Testimony 

Before the Special Committee on Aging, 

U.S. Senate

United States Government Accountability Office

GAO 

For Release on Delivery 

Expected at 10:00 a.m. EDT 

Tuesday, September 28, 2004 INFECTIOUS DISEASE 

PREPAREDNESS 

Federal Challenges in 

Responding to Influenza 

Outbreaks 

Statement of Janet Heinrich 

Director, Health Care—Public Health Issues 

GAO-04-1100T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

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www.gao.gov/cgi-bin/getrpt?GAO-04-1100T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Janet Heinrich 

at (202) 512-7119. 

Highlights of GAO-04-1100T, a testimony 

before the Special Committee on Aging, 

U.S. Senate 

September 28, 2004

INFECTIOUS DISEASE PREPAREDNESS

Federal Challenges in Responding to 

Influenza Outbreaks 

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. 

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. 
Page 1 GAO-04-1100T 

Mr. Chairman and Members of the Committee: 

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.1

 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.2

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 

 1

Department of Health and Human Services, “HHS Orders Avian Flu Vaccine as Preventive 

Measure,” http://www.os.dhhs.gov/news/pres/2004pres/20040921a.html (downloaded Sept. 

26, 2004). 

2

See GAO, 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). 
Page 2 GAO-04-1100T 

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 2000,3

 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. 

 3

See “Related Products,” at the end of this testimony, for a list of our earlier work related to 

flu vaccine and influenza pandemic planning. 
Page 3 GAO-04-1100T 

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. 

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.4

 It takes 

 4

Data collected by states through the CDC Behavioral Risk Factor Surveillance System 

during 2002 indicate that among persons aged 18 years or older reporting receipt of flu 

vaccine, about two-thirds reported getting their last flu vaccination at a health care facility, 

such as a doctor’s office, health center or health department, while about one-third 

reported getting vaccinated at a workplace, community center, store, or other location. 

Background 
Page 4 GAO-04-1100T 

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.5

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 privatesector 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 

 5

A third U.S. manufacturer produces a flu vaccine that is given by nasal spray and is only 

approved for healthy persons aged 5 through 49 years. According to CDC, this 

manufacturer is likely to supply about 1.5 million doses in the 2004-05 season. 
Page 5 GAO-04-1100T 

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. 

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’ 

Challenges Exist in 

Ensuring an Adequate 

and Timely Flu 

Vaccine Supply 
Page 6 GAO-04-1100T 

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 highrisk 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 
Page 7 GAO-04-1100T 

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.6

 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,7

 it undertook several initiatives following the 

2000-01 flu season. More specifically, CDC has taken actions that may 

 6

Data collected by states through the CDC Behavioral Risk Factor Surveillance System 

during 2002 indicated that among persons aged 65 years or older reporting receipt of 

influenza vaccine, about 58 percent reported receiving their last influenza vaccination at 

physicians’ offices and health maintenance organizations; followed by clinics or health 

centers (12 percent); stores (8 percent); community centers (6 percent); health 

departments (6 percent); other locations (5 percent); hospitals (4 percent); and workplaces 

(2 percent). Percentages do not add to 100 due to rounding. 

7

Under the Federal Food Drug and Cosmetic Act, FDA ensures compliance with good 

manufacturing practice and has limited authority to regulate the resale of prescription 

drugs, including influenza vaccine, that have been purchased by health care entities such as 

public or private hospitals. This authority would not extend to resale of the vaccine for 

emergency medical reasons. The term health care entity does not include wholesale 

distributors. CDC has a role in encouraging appropriate public health actions. 
Page 8 GAO-04-1100T 

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. 

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. 

HHS’s Draft Pandemic 

Influenza Plan 

Defines Roles and 

Responsibilities but 

Leaves Some 

Important Issues 

Unresolved 
Page 9 GAO-04-1100T 

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.8 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.9

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 influenzarelated 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 

 8

HHS describes five phases of a pandemic. In phase 1, there is an outbreak in one country, 

confirmation of efficient person-to-person transmission, and serious morbidity and 

mortality. In phase 2, there are regional outbreaks with global disease spread. Phase 3 is 

the end of the first pandemic wave; phase 4 refers to a second seasonal wave. In phase 5, 

the pandemic ends as population immunity has increased. 

9

California, Florida, Indiana, Maryland, Minnesota, and New Jersey have final plans, and 

Massachusetts, New Hampshire, South Carolina, Tennessee, and Texas have draft plans. 

Draft Plan Defines Roles 

and Responsibilities 
Page 10 GAO-04-1100T 

Cooperative Agreement and 2004 Immunization Continuation Grants for 

pandemic preparedness planning.10

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. 

 10Under the CDC’s Public Health Preparedness and Response for Bioterrorism Program, all 

50 states, the District of Columbia, the country’s largest municipalities, and territories 

receive funding to complete specific activities designed to build public health and health 

care capacities. 

Draft Plan Leaves Many 

Important Issues 

Unresolved, Making It 

Difficult for States to Plan 
Page 11 GAO-04-1100T 

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. 

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. 

Officials from CDC provided technical comments that we incorporated as 

appropriate. 

Concluding 

Observations 

Agency Comments 
Page 12 GAO-04-1100T 

Mr. Chairman, this concludes my statement. I would be happy to answer 

any questions you or other Members of the Committee may have. 

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. 

Contact and Staff 

Acknowledgments 
Page 13 GAO-04-1100T 

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 HighRisk 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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