Influenza Pandemic: Applying Lessons Learned from the 2004-05	 
Influenza Vaccine Shortage (04-NOV-05, GAO-06-221T).		 
                                                                 
Concern has been rising about the nation's preparedness to	 
respond to vaccine shortages that could occur in future annual	 
influenza seasons or during an influenza pandemic--a global	 
influenza outbreak. Although the timing or extent of a future	 
influenza pandemic cannot be predicted, studies suggest that its 
effect in the United States could be severe, and shortages of	 
vaccine could occur. For the 2004-05 annual influenza season, the
nation lost about half its expected influenza vaccine supply when
one of two major manufacturers announced in October 2004 that it 
would not release any vaccine. GAO examined federal, state, and  
local actions taken in response to the shortage, including	 
lessons learned. The nation's experience during the unexpected	 
2004-05 vaccine shortfall offers insights into some of the	 
challenges that government entities will face in a pandemic. GAO 
was asked to provide a statement on lessons learned from the	 
2004-05 vaccine shortage and their relevance to planning and	 
preparing for similar situations in the future, including an	 
influenza pandemic. This statement is based on a GAO report,	 
Influenza Vaccine: Shortages in 2004-05 Season Underscore Need	 
for Better Preparation (GAO-05-984), and on previous GAO reports 
and testimonies about influenza vaccine supply and pandemic	 
preparedness.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-06-221T					        
    ACCNO:   A41037						        
  TITLE:     Influenza Pandemic: Applying Lessons Learned from the    
2004-05 Influenza Vaccine Shortage				 
     DATE:   11/04/2005 
  SUBJECT:   Influenza						 
	     Emergency preparedness				 
	     Community health services				 
	     Contingency plans					 
	     Health care planning				 
	     Health care services				 
	     Health hazards					 
	     Health resources utilization			 
	     Health services administration			 
	     Immunization programs				 
	     Immunization services				 
	     Infectious diseases				 
	     Lessons learned					 
	     Policy evaluation					 
	     Intergovernmental relations			 
	     Strategic planning 				 

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GAO-06-221T

     

     * Background
     * Limited Contingency Planning Slows Response
     * Streamlined Mechanisms for Expediting Vaccine Availability A
     * Effective Response Requires Clear and Consistent Communicati
     * Concluding Observations
     * GAO Contact and Staff Acknowledgments
     * Related GAO Products
     * 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. EST

Friday, November 4, 2005

INFLUENZA PANDEMIC

Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage

Statement for the Record by Marcia Crosse

Director, Health Care

GAO-06-221T

Mr. Chairman and Members of the Committee:

I am pleased to have the opportunity to provide information on our recent
review of the 2004-05 influenza vaccine shortage, with lessons to consider
as the nation improves its ability to respond to an influenza pandemic (a
global influenza outbreak resulting from a major genetic change in the
influenza virus).1 Concern about the nation's preparedness to respond to
an influenza pandemic has been growing for some time, in part because of
the increase in the number of identified human cases of avian influenza in
Asia.2 Studies suggest that a pandemic's effects in the United States
could be severe, and shortages of vaccine could occur. The nation's
experience responding to the shortage of annual influenza vaccine for the
2004-05 influenza season-in which the nation faced an unexpected loss of
nearly half its projected vaccine supply-offers insight into the some of
the challenges that federal, state, and local entities will face if a
pandemic occurs.

My statement includes findings from our recent report on last winter's
influenza vaccine shortage and discusses lessons learned from that
experience that could help prepare the nation to respond to future vaccine
shortages in either an annual influenza season or an influenza pandemic.3
My statement also draws from several GAO reports and testimonies on
influenza vaccine supply, pandemic planning, and emergency preparedness
for emerging infectious diseases that we have issued since October 2000.4
This body of work includes interviews with officials in the Department of
Health and Human Services (HHS), such as officials from the Centers for
Disease Control and Prevention (CDC) and the National Vaccine Program
Office. For the report on the 2004-05 influenza vaccine shortage, we
conducted site visits at a sample of states and localities.5 We also
interviewed officials from public health departments and a major influenza
vaccine manufacturer; national organizations, including the Association of
State and Territorial Health Officials and the Association of Immunization
Managers; organizations that conduct mass immunization clinics; and a
large purchaser of influenza vaccine. We conducted all of our work in
accordance with generally accepted government auditing standards.

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. Among the most notorious 20th-century outbreaks was the
"Spanish influenza" of 1918, which is estimated to have killed 500,000 or
more people in the United States and 40-50 million people worldwide.

2Since December 2003, 122 confirmed avian influenza cases in humans have
been reported to the World Health Organization (WHO); these cases have
occurred in four countries, and about half the victims died. See World
Health Organization, "Cumulative Number of Confirmed Human Cases of Avian
Influenza A/(H5N1) Reported to WHO,"
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2005_11_01/en
/index.html, downloaded Nov.1, 2005. Avian influenza has also been
confirmed in birds in Europe.

3GAO, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for
Better Preparation, GAO-05-984 (Washington, D.C.: Sept. 30, 2005).

4See "Related GAO Products" at the end of this testimony.

In summary, a number of lessons emerged from federal, state, and local
responses to the 2004-05 influenza vaccine shortage that carry
implications for handling future vaccine shortages in either an annual
influenza season or an influenza pandemic. First, limited contingency
planning slows response. At the start of the 2004-05 influenza season,
when the nation unexpectedly lost roughly half its projected influenza
vaccine supply, the nation lacked a contingency plan specifically for a
severe vaccine shortage. The absence of such a plan led to delays and
uncertainties on the part of state and local public health entities on how
best to ensure access to vaccine by individuals at high risk of severe
influenza-related complications. Since 2000, we have encouraged the
development of a plan to address critical issues that could arise in an
influenza pandemic. Second, streamlined mechanisms to expedite vaccine
availability are key to an effective response. During the 2004-05
shortage, for example, federal purchases of vaccine licensed for use in
other countries but not the United States were not completed in time to
meet peak demand. Some states' experience also highlighted the importance
of mechanisms to transfer available vaccine quickly and easily from one
state to another. Third, effective response requires clear and consistent
communication. Consistency among federal, state, and local communications
is critical for averting confusion. State and local health officials also
emphasized the value of updated information when responding to changing
circumstances, using diverse media to reach diverse audiences, and
educating providers and the public about prevention alternatives.

5The states were California, Florida, Maine, Minnesota, and Washington,
and the localities were 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 viral respiratory infections, such as
the common cold. During an annual influenza season, 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 years 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. In an average year in the United States, more than 36,000
individuals die and more than 200,000 are hospitalized from influenza and
related complications.

Pandemic influenza differs from annual influenza in several ways.
According to the World Health Organization, pandemic influenza spreads to
all parts of the world very quickly, usually in less than a year, and can
sicken more than a quarter of the global population, including young,
healthy individuals. Although health experts cannot predict with certainty
which strain of influenza virus will be involved in the next pandemic,
they warn that the avian influenza virus identified in the human cases in
Asia, known as H5N1, could lead to a pandemic if it acquires the genetic
ability, so far absent, to spread quickly from person to person.

Vaccination is the primary method for preventing influenza and its
complications. Produced in a complex process that involves growing viruses
in millions of fertilized chicken eggs, influenza vaccine is administered
each year to protect 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 for the annual influenza season, it takes
about 2 weeks for the body to produce the antibodies that protect against
infection. According to CDC recommendations, the optimal time for annual
vaccination is October through November. Because the annual influenza
season typically does not peak until January or February, however, 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 both healthy
individuals and individuals at highest risk for severe complications,
including those with chronic illness and those aged 65 years and older.
The nasal spray vaccine, in contrast, is currently approved for use only
among healthy individuals aged 5 to 49 years who are not pregnant. For the
2003-04 influenza season, two manufacturers-one with production facilities
in the United States (sanofi pasteur6) and one with production facilities
in the United Kingdom (Chiron)-produced about 83 million doses of
injectable vaccine, which represented about 96 percent of the U.S. vaccine
supply. A third U.S. manufacturer (MedImmune) produced the nasal spray
vaccine.7 For the 2004-05 influenza season, CDC and its Advisory Committee
on Immunization Practices (ACIP) initially recommended vaccination for
about 188 million people in designated priority groups, including roughly
85 million people at high risk for severe complications.8 On October 5,
2004, however, Chiron announced that it could not provide its expected
production of 46-48 million doses-about half the expected U.S. influenza
vaccine supply.

Although vaccination is the primary strategy for protecting individuals
who are at greatest risk of severe complications and death from influenza,
antiviral drugs can also help to treat infection. If taken within 2 days
of a person's becoming ill, these drugs can ease symptoms and reduce
contagion. In the event of a pandemic, such drugs could lower the number
of deaths until a pandemic influenza vaccine became available. Four
antiviral drugs have been approved by the Food and Drug Administration
(FDA) for treatment of influenza: amantadine, rimantadine, oseltamivir,
and zanamivir.9

HHS has primary responsibility for coordinating the nation's response to
public health emergencies. Within HHS, CDC is one of the agencies that
protect 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 ACIP recommend which population groups should be
targeted for vaccination each year and, when vaccine supply allows,
recommend that any person who wishes to decrease his or her risk of
influenza be vaccinated.10 In addition, the National Vaccine Program
Office is responsible for coordinating and ensuring collaboration among
the many federal agencies involved in vaccine and immunization activities;
the office also issued a draft national pandemic influenza preparedness
plan in August 2004.11

6The company spells its name without capital letters.

7Another injectable influenza vaccine for adults, produced by
GlaxoSmithKline Biologicals, based in Belgium, was approved and licensed
by FDA on August 31, 2005, for the U.S. market. The company expects to
produce about 8 million doses for the 2005-06 influenza season.

8Not everyone in target populations receives a vaccination each year. For
example, CDC reported that in 2003 an estimated 66 percent of people aged
65 years and older received an influenza vaccination. See Centers for
Disease Control and Prevention, "Prevention and Control of Influenza:
Recommendations of the Advisory Committee on Immunization Practices
(ACIP)," Morbidity and Mortality Weekly Report, vol. 54, no. RR-8 (2004),
1-40.

9According to CDC, the H5N1 avian influenza virus is resistant to
amantadine and rimantadine, commonly used for influenza; oseltamivir and
zanamivir would probably work to treat influenza caused by the H5N1 virus,
but additional studies are still needed to prove their effectiveness.

Preparing for and responding to an influenza pandemic differ in several
respects from preparing for and responding to an annual influenza season.
For example, past influenza pandemics have affected healthy young adults
who are not typically at high risk for severe influenza-related
complications, so the groups given priority for early vaccination may
differ from those given priority in an annual influenza season. In
addition, according to CDC, a vaccine probably would not be available in
the early stages of a pandemic. Shortages of vaccine would therefore be
likely during a pandemic, potentially creating a situation more
challenging than a shortage of vaccine for an annual influenza season.

                  Limited Contingency Planning Slows Response

One lesson learned from the 2004-05 season that is relevant to a future
vaccine shortage in either an annual influenza season or a pandemic is the
importance of planning before a shortage occurs. At the time the influenza
vaccine shortage became apparent, the nation lacked a contingency plan
specifically designed to respond to a severe vaccine shortage. The absence
of such a plan led to delays and uncertainty on the part of many state and
local entities on how best to ensure access to vaccine during the shortage
by individuals at high risk of severe complications and others in priority
groups. Faced with the unanticipated shortfall, CDC redefined the priority
groups it had recommended for vaccination12 and asked sanofi pasteur, the
remaining manufacturer of injectable vaccine, to suspend distribution
until the agency completed its assessment of the shortage's extent and
developed a plan to distribute the manufacturer's remaining vaccine to
providers serving individuals in the priority groups. Developing and
implementing this distribution plan took time and led to delays in
response and some confusion at state and local levels.

10In addition, FDA plays a role in preparing for annual influenza seasons
and a potential pandemic in approving and regulating use of vaccines and
drugs, including antiviral medications. FDA also develops influenza
reference strains and reagents and makes them available to manufacturers
for vaccine development and evaluation.

11Department of Health and Human Services, National Vaccine Program
Office, Draft Pandemic Influenza Preparedness and Response Plan
(Washington, D.C.: August 2004).

Our work showed that several areas of planning are particularly important
for enhancing preparedness before a similar situation occurs in the
future, including defining the responsibilities of federal, state, and
local officials; using emergency preparedness plans and emergency health
directives; and facilitating the distribution and administration of
vaccine.

           o  Clearly defining responsibilities of federal, state, and local
           officials can minimize confusion. During the 2004-05 vaccine
           shortage, even though CDC worked with states and localities to
           coordinate roles and responsibilities, problems occurred. For
           example, CDC worked with national professional associations to
           survey long-term-care providers throughout the country to
           determine if seniors had adequate access to vaccine. Maine and
           other states, however, also surveyed their long-term-care
           providers to make the same determination. This duplication of
           effort expended additional resources, burdened some long-term-care
           providers in the states, and created confusion.13

           o  Emergency preparedness plans help coordinate local response.
           State and local health officials in several locations we visited
           reported that using existing emergency plans or incident command
           centers (the organizational systems set up specifically to handle
           the response to emergency situations) helped coordinate effective
           local responses to the vaccine shortage. For example, public
           health officials from Seattle-King County said that using the
           county's incident command system played a vital role in
           coordinating an effective and timely local response and in
           communicating a clear message to the public and providers. In
           addition, according to public health officials, emergency public
           health directives helped ensure access to vaccine by supporting
           providers in enforcing the CDC recommendations and in helping to
           prevent price gouging in certain states.

           o  Partnerships between the public and private sectors can
           facilitate distribution and administration of vaccine. In San
           Diego County, California, for example, local health officials
           worked with a coalition of partners in public health, private
           businesses, and nonprofit groups throughout the county. Other
           mechanisms facilitated administering the limited supply of
           influenza vaccine to those in high-risk or other priority groups.
           In Stearns County, Minnesota, for example, public health officials
           worked with private providers to implement a system of vaccination
           by appointment. Rather than standing in long lines for
           vaccination, individuals with appointments went to a clinic during
           a given time slot.

           Although an influenza pandemic may differ in some ways from an
           annual influenza season, experience during the 2004-05 shortage
           illustrated the importance of having contingency plans in place
           ahead of time to prevent delays when timing is critical. Some
           health officials indicated that, as a result of the experience
           with the influenza vaccine shortage, they were revising state and
           local preparedness plans or modifying command center protocols to
           prepare for future emergencies. For example, experiences during
           the 2004-05 influenza season led Maine state officials to
           recognize the need to speed completion of their pandemic influenza
           preparedness plan.

           Over the past 5 years, we have reported on the importance of
           planning to address critical issues such as how vaccine will be
           purchased and distributed; how population groups will be given
           priority for vaccination; and how federal resources should be
           deployed before the nation faces a pandemic. We have also urged
           HHS to complete its pandemic preparedness and response plan, which
           the department released in draft form in August 2004. This draft
           plan described options for vaccine purchase and distribution and
           provided planning guidance to state and local health departments.
           As we testified earlier, however, the draft plan lacked clear
           guidance on potential priority groups for vaccination in a
           pandemic, and key questions remained about the federal role in
           purchasing and distributing vaccine.14 The experience in 2004-05
           also highlighted the importance of finalizing such planning
           details. On November 2, 2005, HHS released its pandemic influenza
           plan. We did not, however, have an opportunity to review the plan
           before issuing this statement to determine whether the plan
           addresses these critical issues.

           A second lesson from the experience of the 2004-05 vaccine
           shortage that is relevant to future vaccine shortages in either an
           annual influenza season or a pandemic is the importance of
           streamlined mechanisms to make vaccine available in an expedited
           manner. For example, HHS began efforts to purchase foreign vaccine
           that was licensed for use in other countries but not the United
           States shortly after learning in October 2004 that Chiron would
           not supply any vaccine. The purchase, however, took several months
           to complete, and so vaccine was not available to meet the fall
           2004 demand; by the end of the season, this vaccine had not been
           used. In addition, recipients of this foreign vaccine could have
           been required to sign a consent form and follow up with a health
           care worker after vaccination-steps that, according to health
           officials we interviewed in several states, would be too
           cumbersome to administer.

           Some states' experience during the 2004-05 vaccine shortage also
           highlighted the importance of mechanisms to transfer available
           vaccine quickly and easily from one state to another; the lack of
           mechanisms to do so delayed redistribution to some states. During
           the 2004-05 shortage, some state health officials reported
           problems with their ability to purchase vaccine, both in paying
           for vaccine and in administering the transfer process. Minnesota,
           for example, tried to sell its available vaccine to other states
           seeking additional vaccine for their priority populations.
           According to federal and state health officials, however, certain
           states lacked the funding or flexibility under state law to
           purchase the vaccine when Minnesota offered it. As we have
           previously testified, establishing the funding sources, authority,
           or processes for quick public-sector purchases may be needed as
           part of pandemic preparedness.15

           Recognizing the need for mechanisms to make vaccine available in a
           timely manner in the event of a pandemic, HHS has taken some
           action to address the fragility of the current influenza vaccine
           market. In its budget request for fiscal year 2006, CDC requested
           $30 million to enter into guaranteed-purchase contracts with
           vaccine manufacturers to help ensure vaccine supply. According to
           the agency, maintaining an abundant supply of annual influenza
           vaccine is critically important for improving the nation's
           preparedness for an influenza pandemic. HHS is also taking steps
           toward developing a supply of vaccine to protect against avian
           influenza strains that could be involved in a pandemic.16

           Experience during the 2004-05 shortage also illustrated the
           critical role communication plays when demand for vaccine exceeds
           supply and information about future vaccine availability is
           uncertain, as could happen in a future annual influenza season or
           a pandemic. During the 2004-05 shortage, CDC communicated
           regularly through a variety of media as the situation evolved.
           State and local officials, however, identified several
           communication lessons for future seasons or if an influenza
           pandemic occurred:

           o  Consistency among federal, state, and local communications is
           critical for averting confusion. State health officials reported
           several cases where inconsistent messages created confusion.
           Health officials in California, for example, reported that local
           radio stations in the state were running two public service
           announcements simultaneously-one from CDC advising those aged 65
           years and older to be vaccinated, and one from the state advising
           those aged 50 years and older to be vaccinated.

           o  Disseminating clear, updated information is especially
           important when responding to changing circumstances. Beginning in
           October 2004, CDC asked individuals who were not in a high-risk
           group or another priority group to forgo or defer vaccination;
           this message, however, did not include instructions to check back
           with their providers later in the season, when more vaccine had
           become available. According to CDC, an estimated 17.5 million
           individuals specifically deferred vaccination to save vaccine for
           those in priority groups;17 local health officials said that many
           did not return when vaccine became available.

           o  Using diverse media helps reach diverse audiences. During the
           2004-05 influenza season, public health officials emphasized the
           value of a variety of communication methods-such as telephone
           hotlines, Web sites, and bilingual radio advertisements-to reach
           as many individuals as possible and to increase the effectiveness
           of local efforts to raise vaccination rates. In Seattle-King
           County, Washington, for example, health department officials
           reported that a telephone hotline was important because some
           seniors did not have Internet access. Public health officials in
           Miami-Dade County, Florida, said that bilingual radio
           advertisements promoting influenza vaccine for those in priority
           groups helped increase the effectiveness of local efforts to raise
           vaccination rates.

           o  Education can alert providers and the public to prevention
           alternatives. In the 2004-05 shortage, some of the nasal spray
           vaccine for healthy individuals went unused, in part because of
           fears that the vaccine was too new and untested or that the live
           virus in the nasal spray could be transmitted to others.18
           Further, public health officials we interviewed said that
           education about all available forms of prevention, including the
           use of antiviral medications and good hygiene practices, can help
           reduce the spread of influenza.

           Experience during the 2004-05 influenza vaccine shortage
           highlights the need to prepare the nation for handling future
           shortages in either an annual influenza season or an influenza
           pandemic. In particular, that season's shortage emphasized the
           vital need for early planning, mechanisms to make vaccine
           available, and effective communication to ensure available vaccine
           is targeted to those who need it most. As our work over the past 5
           years has noted, it is important for federal, state, and local
           governments to develop and communicate plans regarding critical
           issues-such as how vaccine will be purchased and distributed,
           which population groups are likely to have priority for
           vaccination, and what communication strategies are most
           effective-before we face another shortage of annual influenza
           vaccine or, worse, an influenza pandemic.

           For further information about this statement, please contact
           Marcia Crosse at (202) 512-7119 or [email protected]. Kim Yamane,
           Assistant Director; George Bogart; Ellen W. Chu; Nicholas Larson;
           Jennifer Major; and Terry Saiki made key contributions to this
           statement.

           Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for
           Better Preparation. GAO-05-984 . Washington, D.C.: September 30,
           2005.

           Influenza Pandemic: Challenges in Preparedness and Response.
           GAO-05-863T . Washington, D.C.: June 30, 2005.

           Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T
           . Washington, D.C.: May 26, 2005.

           Flu Vaccine: Recent Supply Shortages Underscore Ongoing
           Challenges. GAO-05-177T . Washington, D.C.: November 18, 2004.

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

           Public Health Preparedness: Response Capacity Improving, but Much
           Remains to Be Accomplished. GAO-04-458T . Washington, D.C.:
           February 12, 2004.

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

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

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

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12These revised recommendations decreased the number of people in groups
recommended for vaccination by about half, from about 188 million to about
98 million. 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.

13After the 2004-05 influenza season, CDC reviewed its response to the
vaccine shortage and took a number of steps, including issuing interim
guidelines in August 2005 to assist in responding to possible future
shortages.

14See GAO, Influenza Pandemic: Challenges in Preparedness and Response,
GAO-05-863T (Washington, D.C.: June 30, 2005).

Streamlined Mechanisms for Expediting Vaccine Availability Are Key to Effective
                                    Response

15 GAO-05-863T .

         Effective Response Requires Clear and Consistent Communication

16In addition, HHS has also taken steps to stockpile antiviral drugs,
which could be beneficial in the event of a pandemic, before a vaccine
specific for the responsible virus strain is available or during a period
of limited vaccine supply. By December 2004, HHS had purchased and
stockpiled enough of two antiviral medications (rimantadine and
oseltamivir) to treat more than 7 million people, and the department
recently announced intentions to buy enough antiviral drugs to treat 20
million people. Like vaccine, however, antiviral drugs take several months
to produce from raw materials, and HHS's National Vaccine Program Office
has reported that in a pandemic, the manufacturing capacity and supply of
antiviral drugs are likely to be less than global demand.

                            Concluding Observations

17See Centers for Disease Control and Prevention, "Estimated Influenza
Vaccination Coverage among Adults and Children-United States, September 1,
2004-January 31, 2005," Morbidity and Mortality Weekly Report, vol. 54,
no. 12 (2005), 304-307.

18The nasal spray vaccine was recommended for 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.

                     GAO Contact and Staff Acknowledgments

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Highlights of GAO-06-221T , a statement for the record for the Committee
on Government Reform, House of Representatives

November 4, 2005

INFLUENZA PANDEMIC

Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage

Concern has been rising about the nation's preparedness to respond to
vaccine shortages that could occur in future annual influenza seasons or
during an influenza pandemic-a global influenza outbreak. Although the
timing or extent of a future influenza pandemic cannot be predicted,
studies suggest that its effect in the United States could be severe, and
shortages of vaccine could occur. For the 2004-05 annual influenza season,
the nation lost about half its expected influenza vaccine supply when one
of two major manufacturers announced in October 2004 that it would not
release any vaccine. GAO examined federal, state, and local actions taken
in response to the shortage, including lessons learned. The nation's
experience during the unexpected 2004-05 vaccine shortfall offers insights
into some of the challenges that government entities will face in a
pandemic.

GAO was asked to provide a statement on lessons learned from the 2004-05
vaccine shortage and their relevance to planning and preparing for similar
situations in the future, including an influenza pandemic. This statement
is based on a GAO report, Influenza Vaccine: Shortages in 2004-05 Season
Underscore Need for Better Preparation (GAO-05-984), and on previous GAO
reports and testimonies about influenza vaccine supply and pandemic
preparedness.

A number of lessons emerged from federal, state, and local responses to
the 2004-05 influenza vaccine shortage that carry implications for
handling future vaccine shortages in either an annual influenza season or
an influenza pandemic.

           o  First, limited contingency planning slows response. At the
           start of the 2004-05 influenza season, when the supply shortfall
           became apparent, the nation lacked a contingency plan specifically
           to address severe shortages. The absence of such a plan led to
           delays and uncertainties on the part of state and local public
           health entities on how best to ensure access to vaccine by
           individuals at high risk of severe influenza-related
           complications.

           o  Second, streamlined mechanisms to expedite vaccine availability
           are key to an effective response. During the 2004-05 shortage, for
           example, federal purchases of vaccine licensed for use in other
           countries but not the United States were not completed in time to
           meet peak demand. Some states' experience also highlighted the
           importance of mechanisms to transfer available vaccine quickly and
           easily from one state to another.

           o  Third, effective response requires clear and consistent
           communication. Consistency among federal, state, and local
           communications is critical for averting confusion. State and local
           health officials also emphasized the value of updated information
           when responding to changing circumstances, using diverse media to
           reach diverse audiences, and educating providers and the public
           about prevention alternatives.

Over the past 5 years, GAO has urged the Department of Health and Human
Services (HHS) to complete its plan to prepare for and respond to an
influenza pandemic. GAO has reported on the importance of planning to
address critical issues such as how vaccine will be purchased and
distributed; how population groups will be given priority for vaccination;
and how federal resources should be deployed before the nation faces a
pandemic. On November 2, 2005, HHS released its pandemic influenza plan.
GAO did not have the opportunity to review the plan before issuing this
statement to determine the extent to which the plan addresses these
critical issues.
*** End of document. ***