November 30, 2004," Morbidity and Mortality Weekly Report, vol. 53, no.
    49 (2004): 1147-1150.

                                Concluding Observations

    30The nasal spray vaccine was recommended for 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.

    31CDC posted guidance on its Web site in October 2004 about use of
    antiviral medications and other ways to prevent the spread of influenza,
    including covering the mouth when coughing, hand washing, and staying home
    from work when ill. See http://www.cdc.gov/flu/protect/preventing.htm
    (downloaded on Aug. 8, 2005).

                                    Agency Comments

    Appendix I: Comments from the Department of Health and Human Services
    Appendix I: Comments from the Department of Health and Human Services

    Ap Ac Appendix II: GAO Contact and Staff Acknowledgments

                                      GAO Contact

                                    Acknowledgments

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    Highlights of GAO-05-984 , a report to the Committee on Government Reform,
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    September 2005

    INFLUENZA VACCINE

    Shortages in 2004-05 Season Underscore Need for Better Preparation

    In early October 2004, the nation lost about half its expected influenza
    vaccine supply when one of two major manufacturers announced it would not
    release any vaccine for the 2004-05 season because of potential
    contamination. The Centers for Disease Control and Prevention (CDC) had
    earlier recommended vaccination for 188 million individuals, including
    those at high risk of severe complications from influenza (such as seniors
    and those with chronic conditions), and other groups (such as their close
    contacts). Although health officials took actions to distribute the
    limited supply of influenza vaccine, reports persisted of high-risk
    individuals and others in priority groups who could not find a
    vaccination, including those who were turned away and never returned when
    supplies became available. Such reports raised questions about the
    adequacy of U.S. preparedness to respond to significant vaccine shortages.

    GAO was asked to examine actions taken at federal, state, and local levels
    to ensure that high-risk individuals had access to influenza vaccine
    during the shortage, including any lessons learned.

    Federal, state, and local health officials took several actions beginning
    in October 2004 to help ensure that individuals at high risk of severe
    complications from influenza had access to vaccine. Federal officials, for
    example, quickly revised vaccination recommendations to target available
    vaccine to high-risk individuals and to other priority groups. Additional
    actions were aimed to distribute vaccine expeditiously and to communicate
    with providers and the public as events unfolded and vaccine supplies
    changed. Beginning in mid-December, health officials took steps to
    distribute additional vaccine, broadening recommendations on who should be
    vaccinated.

    Although these actions helped achieve vaccination rates approaching past
    levels for certain priority groups, such as those aged 65 years and older,
    several lessons emerged, including some that could help with future
    shortages. First, unless planning for problems is already in place, action
    is delayed. CDC's lack of a contingency plan contributed to delays and
    uncertainty about how to ensure that high-risk individuals had access to
    vaccine. Second, when actions occur late in the influenza season, they are
    likely to have little effect. Third, effective response requires
    communication that is both clear and consistent. CDC has taken a number of
    steps, including issuing interim guidelines in August 2005, to respond to
    possible future shortages. It is too early, however, to assess the
    effectiveness of these efforts in coordinating actions of federal, state,
    and local health agencies and others.

    In commenting on a draft of this report, HHS concurred with GAO's finding
    that contingency planning would improve response efforts, and the agency
    indicated that additional preparations were under way.

    Influenza Vaccination Rates for Selected Priority Groups
    *** End of document. ***