Infectious Disease Preparedness: Federal Challenges in Responding to Influenza Outbreaks
Published: 2004-09-28T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Influenza is associated with an average of 36,000 deaths and more than 200,000 hospitalizations each year in the United States. Persons aged 65 and older are involved in more than 9 of 10 deaths and 1 of 2 hospitalizations related to influenza. The best way to prevent influenza is to be vaccinated each fall. In the 2000-01 flu season, and again in the 2003-04 flu season, this country experienced periods when the demand for flu vaccine exceeded the supply, and there is concern about the availability of vaccines for this and future flu seasons. There is also concern about the prospect of a worldwide influenza epidemic, or pandemic, which many experts believe to be inevitable. Three influenza pandemics occurred in the twentieth century. Experts estimate that the next pandemic could kill up to 207,000 people in the United States and cause major social disruption. Public health experts have raised concerns about the ability of the nation's public health system to respond to an influenza pandemic. GAO was asked to discuss issues related to supply, demand, and distribution of vaccine for a regular flu season and assess the federal plan to respond to an influenza pandemic. GAO based this testimony on products it has issued since October 2000, as well as work it conducted to update key information.
section_title: What GAO Found
paragraphs: Challenges persist in ensuring an adequate and timely flu vaccine supply. The number of producers remains limited, and the potential for manufacturing problems such as those experienced in recent years is still present. If a manufacturer's production is affected, those providers who ordered vaccine from that manufacturer could experience shortages, while providers who received supplies from another manufacturer might have all the vaccine they need. This potential for imbalance is what creates situations in which some providers might not have enough vaccine for persons at highest risk, while other providers might have enough supply to hold mass-immunization clinics even for persons at lower risk for flu-related complications. To help limit the potential for such situations, the Centers for Disease Control and Prevention (CDC) and others have taken such steps as adding flu vaccine to federal stockpiles and more aggressively monitoring the projected supply of vaccine. However, there is no system in place to ensure that seniors and others at high risk for complications receive flu vaccinations first when vaccine is in short supply. The Department of Health and Human Services' (HHS) draft "Pandemic Influenza Preparedness and Response Plan" provides a blueprint for the government's role but leaves some important decisions about the government's response unresolved. In addition to describing the federal role, responsibilities, and actions in collaboration with the states in responding to an influenza pandemic, the plan also provides planning guidance to state and local health departments and the health care system. The draft plan is comprehensive in scope, but it leaves decisions about the purchase, distribution, and administration of vaccines open for public comment and for the states to decide individually. In addition, the draft plan does not make recommendations for how population groups should be prioritized to receive vaccines in a pandemic. Difficulties encountered during the annual flu season in the purchase, distribution, and administration of flu vaccine highlight the importance of resolving these issues for pandemic preparedness. Officials from CDC provided technical comments on this testimony that GAO incorporated as appropriate.

section_title: Letter
paragraphs: I am pleased to be here today as you discuss issues regarding the annual  production and distribution of flu vaccine and preparedness for a  worldwide influenza epidemic—known as a pandemic. Each year,  influenza viruses cause outbreaks in the United States and elsewhere in  the world. Influenza is associated with an average of 36,000 deaths and  more than 200,000 hospitalizations each year in the United States. Persons  aged 65 and older are involved in more than 9 of every 10 deaths and 1 of  every 2 hospitalizations related to influenza. The best way to prevent  influenza is to be vaccinated each fall. In the 2000-01 flu season, and again  in last year’s flu season, this country experienced periods when the  demand for flu vaccine exceeded the supply, and there is concern about  the availability of vaccines for this and future flu seasons.
There has also been increased concern about the prospect of an influenza  pandemic, which many experts believe to be inevitable. Pandemic  influenza, which arises periodically, but unpredictably, from a major  genetic change in the virus, results in a strain that can cause worldwide  disease and death. Three influenza pandemics occurred in the twentieth  century. The worst occurred in 1918 (Spanish flu)and killed more than 20  million people worldwide and about 675,000 people in the United States.  The pandemics of 1957 (Asian flu) and 1968 (Hong Kong flu) caused fewer  fatalities—70,000 and 34,000, respectively, in the United States. Some  experts believe that the next pandemic could be spawned by the recurring  avian flu in Asia. They estimate that the pandemic could kill up to 207,000  people in the United States and cause major social disruption. Public  health experts have raised concerns about the ability of the nation’s public  health system to detect and respond to emerging infectious disease threats  such as pandemic influenza.
You have asked us to provide our perspective on flu vaccine availability  and preparedness for this year’s flu season and an influenza pandemic. In  this testimony, I will (1) discuss issues related to supply, demand, and  distribution of vaccine for a regular flu season and (2) assess the federal  plan to respond to an influenza pandemic.
My remarks are based on reports and testimony we have issued since  October 2000, as well as work conducted to update key information. Our  prior work on flu vaccine included interviews with and analysis of  information provided by Department of Health and Human Services (HHS)  officials, vaccine manufacturers, medical distributors and their trade  associations, companies that provide flu shots at retail outlets and work  sites, physician and other professional associations, and other purchasers.  We also surveyed physician group practices and interviewed health  department officials in all 50 states about their experiences in the 2000-01  flu season. In September 2004 we updated this work with information on  the 2003-04 flu season, Centers for Disease Control and Prevention (CDC)  activities, including its responses to our prior recommendations for  prevention and control of influenza, and the status of this year’s flu  vaccine. To learn about pandemic planning efforts, we interviewed HHS  officials in the National Vaccine Program Office and reviewed HHS’s  August 2004 draft “Pandemic Influenza Preparedness and Response Plan.”  We conducted all of our work in accordance with generally accepted  government auditing standards.
In summary, challenges persist in ensuring an adequate and timely flu  vaccine supply. The number of producers remains limited, and the  potential for manufacturing problems such as those experienced in recent  years is still present. If a manufacturer’s production is affected, those  providers who ordered vaccine from that manufacturer could experience  shortages, while providers who received supplies from another  manufacturer might have all the vaccine they need. This potential for  imbalance is what creates situations in which some providers might not  have enough vaccine for persons at highest risk, while other providers  might have enough supply to hold mass-immunization clinics even for  persons at lower risk for flu-related complications. To help limit the  potential for such situations, CDC and others have taken such steps as  adding flu vaccine to federal stockpiles and more aggressively monitoring  the projected supply of vaccine. However, there is no system in place to  ensure that seniors and others at high risk for complications receive flu  vaccinations first when vaccine is in short supply.
HHS’s draft “Pandemic Influenza Preparedness and Response Plan”  provides a blueprint for the government’s role but leaves some important  decisions about the government’s response unresolved. In addition to  describing the federal role, responsibilities, and actions in collaboration  with the states in responding to an influenza pandemic, the plan also  provides planning guidance to state and local health departments and the  health care system. The draft plan is comprehensive in scope, but it leaves  decisions about the purchase, distribution, and administration of vaccines  open for public comment and for the states to decide individually. In  addition, the draft plan does not make recommendations for how  population groups should be prioritized to receive vaccines in a pandemic.  Difficulties encountered during the annual flu season with the purchase,  distribution, and administration of flu vaccine highlight the importance of  resolving these issues for pandemic preparedness.
subsections: section_title: Background
paragraphs: In almost every year an influenza virus causes acute respiratory disease in  epidemic proportions somewhere in the world. Influenza is more severe  than some of the other viral respiratory infections, such as the common  cold. Most people who get the flu recover completely in 1 to 2 weeks, but  some develop serious and potentially life-threatening medical  complications, such as pneumonia. People who are aged 65 and older,  people of any age with chronic medical conditions, children younger than  2 years, and pregnant women are more likely to get severe complications  from influenza than other people. Influenza and pneumonia rank as the  fifth leading cause of death among persons aged 65 and older.
For the 2004-05 flu season, CDC is recommending that about 185 million  Americans in these at-risk populations and other target groups receive the  vaccine, which is the primary method for preventing influenza. Flu vaccine  is generally widely available in a variety of settings, ranging from the usual  physicians’ offices, clinics, and hospitals to retail outlets such as  drugstores and grocery stores, workplaces, and other convenience  locations. Millions of individuals receive flu vaccinations through mass  immunization campaigns in nonmedical settings, where organizations such  as visiting nurse agencies under contract administer the vaccine. It takes  about 2 weeks after vaccination for antibodies to develop in the body and  provide protection against influenza virus infection. CDC recommends  October through November as the best time to get vaccinated because the  flu season often starts in late November to December and peaks between  late December and early March. However, if influenza activity peaks late,  vaccination in December or later can still be beneficial.
Producing the influenza vaccine is a complex process that involves  growing viruses in millions of fertilized chicken eggs. This process, which  requires several steps, generally takes at least 6 to 8 months from January  through August each year, so vaccine manufacturers must predict demand  and decide on the number of doses to produce well before the onset of the  flu season. Each year’s vaccine is made up of three different strains of  influenza viruses, and, typically, each year one or two of the strains is  changed to better protect against the strains that are likely to be  circulating during the coming flu season. The Food and Drug  Administration (FDA) and its advisory committee decide which strains to  include based on CDC surveillance data, and FDA also licenses and  regulates the manufacturers that produce the vaccine.
In a typical year, manufacturers make flu vaccine available before the  optimal fall season for administering flu vaccine. Currently, two  manufacturers—one in the United States and one in the United Kingdom— produce over 95 percent of the vaccine used in the United States.  According to CDC officials, for the 2002-03 flu season, manufacturers  produced about 95 million doses of vaccine, of which about 83 million  doses were used and 12 million doses went unused. Production for the  2003-04 flu season was based on the previous year’s demand and was  about 87 million doses. For the 2004-05 season, CDC estimates that about  100 million doses will be available.
Currently, flu vaccine production and distribution are largely private- sector responsibilities. Like other pharmaceutical products, flu vaccine is  sold to thousands of purchasers by manufacturers, numerous medical  supply distributors, and other resellers such as pharmacies. These  purchasers provide flu vaccinations at physicians’ offices, public health  clinics, nursing homes, and less traditional locations such as workplaces  and various retail outlets. Most influenza vaccine distribution and  administration are accomplished within the private sector, with relatively  small amounts of vaccine purchased and distributed by CDC or by state  and local health departments.
HHS also has a role in planning to prepare for and respond to an influenza  pandemic. Planning is key to being prepared for and mitigating the  negative effects of the next influenza pandemic, including major illness,  death, economic loss, and social disruption. A national pandemic influenza  plan was first developed in 1978 and was revised in 1983. In 1993, efforts to  revise the national plan were initiated, and these efforts picked up  momentum in the late 1990s. In August 2004, HHS released a draft plan for  comment entitled, “Pandemic Influenza Preparedness and Response Plan.”
To foster state and local pandemic planning and preparedness, CDC first  issued draft interim planning guidance to states in 1997 and posted  guidance on its Web site for state and local health departments in 2001.  Since that time, states have been preparing pandemic response plans, and  many are integrating these plans with existing state plans to respond to  public health emergencies such as natural disasters and bioterrorist  attacks.
section_title: Challenges Exist in Ensuring an Adequate and Timely Flu Vaccine Supply
paragraphs: Ensuring an adequate and timely supply of vaccine is a difficult task. It has  become even more difficult because there are few manufacturers.  Problems at one or more manufacturers can significantly upset the  traditional fall delivery of influenza vaccine. These problems, in turn, can  create variability in who has ready access to the vaccine.
Matching flu vaccine supply and demand is a challenge because the  available supply and demand for vaccine can vary from month to month  and year to year. For example,  In 2000-01, when a substantial proportion of flu vaccine was distributed  much later than usual due to manufacturing difficulties, temporary  shortages in the prime period for vaccinations were followed by decreased  demand as additional vaccine became available later in the year. Despite  efforts by CDC and others to encourage people to seek flu vaccinations  later in the season, providers still reported a drop in demand in December.  The light flu season in 2000-01, which had relatively low influenza  mortality, probably also contributed to the lack of interest. As a result of  the waning demand that year, manufacturers and distributors reported  having more vaccine than they could sell. In addition, some physicians’  offices, employee health clinics, and other organizations that administered  flu shots reported having unused doses in December and later.
For the 2003-04 flu season, shortages of vaccine have been attributed to an  earlier than expected and more severe flu season and to higher than  normal demand, likely resulting from media coverage of pediatric deaths  associated with influenza. According to CDC officials, this increased  demand occurred in a year in which manufacturers had produced about  the same number of doses as in the previous season and that supply was  not adequate to meet the demand.
If production problems delay the availability of vaccine in a given year, the  timing for an individual provider to obtain flu vaccine may depend on  which manufacturer’s vaccine it ordered. This happened in the 2000-01  season, and it could happen again. This year, one of the two major  manufacturers recently announced a delay in its shipments of vaccine. On  August 26, 2004, one manufacturer announced that release of its flu  vaccine would be delayed because of production problems related to  sterility of a small number of doses at its manufacturing facility. The  company stated that it expected to deliver between 46 million and 48  million doses to the U.S. market beginning in October, and CDC issued a  notice on September 24, 2004, stating that some delays might occur for  customers receiving this manufacturer’s vaccine. Those customers may  receive their vaccine later than those who ordered from the other  manufacturer, which reported sending its vaccine on schedule beginning  in August and September. As a result, one provider could hold vaccination  clinics in early October that would be available to anyone who wants a flu  shot, while another provider would not yet have any vaccine for its high- risk patients.
Shortages of flu vaccine can result in temporary spikes in the price of  vaccine. When vaccine supply is limited relative to public demand for flu  shots, distributors and others who have supplies of the vaccine have the  ability—and the economic incentive—to sell their supplies to the highest  bidders rather than filling lower-priced orders they had already received.  When there was a delay and temporary shortage of vaccine in 2000, those  who purchased vaccine that fall—because their earlier orders had been  cancelled, reduced, or delayed, or because they simply ordered later— found themselves paying much higher prices. For example, one physician’s  practice ordered flu vaccine from a supplier in April 2000 at $2.87 per  dose. When none of that vaccine had arrived by November 1, the practice  placed three smaller orders in November with a different supplier at the  escalating prices of $8.80, $10.80, and $12.80 per dose. On December 1, the  practice ordered more vaccine from a third supplier at $10.80 per dose.  The four more expensive orders were delivered immediately, before any  vaccine had been received from the original April order.
Our work has also found that there is no mechanism in place to ensure  distribution of flu vaccine to high-risk individuals before others when the  vaccine is in short supply. When the supply was not sufficient in the fall of  2000, focusing distribution on high-risk individuals was difficult because  all types of providers served at least some high-risk individuals. Some  physicians and public health officials were upset when their local grocery  stores, for example, were offering flu shots to everyone when they, the  health care providers, were unable to obtain vaccine for their high-risk  patients. Many physicians reported that they felt they did not receive  priority for vaccine delivery, even though about two-thirds of seniors—one  of the largest high-risk groups—generally get their flu shots in medical  offices. In our follow-up work, we found no indication that the situation  would be different if there was a shortage today.
This raises the question of what more can be done to better prepare for  possible vaccine delays and shortages in the future. Because flu vaccine  production and distribution largely are private-sector responsibilities,  options are somewhat limited. While CDC can recommend and encourage  providers to immunize high-risk patients first, it does not have control  over the distribution of vaccine, other than the small amount that is  distributed through public health departments.
Although HHS has limited authority to directly control flu vaccine  production and distribution, it undertook several initiatives following the  2000-01 flu season. More specifically, CDC has taken actions that may  encourage manufacturers to supply more vaccine because the action could  lead to increased or more stable demand for flu vaccines. Actions taken by  CDC and its advisory committee include the following:    Extending the optimal period for getting a flu vaccination until the end of  November, to encourage more people to get vaccinations later in the  season.
Expanding the target population to include children aged 6 through 23  months and all persons who take care of children aged 0 to 23 months.
Including the flu vaccine in the Vaccines for Children (VFC) stockpile to  help improve flu vaccine supply. For 2004, CDC has contracted for a  stockpile of approximately 4.5 million doses of flu vaccine through its VFC  authority.
Beginning an annual assessment of the projected vaccine supply, and  making a determination if vaccination should proceed for all persons or if  a tiered approach should be used, targeting limited vaccine supplies to  seniors and other high-risk individuals first.
For both last season and the upcoming flu season, CDC announced that it  did not envision any need for a tiered approach. For the 2004-05 flu  season, CDC issued a notice on September 24 recommending that  vaccination proceed for all recommended persons as soon as vaccine is  available.
section_title: HHS’s Draft Pandemic Influenza Plan Defines Roles and Responsibilities but Leaves Some Important Issues Unresolved
paragraphs: HHS’s draft pandemic influenza plan describes federal roles and  responsibilities in responding to an influenza pandemic and provides  planning guidance to state and local health departments and the health  care system. Although the draft plan is comprehensive in scope, it leaves  some important decisions about the purchase, distribution, and  administration of vaccines unresolved. In addition, the draft plan does not  make recommendations for how population groups should be prioritized  to receive vaccines in a pandemic. Consequently, states are left to make  their own decisions, potentially compromising the timing and adequacy of  a response to an influenza pandemic.
subsections: section_title: Draft Plan Defines Roles and Responsibilities
paragraphs: HHS’s draft pandemic influenza plan describes HHS’s role in coordinating  a national response to an influenza pandemic and provides guidance and  tools to promote pandemic preparedness planning and coordination at  federal, state, and local levels, including both the public and the private  sectors. Pandemic influenza response activities are outlined by the  different phases of a pandemic. The draft plan also provides technical  background information on preparedness and response activities such as  vaccine development and production.
The draft plan acknowledges that states and local areas have important  roles in the national response to a pandemic. To facilitate the state and  local response, the draft plan provides guidance for state and local health  departments and the health care system. The draft plan states that  planning for an influenza pandemic will build on HHS-supported efforts to  prepare for other public health emergencies such as infectious disease  outbreaks, bioterrorist events, or natural disasters, and provides important  guidance on areas specific to an influenza pandemic, including disease  surveillance, delivery of vaccine and other medications, and  communication. According to the Council of State and Territorial  Epidemiologists, currently 11 states have pandemic influenza plans. Six of  these states have final plans, and five states have draft plans.
According to the draft plan, federal agencies are taking steps to ensure and  expand influenza vaccine production capacity; increase influenza  vaccination use; stockpile influenza medications; enhance U.S. and global  disease detection and surveillance infrastructures; expand influenza- related research; support public health planning and laboratory capacity;  and improve health care system readiness at the community level.  Although most of these activities have not been targeted specifically to  pandemic planning, according to HHS officials, spending in these areas  will help prepare for the next influenza pandemic. The draft plan also  encourages states to allocate funding from the CDC Bioterrorism  Cooperative Agreement and 2004 Immunization Continuation Grants for  pandemic preparedness planning.
section_title: Draft Plan Leaves Many Important Issues Unresolved, Making It Difficult for States to Plan
paragraphs: Although HHS’s draft pandemic influenza plan is comprehensive in scope,  it leaves many important decisions about the purchase, distribution, and  administration of vaccines unresolved. These decisions include  determining the public- versus the private-sector roles in the purchase and  distribution of vaccines; the division of responsibility between the federal  government and the states for vaccine distribution; and how population  groups will be prioritized and targeted to receive limited supplies of  vaccines. As we have stated previously, until these key decisions are made,  states will find it difficult to plan, and the timeliness and adequacy of  response efforts may be compromised.
The draft plan does not establish a definitive federal role in the purchasing  and distribution of vaccine. Instead, HHS provides options for vaccine  purchase and distribution that include public-sector purchase and  distribution of all pandemic influenza vaccine; a mixed public-private  system where public-sector supply may be targeted to specific priority  groups; and maintenance of the current largely private system. Currently,  approximately 85 percent of the influenza vaccine produced for annual  outbreaks is purchased by the private sector, and a majority of the annual  vaccinations are also delivered by the private sector. HHS states in the  draft plan that such a distribution method may not be optimal in a  pandemic.
Furthermore, the draft plan delegates to the states responsibility for  distribution of vaccine. The lack of a clearly defined federal role in  distribution complicates pandemic planning for the states. Among the  current state pandemic influenza plans, there is no consistency in terms of  their procurement and distribution of vaccine and the relative role of the  federal government. States also approach annual vaccine procurement and  distribution differently. Approximately half the states handle procurement  and distribution of the influenza vaccine through the state health agency.  The remainder either operate through a third-party contractor for  distribution to providers or use a combination of these two approaches.
In 2003 we reported that state officials were concerned that there were no  national recommendations for how population groups should be  prioritized to receive vaccines. Identifying priority populations from  among high-risk groups and essential health care and emergency  personnel is likely to be a controversial issue. The draft plan does not  identify priority groups, but HHS indicates that it has separately developed  an initial list of suggested priority groups and is soliciting public comment  on this list. The draft pandemic plan instructs the states to prioritize the  persons receiving the initial doses of vaccine and indicates that as  information about the severity of the virus becomes available,  recommendations will be formulated at the national level. Prioritization  will be an iterative process and will be tied to vaccine availability and the  progression of the pandemic. While recognizing that this is an iterative  process, state officials have consistently told us that a lack of detailed  guidance makes it difficult for states to plan for the use of limited supplies  of vaccine.
section_title: Concluding Observations
paragraphs: Ensuring an adequate and timely supply of vaccine to protect seniors and  others from influenza and flu-related complications continues to be  challenging. Only two manufacturers currently produce flu vaccine for  seniors and others at high risk for flu-related complications, and  manufacturing problems experienced in recent years illustrate the fragility  of the current methods of production. Despite efforts by CDC and others,  there remains no system to ensure that persons at high risk for  complications receive flu vaccine first when vaccine is in short supply.
These influenza vaccine supply and distribution problems may become  especially acute in a pandemic. We acknowledge the need for flexibility in  planning because many aspects of an influenza pandemic cannot be  known in advance. However, the absence of more detail in HHS’s draft  plan creates uncertainty for the states regarding how to plan for the use of  limited supplies of vaccine. Until decisions are made about vaccine  purchase, distribution, and administration, and priority populations are  designated, states will not be able to develop strategies consistent with  federal priorities.
section_title: Agency Comments
paragraphs: Officials from CDC provided technical comments that we incorporated as  appropriate.
Mr. Chairman, this concludes my statement. I would be happy to answer  any questions you or other Members of the Committee may have.
section_title: Contact and Staff Acknowledgments
paragraphs: For further information about this testimony, please contact Janet  Heinrich at (202) 512-7119. Gigi Barsoum, Anne Dievler, Martin Gahart,  Jennifer Major, Roseanne Price, and Kim Yamane also made key  contributions to this statement.
section_title: Related GAO Products
paragraphs: SARS Outbreak: Improvements to Public Health Capacity Are Needed for  Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03- 769T, Washington, D.C.: May 7, 2003.
Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have  Improved Public Health Response Capacity, but Gaps Remain. GAO-03- 654T, Washington, D.C.: April 9, 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.
Influenza Pandemic: Plan Needed for Federal and State Response.  GAO-01-4, Washington, D.C.: October 27, 2000.
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