Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage
Published: 2005-11-04T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Concern has been rising about the nation's preparedness to respond to vaccine shortages that could occur in future annual influenza seasons or during an influenza pandemic--a global influenza outbreak. Although the timing or extent of a future influenza pandemic cannot be predicted, studies suggest that its effect in the United States could be severe, and shortages of vaccine could occur. For the 2004-05 annual influenza season, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced in October 2004 that it would not release any vaccine. GAO examined federal, state, and local actions taken in response to the shortage, including lessons learned. The nation's experience during the unexpected 2004-05 vaccine shortfall offers insights into some of the challenges that government entities will face in a pandemic. GAO was asked to provide a statement on lessons learned from the 2004-05 vaccine shortage and their relevance to planning and preparing for similar situations in the future, including an influenza pandemic. This statement is based on a GAO report, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation (GAO-05-984), and on previous GAO reports and testimonies about influenza vaccine supply and pandemic preparedness.
section_title: What GAO Found
paragraphs: A number of lessons emerged from federal, state, and local responses to the 2004-05 influenza vaccine shortage that carry implications for handling future vaccine shortages in either an annual influenza season or an influenza pandemic. First, limited contingency planning slows response. At the start of the 2004-05 influenza season, when the supply shortfall became apparent, the nation lacked a contingency plan specifically to address severe shortages. The absence of such a plan led to delays and uncertainties on the part of state and local public health entities on how best to ensure access to vaccine by individuals at high risk of severe influenza-related complications. Second, streamlined mechanisms to expedite vaccine availability are key to an effective response. During the 2004-05 shortage, for example, federal purchases of vaccine licensed for use in other countries but not the United States were not completed in time to meet peak demand. Some states' experience also highlighted the importance of mechanisms to transfer available vaccine quickly and easily from one state to another. Third, effective response requires clear and consistent communication. Consistency among federal, state, and local communications is critical for averting confusion. State and local health officials also emphasized the value of updated information when responding to changing circumstances, using diverse media to reach diverse audiences, and educating providers and the public about prevention alternatives. Over the past 5 years, GAO has urged the Department of Health and Human Services (HHS) to complete its plan to prepare for and respond to an influenza pandemic. GAO has reported on the importance of planning to address critical issues such as how vaccine will be purchased and distributed; how population groups will be given priority for vaccination; and how federal resources should be deployed before the nation faces a pandemic. On November 2, 2005, HHS released its pandemic influenza plan. GAO did not have the opportunity to review the plan before issuing this statement to determine the extent to which the plan addresses these critical issues.

section_title: Letter
paragraphs: I am pleased to have the opportunity to provide information on our recent  review of the 2004–05 influenza vaccine shortage, with lessons to consider  as the nation improves its ability to respond to an influenza pandemic (a  global influenza outbreak resulting from a major genetic change in the  influenza virus). Concern about the nation’s preparedness to respond to  an influenza pandemic has been growing for some time, in part because of  the increase in the number of identified human cases of avian influenza in  Asia. Studies suggest that a pandemic’s effects in the United States could  be severe, and shortages of vaccine could occur. The nation’s experience  responding to the shortage of annual influenza vaccine for the 2004–05  influenza season—in which the nation faced an unexpected loss of nearly  half its projected vaccine supply—offers insight into the some of the  challenges that federal, state, and local entities will face if a pandemic  occurs.
My statement includes findings from our recent report on last winter’s  influenza vaccine shortage and discusses lessons learned from that  experience that could help prepare the nation to respond to future vaccine  shortages in either an annual influenza season or an influenza pandemic.  My statement also draws from several GAO reports and testimonies on  influenza vaccine supply, pandemic planning, and emergency  preparedness for emerging infectious diseases that we have issued since  October 2000. This body of work includes interviews with officials in the  Department of Health and Human Services (HHS), such as officials from  the Centers for Disease Control and Prevention (CDC) and the National  Vaccine Program Office. For the report on the 2004–05 influenza vaccine  shortage, we conducted site visits at a sample of states and localities. We  also interviewed officials from public health departments and a major  influenza vaccine manufacturer; national organizations, including the  Association of State and Territorial Health Officials and the Association of  Immunization Managers; organizations that conduct mass immunization  clinics; and a large purchaser of influenza vaccine. We conducted all of our  work in accordance with generally accepted government auditing  standards.
In summary, a number of lessons emerged from federal, state, and local  responses to the 2004–05 influenza vaccine shortage that carry  implications for handling future vaccine shortages in either an annual  influenza season or an influenza pandemic. First, limited contingency  planning slows response. At the start of the 2004–05 influenza season,  when the nation unexpectedly lost roughly half its projected influenza  vaccine supply, the nation lacked a contingency plan specifically for a  severe vaccine shortage. The absence of such a plan led to delays and  uncertainties on the part of state and local public health entities on how  best to ensure access to vaccine by individuals at high risk of severe  influenza-related complications. Since 2000, we have encouraged the  development of a plan to address critical issues that could arise in an  influenza pandemic. Second, streamlined mechanisms to expedite vaccine  availability are key to an effective response. During the 2004–05 shortage,  for example, federal purchases of vaccine licensed for use in other  countries but not the United States were not completed in time to meet  peak demand. Some states’ experience also highlighted the importance of  mechanisms to transfer available vaccine quickly and easily from one state  to another. Third, effective response requires clear and consistent  communication. Consistency among federal, state, and local  communications is critical for averting confusion. State and local health  officials also emphasized the value of updated information when  responding to changing circumstances, using diverse media to reach  diverse audiences, and educating providers and the public about  prevention alternatives.
subsections: section_title: Background
paragraphs: Influenza is more severe than some viral respiratory infections, such as the  common cold. During an annual influenza season, most people who  contract influenza recover completely in 1 to 2 weeks, but some develop  serious and potentially life-threatening medical complications, such as  pneumonia. People aged 65 years and older, people of any age with  chronic medical conditions, children younger than 2 years, and pregnant  women are generally more likely than others to develop severe  complications from influenza. In an average year in the United States,  more than 36,000 individuals die and more than 200,000 are hospitalized  from influenza and related complications.
Pandemic influenza differs from annual influenza in several ways.  According to the World Health Organization, pandemic influenza spreads  to all parts of the world very quickly, usually in less than a year, and can  sicken more than a quarter of the global population, including young,  healthy individuals. Although health experts cannot predict with certainty  which strain of influenza virus will be involved in the next pandemic, they  warn that the avian influenza virus identified in the human cases in Asia,  known as H5N1, could lead to a pandemic if it acquires the genetic ability,  so far absent, to spread quickly from person to person.
Vaccination is the primary method for preventing influenza and its  complications. Produced in a complex process that involves growing  viruses in millions of fertilized chicken eggs, influenza vaccine is  administered each year to protect against particular influenza strains  expected to be prevalent that year. Experience has shown that vaccine  production generally takes 6 or more months after a virus strain has been  identified; vaccines for certain influenza strains have been difficult to  mass-produce. After vaccination for the annual influenza season, it takes  about 2 weeks for the body to produce the antibodies that protect against  infection. According to CDC recommendations, the optimal time for  annual vaccination is October through November. Because the annual  influenza season typically does not peak until January or February,  however, in most years vaccination in December or later can still be  beneficial.
At present, two vaccine types are recommended for protection against  influenza in the United States: an inactivated virus vaccine injected into  muscle and a live virus vaccine administered as a nasal spray. The  injectable vaccine—which represents the large majority of influenza  vaccine administered in this country—can be used to immunize both  healthy individuals and individuals at highest risk for 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 to 49 years who are not  pregnant. 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. For the 2004–05 influenza season, CDC  and its Advisory Committee on Immunization Practices (ACIP) initially  recommended vaccination for about 188 million people in designated  priority groups, including roughly 85 million people at high risk for severe  complications. On October 5, 2004, however, Chiron announced that it  could not provide its expected production of 46–48 million doses—about  half the expected U.S. influenza vaccine supply.
Although vaccination is the primary strategy for protecting individuals  who are at greatest risk of severe complications and death from influenza,  antiviral drugs can also help to treat infection. If taken within 2 days of a  person’s becoming ill, these drugs can ease symptoms and reduce  contagion. In the event of a pandemic, such drugs could lower the number  of deaths until a pandemic influenza vaccine became available. Four  antiviral drugs have been approved by the Food and Drug Administration  (FDA) for treatment of influenza: amantadine, rimantadine, oseltamivir,  and zanamivir.
HHS has primary responsibility for coordinating the nation’s response to  public health emergencies. Within HHS, CDC is one of the agencies that  protect the nation’s health and safety. CDC’s activities include efforts to  prevent and control diseases and to respond to public health emergencies.  CDC and ACIP recommend which population groups should be targeted  for vaccination each year and, when vaccine supply allows, recommend  that any person who wishes to decrease his or her risk of influenza be  vaccinated. In addition, the National Vaccine Program Office is  responsible for coordinating and ensuring collaboration among the many  federal agencies involved in vaccine and immunization activities; the office  also issued a draft national pandemic influenza preparedness plan in  August 2004.
Preparing for and responding to an influenza pandemic differ in several  respects from preparing for and responding to an annual influenza season.  For example, past influenza pandemics have affected healthy young adults  who are not typically at high risk for severe influenza-related  complications, so the groups given priority for early vaccination may differ  from those given priority in an annual influenza season. In addition,  according to CDC, a vaccine probably would not be available in the early  stages of a pandemic. Shortages of vaccine would therefore be likely  during a pandemic, potentially creating a situation more challenging than a  shortage of vaccine for an annual influenza season.
section_title: Limited Contingency Planning Slows Response
paragraphs: One lesson learned from the 2004–05 season that is relevant to a future  vaccine shortage in either an annual influenza season or a pandemic is the  importance of planning before a shortage occurs. At the time the influenza  vaccine shortage became apparent, the nation lacked a contingency plan  specifically designed to respond to a severe vaccine shortage. The absence  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 of severe complications and others in priority  groups. Faced with the unanticipated shortfall, CDC redefined the priority  groups it had recommended for vaccination and asked sanofi pasteur, the  remaining manufacturer of injectable vaccine, to suspend distribution until  the agency completed its assessment of the shortage’s extent and  developed a plan to distribute the manufacturer’s remaining vaccine to  providers serving individuals in the priority groups. Developing and  implementing this distribution plan took time and led to delays in response  and some confusion at state and local levels.
Our work showed that several areas of planning are particularly important  for enhancing preparedness before a similar situation occurs in the future,  including defining the responsibilities of federal, state, and local officials;  using emergency preparedness plans and emergency health directives; and  facilitating the distribution and administration of vaccine.
Clearly defining responsibilities of federal, state, and local officials can  minimize confusion. During the 2004–05 vaccine shortage, even though  CDC worked with states and localities to coordinate roles and  responsibilities, problems occurred. For example, 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 same determination. This duplication of effort  expended additional resources, burdened some long-term-care providers  in the states, and created confusion.
Emergency preparedness plans help coordinate local response. State and  local health officials in several locations we visited reported that using  existing emergency plans or incident command centers (the organizational  systems set up specifically to handle the response to emergency  situations) helped coordinate effective local responses 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 the CDC  recommendations and in helping to prevent price gouging in certain states.
Partnerships between the public and private sectors can facilitate  distribution and 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. Other mechanisms facilitated administering the  limited supply of influenza vaccine to those in high-risk or other priority  groups. 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.
Although an influenza pandemic may differ in some ways from an annual  influenza season, experience during the 2004–05 shortage illustrated the  importance of having contingency plans in place ahead of time to prevent  delays when timing is critical. Some health officials indicated that, as a  result of the experience with the influenza vaccine shortage, they were  revising state and local preparedness plans or modifying command center  protocols to prepare for future emergencies. For example, experiences  during the 2004–05 influenza season led Maine state officials to recognize  the need to speed completion of their pandemic influenza preparedness  plan.
Over the past 5 years, we have reported on the importance of planning to  address critical issues such as how vaccine will be purchased and  distributed; how population groups will be given priority for vaccination;  and how federal resources should be deployed before the nation faces a  pandemic. We have also urged HHS to complete its pandemic  preparedness and response plan, which the department released in draft  form in August 2004. This draft plan described options for vaccine  purchase and distribution and provided planning guidance to state and  local health departments. As we testified earlier, however, the draft plan  lacked clear guidance on potential priority groups for vaccination in a  pandemic, and key questions remained about the federal role in  purchasing and distributing vaccine. The experience in 2004–05 also  highlighted the importance of finalizing such planning details. On  November 2, 2005, HHS released its pandemic influenza plan. We did not,  however, have an opportunity to review the plan before issuing this  statement to determine whether the plan addresses these critical issues.
section_title: Streamlined Mechanisms for Expediting Vaccine Availability Are Key to Effective Response
paragraphs: A second lesson from the experience of the 2004–05 vaccine shortage that  is relevant to future vaccine shortages in either an annual influenza season  or a pandemic is the importance of streamlined mechanisms to make  vaccine available in an expedited manner. For example, HHS began efforts  to purchase foreign vaccine that was licensed for use in other countries  but not the United States shortly after learning in October 2004 that Chiron  would not supply any vaccine. The purchase, however, took several  months to complete, and so vaccine was not available to meet the fall 2004  demand; by the end of the season, this vaccine had not been used. In  addition, recipients of this foreign vaccine could have been 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.
Some states’ experience during the 2004–05 vaccine shortage also  highlighted the importance of mechanisms to transfer available vaccine  quickly and easily from one state to another; the lack of mechanisms to do  so delayed redistribution to some states. During the 2004–05 shortage,  some state health officials reported problems with their ability to purchase  vaccine, both in paying for vaccine and in administering the transfer  process. Minnesota, for example, tried to sell its available vaccine to other  states seeking additional vaccine for their priority 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. As we have previously testified, establishing the  funding sources, authority, or processes for quick public-sector purchases  may be needed as part of pandemic preparedness.
Recognizing the need for mechanisms to make vaccine available in a  timely manner in the event of a pandemic, HHS has taken some action to  address the fragility of the current influenza vaccine market. In its budget  request for fiscal year 2006, CDC requested $30 million to enter into  guaranteed-purchase contracts with vaccine manufacturers to help ensure  vaccine supply. According to the agency, maintaining an abundant supply  of annual influenza vaccine is critically important for improving the  nation’s preparedness for an influenza pandemic. HHS is also taking steps  toward developing a supply of vaccine to protect against avian influenza  strains that could be involved in a pandemic.
section_title: Effective Response Requires Clear and Consistent Communication
paragraphs: Experience during the 2004–05 shortage also illustrated the critical role  communication plays when demand for vaccine exceeds supply and  information about future vaccine availability is uncertain, as could happen  in a future annual influenza season or a pandemic. During the 2004–05  shortage, CDC communicated regularly through a variety of media as the  situation evolved. State and local officials, however, identified several  communication lessons for future seasons or if an influenza pandemic  occurred:    Consistency among federal, state, and local communications is critical for  averting confusion. State health officials reported several cases where  inconsistent messages created confusion. Health officials in California, for  example, reported that local radio stations in the state were running two  public service announcements simultaneously—one from CDC advising  those aged 65 years and older to be vaccinated, and one from the state  advising those aged 50 years and older to be vaccinated.
Disseminating clear, updated information is especially important when  responding to changing circumstances. Beginning in October 2004, CDC  asked individuals who were not in a high-risk group or another priority  group to forgo or defer vaccination; this message, however, did not  include instructions to check back with their providers later in the season,  when more vaccine had become available. According to CDC, an  estimated 17.5 million individuals specifically deferred vaccination to save  vaccine for those in priority groups; local health officials said that many  did not return when vaccine became available.
Using diverse media helps reach diverse audiences. During the 2004–05  influenza season, public health officials emphasized the value of a variety  of communication methods—such as telephone hotlines, Web sites, and  bilingual radio advertisements—to reach as many individuals as possible  and to increase the effectiveness of local efforts to raise vaccination rates.  In Seattle–King County, Washington, for example, health department  officials reported that a telephone hotline was important because some  seniors did not have Internet access. Public health officials in Miami-Dade  County, 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 can alert providers and the public to prevention alternatives. In  the 2004–05 shortage, some of the nasal spray vaccine for healthy  individuals went unused, in part because of fears that the vaccine was too  new and untested or that the live virus in the nasal spray could be  transmitted to others. 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.
section_title: Concluding Observations
paragraphs: Experience during the 2004–05 influenza vaccine shortage highlights the  need to prepare the nation for handling future shortages in either an  annual influenza season or an influenza pandemic. In particular, that  season’s shortage emphasized the vital need for early planning,  mechanisms to make vaccine available, and effective communication to  ensure available vaccine is targeted to those who need it most. As our  work over the past 5 years has noted, it is important for federal, state, and  local governments to develop and communicate plans regarding critical  issues—such as how vaccine will be purchased and distributed, which  population groups are likely to have priority for vaccination, and what  communication strategies are most effective—before we face another  shortage of annual influenza vaccine or, worse, an influenza pandemic.
section_title: GAO Contact and Staff Acknowledgments
paragraphs: For further information about this statement, please contact Marcia  Crosse at (202) 512-7119 or crossem@gao.gov. Kim Yamane, Assistant  Director; George Bogart; Ellen W. Chu; Nicholas Larson; Jennifer Major;  and Terry Saiki made key contributions to this statement.
section_title: Related GAO Products
paragraphs: Influenza Vaccine: Shortages in 2004–05 Season Underscore Need for  Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response. GAO-05- 863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.  Washington, D.C.: May 26, 2005.
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.
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.
Influenza Pandemic: Plan Needed for Federal and State Response. GAO- 01-4. Washington, D.C.: October 27, 2000.
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