Infectious Disease Preparedness: Federal Challenges in Responding
to Influenza Outbreaks (28-SEP-04, GAO-04-1100T).		 
                                                                 
Influenza is associated with an average of 36,000 deaths and more
than 200,000 hospitalizations each year in the United States.	 
Persons aged 65 and older are involved in more than 9 of 10	 
deaths and 1 of 2 hospitalizations related to influenza. The best
way to prevent influenza is to be vaccinated each fall. In the	 
2000-01 flu season, and again in the 2003-04 flu season, this	 
country experienced periods when the demand for flu vaccine	 
exceeded the supply, and there is concern about the availability 
of vaccines for this and future flu seasons. There is also	 
concern about the prospect of a worldwide influenza epidemic, or 
pandemic, which many experts believe to be inevitable. Three	 
influenza pandemics occurred in the twentieth century. Experts	 
estimate that the next pandemic could kill up to 207,000 people  
in the United States and cause major social disruption. Public	 
health experts have raised concerns about the ability of the	 
nation's public health system to respond to an influenza	 
pandemic. GAO was asked to discuss issues related to supply,	 
demand, and distribution of vaccine for a regular flu season and 
assess the federal plan to respond to an influenza pandemic. GAO 
based this testimony on products it has issued since October	 
2000, as well as work it conducted to update key information.	 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-04-1100T					        
    ACCNO:   A12796						        
  TITLE:     Infectious Disease Preparedness: Federal Challenges in   
Responding to Influenza Outbreaks				 
     DATE:   09/28/2004 
  SUBJECT:   Diseases						 
	     Health care planning				 
	     Health care programs				 
	     Health hazards					 
	     Health statistics					 
	     Immunization programs				 
	     Immunization services				 
	     Infectious diseases				 
	     Medical information systems			 
	     Respiratory diseases				 
	     Strategic planning 				 
	     Health policy					 
	     Preventive health care services			 
	     HHS Pandemic Influenza Preparedness and		 
	     Response Plan					 
                                                                 

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GAO-04-1100T

United States Government Accountability Office

GAO Testimony

Before the Special Committee on Aging,

U.S. Senate

For Release on Delivery

Expected at 10:00 a.m. EDT INFECTIOUS DISEASE

Tuesday, September 28, 2004

PREPAREDNESS

            Federal Challenges in Responding to Influenza Outbreaks

Statement of Janet Heinrich
Director, Health Care-Public Health Issues

GAO-04-1100T

September 28, 2004

INFECTIOUS DISEASE PREPAREDNESS

Federal Challenges in Responding to Influenza Outbreaks

[IMG]

  What GAO Found

Challenges persist in ensuring an adequate and timely flu vaccine supply.
The number of producers remains limited, and the potential for
manufacturing problems such as those experienced in recent years is still
present. If a manufacturer's production is affected, those providers who
ordered vaccine from that manufacturer could experience shortages, while
providers who received supplies from another manufacturer might have all
the vaccine they need. This potential for imbalance is what creates
situations in which some providers might not have enough vaccine for
persons at highest risk, while other providers might have enough supply to
hold mass-immunization clinics even for persons at lower risk for
flu-related complications. To help limit the potential for such
situations, the Centers for Disease Control and Prevention (CDC) and
others have taken such steps as adding flu vaccine to federal stockpiles
and more aggressively monitoring the projected supply of vaccine. However,
there is no system in place to ensure that seniors and others at high risk
for complications receive flu vaccinations first when vaccine is in short
supply.

The Department of Health and Human Services' (HHS) draft "Pandemic
Influenza Preparedness and Response Plan" provides a blueprint for the
government's role but leaves some important decisions about the
government's response unresolved. In addition to describing the federal
role, responsibilities, and actions in collaboration with the states in
responding to an influenza pandemic, the plan also provides planning
guidance to state and local health departments and the health care system.
The draft plan is comprehensive in scope, but it leaves decisions about
the purchase, distribution, and administration of vaccines open for public
comment and for the states to decide individually. In addition, the draft
plan does not make recommendations for how population groups should be
prioritized to receive vaccines in a pandemic. Difficulties encountered
during the annual flu season in the purchase, distribution, and
administration of flu vaccine highlight the importance of resolving these
issues for pandemic preparedness.

Officials from CDC provided technical comments on this testimony that GAO
incorporated as appropriate.

                 United States Government Accountability Office

Mr. Chairman and Members of the Committee:

I am pleased to be here today as you discuss issues regarding the annual
production and distribution of flu vaccine and preparedness for a
worldwide influenza epidemic-known as a pandemic. Each year, influenza
viruses cause outbreaks in the United States and elsewhere in the world.
Influenza is associated with an average of 36,000 deaths and more than
200,000 hospitalizations each year in the United States. Persons aged 65
and older are involved in more than 9 of every 10 deaths and 1 of every 2
hospitalizations related to influenza. The best way to prevent influenza
is to be vaccinated each fall. In the 2000-01 flu season, and again in
last year's flu season, this country experienced periods when the demand
for flu vaccine exceeded the supply, and there is concern about the
availability of vaccines for this and future flu seasons.

There has also been increased concern about the prospect of an influenza
pandemic, which many experts believe to be inevitable. Pandemic influenza,
which arises periodically, but unpredictably, from a major genetic change
in the virus, results in a strain that can cause worldwide disease and
death. Three influenza pandemics occurred in the twentieth century. The
worst occurred in 1918 (Spanish flu)and killed more than 20 million people
worldwide and about 675,000 people in the United States. The pandemics of
1957 (Asian flu) and 1968 (Hong Kong flu) caused fewer fatalities-70,000
and 34,000, respectively, in the United States. Some experts believe that
the next pandemic could be spawned by the recurring avian flu in Asia.1
They estimate that the pandemic could kill up to 207,000 people in the
United States and cause major social disruption. Public health experts
have raised concerns about the ability of the nation's public health
system to detect and respond to emerging infectious disease threats such
as pandemic influenza.2

You have asked us to provide our perspective on flu vaccine availability
and preparedness for this year's flu season and an influenza pandemic. In
this testimony, I will (1) discuss issues related to supply, demand, and

1Department of Health and Human Services, "HHS Orders Avian Flu Vaccine as
Preventive Measure,"
http://www.os.dhhs.gov/news/pres/2004pres/20040921a.html (downloaded Sept.
26, 2004).

2See GAO, SARS Outbreak: Improvements to Public Health Capacity Are Needed
for Responding to Bioterrorism and Emerging Infectious Diseases,
GAO-03-769T (Washington, D.C.: May 7, 2003).

distribution of vaccine for a regular flu season and (2) assess the
federal plan to respond to an influenza pandemic.

My remarks are based on reports and testimony we have issued since October
2000,3 as well as work conducted to update key information. Our prior work
on flu vaccine included interviews with and analysis of information
provided by Department of Health and Human Services (HHS) officials,
vaccine manufacturers, medical distributors and their trade associations,
companies that provide flu shots at retail outlets and work sites,
physician and other professional associations, and other purchasers. We
also surveyed physician group practices and interviewed health department
officials in all 50 states about their experiences in the 2000-01 flu
season. In September 2004 we updated this work with information on the
2003-04 flu season, Centers for Disease Control and Prevention (CDC)
activities, including its responses to our prior recommendations for
prevention and control of influenza, and the status of this year's flu
vaccine. To learn about pandemic planning efforts, we interviewed HHS
officials in the National Vaccine Program Office and reviewed HHS's August
2004 draft "Pandemic Influenza Preparedness and Response Plan." We
conducted all of our work in accordance with generally accepted government
auditing standards.

In summary, challenges persist in ensuring an adequate and timely flu
vaccine supply. The number of producers remains limited, and the potential
for manufacturing problems such as those experienced in recent years is
still present. If a manufacturer's production is affected, those providers
who ordered vaccine from that manufacturer could experience shortages,
while providers who received supplies from another manufacturer might have
all the vaccine they need. This potential for imbalance is what creates
situations in which some providers might not have enough vaccine for
persons at highest risk, while other providers might have enough supply to
hold mass-immunization clinics even for persons at lower risk for
flu-related complications. To help limit the potential for such
situations, CDC and others have taken such steps as adding flu vaccine to
federal stockpiles and more aggressively monitoring the projected supply
of vaccine. However, there is no system in place to ensure that seniors
and others at high risk for complications receive flu vaccinations first
when vaccine is in short supply.

3See "Related Products," at the end of this testimony, for a list of our
earlier work related to flu vaccine and influenza pandemic planning.

Background

HHS's draft "Pandemic Influenza Preparedness and Response Plan" provides a
blueprint for the government's role but leaves some important decisions
about the government's response unresolved. In addition to describing the
federal role, responsibilities, and actions in collaboration with the
states in responding to an influenza pandemic, the plan also provides
planning guidance to state and local health departments and the health
care system. The draft plan is comprehensive in scope, but it leaves
decisions about the purchase, distribution, and administration of vaccines
open for public comment and for the states to decide individually. In
addition, the draft plan does not make recommendations for how population
groups should be prioritized to receive vaccines in a pandemic.
Difficulties encountered during the annual flu season with the purchase,
distribution, and administration of flu vaccine highlight the importance
of resolving these issues for pandemic preparedness.

In almost every year an influenza virus causes acute respiratory disease
in epidemic proportions somewhere in the world. Influenza is more severe
than some of the other viral respiratory infections, such as the common
cold. Most people who get the flu recover completely in 1 to 2 weeks, but
some develop serious and potentially life-threatening medical
complications, such as pneumonia. People who are aged 65 and older, people
of any age with chronic medical conditions, children younger than 2 years,
and pregnant women are more likely to get severe complications from
influenza than other people. Influenza and pneumonia rank as the fifth
leading cause of death among persons aged 65 and older.

For the 2004-05 flu season, CDC is recommending that about 185 million
Americans in these at-risk populations and other target groups receive the
vaccine, which is the primary method for preventing influenza. Flu vaccine
is generally widely available in a variety of settings, ranging from the
usual physicians' offices, clinics, and hospitals to retail outlets such
as drugstores and grocery stores, workplaces, and other convenience
locations. Millions of individuals receive flu vaccinations through mass
immunization campaigns in nonmedical settings, where organizations such as
visiting nurse agencies under contract administer the vaccine.4 It takes

4Data collected by states through the CDC Behavioral Risk Factor
Surveillance System during 2002 indicate that among persons aged 18 years
or older reporting receipt of flu vaccine, about two-thirds reported
getting their last flu vaccination at a health care facility, such as a
doctor's office, health center or health department, while about one-third
reported getting vaccinated at a workplace, community center, store, or
other location.

about 2 weeks after vaccination for antibodies to develop in the body and
provide protection against influenza virus infection. CDC recommends
October through November as the best time to get vaccinated because the
flu season often starts in late November to December and peaks between
late December and early March. However, if influenza activity peaks late,
vaccination in December or later can still be beneficial.

Producing the influenza vaccine is a complex process that involves growing
viruses in millions of fertilized chicken eggs. This process, which
requires several steps, generally takes at least 6 to 8 months from
January through August each year, so vaccine manufacturers must predict
demand and decide on the number of doses to produce well before the onset
of the flu season. Each year's vaccine is made up of three different
strains of influenza viruses, and, typically, each year one or two of the
strains is changed to better protect against the strains that are likely
to be circulating during the coming flu season. The Food and Drug
Administration (FDA) and its advisory committee decide which strains to
include based on CDC surveillance data, and FDA also licenses and
regulates the manufacturers that produce the vaccine.

In a typical year, manufacturers make flu vaccine available before the
optimal fall season for administering flu vaccine. Currently, two
manufacturers-one in the United States and one in the United Kingdom-
produce over 95 percent of the vaccine used in the United States.5
According to CDC officials, for the 2002-03 flu season, manufacturers
produced about 95 million doses of vaccine, of which about 83 million
doses were used and 12 million doses went unused. Production for the
2003-04 flu season was based on the previous year's demand and was about
87 million doses. For the 2004-05 season, CDC estimates that about 100
million doses will be available.

Currently, flu vaccine production and distribution are largely
privatesector responsibilities. Like other pharmaceutical products, flu
vaccine is sold to thousands of purchasers by manufacturers, numerous
medical supply distributors, and other resellers such as pharmacies. These
purchasers provide flu vaccinations at physicians' offices, public health
clinics, nursing homes, and less traditional locations such as workplaces

5A third U.S. manufacturer produces a flu vaccine that is given by nasal
spray and is only approved for healthy persons aged 5 through 49 years.
According to CDC, this manufacturer is likely to supply about 1.5 million
doses in the 2004-05 season.

and various retail outlets. Most influenza vaccine distribution and
administration are accomplished within the private sector, with relatively
small amounts of vaccine purchased and distributed by CDC or by state and
local health departments.

HHS also has a role in planning to prepare for and respond to an influenza
pandemic. Planning is key to being prepared for and mitigating the
negative effects of the next influenza pandemic, including major illness,
death, economic loss, and social disruption. A national pandemic influenza
plan was first developed in 1978 and was revised in 1983. In 1993, efforts
to revise the national plan were initiated, and these efforts picked up
momentum in the late 1990s. In August 2004, HHS released a draft plan for
comment entitled, "Pandemic Influenza Preparedness and Response Plan."

To foster state and local pandemic planning and preparedness, CDC first
issued draft interim planning guidance to states in 1997 and posted
guidance on its Web site for state and local health departments in 2001.
Since that time, states have been preparing pandemic response plans, and
many are integrating these plans with existing state plans to respond to
public health emergencies such as natural disasters and bioterrorist
attacks.

Ensuring an adequate and timely supply of vaccine is a difficult task. It
has become even more difficult because there are few manufacturers.
Problems at one or more manufacturers can significantly upset the
traditional fall delivery of influenza vaccine. These problems, in turn,
can create variability in who has ready access to the vaccine.

Matching flu vaccine supply and demand is a challenge because the
available supply and demand for vaccine can vary from month to month and
year to year. For example,

  Challenges Exist in Ensuring an Adequate and Timely Flu Vaccine Supply

o  	In 2000-01, when a substantial proportion of flu vaccine was
distributed much later than usual due to manufacturing difficulties,
temporary shortages in the prime period for vaccinations were followed by
decreased demand as additional vaccine became available later in the year.
Despite efforts by CDC and others to encourage people to seek flu
vaccinations later in the season, providers still reported a drop in
demand in December. The light flu season in 2000-01, which had relatively
low influenza mortality, probably also contributed to the lack of
interest. As a result of the waning demand that year, manufacturers and
distributors reported having more vaccine than they could sell. In
addition, some physicians'

offices, employee health clinics, and other organizations that
administered flu shots reported having unused doses in December and later.

o  	For the 2003-04 flu season, shortages of vaccine have been attributed
to an earlier than expected and more severe flu season and to higher than
normal demand, likely resulting from media coverage of pediatric deaths
associated with influenza. According to CDC officials, this increased
demand occurred in a year in which manufacturers had produced about the
same number of doses as in the previous season and that supply was not
adequate to meet the demand.

If production problems delay the availability of vaccine in a given year,
the timing for an individual provider to obtain flu vaccine may depend on
which manufacturer's vaccine it ordered. This happened in the 2000-01
season, and it could happen again. This year, one of the two major
manufacturers recently announced a delay in its shipments of vaccine. On
August 26, 2004, one manufacturer announced that release of its flu
vaccine would be delayed because of production problems related to
sterility of a small number of doses at its manufacturing facility. The
company stated that it expected to deliver between 46 million and 48
million doses to the U.S. market beginning in October, and CDC issued a
notice on September 24, 2004, stating that some delays might occur for
customers receiving this manufacturer's vaccine. Those customers may
receive their vaccine later than those who ordered from the other
manufacturer, which reported sending its vaccine on schedule beginning in
August and September. As a result, one provider could hold vaccination
clinics in early October that would be available to anyone who wants a flu
shot, while another provider would not yet have any vaccine for its
highrisk patients.

Shortages of flu vaccine can result in temporary spikes in the price of
vaccine. When vaccine supply is limited relative to public demand for flu
shots, distributors and others who have supplies of the vaccine have the
ability-and the economic incentive-to sell their supplies to the highest
bidders rather than filling lower-priced orders they had already received.
When there was a delay and temporary shortage of vaccine in 2000, those
who purchased vaccine that fall-because their earlier orders had been
cancelled, reduced, or delayed, or because they simply ordered later-
found themselves paying much higher prices. For example, one physician's
practice ordered flu vaccine from a supplier in April 2000 at $2.87 per
dose. When none of that vaccine had arrived by November 1, the practice
placed three smaller orders in November with a different supplier at the
escalating prices of $8.80, $10.80, and $12.80 per dose. On December 1,
the

practice ordered more vaccine from a third supplier at $10.80 per dose.
The four more expensive orders were delivered immediately, before any
vaccine had been received from the original April order.

Our work has also found that there is no mechanism in place to ensure
distribution of flu vaccine to high-risk individuals before others when
the vaccine is in short supply. When the supply was not sufficient in the
fall of 2000, focusing distribution on high-risk individuals was difficult
because all types of providers served at least some high-risk individuals.
Some physicians and public health officials were upset when their local
grocery stores, for example, were offering flu shots to everyone when
they, the health care providers, were unable to obtain vaccine for their
high-risk patients. Many physicians reported that they felt they did not
receive priority for vaccine delivery, even though about two-thirds of
seniors-one of the largest high-risk groups-generally get their flu shots
in medical offices.6 In our follow-up work, we found no indication that
the situation would be different if there was a shortage today.

This raises the question of what more can be done to better prepare for
possible vaccine delays and shortages in the future. Because flu vaccine
production and distribution largely are private-sector responsibilities,
options are somewhat limited. While CDC can recommend and encourage
providers to immunize high-risk patients first, it does not have control
over the distribution of vaccine, other than the small amount that is
distributed through public health departments.

Although HHS has limited authority to directly control flu vaccine
production and distribution,7 it undertook several initiatives following
the 2000-01 flu season. More specifically, CDC has taken actions that may

6Data collected by states through the CDC Behavioral Risk Factor
Surveillance System during 2002 indicated that among persons aged 65 years
or older reporting receipt of influenza vaccine, about 58 percent reported
receiving their last influenza vaccination at physicians' offices and
health maintenance organizations; followed by clinics or health centers
(12 percent); stores (8 percent); community centers (6 percent); health
departments (6 percent); other locations (5 percent); hospitals (4
percent); and workplaces (2 percent). Percentages do not add to 100 due to
rounding.

7Under the Federal Food Drug and Cosmetic Act, FDA ensures compliance with
good manufacturing practice and has limited authority to regulate the
resale of prescription drugs, including influenza vaccine, that have been
purchased by health care entities such as public or private hospitals.
This authority would not extend to resale of the vaccine for emergency
medical reasons. The term health care entity does not include wholesale
distributors. CDC has a role in encouraging appropriate public health
actions.

encourage manufacturers to supply more vaccine because the action could
lead to increased or more stable demand for flu vaccines. Actions taken by
CDC and its advisory committee include the following:

o  	Extending the optimal period for getting a flu vaccination until the
end of November, to encourage more people to get vaccinations later in the
season.

o  	Expanding the target population to include children aged 6 through 23
months and all persons who take care of children aged 0 to 23 months.

o  	Including the flu vaccine in the Vaccines for Children (VFC) stockpile
to help improve flu vaccine supply. For 2004, CDC has contracted for a
stockpile of approximately 4.5 million doses of flu vaccine through its
VFC authority.

o  	Beginning an annual assessment of the projected vaccine supply, and
making a determination if vaccination should proceed for all persons or if
a tiered approach should be used, targeting limited vaccine supplies to
seniors and other high-risk individuals first.

For both last season and the upcoming flu season, CDC announced that it
did not envision any need for a tiered approach. For the 2004-05 flu
season, CDC issued a notice on September 24 recommending that vaccination
proceed for all recommended persons as soon as vaccine is available.

  HHS's Draft Pandemic Influenza Plan Defines Roles and Responsibilities but
  Leaves Some Important Issues Unresolved

HHS's draft pandemic influenza plan describes federal roles and
responsibilities in responding to an influenza pandemic and provides
planning guidance to state and local health departments and the health
care system. Although the draft plan is comprehensive in scope, it leaves
some important decisions about the purchase, distribution, and
administration of vaccines unresolved. In addition, the draft plan does
not make recommendations for how population groups should be prioritized
to receive vaccines in a pandemic. Consequently, states are left to make
their own decisions, potentially compromising the timing and adequacy of a
response to an influenza pandemic.

Draft Plan Defines Roles and Responsibilities

HHS's draft pandemic influenza plan describes HHS's role in coordinating a
national response to an influenza pandemic and provides guidance and tools
to promote pandemic preparedness planning and coordination at federal,
state, and local levels, including both the public and the private
sectors. Pandemic influenza response activities are outlined by the
different phases of a pandemic.8 The draft plan also provides technical
background information on preparedness and response activities such as
vaccine development and production.

The draft plan acknowledges that states and local areas have important
roles in the national response to a pandemic. To facilitate the state and
local response, the draft plan provides guidance for state and local
health departments and the health care system. The draft plan states that
planning for an influenza pandemic will build on HHS-supported efforts to
prepare for other public health emergencies such as infectious disease
outbreaks, bioterrorist events, or natural disasters, and provides
important guidance on areas specific to an influenza pandemic, including
disease surveillance, delivery of vaccine and other medications, and
communication. According to the Council of State and Territorial
Epidemiologists, currently 11 states have pandemic influenza plans. Six of
these states have final plans, and five states have draft plans.9

According to the draft plan, federal agencies are taking steps to ensure
and expand influenza vaccine production capacity; increase influenza
vaccination use; stockpile influenza medications; enhance U.S. and global
disease detection and surveillance infrastructures; expand
influenzarelated research; support public health planning and laboratory
capacity; and improve health care system readiness at the community level.
Although most of these activities have not been targeted specifically to
pandemic planning, according to HHS officials, spending in these areas
will help prepare for the next influenza pandemic. The draft plan also
encourages states to allocate funding from the CDC Bioterrorism

8HHS describes five phases of a pandemic. In phase 1, there is an outbreak
in one country, confirmation of efficient person-to-person transmission,
and serious morbidity and mortality. In phase 2, there are regional
outbreaks with global disease spread. Phase 3 is the end of the first
pandemic wave; phase 4 refers to a second seasonal wave. In phase 5, the
pandemic ends as population immunity has increased.

9California, Florida, Indiana, Maryland, Minnesota, and New Jersey have
final plans, and Massachusetts, New Hampshire, South Carolina, Tennessee,
and Texas have draft plans.

Cooperative Agreement and 2004 Immunization Continuation Grants for
pandemic preparedness planning.10

Draft Plan Leaves Many Important Issues Unresolved, Making It Difficult
for States to Plan

Although HHS's draft pandemic influenza plan is comprehensive in scope, it
leaves many important decisions about the purchase, distribution, and
administration of vaccines unresolved. These decisions include determining
the public-versus the private-sector roles in the purchase and
distribution of vaccines; the division of responsibility between the
federal government and the states for vaccine distribution; and how
population groups will be prioritized and targeted to receive limited
supplies of vaccines. As we have stated previously, until these key
decisions are made, states will find it difficult to plan, and the
timeliness and adequacy of response efforts may be compromised.

The draft plan does not establish a definitive federal role in the
purchasing and distribution of vaccine. Instead, HHS provides options for
vaccine purchase and distribution that include public-sector purchase and
distribution of all pandemic influenza vaccine; a mixed public-private
system where public-sector supply may be targeted to specific priority
groups; and maintenance of the current largely private system. Currently,
approximately 85 percent of the influenza vaccine produced for annual
outbreaks is purchased by the private sector, and a majority of the annual
vaccinations are also delivered by the private sector. HHS states in the
draft plan that such a distribution method may not be optimal in a
pandemic.

Furthermore, the draft plan delegates to the states responsibility for
distribution of vaccine. The lack of a clearly defined federal role in
distribution complicates pandemic planning for the states. Among the
current state pandemic influenza plans, there is no consistency in terms
of their procurement and distribution of vaccine and the relative role of
the federal government. States also approach annual vaccine procurement
and distribution differently. Approximately half the states handle
procurement and distribution of the influenza vaccine through the state
health agency. The remainder either operate through a third-party
contractor for distribution to providers or use a combination of these two
approaches.

10Under the CDC's Public Health Preparedness and Response for Bioterrorism
Program, all 50 states, the District of Columbia, the country's largest
municipalities, and territories receive funding to complete specific
activities designed to build public health and health care capacities.

Concluding Observations

Agency Comments

In 2003 we reported that state officials were concerned that there were no
national recommendations for how population groups should be prioritized
to receive vaccines. Identifying priority populations from among high-risk
groups and essential health care and emergency personnel is likely to be a
controversial issue. The draft plan does not identify priority groups, but
HHS indicates that it has separately developed an initial list of
suggested priority groups and is soliciting public comment on this list.
The draft pandemic plan instructs the states to prioritize the persons
receiving the initial doses of vaccine and indicates that as information
about the severity of the virus becomes available, recommendations will be
formulated at the national level. Prioritization will be an iterative
process and will be tied to vaccine availability and the progression of
the pandemic. While recognizing that this is an iterative process, state
officials have consistently told us that a lack of detailed guidance makes
it difficult for states to plan for the use of limited supplies of
vaccine.

Ensuring an adequate and timely supply of vaccine to protect seniors and
others from influenza and flu-related complications continues to be
challenging. Only two manufacturers currently produce flu vaccine for
seniors and others at high risk for flu-related complications, and
manufacturing problems experienced in recent years illustrate the
fragility of the current methods of production. Despite efforts by CDC and
others, there remains no system to ensure that persons at high risk for
complications receive flu vaccine first when vaccine is in short supply.

These influenza vaccine supply and distribution problems may become
especially acute in a pandemic. We acknowledge the need for flexibility in
planning because many aspects of an influenza pandemic cannot be known in
advance. However, the absence of more detail in HHS's draft plan creates
uncertainty for the states regarding how to plan for the use of limited
supplies of vaccine. Until decisions are made about vaccine purchase,
distribution, and administration, and priority populations are designated,
states will not be able to develop strategies consistent with federal
priorities.

Officials from CDC provided technical comments that we incorporated as
appropriate.

Mr. Chairman, this concludes my statement. I would be happy to answer any
questions you or other Members of the Committee may have.

Contact and Staff For further information about this testimony, please
contact Janet Heinrich at (202) 512-7119. Gigi Barsoum, Anne Dievler,
Martin Gahart,Acknowledgments Jennifer Major, Roseanne Price, and Kim
Yamane also made key contributions to this statement.

Related GAO Products

SARS Outbreak: Improvements to Public Health Capacity Are Needed for
Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03769T,
Washington, D.C.: May 7, 2003.

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have
Improved Public Health Response Capacity, but Gaps Remain. GAO-03654T,
Washington, D.C.: April 9, 2003.

Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future
Shortages. GAO-01-786T, Washington, D.C.: May 30, 2001.

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

Influenza Pandemic: Plan Needed for Federal and State Response. GAO-01-4,
Washington, D.C.: October 27, 2000.

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