Influenza Pandemic: Challenges Remain in Preparedness (26-MAY-05,
GAO-05-760T).
Vaccine shortages and distribution problems during the 2004-2005
influenza season raised concerns about the nation's ability to
respond to a worldwide influenza epidemic--or influenza
pandemic--which many experts believe to be inevitable. Some
experts believe that the next pandemic could be spawned by the
recurring avian influenza in Asia. If avian influenza strains
directly infect humans and acquire the ability to be readily
transmitted between people, a pandemic could occur. Modeling
studies suggest that its effect in the United States could be
severe, with one estimate from the Centers for Disease Control
and Prevention (CDC) ranging from 89,000 to 207,000 deaths and
from 38 million to 89 million illnesses. GAO was asked to discuss
surveillance systems in place to identify and monitor an
influenza pandemic and concerns about preparedness for and
response to an influenza pandemic. This testimony is based on
GAO's 2004 report on disease surveillance; reports and testimony
on influenza outbreaks, influenza vaccine supply, and pandemic
planning that GAO has issued since October 2000; and work GAO has
done in May 2005 to update key information.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-05-760T
ACCNO: A25218
TITLE: Influenza Pandemic: Challenges Remain in Preparedness
DATE: 05/26/2005
SUBJECT: Disease detection or diagnosis
Emergency preparedness
Health care planning
Health hazards
Immunization programs
Immunization services
Infectious diseases
Respiratory diseases
Influenza
HHS Pandemic Influenza Preparedness and
Response Plan
******************************************************************
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** figure captions are reproduced. Tables are included, but **
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GAO-05-760T
* Background
* Influenza
* Disease Surveillance and Response
* Existing Influenza Surveillance System and Enhancements Woul
* Systems Are in Place to Routinely Monitor for Influenza
* Federal Agencies Have Undertaken Initiatives to Enhance Infl
* Despite Efforts by Federal Officials, Challenges Remain rega
* HHS's Pandemic Influenza Plan Remains in Draft and Leaves Ma
* Challenges Persist in Ensuring an Adequate and Timely Influe
* Challenges Persist in Ensuring an Adequate Supply of Antivir
* Implementation of Control Measures to Prevent Spread of Pand
* Most Hospitals Lack the Capacity to Respond to Large-Scale I
* Concluding Observations
* Contact and Staff Acknowledgments
* Order by Mail or Phone
Testimony
Before the Subcommittee on Health, Committee on Energy and Commerce, House
of Representatives
United States Government Accountability Office
GAO
For Release on Delivery Expected at 10:00 a.m. EDT
Thursday, May 26, 2005
INFLUENZA PANDEMIC
Challenges Remain in Preparedness
Statement of Marcia Crosse
Director, Health Care
GAO-05-760T
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you discuss issues regarding the nation's
preparedness to respond to a worldwide influenza epidemic, or influenza
pandemic.1 The emergence of new diseases such as severe acute respiratory
syndrome (SARS) has raised concerns about our ability to respond to other
infectious disease outbreaks such as an influenza pandemic,2 which many
experts believe to be inevitable. Vaccine shortages and distribution
problems during the 2004-2005 influenza season add to these concerns.
Influenza pandemics arise periodically but unpredictably from a major
genetic change in the virus that results in a new strain.3 Some experts
believe that the next pandemic could be spawned by the recurring avian
influenza in Asia. As of May 19, 2005, 97 people, mostly young and
otherwise healthy, have been confirmed by the World Health Organization
(WHO) to have been infected with avian influenza since 2003, and 53 of
them have died. Recent studies suggest that avian influenza strains are
increasingly capable of causing severe disease in humans and suggest that
these strains have become endemic in some wild birds. If these avian
influenza strains directly infect humans and acquire the ability to be
readily transmitted between people, a pandemic could occur.
While the severity of the next pandemic cannot be predicted, modeling
studies suggest that its effect in the United States could be severe. The
Centers for Disease Control and Prevention (CDC) estimates that if a
"medium-level" influenza pandemic were to occur in the United States, in
the absence of any control measures (e.g., vaccination and drugs), it
could cause 89,000 to 207,000 deaths, 314,000 to 734,000 hospitalizations,
18 million to 42 million outpatient visits, and another 20 million to 47
million cases of the illness.4 From 15 percent to 35 percent of the U.S.
population could be affected by an influenza pandemic, with associated
costs ranging from $71 billion to $167 billion.
1An 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.
2See GAO, SARS Oubreak: Improvements to Publc Healh Capaciy Are Needed for
Responding to Bioterrorsm and Emerging Infectious Diseases, GAO-03-769T
(Washington, D.C.: May 7, 2003).
3Influenza pandemics can have successive "waves" of disease and last for
up to 3 years. Three pandemics occurred in the 20th century: the "Spanish
flu" of 1918, which killed 500,000 people in the United States; the "Asian
flu" of 1957, which caused 70,000 deaths in the United States; and the
"Hong Kong flu" of 1968, which caused 34,000 deaths in the United States.
You asked us to provide our perspective on the nation's ability to conduct
disease surveillance5 for an influenza pandemic, as well as the public
health system's preparedness for an influenza pandemic. In this testimony,
I will discuss (1) surveillance systems in place to identify and monitor
an influenza pandemic and (2) challenges in preparedness and response to
an influenza pandemic.
My testimony today is based largely on our 2004 report on disease
surveillance6 as well as reports and testimony on influenza outbreaks,
influenza vaccine supply, pandemic planning, and the SARS outbreak that we
have issued since October 20007 and work we have conducted to update key
information. Our prior work on disease surveillance and influenza
pandemics included analysis of information provided by multiple federal
departments and agencies, including the Department of Health and Human
Services (HHS)-specifically from CDC and the Food and Drug Administration
(FDA)-and the Departments of Agriculture, Defense, and Homeland Security,
as well as interviews with officials of those departments and agencies. We
also interviewed public health department officials from 11 states,8
vaccine manufacturers, and vaccine distributors and surveyed physician
group practices. 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." Our
prior work on the SARS outbreak included analysis of information provided
by U.S. agencies, WHO, and Asian governments, as well as interviews with
officials from those entities. We also conducted fieldwork on SARS in
Beijing; Hong Kong; Guangdong Province, China; and Taipei, Taiwan. In May
2005, we updated our information to include issues that arose during the
2004-2005 influenza season and to verify the current status of HHS efforts
on surveillance, planning, and preparedness activities. We conducted all
of our work in accordance with generally accepted government auditing
standards.
4See CDC, Fact Sheet, Information about Influenza Pandemics, 3,
www.cdc.gov/flu , downloaded May 12, 2005.
5Disease surveillance is the process of reporting, collecting, analyzing,
and exchanging information related to cases of infectious diseases.
6See GAO, Emerging Infectous Dseases: Review of State and Federa Dsease
SurvelanceEfforts, GAO-04-877 (Washington, D.C.: Sept. 30, 2004).
7See "Related GAO Products" at the end of this testimony for a list of our
earlier work related to emerging infectious diseases and influenza
pandemic planning.
8These states-California, Colorado, Indiana, Louisiana, Minnesota, New
York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin-were
selected based on their participation in CDC's Emerging Infections
Program, each state's most recent infectious disease outbreak, and their
geographic location.
In summary, federal public health officials plan to rely on the nation's
existing influenza surveillance system and enhancements to identify an
influenza pandemic. CDC currently collaborates with multiple public health
partners, including WHO, to obtain data that provide national and
international pictures of influenza activity. Federal public health
officials and health care organizations have undertaken several
initiatives that are intended to enhance influenza surveillance
capabilities. While some of these initiatives are focused more generally
on increasing preparedness for bioterrorism and other emerging infectious
disease health threats, others were undertaken in preparation for an
influenza pandemic. For example, in response to concerns over the past few
years about the potential for avian influenza to become the next influenza
pandemic, CDC implemented an initiative in cooperation with WHO to improve
influenza surveillance in Asia. CDC has also implemented initiatives to
improve the communications systems it uses to collect and disseminate
surveillance information. In addition, CDC, USDA, and FDA have made
efforts to enhance their coordination of surveillance efforts for diseases
that arise in animals and can be transferred to humans, such as SARS and
certain strains of influenza with the potential to become pandemic.
While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with regard
to other aspects of preparedness for and response to an influenza
pandemic. In particular, HHS has not finalized planning for an influenza
pandemic. In 2000, we recommended that HHS complete the national plan for
responding to an influenza pandemic, but the plan has been in draft format
since August 2004. Absent a completed federal plan, key questions about
the federal role in the purchase, distribution, and administration of
vaccines and antiviral drugs during a pandemic remain unanswered. Other
challenges with regard to preparedness for and response to an influenza
pandemic exist across the public and private sectors, including challenges
in ensuring an adequate and timely influenza vaccine and antiviral supply;
addressing regulatory, privacy, and procedural issues surrounding measures
to control the spread of disease, for example, across national borders;
and resolving issues related to an insufficient hospital and health
workforce capacity for responding to a large-scale outbreak such as an
influenza pandemic.
Background
To be prepared for major public health threats such as an influenza
pandemic, public health agencies need several basic capabilities,
including disease surveillance systems. Specifically, to detect cases of
pandemic influenza, especially before they develop into widespread
outbreaks, local, state, and federal public health officials as well as
international organizations collect, analyze, and share information
related to cases of the disease. When effective, surveillance can
facilitate timely action to control outbreaks and promote informed
allocation of resources to meet changing disease conditions.
Influenza
Influenza is more severe than some other viral respiratory infections,
such as the common cold. Most people who get 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 more likely than other people to develop severe
complications from influenza. Influenza and pneumonia rank as the fifth
leading cause of death among persons aged 65 and older.
Influenza viruses undergo minor but continuous genetic changes from year
to year. Almost every year, an influenza virus causes acute respiratory
disease in epidemic proportions somewhere in the world. Vaccination is the
primary method for preventing influenza and its more severe complications.
Influenza vaccine is produced and administered annually to provide
protection against particular influenza strains expected to be prevalent
that year. Influenza vaccine takes several months to produce. Deciding
which viral strains to include in the annual influenza vaccine depends on
data collected from domestic and international surveillance systems that
identify prevalent strains and characterize their effect on human health.
FDA decides which strains to include in the vaccine and also licenses and
regulates the manufacturers that produce the vaccine.9 HHS has limited
authority, however, to directly control influenza vaccine production and
distribution.10
9FDA decides which strains to include in the annual influenza vaccine
based on the recommendations of its Vaccines and Related Biological
Products Advisory Committee.
FDA has approved four antiviral medications (amantadine, rimantadine,
oseltamivir, and zanamivir) for prevention and treatment of influenza.
However, influenza virus strains can become resistant to one or more of
these drugs, and so they may not always be effective.
Disease Surveillance and Response
In the United States, responsibility for disease surveillance is
shared-involving health care providers; more than 3,000 local health
departments, including county, city, and tribal health departments; 59
state and territorial health departments; more than 180,000 public and
private laboratories; and public health officials from multiple federal
departments and agencies.
States, through the use of their state and local health departments, have
principal responsibility for protecting the public's health and therefore
take the lead in conducting disease surveillance and supporting response
efforts. According to the Institute of Medicine (IOM), most states require
health care providers to report any unusual illnesses or deaths-especially
those for which a cause cannot be readily established.11 Generally, local
health departments are responsible for conducting initial investigations
into reports of infectious diseases. Laboratory personnel test clinical
and environmental samples for possible exposures and identification of
illnesses. Epidemiologists in health departments use disease surveillance
systems to detect clusters of suspicious symptoms or diseases in order to
facilitate early detection and treatment. Local and state health
departments monitor disease trends. Local health departments are also
responsible for sharing information they obtain from providers or other
sources with their state departments of health. State health departments
are responsible for collecting surveillance information-which they share
on a voluntary basis with CDC and others-from across their state and for
coordinating investigations and response efforts. Public health officials
provide needed information to the clinical community and the public.
10Under the Federal Food, Drug, and Cosmetic Act, FDA ensures compliance
with good manufacturing practices 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. The term "health care entity" does not include wholesale
distributors. This authority would not extend to resale of the vaccine for
emergency medical reasons. CDC also has a role in encouraging appropriate
public health actions.
11The requirement to report clinically anomalous symptoms is particularly
important for the detection of emerging infectious diseases, many of which
may be unfamiliar to health care providers.
At the federal level, several departments and agencies are involved in
disease surveillance and response. For example,
o 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 planning to prepare for and respond to an
influenza pandemic. One action the department has taken is the
development of a draft national pandemic influenza plan, titled
"Pandemic Influenza Preparedness and Response Plan."
o CDC is charged with protecting the nation's public health by
directing efforts to prevent and control diseases and responding
to public health emergencies. It has primary responsibility for
conducting national disease surveillance and developing
epidemiological and laboratory tools to enhance disease
surveillance. CDC also provides an array of technical and
financial support for state infectious disease surveillance
efforts. In addition, CDC participates in international disease
and laboratory surveillance sponsored by WHO.
o FDA is responsible for ensuring that new vaccines and drugs are
safe and effective and for conducting research on diagnostic tools
and treatment of disease outbreaks. The agency also regulates and
licenses vaccines and antiviral agents through the Center for
Biologics Evaluation and Research and the Center for Drug
Evaluation and Research, respectively. FDA also develops influenza
viral reference strains and reagents and makes them available to
manufacturers for vaccine development and evaluation.
o The Department of Defense (DOD) contributes to global disease
surveillance, training, research, and response to emerging
infectious disease threats. DOD maintains the DOD Influenza
Surveillance Program, a laboratory-based surveillance program. DOD
maintains multiple sites throughout the world that serve as
sentinels for disease outbreaks, where it collects and analyzes
viral specimens.
o The Department of Agriculture (USDA) is responsible for
protecting and improving the health and marketability of animals
and animal products by preventing, controlling, and eliminating
animal diseases. USDA undertakes disease surveillance and response
activities to protect U.S. livestock, ensure the safety of
international trade, and contribute to the national zoonotic
disease12 surveillance effort.
The United States is a member of WHO, which is responsible for
coordinating international disease surveillance and response
efforts. An agency of the United Nations, WHO administers the
International Health Regulations, which outline WHO's role and the
responsibility of member countries and regions in preventing the
global spread of infectious diseases. WHO also helps marshal
resources from its members to control outbreaks within individual
countries or regions. In addition, WHO works with national
governments to improve their surveillance capacities through-for
example-assessing and redesigning national surveillance
strategies, offering training in epidemiologic and laboratory
techniques, and emphasizing more efficient communication systems.
Surveillance is a key component in planning for an influenza
pandemic, and federal public health officials plan to rely on the
nation's existing annual influenza surveillance system and
enhancements to identify an influenza pandemic. Federal public
health officials have undertaken several initiatives that are
intended to enhance influenza surveillance capabilities. These
initiatives have been undertaken both through programs specific to
influenza as well as through programs focused more generally on
increasing preparedness for bioterrorism and other emerging
infectious disease health threats. Federal officials have
implemented and expanded syndromic surveillance systems13 in order
to detect outbreaks more quickly, but there are concerns that
these systems are costly to run and still largely untested.
Federal officials have also implemented initiatives designed to
improve public health communications and have undertaken
initiatives intended to improve the coordination of zoonotic
surveillance efforts.
Current U.S. surveillance for identifying annual influenza
outbreaks as well as an influenza pandemic involves multiple
public health partners at all levels of government and relies on
several data sources. At the federal level, CDC's Influenza Branch
leads the national influenza surveillance effort, monitoring
disease and viral trends using data submitted each week from
October through May. These surveillance data are collected at the
local and state levels and voluntarily submitted to CDC. Data
submitted on influenza activity in the United States include data
from more than 120 laboratories and 2,000 health care providers
and mortality reports from 122 cities. In addition, influenza data
are collected from all 50 state health departments and the health
departments in the District of Columbia and New York City. CDC
also receives data that are specifically focused on influenza in
pediatric patients. When the data are used collectively, they
provide a national picture of influenza activity. Specifically,
they allow CDC to (1) identify when and where influenza activity
is occurring, (2) determine what strains of the influenza virus
are in circulation, (3) detect changes in the influenza virus, (4)
monitor influenza-related illnesses, and (5) measure the impact
influenza is having on deaths in the United States.
DOD also plays a role in national and international influenza
surveillance. Specifically, DOD's Influenza Surveillance Program,
under the direction of the Air Force, collects viral specimens
from its active duty personnel and their dependents at military
facilities around the world. DOD's program also sends specimens to
CDC for further analysis and contributes to the determination of
which viral strains FDA includes in the nation's annual influenza
vaccine. Internationally, DOD provides viral specimens to WHO and
assists in identifying emerging influenza strains.
In countries throughout the world, infectious disease surveillance
is a national responsibility, but WHO assists its members' efforts
through its Global Influenza Surveillance Network. WHO's Network
is composed of 112 institutions, called National Influenza
Centres, from 83 countries. Collectively, these Centres monitor
influenza activity and annually gather more than 175,000 viral
specimens for analysis from patients with influenza-like illnesses
throughout the world. Selected influenza isolates-an estimated
2,000 viruses-may also be sent to one of four WHO Collaborating
Centres14 for further, more specific genetic analysis. The
additional analysis conducted by the WHO Collaborating Centers is
used for the annual WHO recommendations on which strains to
include in the influenza vaccine for the northern and southern
hemispheres. In addition to making recommendations on the
components of the influenza vaccine, this Global Influenza
Surveillance Network also serves as a global alert mechanism for
the emergence of influenza viruses with pandemic potential.
CDC has undertaken several initiatives that are intended to
enhance influenza surveillance capabilities in preparation for an
influenza pandemic. CDC works with its international partners to
improve global surveillance for influenza. For example, CDC
participates in international disease and laboratory surveillance
sponsored by WHO. Also, when concerns were raised over recent
influenza seasons that the avian influenza A (H5N1) could become
the next influenza pandemic, CDC led a variety of efforts with its
international partners to plan for and address threats of
increased influenza activity worldwide. For example, CDC worked
collaboratively with WHO to conduct investigations of avian
influenza A in Vietnam and to provide laboratory testing. CDC also
provided training assistance and has implemented an initiative to
improve influenza surveillance in Asia.
CDC also supports several domestic initiatives to improve
surveillance capabilities for influenza. For example, CDC supports
enhanced influenza surveillance activities through its
Epidemiology and Laboratory Capacity (ELC) Grants. Established in
1997, this program provides funding to state and local influenza
programs. Grants have steadily increased from the first awards in
1997, when less than $100,000 was provided to five states through
August 2004, with funding totaling more than $2 million being
given to about 47 states or major metropolitan areas. States and
cities receiving ELC-influenza funding are encouraged to achieve
three highlighted influenza epidemiology and laboratory
surveillance capacities: sentinel physician surveillance, viral
isolation and subtyping, and year-round surveillance. Each state
targets funding to meet one or more of these three priorities and
uses funding for support of improvements that include the
assignment or hiring of an influenza coordinator, recruitment of
sentinel physicians to collect influenza specimens and report
influenza-like illness to the state, laboratory infrastructure
enhancements to increase influenza testing capabilities for viral
isolation and subtyping, and expansion of influenza surveillance
activities to year-round.
In an effort to enhance the ability to detect infectious disease
outbreaks, particularly in their early stages, federal funding has
supported state efforts to implement numerous syndromic
surveillance systems. These systems collect information on
syndromes from a variety of sources. For example, the National
Retail Data Monitor (NRDM) collects data from retail sources
instead of hospitals. As of February 2004, NRDM collected sales
data from about 19,000 stores, including pharmacies, in order to
monitor sales patterns in such items as over-the-counter influenza
medications for signs of a developing infectious disease outbreak.
CDC is taking steps to enhance its two public health
communications systems, the Health Alert Network (HAN)15 and the
Epidemic Information Exchange (Epi-X),16 which are used in disease
surveillance and response efforts. For example, CDC is working to
increase the number of HAN participants who receive assistance
with their communication capacities. In addition, following
reports of human deaths from avian influenza A in Vietnam in
August 2004, CDC issued a HAN message reiterating criteria for
domestic surveillance, diagnostic evaluation, and infection
control precautions. CDC also issued detailed laboratory testing
procedures for avian influenza through HAN. Similarly, CDC has
expanded Epi-X by giving officials at other federal agencies and
departments, such as DOD, the ability to use the system. CDC is
also adding users to Epi-X from local health departments, giving
access to CDC staff in other countries, and making the system
available to Field Epidemiology Training Programs (FETP) located
in 21 countries.17 Finally, CDC is facilitating Epi-X's interface
with other data sources by allowing users to access the Global
Public Health Intelligence Network (GPHIN), the system that
searches Web-based media for information on infectious disease
outbreaks worldwide.
In addition to the efforts to enhance communication systems,
federal public health officials also have enhanced federal
coordination for zoonotic disease surveillance and expanded
training programs. According to CDC, nearly 70 percent of emerging
infectious disease episodes during the past 10 years have been
zoonotic diseases. Moreover, recent outbreaks of human disease
caused by avian influenza strains in Asia and Europe highlight the
potential for new strains to be introduced into the population.
Surveillance for zoonotic diseases requires collaboration between
animal and human disease specialists. CDC, USDA, and FDA have made
efforts to enhance their coordination of zoonotic disease
surveillance. For example, CDC and UDSA are working with two
national laboratory associations to add veterinary diagnostic
laboratories to the Laboratory Response Network (LRN).18 As of May
2004, 10 veterinary laboratories had been added to LRN, and CDC
officials told us that they had plans to add more veterinary
laboratories in the future. In addition, CDC officials told us the
agency has appointed a staff person whose responsibility, in part,
is to assist in finding ways to enhance zoonotic disease
coordination efforts among federal agencies and departments and
with other organizations. This person is helping CDC develop a
working group of officials from CDC, USDA, and FDA to coordinate
zoonotic disease surveillance.19 According to CDC officials, the
goal of this working group is to explore ways to link existing
surveillance systems to better coordinate and integrate
surveillance for wildlife, domestic animal, and human diseases.
CDC officials also said that the agency is exploring the
feasibility of a pilot project to demonstrate this proposed
integrated zoonotic disease surveillance system. In addition, USDA
officials told us that they hired 23 wildlife biologists in fall
2003 to coordinate disease surveillance, monitoring, and
management activities among USDA, CDC, states, and other federal
agencies. While each of these initiatives is intended to enhance
the surveillance of zoonotic diseases, each is still in the
planning stage or the very early stages of implementation.
USDA also conducts influenza surveillance in domestic animals.
Coordination with USDA is important because a pandemic strain is
likely to arise from genetic mixing of animal and human influenza
viruses. Recent outbreaks in domestic poultry in Asia and Europe
associated with cases of human disease highlight the importance of
coordinating surveillance activities. Surveillance for influenza
viruses in poultry in the United States has increased
substantially since the outbreak of highly pathogenic avian
influenza (HPAI) in Pennsylvania and surrounding states in 1983
and 1984. However, individual states are generally responsible for
the development and implementation of surveillance programs that
are consistent with the size and complexity of the resident
poultry industry.
Challenges regarding the nation's preparedness for and response to
an influenza pandemic remain. Specifically, our prior work has
found that although CDC participated in an interagency working
group that developed the U.S. plan for pandemic preparedness that
was posted for public comment in August 2004, as of May 23, 2005,
the plan had not been finalized. Further, we found that the draft
plan does not address certain critical issues, including how
vaccine for an influenza pandemic will be purchased, distributed,
and administered; how population groups will be prioritized for
vaccination; what quarantine authorities or travel restrictions
may need to be invoked; and how federal resources should be
deployed. At the state level, we found that most hospitals across
the country lack the capacity to respond to large-scale infectious
disease outbreaks.
In August 2004, HHS released its national pandemic influenza plan
for comment. The draft "Pandemic Influenza Preparedness and
Response 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 the
federal, state, and local levels, including both the public and
the private sectors. However, as of May 23, 2005, this document
remained in draft form. Further, although the plan is
comprehensive in scope, it leaves many important decisions
unresolved about the purchase, distribution, and administration of
vaccines. For example, some decisions yet to be made include
determining the public- versus private-sector roles in the
purchase and distribution of pandemic influenza 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.
Until these key 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.
The draft plan does not establish a definitive federal role in the
purchase and distribution of vaccines during an influenza
pandemic. 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. In
its draft plan, HHS does not recommend a specific alternative.
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.
Furthermore, 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. Approximately half of the states handle procurement
and distribution of the annual 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.
Challenges persist in ensuring an adequate and timely influenza
vaccine supply. The number of producers remains limited, and the
potential for manufacturing problems such as those experienced
during the 2004-2005 influenza season is still present. When one
manufacturer's production is affected, providers who order vaccine
from that manufacturer can experience shortages, while providers
who receive supplies from another manufacturer may have all the
vaccine they need. The allocation plan CDC developed for this past
season's shortage was dependent upon voluntary compliance by the
private sector and individuals to forgo vaccination. Most annual
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. In the United States, 85 percent of vaccine
doses are purchased by the private sector, such as private
physicians and pharmacies. HHS has not yet determined how
influenza vaccine will be distributed and administered during an
influenza pandemic.
There are many issues surrounding the production of influenza
vaccine, which will only become exacerbated during an influenza
pandemic. Vaccines, which are considered the first line of defense
to prevent or reduce influenza-related illness and death, may be
unavailable or in short supply. Producing the vaccine is a complex
process that involves growing viruses in millions of fertilized
chicken eggs. Experience has shown that the vaccine production
cycle takes at least 6 to 8 months after a virus strain has been
identified, and vaccines for some influenza strains have been
difficult to mass-produce, causing further delay. The lengthy
process for developing a vaccine may mean that a vaccine would not
be available during the initial stages of a pandemic.
Vaccine shortages during the 2004-2005 influenza season have
highlighted the fragility of the influenza vaccine market and the
need for its expansion and stabilization. Currently, only two
manufacturers are licensed to sell their vaccine in the United
States.20 Maintaining an influenza vaccine supply is critically
important for protecting the public's health and improving our
preparedness for an influenza pandemic. As a result, according to
CDC officials, the agency plans to alleviate the impact of next
year's influenza season by taking aggressive steps to ensure an
expanded influenza supply to protect the nation. To this end, the
agency's fiscal year 2006 budget request includes an increase of
$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. If supplies are sufficient, the
bulk vaccine can be held until the following year's influenza
season and developed into vaccines if the circulating strains
remain the same. In addition, according to CDC, this guarantee
will help to expand the influenza market by providing an incentive
to manufacturers to expand capacity and possibly encourage
additional manufacturers to enter the market. In addition, the
fiscal year 2006 budget request includes an increase of $20
million to support influenza vaccine purchase activities.
Even if sufficient quantities of the vaccine are produced in time,
vaccines against various strains differ in their ability to
produce the immune response necessary to provide effective
protection against the disease. Studies show that it is uncertain
how effective a vaccine will be in preventing or controlling the
spread of a pandemic influenza virus.
Early in an influenza pandemic, especially before a vaccine is
available or during a period of limited vaccine supply, use of
antiviral drugs may have a significant effect. Specifically,
antiviral drugs can help prevent or mitigate the number of
influenza-related deaths until an influenza vaccine becomes
available. They can be used against all strains of pandemic
influenza and have immediate availability as both a prophylactic
to prevent illness and as a treatment if administered within 48
hours of the onset of symptoms. According to HHS, analysis is
ongoing to define optimal antiviral use strategies, potential
health impacts, and cost-effectiveness of antiviral drugs in the
setting of a pandemic.
The United States has a limited supply of influenza antiviral
medications stored for an influenza pandemic. HHS officials expect
the amount produced will be below demand during a pandemic. This
assumption, supported by drug manufacturers, is based on the fact
that current production levels of antiviral drugs are set in
response to current demand, whereas demand in a pandemic is
expected to increase significantly if vaccines are unavailable. In
addition, the production of antiviral medications cannot be
rapidly expanded and involves a long production process. Moreover,
sometimes 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 influenza A (H5N1)
viruses identified in human patients in Asia in 2004 and 2005 have
been resistant to two of the four antiviral drugs, amantadine and
rimantadine.
Another challenge in responding to an influenza pandemic involves
implementing certain control measures to prevent the spread of the
disease. These control measures-case identification and contact
tracing, transmission control, and exposure management-are
well-established and have proved effective in both health care and
community settings.21 However, federal attempts to limit the
spread of SARS into the United States by advising passengers who
traveled to infected countries faced multiple obstacles. For
example, due to airline concerns over authority and privacy, as
well as procedural constraints, CDC was unable to obtain passenger
contact information it needed to trace travelers. Although HHS has
statutory authority to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries into the
United States,22 HHS regulations implementing the statute do not
specifically provide for HHS to obtain passenger manifests or
other passenger contact information from airlines and shipping
companies for disease outbreak control purposes.23
A challenge identified during the SARS outbreak that may also
affect response efforts during an influenza pandemic is lack of
sufficient hospital and workforce capacity. This lack could be
exacerbated during an influenza pandemic, compared to other
natural disasters, such as a tornado or hurricane, or an
intentional release of a bioterrorist agent, because it is likely
that a pandemic would result in both widespread and sustained
effects.
Public health officials we spoke with said 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. As we have
reported earlier, most states lack "surge capacity," that is, the
capacity to respond to the large influx of patients that could
occur during a large public health emergency.24 For example, few
states reported that they had 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 provide treatment to large
numbers of patients. Moreover, a shortage in workforce could
increase during an influenza pandemic because higher disease rates
could result in high rates of absenteeism among health care
workers who are likely to be at increased risk of exposure and
illness.
There are a number of systems in place to identify influenza
outbreaks abroad, to alert us to a pandemic, and these systems
generally appear to be working well. HHS has taken important steps
to enhance surveillance and to fund initiatives for preparedness
and response, including steps to increase the vaccine supply.
However, important challenges remain in our preparedness to
respond, should an influenza pandemic occur in the United States.
The steps HHS is taking to address vaccine production capacity and
stockpiling of antiviral drugs may not be in place in time to fill
the current gaps in preparedness should an influenza pandemic
occur in the next several years. As we learned in the 2004-2005
influenza season, problems affecting even a single manufacturer
can produce major shortages. Once a pandemic influenza strain is
identified, a vaccine will take many months to produce, and our
current stockpile of antiviral drugs is insufficient to meet the
likely demand. Pandemic influenza would have major impacts on the
ability of communities to respond, businesses to function, and
public safety to be maintained when communities across the country
are simultaneously impacted and hospital capacity is overwhelmed.
Since 2000, we have been urging the department to complete its
pandemic plan. A draft plan was issued in August 2004, with a
60-day period for public comment, but as of this week, the plan
had not been finalized. It is important for the federal government
and the states to work through issues such as how vaccine will be
purchased, distributed, and administered, how population groups
will be prioritized for vaccination, what quarantine authorities
or travel restrictions may need to be invoked, and how federal
resources should be deployed before we are in a time of crisis.
Mr. Chairman, this concludes my prepared statement. I would be
happy to respond to any questions you or other Members of the
Subcommittee may have at this time.
For further information about this testimony, please contact
Marcia Crosse at (202) 512-7119. Gloria E. Taylor, Gay Hee Lee,
Elizabeth T. Morrison, and Roseanne Price made key contributions
to this statement.
Emergng Infecious Diseases: Revew of Sate and Federal Disease
Surveillance Effors. GAO-04-877 . Washington, D.C.: September 30,
2004.
nectous Disease Preparedness: Federal Chalenges in Responding
toInfluenza Outbreaks. GAO-04-1100T . Washington, D.C.: September
28, 2004.
Emergng Infecious Diseases: Asian SARS Outbreak Challenged
nernational and Natonal Responses. GAO-04-564 . Washington, D.C.:
April 28, 2004.
Publc Heath Preparedness: Response Capacymproving, bu Much Remains
to Be Accompshed. GAO-04-458T . Washington, D.C.: February 12,
2004.
Infectious Diseases: Gaps Remain in Surveiance Capabilies o State
and Local Agences. GAO-03-1176T . Washington, D.C.: September 24,
2003.
Severe Acute Respiraory Syndrome: Estabished Infectious Dsease
Control Measures Helped Contain Spread, But a Large-Scale
Resurgence May Pose Challenges. GAO-03-1058T . Washington, D.C.:
July 30, 2003.
SARS Outbreak: Improvemens to Pubc Health Capacity Are Needed
forResponding o Bioerrorism and Emergng Infectous Diseases.
GAO-03-769T . Washington, D.C.: May 7, 2003.
Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts
Have mproved Pubc HealhResponse Capacty, but Gaps Reman.
GAO-03-654T . Washington, D.C.: April 9, 2003.
Global Healh: Chalenges in Improving Infectious Disease Surveance
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 Vaccne: Supply Probems Heighen Need o Ensure Access for
HighRisk People. GAO-01-624 . Washington, D.C.: May 15, 2001.
nluenza Pandemic: Pan Needed for Federal and State Response.
GAO-01-4 . Washington, D.C.: October 27, 2000.
West Nile Virus Outbreak: Lessons for Pubic Healh 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.
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12Zoonotic diseases are those diseases that are transmitted from animals
to humans.
Existing Influenza Surveillance System and Enhancements Would Be Used to
Identify an Influenza Pandemic
Systems Are in Place to Routinely Monitor for Influenza
13Many syndromic surveillance systems currently in use in the United
States were developed in response to the September 11, 2001, attacks on
the World Trade Center and Pentagon and to the anthrax outbreaks that
occurred shortly afterwards. The fundamental objective of syndromic
surveillance is to identify illness clusters early, before diagnoses are
confirmed and reported to public health agencies.
14A WHO Collaborating Centre is a national institution designated by WHO
to form part of an international collaborative network that contributes to
implementing WHO's program priorities and to strengthening institutional
capacity in countries and regions. Collaborating Centre activities include
collection and dissemination of information, education and training, and
participation in collaborative research developed under WHO's leadership.
The four Collaborating Centres that are part of WHO's Global Influenza
Surveillance Network are located in the United States, Australia, Japan,
and the United Kingdom.
Federal Agencies Have Undertaken Initiatives to Enhance Influenza Surveillance
15The Health Alert Network (HAN) is an early-warning and response system
operated by CDC that is designed to ensure that state and local health
departments as well as other federal agencies and departments have timely
access to emerging health information.
16The Epidemic Information Exchange (Epi-X) is a secure, Web-based
communication system operating in all 50 states. CDC uses this system
primarily to share information relevant to disease outbreaks with state
and local public health officials and with other federal officials. Epi-X
also serves as a forum for routine professional discussions and
nonemergency inquiries.
17In selected foreign locations, CDC operates international training
programs, such as FETP. Through FETP, each year CDC trains approximately
50 to 60 physicians and social scientists in applied public health,
integrating disease surveillance, applied research, prevention, and
control activities. Graduates of the FETP program serve in their native
country and provide links between CDC and their respective ministries of
health. CDC officials said that trainees from its international programs
have frequently provided important information on disease outbreaks.
18To strengthen the nation's capacity to rapidly detect biological and
chemical agents that could be used as a terrorist weapon, CDC, in
partnership with the Federal Bureau of Investigation and the Association
of Public Health Laboratories, created LRN in 1999. According to CDC, LRN
leverages the resources of 126 laboratories to maintain an integrated
national and international network of laboratories that are fully equipped
to respond quickly to acts of chemical or biological terrorism, emerging
infectious diseases, and other public health threats and emergencies. The
network includes federal, state and local public health, military, and
international laboratories, as well as laboratories that specialize in
food, environmental, and veterinary testing. LRN laboratories have been
used in several public health emergencies. For example, in 2001, a Florida
LRN laboratory discovered the presence of Bacillus anthracs, the pathogen
that causes anthrax, in a clinical specimen it tested.
19This working group was created in response to a congressional mandate
that the Secretary of Health and Human Services, through FDA and CDC, and
USDA, coordinate the surveillance of zoonotic diseases. Public Health
Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L.
No. 107-188, S:313, 116 Stat. 594, 674 (2002).
Despite Efforts by Federal Officials, Challenges Remain regarding Preparedness
for and Response to an Influenza Pandemic
HHS's Pandemic Influenza Plan Remains in Draft and Leaves Many Important Issues
Unresolved
Challenges Persist in Ensuring an Adequate and Timely Influenza Vaccine Supply
20During the 2004-2005 influenza season, the license for a third
manufacturer was suspended by British regulatory authorities due to safety
concerns with the vaccine.
Challenges Persist in Ensuring an Adequate Supply of Antiviral Drugs
Implementation of Control Measures to Prevent Spread of Pandemic Influenza
Presents Difficulties
Most Hospitals Lack the Capacity to Respond to Large-Scale Infectious Disease
Outbreaks
21In the United States, the Healthcare Infection Control Practices
Advisory Committee, a federal advisory committee made up of 14 infection
control experts, develops recommendations and guidelines regarding general
infectious disease control measures for CDC. Expert recommendations
include (1) case identification and contact tracing, which involves
defining what symptoms, laboratory results, and medical histories
constitute a positive case in a patient and tracing and tracking
individuals who may have been exposed to these patients; (2) transmission
control, which involves controlling the transmission of disease-producing
microorganisms through use of proper hand hygiene and personal protective
equipment, such as masks, gowns, and gloves; and (3) exposure management,
which involves separating infected and noninfected individuals.
22Section 361 of the Public Health Service Act, 42 U.S.C. S: 264.
23See 42 C.F.R. pts 70 and 71; 21 C.F.R. pts 1240 and 1250.
Concluding Observations
24See GAO, Public Heath Preparedness: Response Capaciy Improving, but Much
Remansto be Accomplished, GAO-04-458T (Washington, D.C.: Feb. 12, 2004).
Contact and Staff Acknowledgments
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Highlights of GAO-05-760T , a testimony before the Subcommittee on Health,
Committee on Energy and Commerce, House of Representatives
May 26, 2005
INFLUENZA PANDEMIC
Challenges Remain in Preparedness
Vaccine shortages and distribution problems during the 2004-2005 influenza
season raised concerns about the nation's ability to respond to a
worldwide influenza epidemic-or influenza pandemic-which many experts
believe to be inevitable. Some experts believe that the next pandemic
could be spawned by the recurring avian influenza in Asia. If avian
influenza strains directly infect humans and acquire the ability to be
readily transmitted between people, a pandemic could occur. Modeling
studies suggest that its effect in the United States could be severe, with
one estimate from the Centers for Disease Control and Prevention (CDC)
ranging from 89,000 to 207,000 deaths and from 38 million to 89 million
illnesses.
GAO was asked to discuss surveillance systems in place to identify and
monitor an influenza pandemic and concerns about preparedness for and
response to an influenza pandemic. This testimony is based on GAO's 2004
report on disease surveillance; reports and testimony on influenza
outbreaks, influenza vaccine supply, and pandemic planning that GAO has
issued since October 2000; and work GAO has done in May 2005 to update key
information.
Federal public health officials plan to rely on the nation's existing
influenza surveillance system and enhancements to identify an influenza
pandemic. CDC currently collaborates with multiple public health partners,
including the World Health Organization (WHO), to obtain data that provide
national and international pictures of influenza activity. Federal public
health officials and health care organizations have undertaken several
initiatives that are intended to enhance influenza surveillance
capabilities. While some of these initiatives are focused more generally
on increasing preparedness for bioterrorism and other emerging infectious
disease health threats, others have been undertaken in preparation for an
influenza pandemic. For example, in response to concerns over the past few
years about the potential for avian influenza to become the next influenza
pandemic, CDC implemented an initiative in cooperation with WHO to improve
influenza surveillance in Asia. CDC has also implemented initiatives to
improve the communications systems it uses to collect and disseminate
surveillance information. In addition, CDC, the Department of Agriculture,
and the Food and Drug Administration have made efforts to enhance their
coordination of surveillance efforts for diseases that arise in animals
and can be transferred to humans, such as SARS and certain strains of
influenza with the potential to become pandemic.
While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with regard
to other aspects of preparedness for and response to an influenza
pandemic. In particular, the Department of Health and Human Services (HHS)
has not finalized planning for an influenza pandemic. In 2000, GAO
recommended that HHS complete the national plan for responding to an
influenza pandemic, but the plan has been in draft format since August
2004. Absent a completed federal plan, key questions about the federal
role in the purchase, distribution, and administration of vaccines and
antiviral drugs during a pandemic remain unanswered. Other challenges with
regard to preparedness for and response to an influenza pandemic exist
across the public and private sectors, including challenges in ensuring an
adequate and timely influenza vaccine and antiviral supply; addressing
regulatory, privacy, and procedural issues surrounding measures to control
the spread of disease, for example, across national borders; and resolving
issues related to an insufficient hospital and health workforce capacity
for responding to a large-scale outbreak such as an influenza pandemic.
*** End of document. ***