Influenza Pandemic
Challenges in Preparedness and Response Gao ID: GAO-05-863T June 30, 2005Shortages of influenza vaccine in the 2004-05 and previous influenza seasons and mounting concern about recent avian influenza activity in Asia have raised concern about the nation's preparedness to deal with a worldwide influenza epidemic, or influenza pandemic. Although the extent of such a pandemic cannot be predicted, according to the Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), it has been estimated that in the absence of any control measures such as vaccination or antiviral drugs, a "medium-level" influenza pandemic could kill up to 207,000 people in the United States, affect from 15 to 35 percent of the U.S. population, and generate associated costs ranging from $71 billion to $167 billion in the United States. GAO was asked to discuss the challenges the nation faces in responding to the threat of an influenza pandemic, including the lessons learned from previous annual influenza seasons that can be applied to its preparedness and overall ability to respond to a pandemic. This testimony is based on GAO reports and testimony issued since 2000 on influenza vaccine supply, pandemic planning, emergency preparedness, and emerging infectious diseases and on current work examining the influenza vaccine shortage in the United States for the 2004-05 influenza season.
The nation faces multiple challenges to prepare for and respond to an influenza pandemic. First, key questions about the federal role in purchasing and distributing vaccines during a pandemic remain, and clear guidance on potential priority groups is lacking in HHS's current draft of its pandemic preparedness plan. For example, the draft plan does not establish the actions the federal government would take to purchase or distribute vaccine during an influenza pandemic. In addition, as was highlighted in the nation's recent experience responding to the unexpected influenza vaccine shortage for the 2004-05 influenza season, clear communication of the nation's response plan will be a major challenge. During the 2004-05 influenza season, state health officials reported that mixed messages created confusion. For example, CDC advised vaccination for persons aged 65 and older, and at the same time a state advised vaccination for persons aged 50 and older. Further challenges include ensuring an adequate and timely supply of influenza vaccine and antiviral drugs, which can help prevent or mitigate the number of influenza-related deaths. Particularly given the length of time needed to produce vaccines, influenza vaccine may be unavailable or in short supply and might not be widely available during the initial states of a pandemic. Finally, the lack of sufficient hospital and health care workforce capacity to respond to an infectious disease outbreak may also affect response efforts during an influenza pandemic. Public health officials we spoke with said that a large-scale outbreak, such as an influenza pandemic, could strain the available capacity of hospitals by requiring entire hospital sections, along with their staff, to be used as isolation facilities.
GAO-05-863T, Influenza Pandemic: Challenges in Preparedness and Response
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Testimony:
Before the Committee on Government Reform, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 10:00 a.m. EDT:
Thursday, June 30, 2005:
Influenza Pandemic:
Challenges in Preparedness and Response:
Statement of Marcia Crosse:
Director, Health Care:
GAO-05-863T:
GAO Highlights:
Highlights of GAO-05-863T, a testimony before the Committee on
Government Reform, House of Representatives:
Why GAO Did This Study:
Shortages of influenza vaccine in the 2004–05 and previous influenza
seasons and mounting concern about recent avian influenza activity in
Asia have raised concern about the nation‘s preparedness to deal with a
worldwide influenza epidemic, or influenza pandemic. Although the
extent of such a pandemic cannot be predicted, according to the Centers
for Disease Control and Prevention (CDC), an agency within the
Department of Health and Human Services (HHS), it has been estimated
that in the absence of any control measures such as vaccination or
antiviral drugs, a ’medium-level“ influenza pandemic could kill up to
207,000 people in the United States, affect from 15 to 35 percent of
the U.S. population, and generate associated costs ranging from $71
billion to $167 billion in the United States.
GAO was asked to discuss the challenges the nation faces in responding
to the threat of an influenza pandemic, including the lessons learned
from previous annual influenza seasons that can be applied to its
preparedness and overall ability to respond to a pandemic. This
testimony is based on GAO reports and testimony issued since 2000 on
influenza vaccine supply, pandemic planning, emergency preparedness,
and emerging infectious diseases and on current work examining the
influenza vaccine shortage in the United States for the 2004–05
influenza season.
What GAO Found:
The nation faces multiple challenges to prepare for and respond to an
influenza pandemic. First, key questions about the federal role in
purchasing and distributing vaccines during a pandemic remain, and
clear guidance on potential priority groups is lacking in HHS‘s current
draft of its pandemic preparedness plan. For example, the draft plan
does not establish the actions the federal government would take to
purchase or distribute vaccine during an influenza pandemic. In
addition, as was highlighted in the nation‘s recent experience
responding to the unexpected influenza vaccine shortage for the 2004–05
influenza season, clear communication of the nation‘s response plan
will be a major challenge. During the 2004–05 influenza season, state
health officials reported that mixed messages created confusion. For
example, CDC advised vaccination for persons aged 65 and older, and at
the same time a state advised vaccination for persons aged 50 and
older. Further challenges include ensuring an adequate and timely
supply of influenza vaccine and antiviral drugs, which can help prevent
or mitigate the number of influenza-related deaths. Particularly given
the length of time needed to produce vaccines, influenza vaccine may be
unavailable or in short supply and might not be widely available during
the initial states of a pandemic. Finally, the lack of sufficient
hospital and health care workforce capacity to respond to an infectious
disease outbreak may also affect response efforts during an influenza
pandemic. Public health officials we spoke with said that a large-scale
outbreak, such as an influenza pandemic, could strain the available
capacity of hospitals by requiring entire hospital sections, along with
their staff, to be used as isolation facilities.
www.gao.gov/cgi-bin/getrpt?GAO-05-863T.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119.
[End of section]
Mr. Chairman and Members of the Committee:
I am pleased to be here today as you discuss the nation's preparedness
to respond to a worldwide influenza epidemic--known as a
pandemic.[Footnote 1] Shortages of influenza vaccine in the 2004-05 and
previous annual influenza seasons, as well as mounting concern about
recent avian influenza activity in Asia, have raised concern about the
nation's preparedness to deal with a pandemic. Pandemic influenza,
which arises periodically but unpredictably from a major genetic change
in the influenza virus, can lead to worldwide disease and
death.[Footnote 2] Although the extent of the next pandemic cannot be
predicted, modeling studies suggest that its effect in the United
States could be severe. According to the Centers for Disease Control
and Prevention (CDC), it has been estimated that in the absence of any
control measures such as vaccination and drugs, a "medium-level"
influenza pandemic in the United States could kill 89,000 to 207,000
people, affect from 15 to 35 percent of the U.S. population, and
generate associated costs ranging from $71 billion to $167 billion. In
the event of a pandemic, the nation will likely experience a vaccine
shortage. The nation's experience responding to the unexpected shortage
of annual influenza vaccine during the 2004-05 influenza season--in
which public health officials sought to match available vaccine supply
with demand--underscores the challenges that federal, state, and local
entities would need to meet in the event of a pandemic. In addition,
our recent work has highlighted other challenges in responding to
pandemic influenza.
You asked us to provide our perspective on the nation's preparedness
for responding to an influenza pandemic, including the lessons learned
from previous annual influenza seasons that would be applicable to
pandemic preparedness. In this testimony, I will discuss challenges we
identified related to (1) planning for the purchase and distribution of
influenza vaccine, including defining priority groups to be vaccinated;
(2) communicating information about the situation and the response plan
clearly and effectively among health officials, providers, and the
public; (3) ensuring an adequate supply of vaccine and antiviral drugs;
and (4) addressing hospital and workforce capacity to respond to large-
scale outbreaks of infectious disease, including pandemic influenza.
My testimony today is based on reports and testimony on influenza
vaccine supply, pandemic planning, emergency preparedness, and emerging
infectious diseases that we have issued since October 2000[Footnote 3]
and on a review in progress for this committee on actions taken and
lessons learned at federal, state, and local levels to ensure that high-
risk individuals had access to vaccine during the 2004-05 influenza
vaccine shortage. Our prior work includes analysis of information
provided by and interviews with officials in the Department of Health
and Human Services (HHS), specifically from CDC, the Food and Drug
Administration (FDA), and the National Vaccine Program Office. We also
interviewed public health department officials, vaccine manufacturers,
and vaccine distributors; surveyed physician group practices; and
reviewed HHS's August 2004 draft Pandemic Influenza Preparedness and
Response Plan. Since March 2005 we have reviewed documents and
interviewed officials from HHS, CDC, and the National Vaccine Program
Office; national organizations, including the Association of State and
Territorial Health Officials; organizations that conduct mass
immunization clinics; a major vaccine manufacturer; and a large
purchaser of influenza vaccine. We also conducted site visits at a
judgmental sample of states and localities.[Footnote 4] We conducted
our work in accordance with generally accepted government auditing
standards. CDC and the National Vaccine Program Office provided
comments on the facts contained in this statement, and we made changes
as appropriate.
In summary, the nation faces multiple challenges to prepare for and
respond to an influenza pandemic. First, key questions remain about the
federal role in purchasing and distributing vaccines during a pandemic,
and clear guidance on potential priority groups is lacking in HHS's
current draft of its pandemic preparedness plan. In addition, as
highlighted by the nation's recent experience responding to the
unexpected influenza vaccine shortage for the 2004-05 influenza season,
clear communication of the nation's response plan will be a major
challenge. Further challenges include ensuring an adequate and timely
supply of influenza vaccine and antiviral drugs, which can help prevent
or mitigate the number of influenza-related deaths. Finally, the lack
of sufficient hospital and health care workforce capacity to respond to
an infectious disease outbreak may also affect response efforts during
an influenza pandemic.
Background:
Influenza is more severe than some other viral respiratory infections,
such as the common cold. Most people who contract influenza recover
completely in 1 to 2 weeks, but some develop serious and potentially
life-threatening medical complications, such as pneumonia. People aged
65 and older, people of any age with chronic medical conditions,
children younger than 2 years, and pregnant women are generally more
likely than others to develop severe complications from influenza.
Vaccination is the primary method for preventing influenza and its more
severe complications. Produced in a complex process that involves
growing viruses in millions of fertilized chicken eggs, influenza
vaccine is administered annually to provide protection against
particular influenza strains expected to be prevalent that year.
Experience has shown that vaccine production generally takes 6 or more
months after a virus strain has been identified; vaccines for certain
influenza strains have been difficult to mass-produce. After
vaccination, it takes about 2 weeks for the body to produce the
antibodies that protect against infection. According to CDC
recommendations, the optimal time for vaccination is October through
November, because the annual influenza season typically does not peak
until January or February. Thus, in most years vaccination in December
or later can still be beneficial.
At present, two vaccine types are recommended for protection against
influenza in the United States: an inactivated virus vaccine injected
into muscle and a live virus vaccine administered as a nasal spray. The
injectable vaccine--which represents the large majority of influenza
vaccine administered in this country--can be used to immunize healthy
individuals and those at highest risk for complications, including
those with chronic illness and those aged 65 and older, but the nasal
spray vaccine is currently approved for use only among healthy
individuals aged 5 to 49 years who are not pregnant. Vaccine
manufacture and purchase take place largely within the private sector:
for the 2004-05 influenza season, two companies (one producing the
injectable vaccine and one producing the nasal spray) manufactured
vaccine for the U.S. market.[Footnote 5]
Although vaccination is the primary strategy for protecting individuals
who are at greatest risk of serious complications and death from
influenza, antiviral drugs can also contribute to the treatment and
prevention of influenza. Four antiviral drugs have been approved for
treatment. If taken within 2 days after symptoms begin, these drugs can
reduce symptoms and make someone with influenza less contagious to
others. Three of the four antiviral drugs are also approved for
prevention; according to CDC, they are about 70 to 90 percent effective
for preventing illness in healthy adults.
HHS has primary responsibility for coordinating the nation's response
to public health emergencies. As part of its mission, the department
has a role in the planning needed to prepare for and respond to an
influenza pandemic. One action the department has taken is to develop a
draft national pandemic influenza plan, titled Pandemic Influenza
Preparedness and Response Plan, which was released in August 2004 for a
60-day comment period. Within HHS, CDC is the principal agency for
protecting the nation's health and safety. CDC's activities include
efforts to prevent and control diseases and to respond to public health
emergencies. CDC and its Advisory Committee on Immunization Practices
(ACIP) recommend which population groups should be targeted for
vaccination each year and, when vaccine supply allows, recommends that
any person who wishes to decrease his or her risk of influenza-like
illness be vaccinated. FDA, another HHS agency, also plays a role in
preparing for the annual influenza season and for a potential pandemic.
FDA is responsible for ensuring that new vaccines and drugs are safe
and effective. The agency also regulates and licenses vaccines and
antiviral agents.[Footnote 6]
HHS has limited authority to control vaccine production and
distribution directly; influenza vaccine supply and marketing are
largely in the hands of the private sector.[Footnote 7] Although the
Public Health Service Act authorizes the Secretary of HHS to "take such
action as may be appropriate" to respond to a public health emergency,
as determined and declared by the Secretary, it is not clear whether or
to what extent the Secretary could directly influence the manufacture
or distribution of influenza vaccine to respond to an influenza
pandemic.[Footnote 8] The appropriateness of the Secretary's response
would depend on the nature of the public health emergency, for example
on the available evidence relating to a pandemic. According to a senior
HHS official involved in HHS emergency preparedness activities,
manufacturers of vaccine for the U.S. market have agreed in principle
to switch to production of pandemic influenza vaccine should the need
arise and proper compensation and indemnification be provided;
therefore, he said, it would probably be unnecessary for the federal
government to nationalize vaccine production, although the federal
government has the legal authority to do so if circumstances warrant
it.
For the 2004-05 influenza season, CDC estimated as late as September
2004 that about 100 million doses of vaccine would be available for the
U.S. market.[Footnote 9] CDC and ACIP recommended vaccination for about
185 million people, including roughly 85 million people at high risk
for complications.[Footnote 10] On October 5, 2004, however, one
manufacturer announced that it could not provide its expected
production of 46-48 million doses--roughly half of the U.S. supply of
expected vaccine.[Footnote 11] Because a large proportion of vaccine
produced by the other major manufacturer of injectable vaccine had
already been shipped before October 5, 2004, about 25 million doses of
injectable vaccine for high-risk individuals and others, and about 1
million doses of the nasal spray vaccine for healthy people, were
available after the announcement to be distributed to Americans who
wanted an influenza vaccination.
Preparing for and responding to an influenza pandemic differ in several
respects from preparing for and responding to a typical influenza
season. For example, past influenza pandemics have affected healthy
young adults who are not typically at high risk for complications
associated with influenza, and a pandemic could result in an
overwhelming burden of ill persons requiring hospitalization or
outpatient medical care. In addition, the demand for vaccine may be
greater in a pandemic.
Planning for Purchase and Distribution of Vaccine and Defining Priority
Groups:
Challenges remain in planning for purchase and distribution of vaccine
and defining priority groups in the event of a pandemic. HHS has not
finalized planning for an influenza pandemic, leaving unanswered
questions about the nation's ability to prepare for and respond to such
an outbreak. For the past 5 years, we have been urging HHS to complete
its pandemic influenza plan. The document remains in draft form,
although federal officials said in June 2005 that an update of the plan
is being completed and is expected to be available in summer 2005. Key
questions about the federal role in purchasing and distributing
vaccines during a pandemic remain, and clear guidance on potential
groups that would likely have priority for vaccination is lacking in
the current draft plan.
One challenge is that the draft pandemic plan does not establish the
actions the federal government would take to purchase or distribute
vaccine during an influenza pandemic. Rather, it describes options for
vaccine purchase and distribution, which include public-sector purchase
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. The draft plan does
not specifically recommend any of these options. According to the draft
plan, the federal government's role may change over the course of a
pandemic, with greater federal involvement early, when vaccine is in
short supply. Noting that several uncertainties make planning
vaccination strategies difficult, the draft plan states that national,
state, and local planning needs to address possible contingencies, so
that appropriate strategies are in place for whichever situation
arises.
If public-sector vaccine purchase is an option, establishing the
funding sources, authority, or processes to do so quickly may be
needed. During the 2004-05 shortage, some state health officials
reported problems with states' ability, with regard to both funding and
the administrative process, to purchase influenza vaccine. For example,
during the effort to redistribute vaccine to locations of greatest
need, the state of Minnesota tried to sell its available vaccine to
other states seeking additional vaccine for their high-risk
populations. According to federal and state health officials, however,
certain states lacked the funding or authority under state law to
purchase the vaccine when Minnesota offered it. In response to problems
encountered during the 2004-05 shortage, the Association of
Immunization Managers proposed in 2005 that federal funds be set aside
for emergency purchase of vaccine by public health agencies and that
cost not be a barrier in acquiring vaccine to distribute to the
public.[Footnote 12]
Although an influenza pandemic may differ from an annual influenza
season, experience during the 2004-05 shortage illustrates the
importance of having a distribution plan in place ahead of time to
prevent delays when timing is critical:
* Collaborating with stakeholders to create a workable distribution
plan is time consuming. After the October 5, 2004, announcement of the
sharp reduction in influenza vaccine supply, CDC began working with the
sole remaining manufacturer of injectable vaccine on plans to
distribute this manufacturer's remaining supply to providers across the
country. The plan had two phases and benefited from voluntary
compliance by the manufacturer to share proprietary information to help
identify geographic areas of greatest need for vaccine. The first
phase, which began in October 2004, filled or partially filled orders
from certain provider types, including state and local public health
departments and long-term care facilities. The second phase, which
began in November 2004, used a formula to apportion the remaining doses
across the states according to each state's estimated percentage of the
national unmet need. States could then allocate doses from their
apportionment to providers and facilities, which would purchase the
vaccine through a participating distributor. The state ordering process
under the second phase continued through mid-January. Health officials
in several states commented on the late availability of this vaccine;
officials in one state, for example, remarked that the phase two
vaccine was "too much, too late."
* Identifying priority groups in local populations also takes time.
Federal, state, and local officials need to have information on the
population of the priority groups and the locations where they can be
vaccinated to know how, where, and to whom to distribute vaccine in the
event of an influenza pandemic. During the 2004-05 influenza season,
federal officials developed a distribution plan to allocate a limited
amount of vaccine, but the states also had to determine how much
vaccine was needed and where to distribute it within their own borders.
For example, state health officials in Florida did not know exactly how
many high-risk individuals needed vaccination, so they surveyed long-
term care facilities and private providers to estimate the amount of
vaccine needed to cover high-risk populations. It took nearly a month
for state officials to compile the results of the surveys, to decide
how many doses needed to be distributed to local areas, and to receive
and ship vaccine to the counties.
* Distributing the vaccine to a state or locality is not the same as
administering the vaccine to an individual. Once vaccine has been
distributed to a state or local agency, individuals living in those
areas still need to be vaccinated. Vaccinating a large number of people
is challenging, particularly when demand exceeds available supply. For
example, during the 2004-05 influenza season, many places giving
vaccinations right after the shortage was announced were overwhelmed
with individuals wanting to be vaccinated. Certain local public health
departments in California, including the Santa Clara County Public
Health Department, provided chairs and extra water for people waiting
in long lines outdoors in warm weather. Fear of a more virulent
pandemic influenza strain could exacerbate such scenarios. A number of
states reported that they did not have the capacity to immunize large
numbers of people and partnered with other organizations to increase
their capacity. For example, in 2004-05, according to state health
officials in Florida, county health departments, including those in
Orange and Broward Counties, worked with a national home health
organization to immunize high-risk individuals by holding mass
immunization clinics and setting up clinics in providers' offices to
help administer available vaccine quickly. Other locations, including
the local health department in Portland, Maine, held lotteries for
available vaccine; according to local health officials, however,
administrative time was required to arrange and publicize the lottery.
HHS's draft pandemic plan does not define priority groups for
vaccination, although the plan states that HHS is developing an initial
list of suggested priority groups and soliciting public comment on the
list. The draft plan instructs the states to define priority groups for
early vaccination and indicates that as information about virus
severity becomes available, recommendations will be formulated at the
national level. According to the plan, setting priorities will be
iterative, tied to vaccine availability and the pandemic's progression.
Without agreed-upon identification of potential priority groups in
advance, however, problems can arise. During the 2004-05 season, for
example, CDC and ACIP acted quickly on October 5, 2004, to narrow the
priority groups for available vaccine, giving the narrowed groups equal
importance.[Footnote 13] In some places, however, there was not enough
available vaccine to cover everyone in these narrowed priority groups,
so states set their own priorities among these groups. Maine, for
example, excluded health care workers from the state's early priority
groups because state officials estimated that there was not enough
vaccine to cover everyone in CDC and ACIP's priority groups.
Communicating Information about the Situation and Response Plan Clearly
and Effectively:
Another challenge in responding to a pandemic will be to clearly
communicate information about the situation and the nation's response
plans to public health officials, providers, and the public. Experience
during the 2004-05 vaccine shortage illustrates the critical role
communication plays when information about vaccine supply is
unclear.[Footnote 14]
* Communicating a consistent message and clearly explaining any
apparent inconsistencies. In a pandemic, clear communication on who
should be vaccinated will be important, particularly if the priority
population differs from those targeted for annual influenza
vaccination, or if the priority groups in one area of the country
differ from those in others. During the 2004-05 influenza season,
health officials in Minnesota reported that some confusion resulted
when the state determined that vaccine was sufficient to meet demand
among the state's narrower priority groups and made vaccine available
to other groups, such as healthy individuals aged 50-64 years, earlier
than recommended by CDC. Health officials in California reported a
similar situation. State health officials pointed out that in mid-
December, local radio stations in California were running two public
service announcements--one from CDC advising those 65 and older to be
vaccinated and one from the California Department of Health Services
advising those 50 and older to be vaccinated. State officials
emphasized that these mixed messages created confusion.
* Communicating information from a primary source. Having a primary and
timely source of information will be important in a pandemic. In the
2004-05 influenza season, individuals seeking vaccine could have found
themselves in a communication loop that provided no answers. For
example, CDC advised people seeking influenza vaccine to contact their
local public health department; in some cases however, individuals
calling the local public health department would be told to call their
primary care provider, and when they called their primary care
provider, they would be told to call their local public health
department. This lack of a reliable source of information led to
confusion and possibly to high-risk individuals' giving up and not
receiving the protection of an annual influenza vaccination.[Footnote
15]
* Recognizing that different communication mechanisms are important and
require resources. Another challenge in communicating plans in the
event of a pandemic will be to ensure that the communication mechanisms
used reach all affected populations. During the 2004-05 influenza
season, public health officials reported the importance of different
methods of communication. For example, officials from the Seattle-King
County Public Health Department in Washington State reported that it
was important to have a hotline as well as information posted on a Web
site, because some seniors calling Seattle-King County's hotline
reported that they did not have access to the Internet. According to
state and local health officials, however, maintaining these
communication mechanisms took time and strained personnel resources. In
Minnesota, for example, to supplement state employees, the state health
department asked public health nursing students to volunteer to staff
the state's influenza vaccine hotline.
* Educating health care providers and the public about all available
vaccines. For the 2004-05 season, approximately 3 million doses of
nasal spray vaccine were ultimately available for vaccinating healthy
individuals aged 5-49 years who were not pregnant, including some
individuals (such as health care workers in this age group and
household contacts of children younger than 6 months) in the priority
groups defined by CDC and ACIP, yet some of these individuals were
reluctant to use this vaccine because they feared that the live virus
in the nasal spray could be transmitted to others. State health
officials in Maine, for example, reported that the state purchased
about 1,500 doses of the nasal spray vaccine for their emergency
medical service personnel and health care workers, yet administered
only 500 doses.
Ensuring Supply of Influenza Vaccine and Antiviral Drugs:
Challenges in ensuring an adequate and timely supply of influenza
vaccine and antiviral drugs--which can help prevent or mitigate the
number of influenza-related deaths until an pandemic influenza vaccine
becomes available--may be exacerbated during an influenza pandemic.
Particularly given the time needed to produce vaccines, influenza
vaccine may be unavailable or in short supply and may not be widely
available during the initial stages of a pandemic. According to CDC,
maintaining an abundant annual influenza vaccine supply is critically
important for protecting the public's health and improving our
preparedness for an influenza pandemic. The shortages of influenza
vaccine in 2004-05 and previous seasons have highlighted the fragility
of the influenza vaccine market and the need for its expansion and
stabilization.
In its budget request for fiscal year 2006, CDC reports that it plans
to take steps to ensure an expanded influenza vaccine supply. The
agency's fiscal year 2006 budget request includes $30 million for CDC
to enter into guaranteed-purchase contracts with vaccine manufacturers
to ensure the production of bulk monovalent influenza vaccine. If
supplies fall short, this bulk product can be turned into a finished
trivalent influenza vaccine product for annual distribution.[Footnote
16] If supplies are sufficient, the bulk vaccine can be held until the
following year's influenza season and developed into finished vaccines
if the bulk products maintain their potency and the circulating strains
remain the same. According to CDC, this guarantee will help expand the
influenza market by providing an incentive to manufacturers to expand
capacity and possibly encourage additional manufacturers to enter the
market. In addition, CDC's fiscal year 2006 budget request includes an
increase of $20 million to support influenza vaccine purchase
activities.[Footnote 17]
In the event of a pandemic, before a vaccine is available or during a
period of limited vaccine supply, use of antiviral drugs could have a
significant effect. Antiviral drugs can be used against all strains of
pandemic influenza and, because they can be manufactured and stored
before they are needed, could be available both to prevent illness and,
if administered within 48 hours after symptoms begin, to treat it. Like
vaccine, antiviral drugs take several months to produce from raw
materials, and according to one antiviral drug manufacturer, the lead
time needed to scale up production capacity and build stockpiles may
make it difficult to meet any large-scale, unanticipated demand
immediately. HHS' National Vaccine Program Office also reported that in
a pandemic, the manufacturing capacity and supply of antiviral drugs is
likely to be less than the global demand. For these reasons, the
National Vaccine Program Office reported that analysis is under way to
determine optimal strategies for antiviral drug use when supplies are
suboptimal; the office also noted that antiviral drugs have been
included in the national stockpile. HHS has purchased more than 7
million doses of antiviral drugs for the national stockpile.
Nevertheless, this stockpile is limited, and it is unclear how much
will be available in the event of a pandemic, given existing production
capacity. Moreover, some influenza virus strains can become resistant
to one or more of the four approved influenza antiviral drugs, and thus
the drugs may not always work. For example, the avian influenza virus
strain (H5N1) identified in human patients in Asia in 2004 and 2005 has
been resistant to two of four existing antiviral drugs.
Hospital and Workforce Capacity to Respond to Large-Scale Infectious
Disease Outbreaks:
The lack of sufficient hospital and workforce capacity is another
challenge that may affect response efforts during an influenza
pandemic. The lack of sufficient capacity could be more severe during
an influenza pandemic compared with other natural disasters, such as a
tornado or hurricane, or with an intentional release of a bioterrorist
agent because it is likely that a pandemic would result in widespread
and sustained effects. Public health officials we spoke with said that
a large-scale outbreak, such as an influenza pandemic, could strain the
available capacity of hospitals by requiring entire hospital sections,
along with their staff, to be used as isolation facilities. In
addition, most states lack surge capacity--the ability to respond to
the large influx of patients that occurs during a public health
emergency. For example, few states reported having the capacity to
evaluate, diagnose, and treat 500 or more patients involved in a single
incident. In addition, few states reported having the capacity to
rapidly establish clinics to immunize or treat large numbers of
patients. Moreover, shortages in the health care workforce could occur
during an influenza pandemic because higher disease rates could result
in high rates of absenteeism among workers who are likely to be at
increased risk of exposure and illness or who may need to care for ill
family members.
Concluding Observations:
Important challenges remain in the nation's preparedness and response
should an influenza pandemic occur in the United States. As we learned
in the 2004-05 influenza season, when vaccine supply, relative to
demand, is limited, planning and effective communication are critical
to ensure timely delivery of vaccine to those who need it. HHS's
current draft plan lacks some key information for planning our nation's
response to a pandemic. It is important for the federal government and
the states to work through critical issues--such as how vaccine will be
purchased, distributed, and administered; which population groups are
likely to have priority for vaccination; what communication strategies
are most effective; and how to address issues related to vaccine and
antiviral supply and hospital and workforce capacity--before we are in
a time of crisis. Although HHS contends that agency flexibility is
needed during a pandemic, until key federal decisions are made, public
health officials at all levels may find it difficult to plan for an
influenza pandemic, and the timeliness and adequacy of response efforts
may be compromised.
Mr. Chairman, this concludes my prepared statement. I would be happy to
respond to any questions you or other Members of the Committee may have
at this time.
[End of section]
GAO Contact and Staff Acknowledgments:
For further information about this testimony, please contact Marcia
Crosse at (202) 512-7119. Jennifer Major, Nick Larson, Gay Hee Lee, Kim
Yamane, George Bogart, and Ellen W. Chu made key contributions to this
statement.
[End of section]
Related GAO Products:
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.
Washington, D.C.: May 26, 2005.
Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. GAO-
05-177T. Washington, D.C.: November 18, 2004.
Emerging Infectious Diseases: Review of State and Federal Disease
Surveillance Efforts. GAO-04-877. Washington, D.C.: September 30, 2004.
Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28,
2004.
Emerging Infectious Diseases: Asian SARS Outbreak Challenged
International and National Responses. GAO-04-564. Washington, D.C.:
April 28, 2004.
Public Health Preparedness: Response Capacity Improving, but Much
Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: February 12,
2004.
Infectious Diseases: Gaps Remain in Surveillance Capabilities of State
and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003.
Severe Acute Respiratory Syndrome: Established Infectious Disease
Control Measures Helped Contain Spread, but a Large-Scale Resurgence
May Pose Challenges. GAO-03-1058T. Washington, D.C.: July 30, 2003.
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.
Bioterrorism: Preparedness Varied across State and Local Jurisdictions.
GAO-03-373. Washington, D.C.: April 7, 2003.
Global Health: Challenges in Improving Infectious Disease Surveillance
Systems. GAO-01-722. Washington, D.C.: August 31, 2001.
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.
West Nile Virus Outbreak: Lessons for Public Health Preparedness.
GAO/HEHS-00-180. Washington, D.C.: September 11, 2000.
Global Health: Framework for Infectious Disease Surveillance. GAO/NSIAD-
00-205R. Washington, D.C.: July 20, 2000.
FOOTNOTES
[1] An influenza pandemic is defined by the emergence of a novel
influenza virus, to which much or all of the population is susceptible,
that is readily transmitted person to person, and causes outbreaks in
multiple countries.
[2] Influenza pandemics can have successive "waves" of disease and last
for up to 3 years. Three pandemics occurred in the 20th century: the
"Spanish influenza" of 1918, which killed about 500,000 people in the
United States; the "Asian influenza" of 1957, which killed about 70,000
people in the United States; and the "Hong Kong influenza" of 1968,
which killed about 34,000 people in the United States.
[3] See "Related GAO Products" at the end of this testimony for a list
of our earlier work related to infectious diseases, influenza vaccine
supply, and pandemic planning.
[4] The states included California, Florida, Maine, Minnesota, and
Washington, and the localities included San Diego and San Francisco,
California; Miami-Dade County, Florida; Portland, Maine; Stearns
County, Minnesota; and Seattle-King County, Washington. We selected
these states and localities on the basis of geography, population size,
and state vaccination success rates.
[5] HHS also located and purchased about 1.5 million doses of vaccine
from manufacturers not licensed in the United States. Although this
vaccine could be made available to be administered under special
protocols, according to HHS officials, none of the vaccine was used in
the 2004-05 influenza season.
[6] In addition, FDA develops influenza reference strains and reagents
and makes them available to manufacturers for vaccine development and
evaluation.
[7] Under the Federal Food, Drug, and Cosmetic Act, FDA ensures
compliance with good manufacturing practice. FDA has limited authority
to prohibit 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.
[8] According to the act, to declare a public health emergency, the
Secretary must determine that (1) a disease or disorder presents a
public health emergency or (2) a public health emergency, including
significant outbreaks of infectious disease or bioterrorist attacks,
otherwise exists. Public Health Service Act § 319 (current version at
42 U.S.C. § 247d).
[9] See Centers for Disease Control and Prevention, "Supplemental
Recommendations about Timing of Influenza Vaccination, 2004-05 Season,"
Morbidity and Mortality Weekly Report, vol. 53, no. 37 (2004): 878-879.
[10] Not everyone in target populations receives a vaccination each
year. See Centers for Disease Control and Prevention, "Prevention and
Control of Influenza Recommendations of the Advisory Committee on
Immunization Practices (ACIP)," Morbidity and Mortality Weekly Report,
vol. 53, no. RR-06 (2004): 1-40.
[11] The license for this manufacturer, with production facilities in
Liverpool, England, was temporarily suspended by British regulatory
authorities.
[12] The Association of Immunization Managers is an organization that
represents 64 state, territorial, and urban-area immunization programs
funded by CDC.
[13] On October 5, 2004, CDC, in coordination with ACIP, issued interim
recommendations for influenza vaccination during the 2004-05 season
that took precedence over earlier recommendations. The season's
priority groups for vaccination with injectable influenza vaccine were
considered to be of equal importance. They included all children aged 6-
23 months, adults aged 65 years and older, persons aged 2-64 years with
underlying chronic medical conditions, all women who would be pregnant
during the influenza season, residents of nursing homes and long-term
care facilities, children aged 6 months-18 years on chronic aspirin
therapy, health care workers involved in direct patient care, and out-
of-home caregivers and household contacts of children younger than 6
months. See Centers for Disease Control and Prevention, "Interim
Influenza Vaccination Recommendations, 2004-05 Influenza Season,"
Morbidity and Mortality Weekly Report, vol. 53, no. 39 (2004): 923-924.
[14] According to CDC officials, as part of preparations for the 2005-
06 influenza season, the agency is preparing communication strategies
with appropriate messages to respond to the fluctuations in supply and
demand anticipated throughout the season. CDC has developed the
communication plan but has not released the plan, as it is in the
clearance process.
[15] According to data collected during December 1-11, 2004, on self-
reported vaccination during September 1 through November 30, 2004,
among adults in priority groups who had not yet received influenza
vaccine, about 23 percent reported that they attempted to obtain
vaccination but could not. See Centers for Disease Control and
Prevention, "Estimated Influenza Vaccination Coverage among Adults and
Children--United States, September 1-November 30, 2004," Morbidity and
Mortality Weekly Report, vol. 53, no. 49 (2004): 1147-1150.
[16] Monovalent influenza vaccine protects against a single strain of
influenza; trivalent influenza vaccine protects against three strains
of influenza.
[17] The $20 million increase is for CDC's Immunization Grant Program
that provides vaccines for children, adolescents, and adults who
present primarily at local health departments but are not eligible for
CDC's Vaccines for Children program.
