Influenza Pandemic: Challenges in Preparedness and Response	 
(30-JUN-05, GAO-05-863T).					 
                                                                 
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.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-05-863T					        
    ACCNO:   A28577						        
  TITLE:     Influenza Pandemic: Challenges in Preparedness and       
Response							 
     DATE:   06/30/2005 
  SUBJECT:   Disease detection or diagnosis			 
	     Emergency preparedness				 
	     Immunization programs				 
	     Immunization services				 
	     Infectious diseases				 
	     Procurement planning				 
	     Strategic planning 				 
	     Federal/state relations				 
	     Health care planning				 
	     State-administered programs			 
	     Influenza						 

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GAO-05-863T

     

     * Background
     * Planning for Purchase and Distribution of Vaccine and Defini
     * Communicating Information about the Situation and Response P
     * Ensuring Supply of Influenza Vaccine and Antiviral Drugs
     * Hospital and Workforce Capacity to Respond to Large-Scale In
     * Concluding Observations
          * Order by Mail or Phone

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

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.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.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.

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.

2Influenza 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.

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 20003 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
Pandemc nfuenza Preparedness and Response Pan. 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.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.

3See "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.

4The 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.

                                   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.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 Pandemc Inuenza Preparedness and
Response Pan, 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.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.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.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.

5HHS 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.

6In addition, FDA develops influenza reference strains and reagents and
makes them available to manufacturers for vaccine development and
evaluation.

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.9 CDC and ACIP recommended vaccination for about 185 million
people, including roughly 85 million people at high risk for
complications.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.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.

7Under 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.

8According 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 S: 319 (current version at 42 U.S.C. S: 247d).

9See Centers for Disease Control and Prevention, "Supplemental
Recommendations about Timing of Influenza Vaccination, 2004-05 Season,"
Morbidityand Mortality Weekly Report, vol. 53, no. 37 (2004): 878-879.

10Not 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 MortalityWeekly Report, vol. 53, no.
RR-06 (2004): 1-40.

11The license for this manufacturer, with production facilities in
Liverpool, England, was temporarily suspended by British regulatory
authorities.

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.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:

           o  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."
           o  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.

           o  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.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.

           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.14

           o  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.

           o  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.15

           o  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.

           o  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.

           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.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.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.

           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.

           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.

           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.

           nluenza Pandemic: Challenges Reman 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.

           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.

           Bioterrorism: Preparedness Vared across Stae and Local
           Jurisdictions. GAO-03-373 . Washington, D.C.: April 7, 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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12The Association of Immunization Managers is an organization that
represents 64 state, territorial, and urban-area immunization programs
funded by CDC.

  Communicating Information about the Situation and Response Plan Clearly and
                                  Effectively

13On 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.

14According 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.

15According 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.

            Ensuring Supply of Influenza Vaccine and Antiviral Drugs

16Monovalent influenza vaccine protects against a single strain of
influenza; trivalent influenza vaccine protects against three strains of
influenza.

17The $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.

  Hospital and Workforce Capacity to Respond to Large-Scale Infectious Disease
                                   Outbreaks

                            Concluding Observations

GAO Contact and Staff Acknowledgments

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For more information, contact Marcia Crosse at (202) 512-7119.

Highlights of GAO-05-863T , a testimony before the Committee on Government
Reform, House of Representatives

June 30, 2005

INFLUENZA PANDEMIC

Challenges in Preparedness and Response

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.

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.
*** End of document. ***