Infectious Disease Preparedness
Federal Challenges in Responding to Influenza Outbreaks Gao ID: GAO-04-1100T September 28, 2004Influenza 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.
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.
GAO-04-1100T, Infectious Disease Preparedness: Federal Challenges in Responding to Influenza Outbreaks
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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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