Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation
Published: 2005-09-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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. 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.
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.
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;   (3) organizations that conduct mass immunization clinics; (4) sanofi  pasteur, 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. 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.
subsections: section_title: Background
paragraphs: 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.
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.
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.
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. 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.
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. 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.
section_title: Health Officials Took Steps to Vaccinate High-Risk Individuals and Others in Priority Groups
paragraphs: 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).
subsections: section_title: Federal and State Officials Took Quick Actions
paragraphs: 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.
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). 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.
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.
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. Around the same time, FDA  quickly authorized the redistribution of vaccine among hospitals and other  health entities to alleviate shortages. 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.
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.
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, 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.
section_title: Public Health Officials Acted to Distribute Remaining Vaccine
paragraphs: 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.
subsections: section_title: CDC Devised a Plan to Distribute the Limited Supply of Influenza to High-Risk Individuals and to Others in Priority Groups
paragraphs: 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.
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. 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. 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.
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.
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. 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.
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.
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.
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.
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.
section_title: Public Health Officials Used Multiple Communication Strategies to Impart Key Information
paragraphs: 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. 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. 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).
section_title: Late-Season Actions Aimed to Boost Supply and Demand
paragraphs: 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.
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. 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. 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.
CDC made vaccine from the Vaccines for Children program more  widely available. 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.
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.
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, 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.
section_title: Planning, Timely Action, and Communication Are Key to an Effective Response
paragraphs: 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.
subsections: section_title: Lesson Learned: Limited Contingency Planning Slows Response
paragraphs: 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.
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.
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.
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.
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. 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. On  September 2, 2005, CDC published priority recommendations for use of  injectable vaccine through October 24, 2005.
section_title: Lesson Learned: Unless Expedited, Actions to Boost Supply Are Likely to Have Little Effect
paragraphs: 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. 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.
section_title: Lesson Learned: Effective Response Requires Communication to Be Both Clear and Consistent
paragraphs: 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.
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.
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.
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.
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. 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.
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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
section_title: Appendix I: Comments from the Department of Health and Human Services
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: 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.
section_title: Related GAO Products
paragraphs: 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.