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2004.

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Testimony:

Before the Special Committee on Aging: 
U.S. Senate:

United States Government Accountability Office:

GAO:

For Release on Delivery Expected at 10:00 a.m. EDT:

Tuesday, September 28, 2004:

Infectious Disease Preparedness:

Federal Challenges in Responding to Influenza Outbreaks:

Statement of Janet Heinrich:

Director, Health Care--Public Health Issues:

GAO-04-1100T:

GAO Highlights:

Highlights of GAO-04-1100T, a testimony before the Special Committee on 
Aging, U.S. Senate: 

Why GAO Did This Study:

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.

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.

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

To view the full product, including the scope and methodology, click on 
the link above.  For more information, contact Janet Heinrich at (202) 
512-7119.

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.[Footnote 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.[Footnote 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 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,[Footnote 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.

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.

Background:

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.[Footnote 4] It takes about 2 weeks after vaccination for 
antibodies to develop in the body and provide protection against 
influenza virus infection. CDC recommends October through November as 
the best time to get vaccinated because the flu season often starts in 
late November to December and peaks between late December and early 
March. However, if influenza activity peaks late, vaccination in 
December or later can still be beneficial.

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

In a typical year, manufacturers make flu vaccine available before the 
optimal fall season for administering flu vaccine. Currently, two 
manufacturers--one in the United States and one in the United Kingdom-
-produce over 95 percent of the vaccine used in the United 
States.[Footnote 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 private-
sector responsibilities. Like other pharmaceutical products, flu 
vaccine is sold to thousands of purchasers by manufacturers, numerous 
medical supply distributors, and other resellers such as pharmacies. 
These purchasers provide flu vaccinations at physicians' offices, 
public health clinics, nursing homes, and less traditional locations 
such as workplaces and various retail outlets. Most influenza vaccine 
distribution and administration are accomplished within the private 
sector, with relatively small amounts of vaccine purchased and 
distributed by CDC or by state and local health departments.

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

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

Challenges Exist in Ensuring an Adequate and Timely Flu Vaccine Supply:

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

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

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

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

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

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

Our work has also found that there is no mechanism in place to ensure 
distribution of flu vaccine to high-risk individuals before others when 
the vaccine is in short supply. When the supply was not sufficient in 
the fall of 2000, focusing distribution on high-risk individuals was 
difficult because all types of providers served at least some high-risk 
individuals. Some physicians and public health officials were upset 
when their local grocery stores, for example, were offering flu shots 
to everyone when they, the health care providers, were unable to obtain 
vaccine for their high-risk patients. Many physicians reported that 
they felt they did not receive priority for vaccine delivery, even 
though about two-thirds of seniors--one of the largest high-risk 
groups--generally get their flu shots in medical offices.[Footnote 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,[Footnote 7] it undertook several 
initiatives following the 2000-01 flu season. More specifically, CDC 
has taken actions that may encourage manufacturers to supply more 
vaccine because the action could lead to increased or more stable 
demand for flu vaccines. Actions taken by CDC and its advisory 
committee include the following:

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

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

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

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

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

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.[Footnote 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.[Footnote 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 influenza-related research; support public health planning and 
laboratory capacity; and improve health care system readiness at the 
community level. Although most of these activities have not been 
targeted specifically to pandemic planning, according to HHS officials, 
spending in these areas will help prepare for the next influenza 
pandemic. The draft plan also encourages states to allocate funding 
from the CDC Bioterrorism Cooperative Agreement and 2004 Immunization 
Continuation Grants for pandemic preparedness planning.[Footnote 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.

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.

Concluding Observations:

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.

Agency Comments:

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 Acknowledgments:

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

[End of section]

Related GAO Products:

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

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have 
Improved Public Health Response Capacity, but Gaps Remain. GAO-03-654T, 
Washington, D.C.: April 9, 2003.

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

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

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

FOOTNOTES

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

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

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

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

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

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

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

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

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

[10] Under 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.

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