United States Government Accountability Office

GAO Report to Congressional Committees

INFLUENZA 

VACCINE 

Shortages in 2004–05 

Season Underscore 

Need for Better 

Preparation 

September 2005 

 

GAO-05-984 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 2005

INFLUENZA VACCINE

Shortages in 2004–05 Season Underscore 

Highlights of GAO-05-984, a report to the Need for Better Preparation

Committee on Government Reform, 

House of Representatives, and the 

Committee on Homeland Security and 

Governmental Affairs, U.S. Senate

In early October 2004, the nation

lost about half its expected

influenza vaccine supply when one 

of two major manufacturers

announced it would not release any 

vaccine for the 2004–05 season

because of potential

contamination. The Centers for

Disease Control and Prevention

(CDC) had earlier recommended 

vaccination for 188 million 

individuals, including those at high

risk of severe complications from

influenza (such as seniors and 

those with chronic conditions), and 

other groups (such as their close

contacts). Although health officials 

took actions to distribute the

limited supply of influenza vaccine, 

reports persisted of high-risk 

individuals and others in priority

groups who could not find a

vaccination, including those who

were turned away and never

returned when supplies became 

available. Such reports raised

questions about the adequacy of

U.S. preparedness to respond to

significant vaccine shortages. 

GAO was asked to examine actions

taken at federal, state, and local

levels to ensure that high-risk

individuals had access to influenza 

vaccine during the shortage, 

including any lessons learned. 

Federal, state, and local health officials took several actions beginning in

October 2004 to help ensure that individuals at high risk of severe 

complications from influenza had access to vaccine. Federal officials, for 

example, quickly revised vaccination recommendations to target available 

vaccine to high-risk individuals and to other priority groups. Additional

actions were aimed to distribute vaccine expeditiously and to communicate 

with providers and the public as events unfolded and vaccine supplies 

changed. Beginning in mid-December, health officials took steps to

distribute additional vaccine, broadening recommendations on who should

be vaccinated.

Although these actions helped achieve vaccination rates approaching past 

levels for certain priority groups, such as those aged 65 years and older, 

several lessons emerged, including some that could help with future 

shortages. First, unless planning for problems is already in place, action is

delayed. CDC’s lack of a contingency plan contributed to delays and 

uncertainty about how to ensure that high-risk individuals had access to 

vaccine. Second, when actions occur late in the influenza season, they are 

likely to have little effect. Third, effective response requires communication 

that is both clear and consistent. CDC has taken a number of steps, including 

issuing interim guidelines in August 2005, to respond to possible future 

shortages. It is too early, however, to assess the effectiveness of these efforts 

in coordinating actions of federal, state, and local health agencies and others.

In commenting on a draft of this report, HHS concurred with GAO’s finding 

that contingency planning would improve response efforts, and the agency

indicated that additional preparations were under way. 

Influenza Vaccination Rates for Selected Priority Groups 

www.gao.gov/cgi-bin/getrpt?GAO-05-984.

To view the full product, including the scope 

and methodology, click on the link above.

For more information, contact Marcia Crosse

at (202) 512-7119 or crossem@gao.gov.
Contents 

Letter 1

Results in Brief 3

Background 5

Health Officials Took Steps to Vaccinate High-Risk Individuals and 

Others in Priority Groups 10 

Planning, Timely Action, and Communication Are Key to an 

Effective Response 23 

Concluding Observations 32 

Agency Comments 33 

Appendix I Comments from the Department of Health and Human 

Services 35 

Appendix II GAO Contact and Staff Acknowledgments 37 

Related GAO Products 38 

Tables 

Table 1: Groups Recommended for Influenza Vaccination, Before

and After October 5, 2004 13 

Table 2: Phase I of CDC’s Influenza Vaccine Distribution Plan 16 

Table 3: Communication Methods Used by Various Health

Departments to Disseminate Influenza Information 21 

Figures 

Figure 1: Influenza Vaccine Cycle 6 

Figure 2: Influenza Vaccine Production and Distribution 8 

Figure 3: Timeline of the 2004–05 Influenza Vaccine Shortage 11 

Figure 4: Phase II of CDC’s Influenza Vaccine Distribution Plan 17 

Figure 5: Influenza Vaccination Rates for Selected Priority Groups 24 

Page i GAO-05-984 Influenza Vaccine Shortage
Abbreviations 

ACIP Advisory Committee on Immunization Practices

CDC Centers for Disease Control and Prevention 

FDA Food and Drug Administration 

HHS Department of Health and Human Services

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Page ii GAO-05-984 Influenza Vaccine Shortage
United States Government Accountability Office

Washington, DC 20548 

September 30, 2005 

The Honorable Tom Davis 

Chairman 

The Honorable Henry A. Waxman

Ranking Minority Member

Committee on Government Reform

House of Representatives 

The Honorable Susan M. Collins 

Chairman 

Committee on Homeland Security and Governmental Affairs 

United States Senate 

As the traditional influenza vaccination period started in fall 2004, the 

nation faced the unexpected loss of nearly half its projected vaccine 

supply. One of the two major manufacturers of influenza vaccine for the 

United States warned in late August 2004 that deliveries would be delayed 

because a small quantity of its vaccine failed sterility tests. On October 5, 

2004, the manufacturer announced that because of potential

contamination, it would be unable to release any vaccine for the U.S. 

market. The Department of Health and Human Services (HHS) had 

expected that this manufacturer would produce about 47 million doses—

close to half of the 100 million doses estimated for the 2004–05 influenza 

season.1

 Before the October 5 announcement, HHS’s Centers for Disease 

Control and Prevention (CDC) and its Advisory Committee on 

Immunization Practices (ACIP) had recommended that those at high risk 

of severe complications from influenza and those in other priority

groups—such as health care workers and those aged 50–64 years—receive 

an influenza vaccination.2

 After the announcement, with no other U.S.-

 1

See Centers for Disease Control and Prevention, “Supplemental Recommendations about 

Timing of Influenza Vaccination, 2004–05 Season,” Morbidity and Mortality Weekly Report, 

vol. 53, no. 37 (2004): 878–879.

2

ACIP makes recommendations to CDC, and CDC generally adopts them; we refer to such

recommendations as CDC recommendations. Although CDC estimates published in 

October 2004 show about 188 million people in high-risk and other priority groups, not 

everyone in these groups receives a vaccination each year. According to CDC, the prior

maximum number of doses distributed was approximately 83.1 million. Thus CDC 

estimated that an expected 100 million doses of vaccine would be sufficient to meet

demand for the 2004–05 influenza season. 

Page 1 GAO-05-984 Influenza Vaccine Shortage
licensed manufacturers able to replace the large amount of lost vaccine on 

such short notice, concerns arose about the effects of the loss, especially

on those most vulnerable to complications from influenza. 

Media reports of long lines of seniors waiting hours for a chance at a 

vaccination, of others at high risk who could not find a vaccination, and of 

individuals turned away who never returned when supplies became

available fueled worries that the nation was not adequately prepared to 

respond to the significant vaccine shortage or to an influenza pandemic (a 

widespread or worldwide influenza epidemic). Notwithstanding these 

concerns, CDC’s postseason data indicate that 2004–05 vaccination rates 

among certain high-risk groups such as seniors approached historical

rates.

3

You observed that the 2004–05 influenza vaccine shortage was the most

severe in recent history and that lessons learned from this season would

enable the nation to better deal with a similar situation in the future. This 

report examines the response to the 2004–05 shortage and identifies the 

lessons. We address the following questions: 

1. What actions were taken at federal, state, and local levels to ensure 

that high-risk individuals had access to influenza vaccine during the 

2004–05 shortage? 

2. What were the lessons learned from the strategies implemented at the 

federal, state, and local levels to ensure that high-risk individuals had 

access to influenza vaccine? 

To address these objectives, we reviewed documents and interviewed

officials from (1) CDC and HHS’s National Vaccine Program Office; 

(2) national organizations, including the Association of State and 

Territorial Health Officials, the Association of Immunization Managers, 

 3

See Centers for Disease Control and Prevention, “Estimated Influenza Vaccination

Coverage among Adults and Children, United States, September 1, 2004–January 31, 2005,”

Morbidity and Mortality Weekly Report, vol. 54, no. 12 (2005): 304–307. 

Page 2 GAO-05-984 Influenza Vaccine Shortage
and the National Association of County and City Health Officials;4

 

(3) organizations that conduct mass immunization clinics; (4) sanofi

pasteur,

5

 the remaining major manufacturer of influenza vaccine available 

for people at high risk of influenza-related complications; and (5) Kaiser 

Permanente, a health system that is a large purchaser of influenza vaccine. 

We also conducted site visits to a judgmental sample of states (California, 

Florida, Maine, Minnesota, and Washington) and localities (San Diego and 

San Francisco, California; Miami–Dade County, Florida; Portland, Maine;

Stearns County, Minnesota; and Seattle–King County, Washington). We 

selected these states and localities to reflect a mix of geographic locations, 

population size, and vaccination success rates.6 In each state, we reviewed

documents and interviewed officials from public health agencies, 

professional associations, and provider organizations. We also interviewed 

local representatives of home health organizations that conduct mass

immunizations and representatives of the Minnesota Multistate

Contracting Alliance for Pharmacy, which arranges purchase of vaccines 

for use in 43 states. We conducted our work in accordance with generally

accepted government auditing standards from March through September 

2005. 

Upon learning that nearly one-half of the projected vaccine supply would 

be unavailable for the 2004–05 influenza season, federal, state, and local 

health officials took several actions to help ensure that those at high risk 

of severe influenza-related complications had access to available vaccine. 

These efforts prompted federal revision of the recommendations on who 

should be vaccinated, so that vaccine could be directed to those at high 

risk and to other priority groups. Federal, state, and local actions also 

focused on distributing vaccine to priority groups, using a number of 

Results in Brief

 4

Members of the Association of State and Territorial Health Officials include the chief

health officials representing state and territorial public health agencies. Members of the 

Association of Immunization Managers include immunization program directors from state 

health departments, U.S. territories, and selected cities. Members of the National

Association of County and City Health Officials include representatives from local public

health agencies. In addition to officials from these associations, we interviewed some

association members.

5

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

6

We selected our sites on the basis of CDC’s Behavioral Risk Factor Surveillance System

survey data (state-level data) on the percentage of adults in priority groups for 2004–05 

who reported receiving an influenza vaccination during the traditional fall vaccination

period (September–November 2004). 

Page 3 GAO-05-984 Influenza Vaccine Shortage
communication strategies to keep providers and the public informed about

the shortage. CDC, for example, developed and implemented a complex 

plan to distribute vaccine to providers serving priority groups across the 

states. Late in the influenza vaccination period—from mid-December 

through January—health officials took various actions to increase vaccine 

availability and attempted to distribute vaccine across the wider 

population by broadening recommendations on who should be vaccinated.

A number of lessons emerged from federal, state, and local responses to

the 2004–05 influenza vaccine shortage, some specific to that season’s 

shortage, others with wider ramifications for potential future shortages or

a public health emergency. The primary lessons fall into three broad, 

interrelated categories: planning, timely action, and communication. 

• Limited contingency planning slows response. At the start of the 

traditional fall vaccination period, CDC did not have a contingency plan 

specifically designed to respond to a severe influenza vaccine shortage. 

The lack of such a plan led to delays and uncertainty on the part of many 

state and local entities on how best to ensure access to vaccine during the 

shortage by individuals at high risk and others in priority groups.

Nevertheless, some state and local entities used strategies that enabled 

them to respond relatively efficiently. For example, a number of states 

used existing emergency preparedness plans and issued emergency health 

directives to improve priority groups’ access to vaccine during the 

shortage. Some public health departments also facilitated the 

administration of vaccine in an orderly fashion when demand was highest,

including scheduling vaccinations by appointment and holding lotteries. 

• Unless expedited, actions to boost available supply may have little

effect. Although federal agencies attempted to boost influenza vaccine

supply, their efforts came too late in what turned out to be a relatively

moderate influenza season. For example, HHS officials purchased vaccine

that was not licensed for the U.S. market, but the purchases occurred in

December 2004 and January 2005, by which time demand had already 

waned. Similarly, state officials reported that CDC’s attempt to expand 

availability to other children and to adults of the vaccine purchased for its 

Vaccines for Children program came after demand for vaccine had 

dropped. 

• Effective response requires communication that is both clear and

consistent. Although CDC quickly communicated with nonfederal

agencies, providers, and the public throughout the changing environment 

of the 2004–05 influenza season, communication was not always 

coordinated among these entities, and inconsistent messages did occur, 

contributing to delays and confusion and ultimately resulting in a lateseason vaccine surplus. For example, in California, state officials in midPage 4 GAO-05-984 Influenza Vaccine Shortage
December were advising vaccinations for those aged 50 years and older, 

while CDC was simultaneously recommending vaccinations only for those 

aged 65 years and older. In addition, although a national campaign 

communicated the early-season messages to step aside in favor of those in 

priority groups, the campaign did not include a message to come back 

later when more vaccine became available. In certain locations, 

individuals seeking vaccination found themselves in a communication 

loop if they tried to follow CDC’s advice to contact their local public

health department for vaccine availability: when they did so, they were 

told to call their primary care provider, but when they called their primary 

care provider, they were told to call their local public health department. 

Furthermore, public education about the various forms of vaccine fell

short. For example, despite the availability of a nasal spray vaccine for 

healthy individuals aged 5–49 years who were not pregnant, inadequate

education about the vaccine contributed to the reluctance of some

individuals to use it. 

After the 2004–05 influenza season, CDC reviewed its response to the 

vaccine shortage and took a number of steps, including issuing interim

guidelines in August 2005 to assist in responding to possible future

shortages. 

We provided a draft of this report to HHS, and pertinent sections to the 

states and localities we visited and to sanofi pasteur, for their review. HHS 

concurred with our finding that contingency planning is important and 

indicated that further actions, such as approval of additional influenza 

vaccines for the U.S. market, were under way. HHS, states, localities, and 

sanofi pasteur provided technical comments, which we incorporated as 

appropriate. HHS’s written comments appear in appendix I.

Influenza is characterized by cough, fever, headache, and other symptoms 

and is more severe than some viral respiratory infections, such as the

common cold. Most people who contract influenza recover completely in 

1 to 2 weeks, but some develop serious and potentially life-threatening 

medical complications, such as pneumonia. On average each year in the 

United States, more than 36,000 individuals die and more than 200,000 are 

hospitalized from influenza and related complications. People aged 65 

years and older, people of any age with chronic medical conditions, 

children younger than 2 years of age, and pregnant women are generally 

more likely than others to develop severe influenza-related complications. 

Background 

Page 5 GAO-05-984 Influenza Vaccine Shortage
Vaccination is the primary method for preventing influenza and its more

severe complications. Produced in a complex process that involves 

growing viruses in millions of fertilized chicken eggs, influenza vaccine is 

administered annually to provide protection against particular influenza 

strains expected to be prevalent that year. Experience has shown that

vaccine production generally takes 6 or more months after a virus strain 

has been identified, and vaccines for certain influenza strains have been 

difficult to mass-produce. After vaccination, the body takes about 2 weeks 

to produce the antibodies that protect against infection. According to 

CDC, the optimal time for vaccination is October through November, 

because the annual influenza season typically does not peak until January 

or February. Thus in most years, vaccination in December or later can still

be beneficial (see fig. 1). If supplies permit, CDC recommends a 

vaccination for anyone who wants one. Because circulating influenza 

strains change, a new vaccine is created each year. For this reason, and 

because immunity declines over time, CDC recommends a new influenza 

vaccination every year for high-risk individuals and other priority groups, 

including close contacts of those at high risk. 

Figure 1: Influenza Vaccine Cycle 

Source: GAO (analysis), Art Explosion (clip art). 

Manufacturing

Influenza seasona

Jan. Feb. Mar. Apr. May Jun. Jul. Aug. Sept. Oct. Nov. Dec. Jan. Feb. Mar. Apr.

Vaccination period

a

The influenza season varies from year to year, generally beginning in late October and peaking in

January or February.

Page 6 GAO-05-984 Influenza Vaccine Shortage
Two types of vaccine are recommended for protection against influenza in 

the United States: (1) an inactivated virus vaccine injected into muscle and 

(2) a live virus vaccine administered as a nasal spray. The injectable

vaccine—which represents the large majority (over 95 percent) of 

influenza vaccine administered in this country—can be used to immunize

healthy individuals and those at high risk of severe complications, 

including those with chronic illness and those aged 65 years and older. The

nasal spray vaccine, in contrast, is currently approved for use only among 

healthy individuals aged 5–49 years who are not pregnant. Although 

vaccination is the primary strategy for protecting individuals who are at

greatest risk of serious complications and death from influenza, antiviral

drugs can also contribute to the treatment and prevention of the disease.

7

In a typical year, manufacturers make influenza vaccine available before 

the optimal fall vaccination season. For the 2003–04 influenza season, two 

manufacturers—one with production facilities in the United States (sanofi

pasteur) and one with production facilities in the United Kingdom

(Chiron)—produced about 83 million doses of injectable vaccine, which 

represented about 96 percent of the U.S. vaccine supply. A third U.S. 

manufacturer (MedImmune) produced the nasal spray vaccine. According 

to CDC, MedImmune produced about 3 million doses of the nasal spray

vaccine, or about 4 percent of the overall influenza vaccine supply, for the 

2003–04 season. 

Influenza vaccine production and distribution are largely private-sector

activities. Manufacturers sell influenza vaccine to resellers (such as 

medical supply distributors and pharmacies), to federal agencies and state 

and local public health departments, or directly to providers (see fig. 2). 

Individuals can obtain an influenza vaccination at a number of places, 

including physicians’ offices, public health clinics, nursing homes, and 

nonmedical locations such as workplaces or retail outlets. Millions of

individuals receive influenza vaccinations through mass immunization

campaigns in these nonmedical settings, where organizations such as 

visiting nurse agencies under contract administer the vaccine. 

 7

Four antiviral drugs have been approved for treatment. If taken within 2 days of illness, 

these drugs can reduce symptoms and make someone with influenza less contagious to 

others. 

Page 7 GAO-05-984 Influenza Vaccine Shortage
Figure 2: Influenza Vaccine Production and Distribution

Source: GAO (analysis), Art Explosion (clip art). 

Providers

Include physicians, clinics, 

nursing homes, and home 

health organizations

Resellers

Include distributors and 

pharmacies

Governments

Include federal agencies and 

state and local health 

departments 

Individuals

Include high-risk individuals, 

other target groups such as 

health care workers, and others 

who want a vaccination

Manufacturers

Include producers of

injectable influenza vaccine 

and of a nasal 

spray vaccine

HHS has limited authority to control vaccine production and distribution 

directly; influenza vaccine supply and marketing are largely in the hands of 

the private sector.8

 In the event that the Secretary of HHS determines and

declares a public health emergency, the Public Health Service Act 

 8

FDA has limited authority to prohibit the resale of prescription drugs, including influenza

vaccine that has been purchased by health care entities such as public or private hospitals. 

This authority does not extend to resale of the vaccine for emergency medical reasons. The 

term “health care entity” does not include wholesale distributors.

Page 8 GAO-05-984 Influenza Vaccine Shortage
authorizes the Secretary to “take such action as may be appropriate” to 

respond.9

Within HHS, CDC is one of the agencies that help protect the nation’s 

health and safety. CDC’s activities include efforts to prevent and control

diseases and to respond to public health emergencies. ACIP, after 

consulting with CDC, makes recommendations on which population

groups should be targeted for vaccination. CDC also administers a number

of programs to help make vaccines, including influenza vaccine, affordable

for low-income and other populations. For example, under CDC’s Vaccines 

for Children program, vaccines are provided free of charge for certain

children 18 years of age or younger, including those who are Medicaideligible, uninsured, or underinsured (that is, their insurance does not

include vaccinations). CDC also reserves stockpiles of certain vaccines. 

For the 2004–05 influenza season, CDC contracted with vaccine 

manufacturers to supply influenza vaccine for a national stockpile for the 

first time. The agency originally contracted for 4.5 million doses, including 

2 million doses from Chiron, which were therefore not available. CDC also 

maintains stockpiles of antiviral medications that can alleviate influenza 

symptoms and reduce contagion in those who contract the disease. 

Other organizations within HHS that are involved with immunization 

activities include the National Vaccine Program Office, which is

responsible for coordinating and ensuring collaboration among the many 

federal agencies involved in vaccine and immunization activities, and the 

Food and Drug Administration (FDA), which in approving and regulating 

the use of vaccines and drugs, including antiviral medications, is 

responsible for ensuring that they are safe and effective. In addition to

federal agencies, state and local health departments are often the first 

responders in situations affecting public health. 

Initially for the 2004–05 influenza season, CDC in May 2004 recommended 

that about 188 million Americans receive a vaccination—about 85 million 

at high risk of severe complications and about 103 million in other priority

groups, such as people in close contact with high-risk individuals, healthy

 9

According to the act, to declare a public health emergency, the Secretary must determine 

that (1) a disease or disorder presents a public health emergency, or (2) a public health 

emergency, including significant outbreaks of infectious disease or bioterrorist attacks,

otherwise exists. Public Health Improvement Act, Pub. L. No. 106-505, § 102, 114 Stat. 2314, 

2315 (2002) (adding §319 to the Public Health Service Act) (codified at 42 U.S.C. § 247d).

Page 9 GAO-05-984 Influenza Vaccine Shortage
people aged 50–64 years, and health care workers.10 CDC also suggested

that, depending on the availability of vaccine, other individuals who 

should receive a vaccination include (1) any person who wished to reduce 

the likelihood of contracting influenza, (2) individuals who provide 

essential community services, and (3) students and others in institutional

settings. Although Chiron had announced that it was experiencing 

production problems in August 2004, according to CDC, the manufacturer

had assured the agency that the production issues were being resolved. 

Subsequently, on September 24, 2004, CDC reiterated its recommendation

that 188 million individuals in high-risk and other groups be vaccinated as

vaccine became available. CDC also recommended that anyone wanting to 

reduce the risk of contracting influenza be vaccinated. Not everyone in 

these high-risk and priority groups, however, receives a vaccination each 

year. Among health care workers, for example, about 40 percent received 

a vaccination in the 2002–03 and 2003–04 seasons, according to one CDC 

survey. Similarly, about 66 percent of individuals aged 65 years and older

reported receiving influenza vaccination in the 2002–03 and 2003–04 

influenza seasons, according to CDC estimates.11

After the October 5, 2004, announcement of the sharp reduction in 

expected influenza vaccine supply, federal, state, and local health officials 

took steps to help ensure that those at high risk of severe complications 

from infection had access to influenza vaccine. For example, health 

officials quickly revised vaccination recommendations so that the 

remaining supply could be targeted to those in priority groups comprising 

those at high risk, certain health care workers, and household contacts of

children younger than 6 months of age. Other efforts focused on

distributing vaccine to priority groups and on keeping providers and the 

public updated as to vaccine availability. Finally, late in the influenza 

vaccination period—from mid-December through January—health 

officials’ actions focused on further augmenting the vaccine supply and, 

Health Officials Took 

Steps to Vaccinate 

High-Risk Individuals 

and Others in Priority 

Groups 

 10CDC recommended vaccination for people aged 50–64 years to raise the low vaccination 

rates among people with high-risk conditions in this age group. Further, people in this age 

group without high-risk conditions also benefit from lower influenza rates, fewer medical 

visits, and less medication. See Centers for Disease Control and Prevention, “Prevention

and Control of Influenza: Recommendations of the Advisory Committee on Immunization

Practices,” Morbidity and Mortality Weekly Report, vol. 53, RR-6 (2004): 1–40. 

11See Centers for Disease Control and Prevention, “Estimated Influenza Vaccination

Coverage among Adults and Children, United States, September 1, 2004–January 31, 2005,”

Morbidity and Mortality Weekly Report, vol. 54, no. 12 (2005): 304–307. 

Page 10 GAO-05-984 Influenza Vaccine Shortage
once supply increased, on encouraging vaccination for anyone remaining 

in the priority groups and for others who had earlier deferred vaccination 

(see fig. 3). 

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

Source: GAO. 

October 5 

Chiron’s license is 

suspended by the 

United Kingdom, 

cutting the U.S. 

supply in half. CDC 

issues a revised list 

of priority groups it 

recommends for 

vaccination and 

asks others to defer 

vaccination.

October 12 

CDC begins phase I of a distribution 

plan, to ship about 13 million doses to 

providers serving high-risk individuals.

October 14 

HHS urges all state attorneys general 

to investigate and prosecute anyone 

engaging in price gouging of influenza 

vaccine.

August September October November December January

January 3, 2005 

CDC broadens 

vaccine 

recommendations 

to those aged 50 

years and older 

and to household 

contacts of highrisk individuals.a

January 27 

CDC advises 

anyone wanting an 

influenza vaccination 

to seek one and 

makes available 

late-season doses 

previously reserved 

for the federal 

vaccine stockpile 

or Vaccines for 

Children program.a

December 7 

HHS agrees to 

purchase from 

Europe influenza 

vaccine not licensed 

for use in the United 

States.

December 15 

Nine states have 

begun offering 

influenza vaccine 

to people aged 50 

years and older 

and to household 

contacts of high-risk 

individuals.

November 17 

CDC begins phase 

II of a distribution 

plan, where states 

order vaccine 

through CDC to 

fill their estimated 

unmet needs for 

vaccinating priority 

groups.

September 24 

CDC recommends 

that influenza 

vaccination 

proceed as soon 

as influenza vaccine 

is available, as it 

recommended 

in May.

August 26 

CDC says Chiron’s 

vaccine may be 

delayed because 

of production 

problems.

May 28, 2004 

CDC recommends 

that 188 million 

Americans, 

including about 

85 million people 

at high risk of severe 

complications, be 

vaccinated for 

influenza.

Spring May

a

CDC actions broadening recommendations on who should be vaccinated applied only in locations

where state and local health officials judged vaccine supply to be adequate.

Federal and State Officials 

Took Quick Actions

Several responses by public health officials took place within hours or 

days of the public announcement that a severe shortage of influenza 

vaccine was imminent. 

• Federal and state health officials redefined priority groups for 

influenza vaccination. CDC immediately redefined the groups 

recommended to receive vaccine in 2004–05 for protection against

influenza and its complications and issued revised recommendations on 

October 5, 2004. These revised recommendations focused on priority 

groups that included high-risk individuals, health care workers involved in

Page 11 GAO-05-984 Influenza Vaccine Shortage
direct patient care, and household contacts of children younger than 

6 months of age. CDC’s revised recommendations decreased the number

of people in groups recommended for vaccination from about 188 million 

to about 98 million (see table 1).

12 At the same time, CDC also asked

people not in these priority groups to forgo or defer vaccination. State and 

local health officials we met with reported having quickly adopted CDC’s 

revised recommendations. Some health departments, however, found that

they did not have enough vaccine to cover everyone in CDC’s priority 

groups and therefore subdivided CDC’s priority groups. For example, in

Maine, all health care workers were initially excluded from the state’s 

priority groups, although later, Maine health officials recommended

vaccination for particular types of health care workers, such as those 

working in intensive care units and emergency departments, if local 

vaccine supply allowed. 

 12On October 5, 2004, CDC issued interim recommendations for influenza vaccination 

during the 2004–05 season, which took precedence over earlier recommendations. The 

season’s priority groups for vaccination with injectable influenza vaccine were considered 

to be of equal importance. See Centers for Disease Control and Prevention, “Interim

Influenza Vaccination Recommendations, 2004–05 Influenza Season,” Morbidity and 

Mortality Weekly Report, vol. 53, no. 39 (2004): 923–924.

Page 12 GAO-05-984 Influenza Vaccine Shortage
Table 1: Groups Recommended for Influenza Vaccination, Before and After October 5, 2004 

Population

(millions)

a

May 2004b,cOctober 5, 2004c

High-risk groups 

People aged 65 years and older 35.6 9 9

Adults and children with chronic illness 39.4 9 9

Pregnant women 4.0 9 9

All children aged 6–23 months 5.9 9 9

Other priority groups 

Health care workers aged 64 years and younger 7.0 9 9

People aged 2–64 years who are household contacts of high-risk individualsd69.5 9

People aged 2–64 years who are household contacts of children younger than 

6 months

d

6.3 9 9

Healthy people aged 50–64 years who are not household contacts of high-risk 

individuals 20.1 9

Totals 187.8 98.2

Source: CDC. 

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

a

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

b

CDC suggested that, depending on vaccine availability, anyone wishing to reduce the likelihood of

contracting influenza, individuals who provide essential community services, and students and others 

in institutional settings also be vaccinated.

c

CDC suggested that residents of nursing homes and long-term-care facilities, and children 

6 months–18 years old receiving chronic aspirin therapy, also be vaccinated.

d

These groups belonged to a single category in CDC’s May 2004 recommendations.

• HHS collaborated with manufacturers to temporarily halt further 

distribution of injectable influenza vaccine and to ramp up

production of nasal spray vaccine. At the request of CDC, sanofi 

pasteur, the sole remaining manufacturer of injectable influenza vaccine

for the U.S. market, voluntarily suspended further distribution of the 

approximately 25 million doses it had not yet shipped on October 5, 2004, 

until the week of October 11, 2004, when CDC completed its assessment of

the situation. Distribution was temporarily halted because CDC needed 

time to devise a plan to better target vaccine distribution to providers 

serving individuals in the priority groups. HHS officials also worked with

MedImmune, the maker of the nasal spray vaccine, to increase its 

production for the 2004–05 influenza season from about 1 million doses to 

a total of 3 million doses.

Page 13 GAO-05-984 Influenza Vaccine Shortage
• Federal officials evaluated foreign sources of influenza vaccine and

assessed the federal stockpile of antiviral medications. On October

11, 2004, HHS convened an interagency team, comprising officials from 

HHS’s Office of the Secretary, CDC, FDA, and others, to devise a plan to 

import influenza vaccine not licensed for the U.S. market from foreign 

manufacturers; this vaccine could be administered in the United States 

under an investigational new drug protocol.

13 Around the same time, FDA 

quickly authorized the redistribution of vaccine among hospitals and other

health entities to alleviate shortages.14 HHS also assessed its stockpile of 

antiviral medications that could be used to prevent or treat influenza and 

began the process of purchasing more. According to HHS officials, by 

December 2004 the federal government purchased and stockpiled enough 

antiviral medicines to treat more than 7 million people. 

• State and local health departments used existing emergency plans 

and incident command systems. Some state and local health 

departments used their emergency preparedness plans and incident

command systems (the organizational systems set up specifically to

handle the coordinated response to emergency situations) during the 

influenza vaccine shortage. The five state health departments and two of

the local health departments we visited used their incident command 

systems to help manage shortage-related activities, and three of the state 

health departments reported using their emergency plans. In addition, 

officials from the Florida Health Care Association, an organization 

representing long-term-care providers in that state, reported using certain 

elements in their disaster planning guide, which includes plans for 

disasters like hurricanes or bioterrorism. 

• Federal and state officials took measures against price gouging. 

Around the time (October 13, 2004) that one Florida-based distributor was 

sued by that state for selling influenza vaccine at significantly inflated 

prices,

15 several states began issuing warnings that all suspected cases of

 13FDA requires the submission of an investigational new drug application before the initial 

entry of an unapproved drug—including vaccines licensed for use in other countries—into 

human studies in the United States. This investigational new drug application includes a 

description of the vaccine and its method of manufacture, and results of previously

conducted quality control and toxicology testing.

14Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act allows such entities to sell, 

purchase, or trade a drug or vaccine or offer to sell, purchase, or trade a drug or vaccine for

emergency medical reasons. On October 9, 2004, CDC issued a statement noting that

“anticipated shortages of influenza vaccine this influenza season constitute emergency 

medical reasons.”

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

agreement filed May 19, 2005).

Page 14 GAO-05-984 Influenza Vaccine Shortage
price gouging by vaccine distributors and providers would be reported to 

the states’ attorneys general for further investigation and possible 

prosecution. In support of states’ efforts to curtail the overpricing of

limited influenza vaccine, CDC began collecting reports of price gouging 

and shared the information with the National Association of Attorneys 

General and state prosecutors. On October 14, 2004, the Secretary of HHS 

sent a letter to the attorney general of each state, urging thorough

investigation of reports of price gouging, and on October 22, 2004, HHS 

filed a “friend of the court” brief in support of the Florida lawsuit.

Beginning in mid-October, federal, state, and local public health officials 

acted to distribute the remaining 25 million doses of injectable influenza 

vaccine across the states and directed the limited amount of available

injectable vaccine to those in priority groups. State and local public health 

departments also took steps to help ensure that vaccine was distributed to

those within their jurisdictions who were in priority groups. 

In October and November, working with representatives from national

public health organizations and sanofi pasteur, CDC developed a plan to 

distribute sanofi pasteur’s unshipped vaccine. The plan consisted of two 

overlapping phases and was aided by the manufacturer’s voluntary sharing 

of proprietary information to help identify geographic areas in greatest

need of vaccine. 

Phase I, which began the week of October 11, 2004, consisted of filling 

orders that were clearly identifiable as public-sector orders and orders, 

such as those from long-term-care facilities, that had been placed with 

sanofi pasteur. Orders selected for full or partial filling included those that

could be immediately identified as placed by the Department of Veterans

Affairs, the Indian Health Service, long-term-care facilities and hospitals, 

and others (see table 2). Filling these orders distributed approximately 

13 million doses of vaccine over a 6–8 week period. 

Public Health Officials 

Acted to Distribute 

Remaining Vaccine 

CDC Devised a Plan to 

Distribute the Limited Supply 

of Influenza to High-Risk 

Individuals and to Others in 

Priority Groups

Page 15 GAO-05-984 Influenza Vaccine Shortage
Table 2: Phase I of CDC’s Influenza Vaccine Distribution Plan

Provider type

Percentage of 

orders filled 

Department of Veterans Affairs 100

Indian Health Service 100

Long-term-care facilities and hospitals 100

Providers who care for children (Vaccines for Children program

providers, office-based pediatricians) 100

Community immunization providers 75

Visiting Nurses Association of America 50

Department of Defense 50

Office-based primary care providers 50

State and local public health departments 50

Source: CDC. 

Phase II, which was announced by CDC on November 9, 2004, consisted of

distributing approximately 12 million doses: about 3 million doses for 

some of the remaining public-sector orders from phase I and about 

9 million doses across the states according to a formula based on each 

state’s percentage of the estimated nationwide unmet need.16 CDC 

calculated a state’s unmet need by taking the total estimated number of

individuals in priority groups in the state and subtracting the total number 

of doses that had been delivered before and during phase I. To help state 

health officials identify the regions within their states needing vaccine 

from phase II distribution, CDC developed an Internet-based program 

called the Flu Vaccine Finder on its secure data network.17 The program

allowed state health officials to view, county by county, a list of vaccine 

orders shipped by sanofi pasteur to various types of customers, such as 

pediatricians and hospitals. Officials could then allocate vaccine available 

to their state under phase II to providers within their state that needed, but

had not yet received, vaccine (see fig. 4). According to CDC officials, the

agency understood that not all of the phase II doses would be ready to

ship to states at once, so orders were partially filled and shipped in waves. 

 16To determine the number of individuals in priority groups in each state, CDC used U.S.

Census data and available data from the National Health Interview Survey for each of the 

groups. 

17The secure data network is an ongoing project sponsored by CDC that allows CDC field 

staff, researchers, and public health partners to securely exchange confidential,

proprietary, or sensitive data over the Internet. 

Page 16 GAO-05-984 Influenza Vaccine Shortage
Furthermore, the formula for determining each state’s allocation was 

imperfect, according to CDC, resulting in some states’ having more 

vaccine than needed to cover demand from those in priority groups and 

other states’ having too little. In response, CDC reallocated vaccine

available for ordering by states in December 2004. In addition, some states

found it necessary to redistribute vaccine within their own borders, or

they attempted to purchase or sell vaccine to other states to best align 

supply and demand at local levels. States could begin ordering their 

vaccine allotments through the secure data network on November 17,

2004, and ordering continued through mid-January. 

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

Note: Not all states (for example, Minnesota and Maine) chose to order vaccine through phase II of

CDC’s influenza vaccine distribution plan.

Source: GAO (analysis), Art Explosion (clip art).

1. CDC notifies states 

of doses available 

CDC in phase II

Manufacturer

4. CDC directs sanofi 

pasteur to send orders

to distributors

5. Manufacturer 

sanofi pasteur 

ships orders 

to distributors

4. CDC processes 

orders and forwards 

them to distributors

3. States place 

orders through 

CDC on CDC’s

 secure data

 network

6. Distributors ship 

orders to states and 

to providers

7. States 

distribute 

orders to 

providers

2. Providers 

place orders 

with states

Distributors States

Providers

Page 17 GAO-05-984 Influenza Vaccine Shortage
Public health officials at all levels implemented various strategies to help 

ensure that their vaccine supplies were targeted to high-risk individuals 

and others in priority groups. 

Federal, State, and Local 

Actions Limited Vaccine to 

High-Risk Individuals and 

Others in Priority Groups • Emergency directives issued. To help support providers in vaccinating 

only those individuals in CDC’s priority groups, a number of states, such

as California and Florida, issued emergency public health directives 

requiring health care providers to limit influenza vaccination to people in

priority groups and to refrain from vaccinating individuals not in CDC’s 

priority groups.18 Some of these directives, including those of the District 

of Columbia and Michigan, explicitly stated that providers failing to

comply with these directives could face penalties, such as fines or 

imprisonment. But some states chose not to issue emergency directives. 

For example, Minnesota state health officials reported that they had such 

strong voluntary compliance and cooperation from the state’s provider

community that they decided it was not necessary to post a directive 

mandating compliance. 

• Surveys conducted of providers and long-term-care facilities. During

mid-October, working with national professional organizations, CDC 

conducted a survey of long-term-care facilities to identify those that had 

placed orders with Chiron. A number of health departments, including six 

we visited, had also surveyed long-term-care facilities, and at least two, 

Minnesota and Seattle–King County in Washington State, completed their 

surveys before CDC began administering its version. In addition, many 

state health departments, including three we visited, surveyed providers 

about vaccine availability and the need for covering those in priority 

groups. In an effort to assess the degree of the vaccine supply shortage, for 

example, Minnesota public health officials developed and administered a 

survey to identify how much influenza vaccine was available in each of its 

92 local public health jurisdictions, not knowing before the shortage which 

providers had ordered vaccine from Chiron or which ones had ordered 

from sanofi pasteur. 

• Vaccine transferred among states. Because CDC’s distribution plan 

was based in part on estimated need for vaccine, some states received 

more than enough to cover demand from their priority groups, and some

states received too little. To redistribute vaccine to locations that needed 

vaccine to meet demand from priority groups, a state could attempt to sell 

its available vaccine to another state. According to the Association of State 

and Territorial Officials, Nebraska shipped some vaccine to other states 

 18During the 2004–05 influenza season, the Association of State and Territorial Health

Officials reported that 15 states and the District of Columbia issued emergency public

health directives. 

Page 18 GAO-05-984 Influenza Vaccine Shortage
when its own demand was met. Minnesota state health officials also

reported offering to sell available vaccine to other states. At the same time,

states without enough vaccine, such as Maryland, tried to obtain it from

another. 

• Partnerships established with the private sector. To augment state 

and local vaccine supply, public health departments looked to the private 

sector for help. A number of state and local health departments we talked 

with reported facilitating redistribution or acting as brokers for donations 

of vaccine that had been purchased by large employers for employee 

vaccination campaigns before the shortage. According to health officials in 

Washington, for example, one large employer donated about 700 doses of

influenza vaccine to the health department in Seattle–King County, which 

was then able to supply local nursing homes. Certain states and localities 

partnered with for-profit and not-for-profit home health organizations, 

which held mass immunization clinics and set up clinics in providers’ 

offices to help administer the vaccine quickly. For example, the Visiting 

Nurses Association of Southern Maine held a mass immunization clinic on 

a local college campus. These organizations followed CDC’s 

recommendations for vaccinating priority groups by screening potential

vaccine recipients. 

• Crowding alleviated through appointments and lotteries. In an effort

to control crowding, health officials in some localities created vaccination

appointments for individuals who were at high risk or in another priority

group. When available supplies were insufficient to cover every qualified 

person who wanted a vaccination, some health departments held lotteries

for available vaccine. The local public health department in Portland, 

Maine, for example, held a lottery for the small amount of vaccine it had 

received before the shortage plus the several hundred doses donated by an 

area medical center and the state department of health. To register for the 

lottery, people had to show they belonged to a priority group by supplying 

a note from their provider. 

Throughout the 2004–05 influenza vaccine shortage, federal, state, and 

local health officials used a variety of communication mechanisms to keep 

health officials, providers, and the public updated about vaccine 

availability and about the various strategies for distribution to providers 

and the public. At the federal level, CDC held frequent press conferences 

beginning in early October 2004. At these events, the agency updated the 

public on current efforts and recommendations, and it asked people who 

did not belong to a priority group to step aside and defer vaccination so 

that those in the priority groups would have access. CDC also conducted 

biweekly conference calls with representatives from various national 

health organizations to update them and obtain their feedback on

Public Health Officials 

Used Multiple

Communication Strategies 

to Impart Key Information 

Page 19 GAO-05-984 Influenza Vaccine Shortage
distribution efforts.19 According to CDC officials, state and local health 

officials could generally access the minutes from these discussions the

following day on CDC’s Health Alert Network.20 CDC also used this

network to send advisories and updates on the influenza vaccine situation, 

beginning on October 5, 2004, and continuing through the end of January. 

The majority of the state health officials we met with reported receiving 

key information about the shortage from this network; the information 

was then forwarded to local health officials, hospitals, and medical

associations that, in turn, passed the information on to providers. 

State and local health officials we met with also reported using various 

communication methods to relay national guidance, along with state and 

local guidance, and information about vaccine availability. These 

communication methods included mass e-mails and faxes; public 

education campaigns for influenza prevention; the media, including 

television, radio, and newspapers; telephone hotlines; and Web sites (see 

table 3). 

 19National health organizations included the Association of State and Territorial Health

Officials, National Association of County and City Health Officials, Council of State and 

Territorial Epidemiologists, and Association of Public Health Laboratories.

20The Health Alert Network is an early-warning and response system operated by CDC,

which is designed to ensure that state and local health departments, as well as other

federal agencies and departments, have timely access to emerging health information. 

Page 20 GAO-05-984 Influenza Vaccine Shortage
Table 3: Communication Methods Used by Various Health Departments to Disseminate Influenza Information 

Mass 

e-mails, 

faxes 

Health Alert 

Network

Provider 

education 

campaign 

Public 

education 

campaign 

(posters, 

flyers) 

Media

publicity 

Telephone

hotline Web site

California 

State health agency 9 9 9 9 9 9 9

San Diego 9 9 9 9 9 9

San Francisco 9 9 9 9 9 9

Florida 

State health agency 9 9 9 9 9 9 9

Miami–Dade County 9 9 9 9 9 9 9

Maine

State health agency 9 9 9 9 9 9 9

Portland 9 9 9

Minnesota 

State health agency 9 9 9 9 9 9 9

Stearns County 9 9 9 9 9

Washington 

State health agency 9 9 9 9 9 9

Seattle–King County 9 9 9

Source: GAO. 

Late-Season Actions 

Aimed to Boost Supply and 

Demand 

At the latest part of the influenza vaccination period, from mid-December 

2004 through January 2005, federal and state health officials took several

actions intended to further augment the vaccine supply and make vaccine

more accessible. Four areas were addressed: broadened recommendations 

for groups to be vaccinated, modifications to the Vaccines for Children 

program, purchase of foreign-made vaccine, and release of the federal 

stockpile of influenza vaccine. 

• CDC and states broadened the priority groups for influenza

vaccination. On December 17, 2004, CDC announced broadened

vaccination recommendations to include those aged 50–64 years and 

household contacts of high-risk individuals in locations where state and 

local health officials judged vaccine supply to be adequate. CDC’s 

broadened recommendations became effective January 3, 2005, allowing

extra time for vaccination of individuals in the original priority groups and 

time for state and local health departments to prepare for increased 

Page 21 GAO-05-984 Influenza Vaccine Shortage
requests for vaccine.21 As of January 3, 2005, however, according to 

information from the Association of State and Territorial Health Officials, 

20 states had already expanded vaccination recommendations: 13 

specified the additional groups identified by CDC, and 7 lifted all

vaccination restrictions, allowing anyone wanting a vaccination to get 

one.22 On January 27, 2005, CDC endorsed states’ efforts to broaden 

vaccination recommendations to include all people wanting influenza 

immunization in states and localities where vaccine supply was sufficient

to do so. Before that date, according to association officials, 27 states had 

already expanded recommendations to include everyone, although a few

states waited longer to expand recommendations.

• CDC made vaccine from the Vaccines for Children program more

widely available.

23 CDC’s ACIP passed a resolution for CDC’s Vaccines

for Children program, effective December 17, 2004, that expanded the 

groups of children eligible to receive the program’s influenza vaccine to 

include program-eligible children outside of CDC’s priority groups who 

were household contacts of people in high-risk groups. Later, on January 

27, 2005, CDC authorized limited amounts of influenza vaccine from the 

Vaccines for Children program and held by the states to be transferred to

state health departments for nonprogram use where the demand among 

program-eligible children had already been met. Public providers that had 

a reserve of program vaccine after vaccinating their program-eligible 

children could then use this vaccine for adults and children who were not 

eligible for the Vaccines for Children program. 

• HHS purchased foreign-manufactured influenza vaccine for the U.S. 

market. After efforts initiated in early October to develop a plan to obtain 

foreign-made influenza vaccine that was not licensed for the U.S. market 

and make it available under an investigational new drug protocol, HHS in

December 2004 purchased about 1.2 million doses from one manufacturer 

in Germany and, in January 2005, purchased about 250,000 doses from

another manufacturer in Switzerland. CDC could then make this vaccine 

available to those states and localities wanting additional vaccine to 

 21See Centers for Disease Control and Prevention, “Updated Interim Influenza Vaccination 

Recommendations, 2004–05 Influenza Season,” Morbidity and Mortality Weekly Report, 

vol. 53, no. 50 (2004): 1183–1184. 

22By December 15, 2004, nine states had begun offering influenza vaccine to people aged 50

years and older and to household contacts of high-risk individuals. 

23In November 2004, CDC provided guidance for providers to borrow influenza vaccine 

from the Vaccines for Children program, to immunize children ineligible for the program, if, 

among other things, the providers anticipated being able to replace the borrowed doses in

the near term. 

Page 22 GAO-05-984 Influenza Vaccine Shortage
alleviate shortages. According to HHS officials, however, none of the 

additional doses were used in the 2004–05 influenza season. 

• CDC made stockpiled vaccine available to providers. On January 27, 

2005, after the production of 3.1 million late-season doses designated for 

CDC’s stockpile of influenza vaccine,24 CDC announced that that it would 

make this vaccine available to sanofi pasteur, which, in turn, could market

and sell the vaccine to public and private providers and then replenish 

CDC’s stockpile. This strategy allowed providers to order influenza 

vaccine directly from the manufacturer or a distributor, rather than go 

through state or local health departments. Providers who purchased these 

stockpiled doses would also be allowed to return unused vaccine for a 

credit and would have to pay only shipping costs for returned vaccine. 

Although the actions taken to address the influenza vaccine shortage

helped achieve vaccination rates approaching past levels for certain 

priority groups (see fig. 5), a number of lessons emerged from federal,

state, and local responses to the 2004–05 influenza shortage. Some lessons

were specific to that season’s shortage, and others have wider 

ramifications for potential future shortages or a pandemic. The primary 

lessons can be grouped into three broad, interrelated categories: planning, 

timely action, and communication. 

Planning, Timely 

Action, and

Communication Are

Key to an Effective 

Response 

 24Before Chiron’s announcement, CDC had planned to establish a stockpile of

approximately 4.5 million doses of injectable influenza vaccine purchased from both 

Chiron and sanofi pasteur. The primary purpose of the planned stockpile was to meet lateseason, unmet pediatric demand. 

Page 23 GAO-05-984 Influenza Vaccine Shortage
Figure 5: Influenza Vaccination Rates for Selected Priority Groups 

Before October 5, 2004, CDC lacked a contingency plan specifically 

designed to respond to a scenario involving a severe influenza vaccine 

shortage at the start of the traditional fall vaccination period; the absence 

of a plan led to a delay in response. Faced with the unanticipated shortfall 

in the amount of influenza vaccine expected to be available for the 

2004–05 influenza season, CDC revised recommendations and worked 

with sanofi pasteur to begin assessing available supply and to create a

distribution plan for the remaining vaccine. Developing and implementing 

this plan took time and led to delays in response and some confusion at

the state and local levels, particularly right after Chiron’s October 5, 2004, 

announcement. Public health officials in all five states we visited remarked

that although phase I of CDC’s redistribution plan quickly and effectively

distributed some vaccine to public and private providers serving priority 

groups, the vaccine available in phase II of CDC’s redistribution plan was 

too much, too late. Phase II ordering began on November 17, 2004, and 

continued into January 2005, but several weeks could elapse after orders 

were placed until vaccine was delivered. According to state and local 

public health officials we interviewed, by the time the vaccine was 

delivered through a cumbersome distribution process, demand for the 

vaccine had substantially waned, and public and private providers were 

left to redistribute the excess. The phase II distribution problem was 

65.6

34.2

40.1

62.7

25.5

35.7

0

10

20

30

40

50

60

70

Individuals 

aged 65

and older

Individuals aged

18–64 with high-risk

condition

Health

care

workers

2003 National Health Interview Survey

2004–05 Behavioral Risk Factor Surveillance System 

High-risk groups

Source: CDC.

Percent

Lesson Learned: Limited 

Contingency Planning 

Slows Response 

Page 24 GAO-05-984 Influenza Vaccine Shortage
compounded for state and local health officials because CDC restricted

access to its secure data network to two people per state. This narrow

restriction left several state and local public health officials, according to 

those we interviewed, without vital information about the supply or 

demand for vaccine. 

Our work showed that four areas of planning are particularly important for 

enhancing preparedness before a similar situation in the future: 

(1) defining the responsibilities of federal, state, and local officials; 

(2) using emergency preparedness plans and emergency health directives; 

(3) distinguishing between demand and need; and (4) identifying 

mechanisms for distributing and administering vaccine. 

• Better defining responsibilities of federal, state, and local officials

can minimize confusion. During the 2004–05 vaccine shortage, CDC 

worked with national organizations representing states and localities to

coordinate roles and responsibilities. Several public health officials we

spoke with reported that CDC effectively worked with sanofi pasteur and 

national organizations representing state and local health officials to 

coordinate responsibilities shortly after Chiron’s announcement. Despite 

these efforts, however, problems occurred. For example, to identify

national demand for vaccine, federal, state, and local health officials 

surveyed providers in states and localities to assess existing supply and 

additional need. CDC worked with national professional associations to

survey long-term-care providers throughout the country to determine if 

seniors had adequate access to vaccine. Maine and other states, however, 

also surveyed their long-term-care providers to make the identical 

determination. This duplication of effort expended additional resources, 

burdened some long-term-care providers in the states, and created 

confusion. 

• Emergency preparedness plans and emergency health directives 

help coordinate local response. State and local health officials in 

several locations we visited reported that using existing emergency plans 

or incident command centers helped coordinate effective local response to 

the vaccine shortage. For example, public health officials from Seattle–

King County said that using the county’s incident command system played 

a vital role in coordinating an effective and timely local response and in

communicating a clear message to the public and providers. In addition, 

according to public health officials, emergency public health directives

helped ensure access to vaccine by supporting providers in enforcing 

CDC’s recommendations and in helping to prevent price gouging in those 

states whose directives addressed price gouging. Certain officials we

spoke with, however, reported that although plans and directives helped, 

improvements were still needed. Some health officials indicated that as a 

Page 25 GAO-05-984 Influenza Vaccine Shortage
result of the past influenza season, they were revising state and local

preparedness plans or modifying command center protocols to prepare for

future emergency situations. For example, in Maine, after experiences 

during the 2004–05 influenza season, state officials recognized the need to 

speed completion of their pandemic influenza preparedness plan. In

addition, they said the vaccine shortage experience helped identify which 

officials should attend which meetings during a crisis to ensure the right

people have the right information. 

• Distinguishing between demand and need for vaccine can improve 

distribution. In discussing the adequacy of vaccine supplies, public 

health officials make a distinction between demand and need for vaccine 

by a high-risk group. In this context, demand is the number of high-risk 

individuals who want to receive an influenza vaccination, and need is the 

total number of high-risk individuals in an area or region, regardless of 

whether they want to receive a vaccination. Because some individuals in 

high-risk groups are unlikely to be vaccinated, estimating vaccine amounts 

on the basis of total need, rather than demand, can overstate the amount 

that will likely be used in any given location. Differentiating between 

demand and need would have helped states avoid substantially over- or 

underordering vaccine from CDC or a manufacturer. California state 

officials said that differentiating between demand and need earlier in the

season could have reduced delays and confusion during the shortage. 

Certain states and localities we visited had taken time before the season to

address contingencies for vaccine supply fluctuations. For example, 

Minnesota state officials used experiences in previous influenza seasons to

build a state influenza plan that educated providers and local public health

officials about the difference between demand and need. According to

state officials, communicating this difference to local providers and health

officials helped more accurately identify how much vaccine was in 

demand throughout the state. 

• The distribution and administration of vaccine can be facilitated. 

One mechanism used in a majority of the states and localities we visited 

was building partnerships between public and private sectors. This

mechanism was effective in both the distribution and the administration of

vaccine. In San Diego County, California, for example, local health 

officials worked with a coalition of partners in public health, private 

businesses, and nonprofit groups throughout the county. In addition, 

several states and localities also partnered with other organizations, 

including home health organizations, to increase their capacity to 

administer vaccine to large numbers of people. For example, public health 

officials, including those in California and Florida, worked with national

home health organizations to quickly immunize those in high-risk and 

other priority groups by holding mass immunization clinics. Other 

mechanisms we identified, aimed mainly at addressing the challenge of

Page 26 GAO-05-984 Influenza Vaccine Shortage
administering a limited amount of vaccine, included scheduling 

appointments and holding lotteries. In Stearns County, Minnesota, for 

example, public health officials worked with private providers to

implement a system of vaccination by appointment. Rather than standing 

in long lines for vaccination, individuals with appointments went to a 

clinic during a given time slot. Public health officials in Portland, Maine, 

emphasized the effectiveness of holding a lottery as a way to equitably 

administer limited amounts of vaccine to people and as an alternative to 

having large crowds show up for a limited number of doses. 

After the 2004–05 influenza season, CDC officials developed lessons 

learned from their experiences, including lessons on the importance of

contingency planning and defining which groups have higher priority in 

the event of a vaccine shortage. In August 2005, CDC issued interim 

guidelines to assist state and other immunization programs in planning for 

and dealing with an influenza vaccine shortage during the 2005–06 

season.25 Also in August 2005, CDC published potential priority groups for 

vaccination in the event of a shortage. Because the total vaccine supply for

the 2005–06 influenza season was not then known, however, CDC did not 

recommend setting priorities for injectable vaccine at that time.26 On 

September 2, 2005, CDC published priority recommendations for use of

injectable vaccine through October 24, 2005.27

During the 2004–05 influenza vaccine shortage, federal, state, and local 

officials needed to continually adapt to changing vaccine supply and 

demand, to make decisions, and to take action quickly. The actions they 

took after the traditional fall vaccination period, however, came too late to

boost supply while demand was still high. These actions included making 

available foreign-manufactured vaccine that was not licensed for the U.S. 

Lesson Learned: Unless 

Expedited, Actions to 

Boost Supply Are Likely to 

Have Little Effect 

 25CDC indicated that it had assembled a team in December 2004 to begin contingency 

planning for the 2005–06 influenza season. See Centers for Disease Control and Prevention,

“Interim Guideline: Planning for a Possible U.S. Influenza Vaccine Shortage, 2005–06 

Season,” August 4, 2005, http://www.cdc.gov/flu/professionals/vaccination/pdf 

/vaccshortguide.pdf (downloaded on Aug. 24, 2005).

26See Centers for Disease Control and Prevention, “Tiered Use of Inactivated Influenza 

Vaccine in the Event of a Vaccine Shortage,” Morbidity and Mortality Weekly Report, vol.

54, no. 30 (2005): 749–750.

27See Centers for Disease Control and Prevention, “Update: Influenza Vaccine Supply and 

Recommendations for Prioritization during 2005–06 Influenza Season,” Morbidity and 

Mortality Weekly Report, vol. 54, no. 34 (2005): 850.

Page 27 GAO-05-984 Influenza Vaccine Shortage
market, expanding availability of vaccine from the Vaccines for Children 

program, and releasing vaccine reserved for the federal stockpile. 

HHS’s decision to purchase influenza vaccine not licensed for the U.S. 

market and to make it available under an investigational new drug 

protocol was too late to mitigate the shortage’s effects because of when 

such vaccines became available and because of cumbersome 

administrative requirements. Soon after Chiron’s October 5, 2005, 

announcement, HHS started looking into foreign vaccine that was licensed 

for use in other countries but not in the United States. Nonetheless, by the 

time HHS purchased this vaccine in December 2004 and January 2005, 

there was little demand for it. CDC officials acknowledged that one lesson 

learned from experience in 2004–05 was that use of foreign-licensed 

vaccine under an investigational new drug protocol during the influenza 

season requires that vaccine be shipped no later than the beginning of 

October. Further, recipients of such vaccines may be required to sign a 

consent form and follow up with a health care worker after vaccination—

steps that, according to health officials we interviewed in several states,

would be too cumbersome to administer and could dampen public

enthusiasm for being vaccinated. Although about 1.5 million doses of this

vaccine became available, none were used because demand had fallen, 

and injectable vaccine licensed for the U.S. market was still available. 

CDC’s December 2004 and January 2005 implementation of decisions to 

make vaccine from the Vaccines for Children program more widely

available was not timely and lacked flexibility. CDC explored options to 

use program vaccine to vaccinate three groups of people—children 

eligible for the Vaccines for Children program but not in a priority group, 

children not eligible for the program, and adults—but only in geographic 

areas where the needs of eligible children in high-risk groups had been 

met.28 But by the time CDC determined that demand from eligible children

had been met and announced that it was taking steps to make more 

program vaccine available for others, many states’ demand for additional 

vaccine had dropped. Because vaccine purchased under the Vaccines for 

Children program became available for nonprogram use so late, some

states reported they were unable to vaccinate all their state’s children in 

CDC’s priority groups. In other states, vaccine purchased under the 

 28CDC indicated that because the Vaccines for Children program is an entitlement, moving

too rapidly to release vaccine to ineligible people may risk denying vaccine to children for

whom the law requires availability. 

Page 28 GAO-05-984 Influenza Vaccine Shortage
program remained unused after all program-eligible children were

vaccinated, but completing the process to transfer the unused vaccine 

delayed some states from administering the remaining vaccine to 

individuals not eligible for Vaccines for Children. Since CDC expanded 

program vaccine availability too late, vaccine purchased under the 

Vaccines for Children program ultimately went unused. As a result, CDC is

surveying epidemiologists, state health officials, and immunization 

managers on lessons learned to connect activities to outcomes, such as

releasing program vaccine to increase immunization rates. Further, state 

health officials we interviewed reported that administrative difficulties in 

making vaccine available to a broader population hindered its ready use 

during the shortage. According to state health officials in California and 

Washington, if broadening Vaccines for Children eligibility had been more 

flexible and allowed more efficient transfer of vaccine to those not in the 

program, vaccine could have been made available sooner and more widely

to people in priority groups. 

CDC’s decision to release influenza vaccine produced for its national 

stockpile was also ineffective because the action came too late. The

majority of doses reserved for the stockpile were not delivered until

January 2005 because CDC wanted doses produced earlier in the season to 

be available to fill state orders. By the time the stockpiled doses were 

released back to the manufacturer for purchase by providers and others in

January, national demand had shrunk. Of the 3.1 million doses of

injectable vaccine released from the stockpile in January 2005, only 

approximately 115,000 were ordered. Without exception, state health

officials in the five states we visited reported that this vaccine became 

available too late in the season to be useful. 

Finally, certain states faced barriers when trying to buy available influenza 

vaccine from other states, preventing timely redistribution. During the 

2004–05 shortage, some state health officials reported problems with their 

ability—both in paying for vaccine and in administering the transfer 

process—to purchase influenza vaccine. For example, Minnesota tried to 

sell its available vaccine to other states seeking additional vaccine for their 

high-risk populations. According to federal and state health officials,

however, certain states lacked the funding or flexibility under state law to

purchase the vaccine when Minnesota offered it. In response to problems 

encountered during the 2004–05 shortage, the Association of Immunization

Managers proposed in 2005 that federal funds be set aside for emergency 

purchase of vaccine by public health agencies, eliminating cost as a barrier

in acquiring vaccine to distribute to the public. 

Page 29 GAO-05-984 Influenza Vaccine Shortage
While part of the lesson learned about communication was positive, some

aspects of this lesson pointed to need for improvement. Positives can be

seen, for example, in the extent of CDC’s communication. During the 

2004–05 shortage, CDC communicated regularly through a variety of media 

as the situation evolved. Officials from most states and localities we talked

with reported that CDC played an active role in communicating 

information despite a changing environment. Several state and local 

officials we spoke with said that biweekly conference calls were effective 

in providing updates and coordinating responsibilities. The state health

officer from Alabama, for instance, noted the frequency and quality of the 

communications that CDC put forth during the influenza season. 

Despite these positives, when examining the 2004–05 influenza season, 

state and local officials identified areas of communication to improve for 

future seasons. During our visits to states and localities, we found four 

particularly important communication issues. These issues included 

maintaining consistency of communications to avert confusion, 

understanding the importance of changing messages under changing

circumstances, using diverse media to reach diverse audiences, and

educating providers and the public about prevention alternatives. 

Lesson Learned: Effective 

Response Requires 

Communication to Be Both 

Clear and Consistent 

• Consistency among federal, state, and local communications is

critical for averting confusion. Health officials in Minnesota, for 

example, reported that some confusion resulted when the state 

determined that the influenza vaccine supply was sufficient to meet 

demand and therefore made vaccine available to other groups, such as 

healthy individuals aged 50–64 years, earlier than recommended by CDC. 

Similarly, health officials in California reported that in mid-December,

local radio stations in the state were running two public service 

announcements—one from CDC advising those aged 65 years and older to

be vaccinated, and one from the California Department of Health Services 

advising those aged 50 years and older to be vaccinated. They emphasized 

that these mixed messages created confusion. In addition, some

individuals seeking influenza vaccine in other regions could have found

themselves in a communication loop that provided no answers. For 

example, CDC advised people seeking influenza vaccine to contact their 

local public health department; in some cases, however, individuals calling

the local public health department were told to call their primary care 

provider, and when they called their primary care provider, they were told 

to call their local public health department. This inconsistency in

information from authoritative sources led to confusion and possibly to

Page 30 GAO-05-984 Influenza Vaccine Shortage
high-risk individuals’ giving up and not receiving an influenza 

vaccination.29

• Modifying messages to respond to changing circumstances can 

prevent unintended consequences. Beginning in October, CDC 

communicated a message asking individuals who were not in a high-risk 

group or another priority group to forgo or defer vaccination, or to step 

aside, so that that those in priority groups could have access to available 

vaccine. According to CDC, this message resulted in an estimated 

17.5 million individuals who specifically deferred vaccination to save 

vaccine for those in the priority groups. Public health officials we

interviewed, however, lamented the fact that this nationwide effort did not

also include a message to individuals who did step aside to check back 

with their providers or to seek an influenza vaccination later in the season.

State and local officials suggested that CDC should have had a message to 

step aside until a certain estimated date, when more vaccine would be

available and demand from individuals in the narrowed CDC priority 

groups would ease. These officials noted that many people in priority

groups, including those aged 65 years and older who should have been 

vaccinated, stepped aside. These officials also said that they were

concerned about other individuals, particularly those aged 50–64 years, 

who were not vaccinated during the moderate 2004–05 influenza season 

and, as a result, might think vaccination was not important enough to seek

in future seasons. 

• Using diverse media helps reach diverse audiences. During the 

2004–05 influenza season, public health officials reported the importance

of using a variety of communication methods to help ensure that messages

reached as many individuals as possible. For example, officials from the 

health department in Seattle–King County, Washington, reported that it

was important to have a telephone hotline as well as information posted 

on a Web site, because some seniors calling Seattle–King County’s hotline 

reported that they did not have access to the Internet. Further, public 

health officials in Miami–Dade County in Florida said that bilingual radio 

advertisements promoting influenza vaccine for those in priority groups 

helped increase the effectiveness of local efforts to raise vaccination rates.

 29According to data collected during December 1–11, 2004, on self-reported vaccination

during September 1 through November 30, 2004, among adults in priority groups who had 

not yet received influenza vaccine, about 23 percent reported that they attempted to obtain

a vaccination but could not. See Centers for Disease Control and Prevention, “Estimated

Influenza Vaccination Coverage among Adults and Children—United States, September 1–

November 30, 2004,” Morbidity and Mortality Weekly Report, vol. 53, no. 49 (2004): 1147–

1150. 

Page 31 GAO-05-984 Influenza Vaccine Shortage
• Education is important in alerting providers and the public about 

prevention alternatives. Educating health care providers and the public 

about all available influenza vaccines and forms of prevention may 

increase the number of vaccinated individuals and also reduce the spread 

of influenza. Experience with the nasal spray vaccine in 2004–05 illustrates

the importance of education. Approximately 3 million doses of nasal spray 

vaccine were ultimately available during the season for vaccinating

healthy individuals.

30 According to public health officials we interviewed, 

however, some individuals were reluctant to use this vaccine because they 

feared that the vaccine was too new and untested or that the live virus in 

the nasal spray could be transmitted to others. State health officials in

Maine, for example, reported that the state purchased about 1,500 doses of

the nasal spray vaccine for their emergency medical service personnel and

health care workers, yet 500 doses were administered. Further, public 

health officials we interviewed said that education about all available 

forms of prevention, including the use of antiviral medications and good 

hygiene practices, can help reduce the spread of influenza.31

According to CDC officials, as part of preparations for the 2005–06 

influenza season, the agency developed a draft communication plan—

separate from the interim guidelines issued to states—from lessons 

learned, which includes messages for responding to the fluctuations in 

supply and demand anticipated throughout the season. As of August 2005, 

CDC officials said that this plan will remain in draft form because tactics

will be changed and updated as circumstances change. 

Aided by a relatively moderate influenza season, efforts to mitigate the 

sudden and unexpected shortage of influenza vaccine for the 2004–05 

season were largely successful, although the season was not without

problems. Lacking a preseason plan to address a significant shortfall after 

the beginning of the traditional fall vaccination period, the federal 

government reacted to the shortage and its aftereffects as they unfolded 

Concluding

Observations 

 30The nasal spray vaccine was recommended for individuals aged 5–49 years who were not

pregnant, including some individuals, such as health care workers in this age group and 

household contacts of children younger than 6 months, in the priority groups defined by

CDC. 

31CDC posted guidance on its Web site in October 2004 about use of antiviral medications 

and other ways to prevent the spread of influenza, including covering the mouth when 

coughing, hand washing, and staying home from work when ill. See 

http://www.cdc.gov/flu/protect/preventing.htm (downloaded on Aug. 8, 2005).

Page 32 GAO-05-984 Influenza Vaccine Shortage
throughout the season. This lack of preseason planning created confusion 

and delays during the optimal fall influenza vaccination window, when 

state and local public health agencies and health care providers most 

needed vaccine to protect individuals at high risk of severe complications. 

Conversely, federal efforts to boost supply late in the season had little

effect, because demand fell off sharply in December and January, and

vaccine became available too late. In some instances, uncoordinated 

communication from federal to state and local jurisdictions, and to

providers and the general public, contributed to confusion, frustration, 

and individuals’ failure to seek or receive an influenza vaccination. 

Drawing from experiences during the 2004–05 shortage, CDC has taken a 

number of steps, including issuing interim guidelines in August 2005, to

assist in responding to possible future shortages. It is too early, however, 

to assess the effectiveness of these efforts in coordinating actions of 

federal, state, and local health agencies and others who play a part in the

annual influenza vaccination process. 

In commenting on a draft of this report, HHS noted that the draft

summarized in detail the activities undertaken by CDC and its public- and 

private-sector partners to deal with the influenza vaccine shortage of

2004–05, and the agency concurred with our finding that contingency

planning will greatly improve response efforts. The agency also provided 

details on other actions, such as approval of additional influenza vaccines 

for the U.S. market, that were under way. HHS also agreed that 

adjustments to vaccination recommendations and vaccine supply ideally 

should occur earlier in the influenza season, but such adjustments cannot

always be implemented in a shortage year. HHS’s written comments 

appear in appendix I.

As arranged with your office, unless you publicly announce the contents of

this report earlier, we plan no further distribution of it until 30 days after 

its issue date. At that time, we will send copies of this report to the 

Secretary of HHS, the Directors of CDC and the National Vaccine Program 

Office, and other interested parties. We will also make copies available to 

others upon request. In addition, the report will be available at no charge

on the GAO Web site at http://www.gao.gov. 

Agency Comments 

Page 33 GAO-05-984 Influenza Vaccine Shortage
If you or your staff members have any questions, please contact me at

(202) 512-7119 or crossem@gao.gov. Contact points for our Offices of

Congressional Relations and Public Affairs may be found on the last page 

of this report. GAO staff members who made major contributions to this

report are listed in appendix II. 

Marcia Crosse 

Director, Health Care

Page 34 GAO-05-984 Influenza Vaccine Shortage
Appendix I: Comments from the Department Appendix I: Comments from the Department of Health and Human Services 

of Health and Human Services 

Page 35 GAO-05-984 Influenza Vaccine Shortage
Appendix I: Comments from the Department 

of Health and Human Services 

Page 36 GAO-05-984 Influenza Vaccine Shortage
Ap

Ac

pendix II: GAO Contact and Staff

knowledgments

Page 37 GAO-05-984

Appendix II: GAO Contact and Staff 

Acknowledgments 

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

In addition to the contact named above, Kim Yamane, Assistant Director; 

George Bogart; Ellen W. Chu; Nicholas Larson; Jennifer Major; Terry Saiki;

and Stan Stenersen made key contributions to this report.

Acknowledgments 

Influenza Vaccine Shortage
Related GAO Products

Related GAO Products 

Influenza Pandemic: Challenges in Preparedness and Response. GAO-05-

863T. Washington, D.C.: June 30, 2005. 

Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T. 

Washington, D.C.: May 26, 2005. 

Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. 

GAO-05-177T. Washington, D.C.: November 18, 2004. 

Infectious Disease Preparedness: Federal Challenges in Responding to

Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28, 

2004. 

Public Health Preparedness: Response Capacity Improving, but Much 

Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: 

February 12, 2004. 

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have

Improved Public Health Response Capacity, but Gaps Remain. GAO-03-

654T. Washington, D.C.: April 9, 2003. 

Bioterrorism: Preparedness Varied across State and Local Jurisdictions. 

GAO-03-373. Washington, D.C.: April 7, 2003. 

Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future 

Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001. 

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

Flu Pandemic: Plan Needed for Federal and State Response. GAO-01-4. 

Washington, D.C.: October 27, 2000. 

(290430) Page 38 GAO-05-984 Influenza Vaccine Shortage
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