Influenza Vaccine
Shortages in 2004-05 Season Underscore Need for Better Preparation
Gao ID: GAO-05-984 September 30, 2005
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.
GAO-05-984, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation
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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
September 2005:
Influenza Vaccine:
Shortages in 2004-05 Season Underscore Need for Better Preparation:
GAO-05-984:
GAO Highlights:
Highlights of GAO-05-984, a report to the Committee on Government
Reform, House of Representatives, and the Committee on Homeland
Security and Governmental Affairs, U.S. Senate:
Why GAO Did This Study:
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.
What GAO Found:
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:
[See PDF for image]
[End of figure]
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[End of section]
Contents:
Letter:
Results in Brief:
Background:
Health Officials Took Steps to Vaccinate High-Risk Individuals and
Others in Priority Groups:
Planning, Timely Action, and Communication Are Key to an Effective
Response:
Concluding Observations:
Agency Comments:
Appendix I: Comments from the Department of Health and Human Services:
Appendix II: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Groups Recommended for Influenza Vaccination, Before and After
October 5, 2004:
Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan:
Table 3: Communication Methods Used by Various Health Departments to
Disseminate Influenza Information:
Figures:
Figure 1: Influenza Vaccine Cycle:
Figure 2: Influenza Vaccine Production and Distribution:
Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage:
Figure 4: Phase II of CDC's Influenza Vaccine Distribution Plan:
Figure 5: Influenza Vaccination Rates for Selected Priority Groups:
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:
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.[Footnote 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.[Footnote 2] After the
announcement, with no other U.S.-licensed manufacturers able to replace
the large amount of lost vaccine on such short notice, concerns arose
about the effects of the loss, especially on those most vulnerable to
complications from influenza.
Media reports of long lines of seniors waiting hours for a chance at a
vaccination, of others at high risk who could not find a vaccination,
and of individuals turned away who never returned when supplies became
available fueled worries that the nation was not adequately prepared to
respond to the significant vaccine shortage or to an influenza pandemic
(a widespread or worldwide influenza epidemic). Notwithstanding these
concerns, CDC's postseason data indicate that 2004-05 vaccination rates
among certain high-risk groups such as seniors approached historical
rates.[Footnote 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,
and the National Association of County and City Health
Officials;[Footnote 4] (3) organizations that conduct mass immunization
clinics; (4) sanofi pasteur,[Footnote 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.[Footnote 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.
Results in Brief:
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 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 late-season
vaccine surplus. For example, in California, state officials in mid-
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.
Background:
Influenza is characterized by cough, fever, headache, and other
symptoms and is more severe than some viral respiratory infections,
such as the common cold. Most people who contract influenza recover
completely in 1 to 2 weeks, but some develop serious and potentially
life-threatening medical complications, such as pneumonia. On average
each year in the United States, more than 36,000 individuals die and
more than 200,000 are hospitalized from influenza and related
complications. People aged 65 years and older, people of any age with
chronic medical conditions, children younger than 2 years of age, and
pregnant women are generally more likely than others to develop severe
influenza-related complications.
Vaccination is the primary method for preventing influenza and its more
severe complications. Produced in a complex process that involves
growing viruses in millions of fertilized chicken eggs, influenza
vaccine is administered annually to provide protection against
particular influenza strains expected to be prevalent that year.
Experience has shown that vaccine production generally takes 6 or more
months after a virus strain has been identified, and vaccines for
certain influenza strains have been difficult to mass-produce. After
vaccination, the body takes about 2 weeks to produce the antibodies
that protect against infection. According to CDC, the optimal time for
vaccination is October through November, because the annual influenza
season typically does not peak until January or February. Thus in most
years, vaccination in December or later can still be beneficial (see
fig. 1). If supplies permit, CDC recommends a vaccination for anyone
who wants one. Because circulating influenza strains change, a new
vaccine is created each year. For this reason, and because immunity
declines over time, CDC recommends a new influenza vaccination every
year for high-risk individuals and other priority groups, including
close contacts of those at high risk.
Figure 1: Influenza Vaccine Cycle:
[See PDF for image]
[A] The influenza season varies from year to year, generally beginning
in late October and peaking in January or February.
[End of figure]
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.[Footnote 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.
Figure 2: Influenza Vaccine Production and Distribution:
[See PDF for image]
[End of figure]
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.[Footnote 8] In the event
that the Secretary of HHS determines and declares a public health
emergency, the Public Health Service Act authorizes the Secretary to
"take such action as may be appropriate" to respond.[Footnote 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 Medicaid-eligible, uninsured, or underinsured (that is, their
insurance does not include vaccinations). CDC also reserves stockpiles
of certain vaccines. For the 2004-05 influenza season, CDC contracted
with vaccine manufacturers to supply influenza vaccine for a national
stockpile for the first time. The agency originally contracted for 4.5
million doses, including 2 million doses from Chiron, which were
therefore not available. CDC also maintains stockpiles of antiviral
medications that can alleviate influenza symptoms and reduce contagion
in those who contract the disease.
Other organizations within HHS that are involved with immunization
activities include the National Vaccine Program Office, which is
responsible for coordinating and ensuring collaboration among the many
federal agencies involved in vaccine and immunization activities, and
the Food and Drug Administration (FDA), which in approving and
regulating the use of vaccines and drugs, including antiviral
medications, is responsible for ensuring that they are safe and
effective. In addition to federal agencies, state and local health
departments are often the first responders in situations affecting
public health.
Initially for the 2004-05 influenza season, CDC in May 2004 recommended
that about 188 million Americans receive a vaccination-- about 85
million at high risk of severe complications and about 103 million in
other priority groups, such as people in close contact with high-risk
individuals, healthy people aged 50-64 years, and health care
workers.[Footnote 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.[Footnote 11]
Health Officials Took Steps to Vaccinate High-Risk Individuals and
Others in Priority Groups:
After the October 5, 2004, announcement of the sharp reduction in
expected influenza vaccine supply, federal, state, and local health
officials took steps to help ensure that those at high risk of severe
complications from infection had access to influenza vaccine. For
example, health officials quickly revised vaccination recommendations
so that the remaining supply could be targeted to those in priority
groups comprising those at high risk, certain health care workers, and
household contacts of children younger than 6 months of age. Other
efforts focused on distributing vaccine to priority groups and on
keeping providers and the public updated as to vaccine availability.
Finally, late in the influenza vaccination period--from mid-December
through January--health officials' actions focused on further
augmenting the vaccine supply and, once supply increased, on
encouraging vaccination for anyone remaining in the priority groups and
for others who had earlier deferred vaccination (see fig. 3).
Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage:
[See PDF for image]
[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.
[End of figure]
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 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).[Footnote 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.
Table 1: Groups Recommended for Influenza Vaccination, Before and After
October 5, 2004:
High-risk groups:
People aged 65 years and older;
Population (millions)[A]: 35.6;
May 2004[B,C];
October 5, 2004[C].
Adults and children with chronic illness;
Population (millions)[A]: 39.4;
May 2004[B,C];
October 5, 2004[C].
Pregnant women;
Population (millions)[A]: 4.0;
May 2004[B,C];
October 5, 2004[C].
All children aged 6-23 months;
Population (millions)[A]: 5.9;
May 2004[B,C];
October 5, 2004[C].
Other priority groups:
Health care workers aged 64 years and younger;
Population (millions)[A]: 7.0;
May 2004[B,C];
October 5, 2004[C].
People aged 2-64 years who are household contacts of high-risk
individuals[D];
Population (millions)[A]: 69.5;
May 2004[B,C].
People aged 2-64 years who are household contacts of children younger
than 6 months[D];
Population (millions)[A]: 6.3;
May 2004[B,C];
October 5, 2004[C].
Healthy people aged 50-64 years who are not household contacts of high-
risk individuals;
Population (millions)[A]: 20.1;
May 2004[B,C].
Totals;
May 2004[B,C]: 187.8;
October 5, 2004[C]: 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.
[End of table]
* HHS collaborated with manufacturers to temporarily halt further
distribution of injectable influenza vaccine and to ramp up production
of nasal spray vaccine. At the request of CDC, sanofi pasteur, the sole
remaining manufacturer of injectable influenza vaccine for the U.S.
market, voluntarily suspended further distribution of the approximately
25 million doses it had not yet shipped on October 5, 2004, until the
week of October 11, 2004, when CDC completed its assessment of the
situation. Distribution was temporarily halted because CDC needed time
to devise a plan to better target vaccine distribution to providers
serving individuals in the priority groups. HHS officials also worked
with MedImmune, the maker of the nasal spray vaccine, to increase its
production for the 2004-05 influenza season from about 1 million doses
to a total of 3 million doses.
* Federal officials evaluated foreign sources of influenza vaccine and
assessed the federal stockpile of antiviral medications. On October 11,
2004, HHS convened an interagency team, comprising officials from HHS's
Office of the Secretary, CDC, FDA, and others, to devise a plan to
import influenza vaccine not licensed for the U.S. market from foreign
manufacturers; this vaccine could be administered in the United States
under an investigational new drug protocol.[Footnote 13] Around the
same time, FDA quickly authorized the redistribution of vaccine among
hospitals and other health entities to alleviate shortages.[Footnote
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,[Footnote 15] several states began issuing warnings
that all suspected cases of price gouging by vaccine distributors and
providers would be reported to the states' attorneys general for
further investigation and possible prosecution. In support of states'
efforts to curtail the overpricing of limited influenza vaccine, CDC
began collecting reports of price gouging and shared the information
with the National Association of Attorneys General and state
prosecutors. On October 14, 2004, the Secretary of HHS sent a letter to
the attorney general of each state, urging thorough investigation of
reports of price gouging, and on October 22, 2004, HHS filed a "friend
of the court" brief in support of the Florida lawsuit.
Public Health Officials Acted to Distribute Remaining Vaccine:
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.
CDC Devised a Plan to Distribute the Limited Supply of Influenza to
High-Risk Individuals and to Others 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.
Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan:
Provider type: Department of Veterans Affairs;
Percentage of orders filled: 100.
Provider type: Indian Health Service;
Percentage of orders filled: 100.
Provider type: Long-term-care facilities and hospitals;
Percentage of orders filled: 100.
Provider type: Providers who care for children (Vaccines for Children
program providers, office-based pediatricians);
Percentage of orders filled: 100.
Provider type: Community immunization providers;
Percentage of orders filled: 75.
Provider type: Visiting Nurses Association of America;
Percentage of orders filled: 50.
Provider type: Department of Defense;
Percentage of orders filled: 50.
Provider type: Office-based primary care providers;
Percentage of orders filled: 50.
Provider type: State and local public health departments;
Percentage of orders filled: 50.
Source: CDC.
[End of table]
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.[Footnote 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.[Footnote 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. 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:
[See PDF for image]
Note: Not all states (for example, Minnesota and Maine) chose to order
vaccine through phase II of CDC's influenza vaccine distribution plan.
[End of figure]
Federal, State, and Local Actions Limited Vaccine to High-Risk
Individuals and Others in Priority Groups:
Public health officials at all levels implemented various strategies to
help ensure that their vaccine supplies were targeted to high-risk
individuals and others in priority groups.
* Emergency directives issued. To help support providers in vaccinating
only those individuals in CDC's priority groups, a number of states,
such as California and Florida, issued emergency public health
directives requiring health care providers to limit influenza
vaccination to people in priority groups and to refrain from
vaccinating individuals not in CDC's priority groups.[Footnote 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 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.
Public Health Officials Used Multiple Communication Strategies to
Impart Key Information:
Throughout the 2004-05 influenza vaccine shortage, federal, state, and
local health officials used a variety of communication mechanisms to
keep health officials, providers, and the public updated about vaccine
availability and about the various strategies for distribution to
providers and the public. At the federal level, CDC held frequent press
conferences beginning in early October 2004. At these events, the
agency updated the public on current efforts and recommendations, and
it asked people who did not belong to a priority group to step aside
and defer vaccination so that those in the priority groups would have
access. CDC also conducted biweekly conference calls with
representatives from various national health organizations to update
them and obtain their feedback on distribution efforts.[Footnote 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.[Footnote 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).
Table 3: Communication Methods Used by Various Health Departments to
Disseminate Influenza Information:
California:
State health agency;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
San Diego;
Mass e-mails, faxes;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
San Francisco;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Telephone hotline;
Web site.
Florida:
State health agency;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
Miami-Dade County;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
Maine:
State health agency;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
Portland;
Media publicity;
Telephone hotline;
Web site.
Minnesota:
State health agency;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Telephone hotline;
Web site.
Stearns County;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Web site.
Washington:
State health agency;
Mass e-mails, faxes;
Health Alert Network;
Provider education campaign;
Public education campaign (posters, flyers);
Media publicity;
Web site.
Seattle-King County;
Mass e-mails, faxes;
Telephone hotline;
Web site.
Source: GAO.
[End of table]
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
requests for vaccine.[Footnote 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.[Footnote 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.[Footnote 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 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,[Footnote 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.
Planning, Timely Action, and Communication Are Key to an Effective
Response:
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.
Figure 5: Influenza Vaccination Rates for Selected Priority Groups:
[See PDF for image]
[End of figure]
Lesson Learned: Limited Contingency Planning Slows Response:
Before October 5, 2004, CDC lacked a contingency plan specifically
designed to respond to a scenario involving a severe influenza vaccine
shortage at the start of the traditional fall vaccination period; the
absence of a plan led to a delay in response. Faced with the
unanticipated shortfall in the amount of influenza vaccine expected to
be available for the 2004-05 influenza season, CDC revised
recommendations and worked with sanofi pasteur to begin assessing
available supply and to create a distribution plan for the remaining
vaccine. Developing and implementing this plan took time and led to
delays in response and some confusion at the state and local levels,
particularly right after Chiron's October 5, 2004, announcement. Public
health officials in all five states we visited remarked that although
phase I of CDC's redistribution plan quickly and effectively
distributed some vaccine to public and private providers serving
priority groups, the vaccine available in phase II of CDC's
redistribution plan was too much, too late. Phase II ordering began on
November 17, 2004, and continued into January 2005, but several weeks
could elapse after orders were placed until vaccine was delivered.
According to state and local public health officials we interviewed, by
the time the vaccine was delivered through a cumbersome distribution
process, demand for the vaccine had substantially waned, and public and
private providers were left to redistribute the excess. The phase II
distribution problem was compounded for state and local health
officials because CDC restricted access to its secure data network to
two people per state. This narrow restriction left several state and
local public health officials, according to those we interviewed,
without vital information about the supply or demand for vaccine.
Our work showed that four areas of planning are particularly important
for enhancing preparedness before a similar situation in the future:
(1) defining the responsibilities of federal, state, and local
officials; (2) using emergency preparedness plans and emergency health
directives; (3) distinguishing between demand and need; and (4)
identifying mechanisms for distributing and administering vaccine.
* Better defining responsibilities of federal, state, and local
officials can minimize confusion. During the 2004-05 vaccine shortage,
CDC worked with national organizations representing states and
localities to coordinate roles and responsibilities. Several public
health officials we spoke with reported that CDC effectively worked
with sanofi pasteur and national organizations representing state and
local health officials to coordinate responsibilities shortly after
Chiron's announcement. Despite these efforts, however, problems
occurred. For example, to identify national demand for vaccine,
federal, state, and local health officials surveyed providers in states
and localities to assess existing supply and additional need. CDC
worked with national professional associations to survey long-term-care
providers throughout the country to determine if seniors had adequate
access to vaccine. Maine and other states, however, also surveyed their
long-term-care providers to make the identical determination. This
duplication of effort expended additional resources, burdened some long-
term-care providers in the states, and created confusion.
* Emergency preparedness plans and emergency health directives help
coordinate local response. State and local health officials in several
locations we visited reported that using existing emergency plans or
incident command centers helped coordinate effective local response to
the vaccine shortage. For example, public health officials from Seattle-
King County said that using the county's incident command system played
a vital role in coordinating an effective and timely local response and
in communicating a clear message to the public and providers. In
addition, according to public health officials, emergency public health
directives helped ensure access to vaccine by supporting providers in
enforcing CDC's recommendations and in helping to prevent price gouging
in those states whose directives addressed price gouging. Certain
officials we spoke with, however, reported that although plans and
directives helped, improvements were still needed. Some health
officials indicated that as a result of the past influenza season, they
were revising state and local preparedness plans or modifying command
center protocols to prepare for future emergency situations. For
example, in Maine, after experiences during the 2004-05 influenza
season, state officials recognized the need to speed completion of
their pandemic influenza preparedness plan. In addition, they said the
vaccine shortage experience helped identify which officials should
attend which meetings during a crisis to ensure the right people have
the right information.
* Distinguishing between demand and need for vaccine can improve
distribution. In discussing the adequacy of vaccine supplies, public
health officials make a distinction between demand and need for vaccine
by a high-risk group. In this context, demand is the number of high-
risk individuals who want to receive an influenza vaccination, and need
is the total number of high-risk individuals in an area or region,
regardless of whether they want to receive a vaccination. Because some
individuals in high-risk groups are unlikely to be vaccinated,
estimating vaccine amounts on the basis of total need, rather than
demand, can overstate the amount that will likely be used in any given
location. Differentiating between demand and need would have helped
states avoid substantially over-or underordering vaccine from CDC or a
manufacturer. California state officials said that differentiating
between demand and need earlier in the season could have reduced delays
and confusion during the shortage. Certain states and localities we
visited had taken time before the season to address contingencies for
vaccine supply fluctuations. For example, Minnesota state officials
used experiences in previous influenza seasons to build a state
influenza plan that educated providers and local public health
officials about the difference between demand and need. According to
state officials, communicating this difference to local providers and
health officials helped more accurately identify how much vaccine was
in demand throughout the state.
* The distribution and administration of vaccine can be facilitated.
One mechanism used in a majority of the states and localities we
visited was building partnerships between public and private sectors.
This mechanism was effective in both the distribution and the
administration of vaccine. In San Diego County, California, for
example, local health officials worked with a coalition of partners in
public health, private businesses, and nonprofit groups throughout the
county. In addition, several states and localities also partnered with
other organizations, including home health organizations, to increase
their capacity to administer vaccine to large numbers of people. For
example, public health officials, including those in California and
Florida, worked with national home health organizations to quickly
immunize those in high-risk and other priority groups by holding mass
immunization clinics. Other mechanisms we identified, aimed mainly at
addressing the challenge of administering a limited amount of vaccine,
included scheduling appointments and holding lotteries. In Stearns
County, Minnesota, for example, public health officials worked with
private providers to implement a system of vaccination by appointment.
Rather than standing in long lines for vaccination, individuals with
appointments went to a clinic during a given time slot. Public health
officials in Portland, Maine, emphasized the effectiveness of holding a
lottery as a way to equitably administer limited amounts of vaccine to
people and as an alternative to having large crowds show up for a
limited number of doses.
After the 2004-05 influenza season, CDC officials developed lessons
learned from their experiences, including lessons on the importance of
contingency planning and defining which groups have higher priority in
the event of a vaccine shortage. In August 2005, CDC issued interim
guidelines to assist state and other immunization programs in planning
for and dealing with an influenza vaccine shortage during the 2005-06
season.[Footnote 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.[Footnote 26] On September 2, 2005, CDC published
priority recommendations for use of injectable vaccine through October
24, 2005.[Footnote 27]
Lesson Learned: Unless Expedited, Actions to Boost Supply Are Likely to
Have Little Effect:
During the 2004-05 influenza vaccine shortage, federal, state, and
local officials needed to continually adapt to changing vaccine supply
and demand, to make decisions, and to take action quickly. The actions
they took after the traditional fall vaccination period, however, came
too late to boost supply while demand was still high. These actions
included making available foreign-manufactured vaccine that was not
licensed for the U.S. market, expanding availability of vaccine from
the Vaccines for Children program, and releasing vaccine reserved for
the federal stockpile.
HHS's decision to purchase influenza vaccine not licensed for the U.S.
market and to make it available under an investigational new drug
protocol was too late to mitigate the shortage's effects because of
when such vaccines became available and because of cumbersome
administrative requirements. Soon after Chiron's October 5, 2005,
announcement, HHS started looking into foreign vaccine that was
licensed for use in other countries but not in the United States.
Nonetheless, by the time HHS purchased this vaccine in December 2004
and January 2005, there was little demand for it. CDC officials
acknowledged that one lesson learned from experience in 2004-05 was
that use of foreign-licensed vaccine under an investigational new drug
protocol during the influenza season requires that vaccine be shipped
no later than the beginning of October. Further, recipients of such
vaccines may be required to sign a consent form and follow up with a
health care worker after vaccination--steps that, according to health
officials we interviewed in several states, would be too cumbersome to
administer and could dampen public enthusiasm for being vaccinated.
Although about 1.5 million doses of this vaccine became available, none
were used because demand had fallen, and injectable vaccine licensed
for the U.S. market was still available.
CDC's December 2004 and January 2005 implementation of decisions to
make vaccine from the Vaccines for Children program more widely
available was not timely and lacked flexibility. CDC explored options
to use program vaccine to vaccinate three groups of people--children
eligible for the Vaccines for Children program but not in a priority
group, children not eligible for the program, and adults--but only in
geographic areas where the needs of eligible children in high-risk
groups had been met.[Footnote 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 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.
Lesson Learned: Effective Response Requires Communication to Be Both
Clear and Consistent:
While part of the lesson learned about communication was positive, some
aspects of this lesson pointed to need for improvement. Positives can
be seen, for example, in the extent of CDC's communication. During the
2004-05 shortage, CDC communicated regularly through a variety of media
as the situation evolved. Officials from most states and localities we
talked with reported that CDC played an active role in communicating
information despite a changing environment. Several state and local
officials we spoke with said that biweekly conference calls were
effective in providing updates and coordinating responsibilities. The
state health officer from Alabama, for instance, noted the frequency
and quality of the communications that CDC put forth during the
influenza season.
Despite these positives, when examining the 2004-05 influenza season,
state and local officials identified areas of communication to improve
for future seasons. During our visits to states and localities, we
found four particularly important communication issues. These issues
included maintaining consistency of communications to avert confusion,
understanding the importance of changing messages under changing
circumstances, using diverse media to reach diverse audiences, and
educating providers and the public about prevention alternatives.
* Consistency among federal, state, and local communications is
critical for averting confusion. Health officials in Minnesota, for
example, reported that some confusion resulted when the state
determined that the influenza vaccine supply was sufficient to meet
demand and therefore made vaccine available to other groups, such as
healthy individuals aged 50-64 years, earlier than recommended by CDC.
Similarly, health officials in California reported that in mid-
December, local radio stations in the state were running two public
service announcements--one from CDC advising those aged 65 years and
older to be vaccinated, and one from the California Department of
Health Services advising those aged 50 years and older to be
vaccinated. They emphasized that these mixed messages created
confusion. In addition, some individuals seeking influenza vaccine in
other regions could have found themselves in a communication loop that
provided no answers. For example, CDC advised people seeking influenza
vaccine to contact their local public health department; in some cases,
however, individuals calling the local public health department were
told to call their primary care provider, and when they called their
primary care provider, they were told to call their local public health
department. This inconsistency in information from authoritative
sources led to confusion and possibly to high-risk individuals' giving
up and not receiving an influenza vaccination.[Footnote 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.
* 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.[Footnote 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.[Footnote
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.
Concluding Observations:
Aided by a relatively moderate influenza season, efforts to mitigate
the sudden and unexpected shortage of influenza vaccine for the 2004-05
season were largely successful, although the season was not without
problems. Lacking a preseason plan to address a significant shortfall
after the beginning of the traditional fall vaccination period, the
federal government reacted to the shortage and its aftereffects as they
unfolded throughout the season. This lack of preseason planning created
confusion and delays during the optimal fall influenza vaccination
window, when state and local public health agencies and health care
providers most needed vaccine to protect individuals at high risk of
severe complications. Conversely, federal efforts to boost supply late
in the season had little effect, because demand fell off sharply in
December and January, and vaccine became available too late. In some
instances, uncoordinated communication from federal to state and local
jurisdictions, and to providers and the general public, contributed to
confusion, frustration, and individuals' failure to seek or receive an
influenza vaccination. Drawing from experiences during the 2004-05
shortage, CDC has taken a number of steps, including issuing interim
guidelines in August 2005, to assist in responding to possible future
shortages. It is too early, however, to assess the effectiveness of
these efforts in coordinating actions of federal, state, and local
health agencies and others who play a part in the annual influenza
vaccination process.
Agency Comments:
In commenting on a draft of this report, HHS noted that the draft
summarized in detail the activities undertaken by CDC and its public-
and private-sector partners to deal with the influenza vaccine shortage
of 2004-05, and the agency concurred with our finding that contingency
planning will greatly improve response efforts. The agency also
provided details on other actions, such as approval of additional
influenza vaccines for the U.S. market, that were under way. HHS also
agreed that adjustments to vaccination recommendations and vaccine
supply ideally should occur earlier in the influenza season, but such
adjustments cannot always be implemented in a shortage year. HHS's
written comments appear in appendix I.
As arranged with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 30
days after its issue date. At that time, we will send copies of this
report to the Secretary of HHS, the Directors of CDC and the National
Vaccine Program Office, and other interested parties. We will also make
copies available to others upon request. In addition, the report will
be available at no charge on the GAO Web site at http//www.gao.gov.
If you or your staff members have any questions, please contact me at
(202) 512-7119 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last
page of this report. GAO staff members who made major contributions to
this report are listed in appendix II.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Comments from the Department of Health and Human Services:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Office of Inspector General:
Washington, D.C. 20201:
SEP 19 2005:
Ms. Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Ms. Crosse:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO's) draft report entitled, "INFLUENZA
VACCINE: Shortages in 2004-05 Season Underscore Need for Better
Preparation" (GAO-05-984). These comments represent the tentative
position of the Department and are subject to reevaluation when the
final version of this report is received.
The Department provided several technical comments directly to your
staff.
The Department appreciates the opportunity to comment on this draft
report before its publication.
Sincerely,
Signed by:
Daniel R. Levinson:
Inspector General:
Enclosure:
The Office of Inspector General (OIG) is transmitting the Department's
response to this draft report in our capacity as the Department's
designated focal point and coordinator for U.S. Government
Accountability Office reports. OIG has not conducted an independent
assessment of these comments and therefore expresses no opinion on
them.
COMMENTS OF THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES ON THE
U.S. GOVERNMENT ACCOUNTABILITY OFFICE'S DRAFT REPORT ENTITLED,
"INFLUENZA VACCINE: SHORTAGES IN 2004-05 SEASON UNDERSCORE NEED FOR
BETTER PREPARATION" (GAO-05-984):
General Comments:
The Department of Health and Human Services (HHS) appreciates the U.S.
Government Accountability Office's (GAO's) detailed summary of
activities undertaken by the Centers for Disease Control and Prevention
(CDC) and its public and private sector partners in dealing with the
influenza vaccine shortage of 2004. HHS concurs with GAO's finding that
contingency planning for such events achieved in advance will greatly
improve response efforts. As noted in the draft report, CDC has issued
guidelines for State and local public health jurisdictions for any
subsequent influenza vaccine supply disruptions. In addition, CDC has
worked closely with a planning group of public and private sector
partners to develop options for response to another vaccine shortage.
Part of this work has included communicating the recommendations of the
Advisory Committee on Immunization Practices (ACIP) for prioritization
and sub-prioritization, if necessary, of groups who should receive
initial supplies of influenza vaccine in the 2005-06 season. These
recommendations were published in CDC's Morbidity and Mortality Weekly
Report (MMWR) on September 2, 2005.
In the longer term, HHS is encouraged that influenza vaccine supply
will improve as a result of additional vaccine companies such as
GlaxoSmithKline (GSK) selling influenza vaccine in the U.S. GSK's
Fluarix vaccine was licensed on August 31, 2005, and ID Biomedical has
stated that it will submit its influenza vaccine license application
soon. Also, there are additional vaccine factories in the U.S., such as
the one in Pennsylvania purchased by GSK.
HHS also agrees that adjustments in influenza vaccine recommendations
and supply should ideally occur before November; however, such
adjustments cannot always be implemented in a vaccine shortage year.
Indeed, approximately 20 percent of influenza vaccine administered in
2004-05 occurred in December and later, demonstrating that significant
vaccine delivery can occur following later recommendations.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7119 or crossem@gao.gov:
Acknowledgments:
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.
[End of section]
Related GAO Products:
Before 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 late-season, unmet pediatric demand.
Influenza Pandemic: Challenges in Preparedness and Response. GAO-05-
863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.
Washington, D.C.: May 26, 2005.
Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. GAO-
05-177T. Washington, D.C.: November 18, 2004.
Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28,
2004.
Public Health Preparedness: Response Capacity Improving, but Much
Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: February 12,
2004.
Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have
Improved Public Health Response Capacity, but Gaps Remain. GAO-03-654T.
Washington, D.C.: April 9, 2003.
Bioterrorism: Preparedness Varied across State and Local Jurisdictions.
GAO-03-373. Washington, D.C.: April 7, 2003.
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future
Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-
Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.
Flu Pandemic: Plan Needed for Federal and State Response. GAO-01-4.
Washington, D.C.: October 27, 2000.
FOOTNOTES
[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.
[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.
[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).
[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.
[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.
[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).
[10] CDC 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.
[11] 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.
[12] On 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.
[13] FDA 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.
[14] Section 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."
[15] Florida v. ASAP Meds. Inc., No. 04-16032(09) (Fla. Cir. Ct. filed
Oct. 13, 2004) (settlement agreement filed May 19, 2005).
[16] To 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.
[17] The 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.
[18] During 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.
[19] National 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.
[20] The 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.
[21] See 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.
[22] By 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.
[23] In 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.
[24] Before 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.
[25] CDC 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).
[26] See 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.
[27] See 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.
[28] CDC 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.
[29] According 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.
[30] The 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.
[31] CDC 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).
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