Influenza Vaccine: Shortages in 2004-05 Season Underscore Need	 
for Better Preparation (30-SEP-05, GAO-05-984). 		 
                                                                 
In early October 2004, the nation lost about half its expected	 
influenza vaccine supply when one of two major manufacturers	 
announced it would not release any vaccine for the 2004-05 season
because of potential contamination. The Centers for Disease	 
Control and Prevention (CDC) had earlier recommended vaccination 
for 188 million individuals, including those at high risk of	 
severe complications from influenza (such as seniors and those	 
with chronic conditions), and other groups (such as their close  
contacts). Although health officials took actions to distribute  
the limited supply of influenza vaccine, reports persisted of	 
high-risk individuals and others in priority groups who could not
find a vaccination, including those who were turned away and	 
never returned when supplies became available. Such reports	 
raised questions about the adequacy of U.S. preparedness to	 
respond to significant vaccine shortages. GAO was asked to	 
examine actions taken at federal, state, and local levels to	 
ensure that high-risk individuals had access to influenza vaccine
during the shortage, including any lessons learned.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-05-984 					        
    ACCNO:   A38837						        
  TITLE:     Influenza Vaccine: Shortages in 2004-05 Season Underscore
Need for Better Preparation					 
     DATE:   09/30/2005 
  SUBJECT:   Community health services				 
	     Contingency plans					 
	     Emergency preparedness				 
	     Health care planning				 
	     Influenza						 
	     Health care services				 
	     Health hazards					 
	     Health resources utilization			 
	     Health services administration			 
	     Immunization programs				 
	     Immunization services				 
	     Infectious diseases				 
	     Intergovernmental relations			 
	     Lessons learned					 
	     Policy evaluation					 
	     Strategic planning 				 

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GAO-05-984

     

     * Results in Brief
     * Background
     * Health Officials Took Steps to Vaccinate High-Risk Individua
     * Federal and State Officials Took Quick Actions
     * Public Health Officials Acted to Distribute Remaining Vaccin
          * CDC Devised a Plan to Distribute the Limited Supply of Influ
          * Federal, State, and Local Actions Limited Vaccine to High-Ri
     * Public Health Officials Used Multiple Communication Strategi
     * Late-Season Actions Aimed to Boost Supply and Demand
          * Planning, Timely Action, and Communication Are Key to an Eff
     * Lesson Learned: Limited Contingency Planning Slows Response
     * Lesson Learned: Unless Expedited, Actions to Boost Supply Ar
     * Lesson Learned: Effective Response Requires Communication to
          * Concluding Observations
          * Agency Comments
     * Appendix I: Comments from the Department of Health and Human
     * Appendix II: GAO Contact and Staff Acknowledgments
          * GAO Contact
          * Acknowledgments
     * Related GAO Products
     * Order by Mail or Phone

Report to Congressional Committees

United States Government Accountability Office

GAO

September 2005

INFLUENZA VACCINE

Shortages in 2004-05 Season Underscore Need for Better Preparation

Influenza Vaccine Shortage Influenza Vaccine Shortage Influenza Vaccine
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GAO-05-984

Contents

Letter 1

Results in Brief 3
Background 5
Health Officials Took Steps to Vaccinate High-Risk Individuals and Others
in Priority Groups 10
Planning, Timely Action, and Communication Are Key to an Effective
Response 23
Concluding Observations 32
Agency Comments 33
Appendix I Comments from the Department of Health and Human Services 35
Appendix II GAO Contact and Staff Acknowledgments 37
Related GAO Products 38

Tables

Table 1: Groups Recommended for Influenza Vaccination, Before and After
October 5, 2004 13
Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan 16
Table 3: Communication Methods Used by Various Health Departments to
Disseminate Influenza Information 21

Figures

Figure 1: Influenza Vaccine Cycle 6
Figure 2: Influenza Vaccine Production and Distribution 8
Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage 11
Figure 4: Phase II of CDC's Influenza Vaccine Distribution Plan 17
Figure 5: Influenza Vaccination Rates for Selected Priority Groups 24

Abbreviations

ACIP Advisory Committee on Immunization Practices CDC Centers for Disease
Control and Prevention FDA Food and Drug Administration HHS Department of
Health and Human Services

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protection in the United States. It may be reproduced and distributed in
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copyright holder may be necessary if you wish to reproduce this material
separately.

United States Government Accountability Office

Washington, DC 20548

September 30, 2005

The Honorable Tom Davis Chairman The Honorable Henry A. Waxman Ranking
Minority Member Committee on Government Reform House of Representatives

The Honorable Susan M. Collins Chairman Committee on Homeland Security and
Governmental Affairs United States Senate

As the traditional influenza vaccination period started in fall 2004, the
nation faced the unexpected loss of nearly half its projected vaccine
supply. One of the two major manufacturers of influenza vaccine for the
United States warned in late August 2004 that deliveries would be delayed
because a small quantity of its vaccine failed sterility tests. On October
5, 2004, the manufacturer announced that because of potential
contamination, it would be unable to release any vaccine for the U.S.
market. The Department of Health and Human Services (HHS) had expected
that this manufacturer would produce about 47 million doses-close to half
of the 100 million doses estimated for the 2004-05 influenza season.1
Before the October 5 announcement, HHS's Centers for Disease Control and
Prevention (CDC) and its Advisory Committee on Immunization Practices
(ACIP) had recommended that those at high risk of severe complications
from influenza and those in other priority groups-such as health care
workers and those aged 50-64 years-receive an influenza vaccination.2
After the announcement, with no other U.S.-licensed manufacturers able to
replace the large amount of lost vaccine on such short notice, concerns
arose about the effects of the loss, especially on those most vulnerable
to complications from influenza.

1See Centers for Disease Control and Prevention, "Supplemental
Recommendations about Timing of Influenza Vaccination, 2004-05 Season,"
Morbidity and Mortality Weekly Report, vol. 53, no. 37 (2004): 878-879.

2ACIP makes recommendations to CDC, and CDC generally adopts them; we
refer to such recommendations as CDC recommendations. Although CDC
estimates published in October 2004 show about 188 million people in
high-risk and other priority groups, not everyone in these groups receives
a vaccination each year. According to CDC, the prior maximum number of
doses distributed was approximately 83.1 million. Thus CDC estimated that
an expected 100 million doses of vaccine would be sufficient to meet
demand for the 2004-05 influenza season.

Media reports of long lines of seniors waiting hours for a chance at a
vaccination, of others at high risk who could not find a vaccination, and
of individuals turned away who never returned when supplies became
available fueled worries that the nation was not adequately prepared to
respond to the significant vaccine shortage or to an influenza pandemic (a
widespread or worldwide influenza epidemic). Notwithstanding these
concerns, CDC's postseason data indicate that 2004-05 vaccination rates
among certain high-risk groups such as seniors approached historical
rates.3

You observed that the 2004-05 influenza vaccine shortage was the most
severe in recent history and that lessons learned from this season would
enable the nation to better deal with a similar situation in the future.
This report examines the response to the 2004-05 shortage and identifies
the lessons. We address the following questions:

           1. What actions were taken at federal, state, and local levels to
           ensure that high-risk individuals had access to influenza vaccine
           during the 2004-05 shortage?
           2. What were the lessons learned from the strategies implemented
           at the federal, state, and local levels to ensure that high-risk
           individuals had access to influenza vaccine?

To address these objectives, we reviewed documents and interviewed
officials from (1) CDC and HHS's National Vaccine Program Office; (2)
national organizations, including the Association of State and Territorial
Health Officials, the Association of Immunization Managers, and the
National Association of County and City Health Officials;4 (3)
organizations that conduct mass immunization clinics; (4) sanofi pasteur,5
the remaining major manufacturer of influenza vaccine available for people
at high risk of influenza-related complications; and (5) Kaiser
Permanente, a health system that is a large purchaser of influenza
vaccine. We also conducted site visits to a judgmental sample of states
(California, Florida, Maine, Minnesota, and Washington) and localities
(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 to reflect a mix of
geographic locations, population size, and vaccination success rates.6 In
each state, we reviewed documents and interviewed officials from public
health agencies, professional associations, and provider organizations. We
also interviewed local representatives of home health organizations that
conduct mass immunizations and representatives of the Minnesota Multistate
Contracting Alliance for Pharmacy, which arranges purchase of vaccines for
use in 43 states. We conducted our work in accordance with generally
accepted government auditing standards from March through September 2005.

3See 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.

                                Results in Brief

Upon learning that nearly one-half of the projected vaccine supply would
be unavailable for the 2004-05 influenza season, federal, state, and local
health officials took several actions to help ensure that those at high
risk of severe influenza-related complications had access to available
vaccine. These efforts prompted federal revision of the recommendations on
who should be vaccinated, so that vaccine could be directed to those at
high risk and to other priority groups. Federal, state, and local actions
also focused on distributing vaccine to priority groups, using a number of
communication strategies to keep providers and the public informed about
the shortage. CDC, for example, developed and implemented a complex plan
to distribute vaccine to providers serving priority groups across the
states. Late in the influenza vaccination period-from mid-December through
January-health officials took various actions to increase vaccine
availability and attempted to distribute vaccine across the wider
population by broadening recommendations on who should be vaccinated.

4Members of the Association of State and Territorial Health Officials
include the chief health officials representing state and territorial
public health agencies. Members of the Association of Immunization
Managers include immunization program directors from state health
departments, U.S. territories, and selected cities. Members of the
National Association of County and City Health Officials include
representatives from local public health agencies. In addition to
officials from these associations, we interviewed some association
members.

5Aventis Pasteur became sanofi pasteur (spelled without capital letters)
in January 2005.

6We selected our sites on the basis of CDC's Behavioral Risk Factor
Surveillance System survey data (state-level data) on the percentage of
adults in priority groups for 2004-05 who reported receiving an influenza
vaccination during the traditional fall vaccination period
(September-November 2004).

A number of lessons emerged from federal, state, and local responses to
the 2004-05 influenza vaccine shortage, some specific to that season's
shortage, others with wider ramifications for potential future shortages
or a public health emergency. The primary lessons fall into three broad,
interrelated categories: planning, timely action, and communication.

           o  Limited contingency planning slows response. At the start of
           the traditional fall vaccination period, CDC did not have a
           contingency plan specifically designed to respond to a severe
           influenza vaccine shortage. The lack 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 and others in priority groups.
           Nevertheless, some state and local entities used strategies that
           enabled them to respond relatively efficiently. For example, a
           number of states used existing emergency preparedness plans and
           issued emergency health directives to improve priority groups'
           access to vaccine during the shortage. Some public health
           departments also facilitated the administration of vaccine in an
           orderly fashion when demand was highest, including scheduling
           vaccinations by appointment and holding lotteries.
           o  Unless expedited, actions to boost available supply may have
           little effect. Although federal agencies attempted to boost
           influenza vaccine supply, their efforts came too late in what
           turned out to be a relatively moderate influenza season. For
           example, HHS officials purchased vaccine that was not licensed for
           the U.S. market, but the purchases occurred in December 2004 and
           January 2005, by which time demand had already waned. Similarly,
           state officials reported that CDC's attempt to expand availability
           to other children and to adults of the vaccine purchased for its
           Vaccines for Children program came after demand for vaccine had
           dropped.
           o  Effective response requires communication that is both clear
           and consistent. Although CDC quickly communicated with nonfederal
           agencies, providers, and the public throughout the changing
           environment of the 2004-05 influenza season, communication was not
           always coordinated among these entities, and inconsistent messages
           did occur, contributing to delays and confusion and ultimately
           resulting in a late-season vaccine surplus. For example, in
           California, state officials in mid-December were advising
           vaccinations for those aged 50 years and older, while CDC was
           simultaneously recommending vaccinations only for those aged 65
           years and older. In addition, although a national campaign
           communicated the early-season messages to step aside in favor of
           those in priority groups, the campaign did not include a message
           to come back later when more vaccine became available. In certain
           locations, individuals seeking vaccination found themselves in a
           communication loop if they tried to follow CDC's advice to contact
           their local public health department for vaccine availability:
           when they did so, they were told to call their primary care
           provider, but when they called their primary care provider, they
           were told to call their local public health department.
           Furthermore, public education about the various forms of vaccine
           fell short. For example, despite the availability of a nasal spray
           vaccine for healthy individuals aged 5-49 years who were not
           pregnant, inadequate education about the vaccine contributed to
           the reluctance of some individuals to use it.

           After 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.

           We provided a draft of this report to HHS, and pertinent sections
           to the states and localities we visited and to sanofi pasteur, for
           their review. HHS concurred with our finding that contingency
           planning is important and indicated that further actions, such as
           approval of additional influenza vaccines for the U.S. market,
           were under way. HHS, states, localities, and sanofi pasteur
           provided technical comments, which we incorporated as appropriate.
           HHS's written comments appear in appendix I.

           Influenza is characterized by cough, fever, headache, and other
           symptoms and is more severe than some 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. On average each year in the United States, more
           than 36,000 individuals die and more than 200,000 are hospitalized
           from influenza and related complications. People aged 65 years and
           older, people of any age with chronic medical conditions, children
           younger than 2 years of age, and pregnant women are generally more
           likely than others to develop severe influenza-related
           complications.

           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, and
           vaccines for certain influenza strains have been difficult to
           mass-produce. After vaccination, the body takes about 2 weeks to
           produce the antibodies that protect against infection. According
           to CDC, 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 (see fig. 1). If
           supplies permit, CDC recommends a vaccination for anyone who wants
           one. Because circulating influenza strains change, a new vaccine
           is created each year. For this reason, and because immunity
           declines over time, CDC recommends a new influenza vaccination
           every year for high-risk individuals and other priority groups,
           including close contacts of those at high risk.

                                   Background

Figure 1: Influenza Vaccine Cycle

aThe influenza season varies from year to year, generally beginning in
late October and peaking in January or February.

Two types of vaccine are recommended for protection against influenza in
the United States: (1) an inactivated virus vaccine injected into muscle
and (2) a live virus vaccine administered as a nasal spray. The injectable
vaccine-which represents the large majority (over 95 percent) of influenza
vaccine administered in this country-can be used to immunize healthy
individuals and those at high risk of 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 5-49 years who are not pregnant. 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 the disease.7

In a typical year, manufacturers make influenza vaccine available before
the optimal fall vaccination season. For the 2003-04 influenza season, two
manufacturers-one with production facilities in the United States (sanofi
pasteur) 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. According to
CDC, MedImmune produced about 3 million doses of the nasal spray vaccine,
or about 4 percent of the overall influenza vaccine supply, for the
2003-04 season.

Influenza vaccine production and distribution are largely private-sector
activities. Manufacturers sell influenza vaccine to resellers (such as
medical supply distributors and pharmacies), to federal agencies and state
and local public health departments, or directly to providers (see fig.
2). Individuals can obtain an influenza vaccination at a number of places,
including physicians' offices, public health clinics, nursing homes, and
nonmedical locations such as workplaces or retail outlets. Millions of
individuals receive influenza vaccinations through mass immunization
campaigns in these nonmedical settings, where organizations such as
visiting nurse agencies under contract administer the vaccine.

7Four antiviral drugs have been approved for treatment. If taken within 2
days of illness, these drugs can reduce symptoms and make someone with
influenza less contagious to others.

Figure 2: Influenza Vaccine Production and Distribution

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.8 In the event that the Secretary of HHS determines
and declares a public health emergency, the Public Health Service Act
authorizes the Secretary to "take such action as may be appropriate" to
respond.9

8FDA has limited authority to prohibit the resale of prescription drugs,
including influenza vaccine that has been purchased by health care
entities such as public or private hospitals. This authority does not
extend to resale of the vaccine for emergency medical reasons. The term
"health care entity" does not include wholesale distributors.

Within HHS, CDC is one of the agencies that help protect the nation's
health and safety. CDC's activities include efforts to prevent and control
diseases and to respond to public health emergencies. ACIP, after
consulting with CDC, makes recommendations on which population groups
should be targeted for vaccination. CDC also administers a number of
programs to help make vaccines, including influenza vaccine, affordable
for low-income and other populations. For example, under CDC's Vaccines
for Children program, vaccines are provided free of charge for certain
children 18 years of age or younger, including those who are
Medicaid-eligible, uninsured, or underinsured (that is, their insurance
does not include vaccinations). CDC also reserves stockpiles of certain
vaccines. For the 2004-05 influenza season, CDC contracted with vaccine
manufacturers to supply influenza vaccine for a national stockpile for the
first time. The agency originally contracted for 4.5 million doses,
including 2 million doses from Chiron, which were therefore not available.
CDC also maintains stockpiles of antiviral medications that can alleviate
influenza symptoms and reduce contagion in those who contract the disease.

Other organizations within HHS that are involved with immunization
activities include the National Vaccine Program Office, which is
responsible for coordinating and ensuring collaboration among the many
federal agencies involved in vaccine and immunization activities, and the
Food and Drug Administration (FDA), which in approving and regulating the
use of vaccines and drugs, including antiviral medications, is responsible
for ensuring that they are safe and effective. In addition to federal
agencies, state and local health departments are often the first
responders in situations affecting public health.

Initially for the 2004-05 influenza season, CDC in May 2004 recommended
that about 188 million Americans receive a vaccination-about 85 million at
high risk of severe complications and about 103 million in other priority
groups, such as people in close contact with high-risk individuals,
healthy people aged 50-64 years, and health care workers.10 CDC also
suggested that, depending on the availability of vaccine, other
individuals who should receive a vaccination include (1) any person who
wished to reduce the likelihood of contracting influenza, (2) individuals
who provide essential community services, and (3) students and others in
institutional settings. Although Chiron had announced that it was
experiencing production problems in August 2004, according to CDC, the
manufacturer had assured the agency that the production issues were being
resolved. Subsequently, on September 24, 2004, CDC reiterated its
recommendation that 188 million individuals in high-risk and other groups
be vaccinated as vaccine became available. CDC also recommended that
anyone wanting to reduce the risk of contracting influenza be vaccinated.
Not everyone in these high-risk and priority groups, however, receives a
vaccination each year. Among health care workers, for example, about 40
percent received a vaccination in the 2002-03 and 2003-04 seasons,
according to one CDC survey. Similarly, about 66 percent of individuals
aged 65 years and older reported receiving influenza vaccination in the
2002-03 and 2003-04 influenza seasons, according to CDC estimates.11

9According 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 Improvement Act, Pub. L. No. 106-505, S: 102, 114 Stat.
2314, 2315 (2002) (adding S:319 to the Public Health Service Act)
(codified at 42 U.S.C. S: 247d).

  Health Officials Took Steps to Vaccinate High-Risk Individuals and Others in
                                Priority Groups

After the October 5, 2004, announcement of the sharp reduction in expected
influenza vaccine supply, federal, state, and local health officials took
steps to help ensure that those at high risk of severe complications from
infection had access to influenza vaccine. For example, health officials
quickly revised vaccination recommendations so that the remaining supply
could be targeted to those in priority groups comprising those at high
risk, certain health care workers, and household contacts of children
younger than 6 months of age. Other efforts focused on distributing
vaccine to priority groups and on keeping providers and the public updated
as to vaccine availability. Finally, late in the influenza vaccination
period-from mid-December through January-health officials' actions focused
on further augmenting the vaccine supply and, once supply increased, on
encouraging vaccination for anyone remaining in the priority groups and
for others who had earlier deferred vaccination (see fig. 3).

10CDC recommended vaccination for people aged 50-64 years to raise the low
vaccination rates among people with high-risk conditions in this age
group. Further, people in this age group without high-risk conditions also
benefit from lower influenza rates, fewer medical visits, and less
medication. See Centers for Disease Control and Prevention, "Prevention
and Control of Influenza: Recommendations of the Advisory Committee on
Immunization Practices," Morbidity and Mortality Weekly Report, vol. 53,
RR-6 (2004): 1-40.

11See 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.

Figure 3: Timeline of the 2004-05 Influenza Vaccine Shortage

aCDC actions broadening recommendations on who should be vaccinated
applied only in locations where state and local health officials judged
vaccine supply to be adequate.

Federal and State Officials Took Quick Actions

Several responses by public health officials took place within hours or
days of the public announcement that a severe shortage of influenza
vaccine was imminent.

           o  Federal and state health officials redefined priority groups
           for influenza vaccination. CDC immediately redefined the groups
           recommended to receive vaccine in 2004-05 for protection against
           influenza and its complications and issued revised recommendations
           on October 5, 2004. These revised recommendations focused on
           priority groups that included high-risk individuals, health care
           workers involved in direct patient care, and household contacts of
           children younger than 6 months of age. CDC's revised
           recommendations decreased the number of people in groups
           recommended for vaccination from about 188 million to about 98
           million (see table 1).12 At the same time, CDC also asked people
           not in these priority groups to forgo or defer vaccination. State
           and local health officials we met with reported having quickly
           adopted CDC's revised recommendations. Some health departments,
           however, found that they did not have enough vaccine to cover
           everyone in CDC's priority groups and therefore subdivided CDC's
           priority groups. For example, in Maine, all health care workers
           were initially excluded from the state's priority groups, although
           later, Maine health officials recommended vaccination for
           particular types of health care workers, such as those working in
           intensive care units and emergency departments, if local vaccine
           supply allowed.

12On October 5, 2004, CDC issued interim recommendations for influenza
vaccination during the 2004-05 season, which took precedence over earlier
recommendations. The season's priority groups for vaccination with
injectable influenza vaccine were considered to be of equal importance.
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.

Table 1: Groups Recommended for Influenza Vaccination, Before and After
October 5, 2004

                                            Population             October 5, 
                                           (millions)a May 2004b,c      2004c 
High-risk groups                                                
People aged 65 years and older                 35.6             
Adults and children with chronic               39.4             
illness                                                         
Pregnant women                                  4.0             
All children aged 6-23 months                   5.9             
Other priority groups                                           
Health care workers aged 64 years and           7.0             
younger                                                         
People aged 2-64 years who are                 69.5             
household contacts of high-risk                                 
individualsd                                                    
People aged 2-64 years who are                                  
household contacts of children younger                          
than 6 monthsd                                  6.3             
Healthy people aged 50-64 years who are                         
not household contacts of high-risk                             
individuals                                    20.1             
Totals                                                    187.8       98.2 

Source: CDC.

Note: Check marks denote priority groups recommended by CDC, at the time
shown, for vaccination.

aBased on July 1, 2002, population estimates, U.S. Census Bureau.

bCDC suggested that, depending on vaccine availability, anyone wishing to
reduce the likelihood of contracting influenza, individuals who provide
essential community services, and students and others in institutional
settings also be vaccinated.

cCDC suggested that residents of nursing homes and long-term-care
facilities, and children 6 months-18 years old receiving chronic aspirin
therapy, also be vaccinated.

dThese groups belonged to a single category in CDC's May 2004
recommendations.

           o  HHS collaborated with manufacturers to temporarily halt further
           distribution of injectable influenza vaccine and to ramp up
           production of nasal spray vaccine. At the request of CDC, sanofi
           pasteur, the sole remaining manufacturer of injectable influenza
           vaccine for the U.S. market, voluntarily suspended further
           distribution of the approximately 25 million doses it had not yet
           shipped on October 5, 2004, until the week of October 11, 2004,
           when CDC completed its assessment of the situation. Distribution
           was temporarily halted because CDC needed time to devise a plan to
           better target vaccine distribution to providers serving
           individuals in the priority groups. HHS officials also worked with
           MedImmune, the maker of the nasal spray vaccine, to increase its
           production for the 2004-05 influenza season from about 1 million
           doses to a total of 3 million doses.

           o  Federal officials evaluated foreign sources of influenza
           vaccine and assessed the federal stockpile of antiviral
           medications. On October 11, 2004, HHS convened an interagency
           team, comprising officials from HHS's Office of the Secretary,
           CDC, FDA, and others, to devise a plan to import influenza vaccine
           not licensed for the U.S. market from foreign manufacturers; this
           vaccine could be administered in the United States under an
           investigational new drug protocol.13 Around the same time, FDA
           quickly authorized the redistribution of vaccine among hospitals
           and other health entities to alleviate shortages.14 HHS also
           assessed its stockpile of antiviral medications that could be used
           to prevent or treat influenza and began the process of purchasing
           more. According to HHS officials, by December 2004 the federal
           government purchased and stockpiled enough antiviral medicines to
           treat more than 7 million people.
           o  State and local health departments used existing emergency
           plans and incident command systems. Some state and local health
           departments used their emergency preparedness plans and incident
           command systems (the organizational systems set up specifically to
           handle the coordinated response to emergency situations) during
           the influenza vaccine shortage. The five state health departments
           and two of the local health departments we visited used their
           incident command systems to help manage shortage-related
           activities, and three of the state health departments reported
           using their emergency plans. In addition, officials from the
           Florida Health Care Association, an organization representing
           long-term-care providers in that state, reported using certain
           elements in their disaster planning guide, which includes plans
           for disasters like hurricanes or bioterrorism.
           o  Federal and state officials took measures against price
           gouging. Around the time (October 13, 2004) that one Florida-based
           distributor was sued by that state for selling influenza vaccine
           at significantly inflated prices,15 several states began issuing
           warnings that all suspected cases of price gouging by vaccine
           distributors and providers would be reported to the states'
           attorneys general for further investigation and possible
           prosecution. In support of states' efforts to curtail the
           overpricing of limited influenza vaccine, CDC began collecting
           reports of price gouging and shared the information with the
           National Association of Attorneys General and state prosecutors.
           On October 14, 2004, the Secretary of HHS sent a letter to the
           attorney general of each state, urging thorough investigation of
           reports of price gouging, and on October 22, 2004, HHS filed a
           "friend of the court" brief in support of the Florida lawsuit.

           Beginning in mid-October, federal, state, and local public health
           officials acted to distribute the remaining 25 million doses of
           injectable influenza vaccine across the states and directed the
           limited amount of available injectable vaccine to those in
           priority groups. State and local public health departments also
           took steps to help ensure that vaccine was distributed to those
           within their jurisdictions who were in priority groups.

           In October and November, working with representatives from
           national public health organizations and sanofi pasteur, CDC
           developed a plan to distribute sanofi pasteur's unshipped vaccine.
           The plan consisted of two overlapping phases and was aided by the
           manufacturer's voluntary sharing of proprietary information to
           help identify geographic areas in greatest need of vaccine.

           Phase I, which began the week of October 11, 2004, consisted of
           filling orders that were clearly identifiable as public-sector
           orders and orders, such as those from long-term-care facilities,
           that had been placed with sanofi pasteur. Orders selected for full
           or partial filling included those that could be immediately
           identified as placed by the Department of Veterans Affairs, the
           Indian Health Service, long-term-care facilities and hospitals,
           and others (see table 2). Filling these orders distributed
           approximately 13 million doses of vaccine over a 6-8 week period.

           Table 2: Phase I of CDC's Influenza Vaccine Distribution Plan

           Source: CDC.

           Phase II, which was announced by CDC on November 9, 2004,
           consisted of distributing approximately 12 million doses: about 3
           million doses for some of the remaining public-sector orders from
           phase I and about 9 million doses across the states according to a
           formula based on each state's percentage of the estimated
           nationwide unmet need.16 CDC calculated a state's unmet need by
           taking the total estimated number of individuals in priority
           groups in the state and subtracting the total number of doses that
           had been delivered before and during phase I. To help state health
           officials identify the regions within their states needing vaccine
           from phase II distribution, CDC developed an Internet-based
           program called the Flu Vaccine Finder on its secure data
           network.17 The program allowed state health officials to view,
           county by county, a list of vaccine orders shipped by sanofi
           pasteur to various types of customers, such as pediatricians and
           hospitals. Officials could then allocate vaccine available to
           their state under phase II to providers within their state that
           needed, but had not yet received, vaccine (see fig. 4). According
           to CDC officials, the agency understood that not all of the phase
           II doses would be ready to ship to states at once, so orders were
           partially filled and shipped in waves. Furthermore, the formula
           for determining each state's allocation was imperfect, according
           to CDC, resulting in some states' having more vaccine than needed
           to cover demand from those in priority groups and other states'
           having too little. In response, CDC reallocated vaccine available
           for ordering by states in December 2004. In addition, some states
           found it necessary to redistribute vaccine within their own
           borders, or they attempted to purchase or sell vaccine to other
           states to best align supply and demand at local levels. States
           could begin ordering their vaccine allotments through the secure
           data network on November 17, 2004, and ordering continued through
           mid-January.

           Figure 4: Phase II of CDC's Influenza Vaccine Distribution Plan

           Note: Not all states (for example, Minnesota and Maine) chose to
           order vaccine through phase II of CDC's influenza vaccine
           distribution plan.

           Public health officials at all levels implemented various
           strategies to help ensure that their vaccine supplies were
           targeted to high-risk individuals and others in priority groups.

           o  Emergency directives issued. To help support providers in
           vaccinating only those individuals in CDC's priority groups, a
           number of states, such as California and Florida, issued emergency
           public health directives requiring health care providers to limit
           influenza vaccination to people in priority groups and to refrain
           from vaccinating individuals not in CDC's priority groups.18 Some
           of these directives, including those of the District of Columbia
           and Michigan, explicitly stated that providers failing to comply
           with these directives could face penalties, such as fines or
           imprisonment. But some states chose not to issue emergency
           directives. For example, Minnesota state health officials reported
           that they had such strong voluntary compliance and cooperation
           from the state's provider community that they decided it was not
           necessary to post a directive mandating compliance.
           o  Surveys conducted of providers and long-term-care facilities.
           During mid-October, working with national professional
           organizations, CDC conducted a survey of long-term-care facilities
           to identify those that had placed orders with Chiron. A number of
           health departments, including six we visited, had also surveyed
           long-term-care facilities, and at least two, Minnesota and
           Seattle-King County in Washington State, completed their surveys
           before CDC began administering its version. In addition, many
           state health departments, including three we visited, surveyed
           providers about vaccine availability and the need for covering
           those in priority groups. In an effort to assess the degree of the
           vaccine supply shortage, for example, Minnesota public health
           officials developed and administered a survey to identify how much
           influenza vaccine was available in each of its 92 local public
           health jurisdictions, not knowing before the shortage which
           providers had ordered vaccine from Chiron or which ones had
           ordered from sanofi pasteur.
           o  Vaccine transferred among states. Because CDC's distribution
           plan was based in part on estimated need for vaccine, some states
           received more than enough to cover demand from their priority
           groups, and some states received too little. To redistribute
           vaccine to locations that needed vaccine to meet demand from
           priority groups, a state could attempt to sell its available
           vaccine to another state. According to the Association of State
           and Territorial Officials, Nebraska shipped some vaccine to other
           states when its own demand was met. Minnesota state health
           officials also reported offering to sell available vaccine to
           other states. At the same time, states without enough vaccine,
           such as Maryland, tried to obtain it from another.
           o  Partnerships established with the private sector. To augment
           state and local vaccine supply, public health departments looked
           to the private sector for help. A number of state and local health
           departments we talked with reported facilitating redistribution or
           acting as brokers for donations of vaccine that had been purchased
           by large employers for employee vaccination campaigns before the
           shortage. According to health officials in Washington, for
           example, one large employer donated about 700 doses of influenza
           vaccine to the health department in Seattle-King County, which was
           then able to supply local nursing homes. Certain states and
           localities partnered with for-profit and not-for-profit home
           health organizations, which held mass immunization clinics and set
           up clinics in providers' offices to help administer the vaccine
           quickly. For example, the Visiting Nurses Association of Southern
           Maine held a mass immunization clinic on a local college campus.
           These organizations followed CDC's recommendations for vaccinating
           priority groups by screening potential vaccine recipients.
           o  Crowding alleviated through appointments and lotteries. In an
           effort to control crowding, health officials in some localities
           created vaccination appointments for individuals who were at high
           risk or in another priority group. When available supplies were
           insufficient to cover every qualified person who wanted a
           vaccination, some health departments held lotteries for available
           vaccine. The local public health department in Portland, Maine,
           for example, held a lottery for the small amount of vaccine it had
           received before the shortage plus the several hundred doses
           donated by an area medical center and the state department of
           health. To register for the lottery, people had to show they
           belonged to a priority group by supplying a note from their
           provider.

           Throughout the 2004-05 influenza vaccine shortage, federal, state,
           and local health officials used a variety of communication
           mechanisms to keep health officials, providers, and the public
           updated about vaccine availability and about the various
           strategies for distribution to providers and the public. At the
           federal level, CDC held frequent press conferences beginning in
           early October 2004. At these events, the agency updated the public
           on current efforts and recommendations, and it asked people who
           did not belong to a priority group to step aside and defer
           vaccination so that those in the priority groups would have
           access. CDC also conducted biweekly conference calls with
           representatives from various national health organizations to
           update them and obtain their feedback on distribution efforts.19
           According to CDC officials, state and local health officials could
           generally access the minutes from these discussions the following
           day on CDC's Health Alert Network.20 CDC also used this network to
           send advisories and updates on the influenza vaccine situation,
           beginning on October 5, 2004, and continuing through the end of
           January. The majority of the state health officials we met with
           reported receiving key information about the shortage from this
           network; the information was then forwarded to local health
           officials, hospitals, and medical associations that, in turn,
           passed the information on to providers.

           State and local health officials we met with also reported using
           various communication methods to relay national guidance, along
           with state and local guidance, and information about vaccine
           availability. These communication methods included mass e-mails
           and faxes; public education campaigns for influenza prevention;
           the media, including television, radio, and newspapers; telephone
           hotlines; and Web sites (see table 3).

13FDA requires the submission of an investigational new drug application
before the initial entry of an unapproved drug-including vaccines licensed
for use in other countries-into human studies in the United States. This
investigational new drug application includes a description of the vaccine
and its method of manufacture, and results of previously conducted quality
control and toxicology testing.

14Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act allows such
entities to sell, purchase, or trade a drug or vaccine or offer to sell,
purchase, or trade a drug or vaccine for emergency medical reasons. On
October 9, 2004, CDC issued a statement noting that "anticipated shortages
of influenza vaccine this influenza season constitute emergency medical
reasons."

15Florida v. ASAP Meds. Inc., No. 04-16032(09) (Fla. Cir. Ct. filed Oct.
13, 2004) (settlement agreement filed May 19, 2005).

Public Health Officials Acted to Distribute Remaining Vaccine

  CDC Devised a Plan to Distribute the Limited Supply of Influenza to High-Risk
  Individuals and to Others in Priority Groups

                                                         Percentage of orders 
Provider type                                                       filled 
Department of Veterans Affairs                                         100 
Indian Health Service                                                  100 
Long-term-care facilities and hospitals                                100 
Providers who care for children (Vaccines for                              
Children program providers, office-based              
pediatricians)                                                         100
Community immunization providers                                        75 
Visiting Nurses Association of America                                  50 
Department of Defense                                                   50 
Office-based primary care providers                                     50 
State and local public health departments                               50 

16To determine the number of individuals in priority groups in each state,
CDC used U.S. Census data and available data from the National Health
Interview Survey for each of the groups.

17The secure data network is an ongoing project sponsored by CDC that
allows CDC field staff, researchers, and public health partners to
securely exchange confidential, proprietary, or sensitive data over the
Internet.

  Federal, State, and Local Actions Limited Vaccine to High-Risk Individuals and
  Others in Priority Groups

18During the 2004-05 influenza season, the Association of State and
Territorial Health Officials reported that 15 states and the District of
Columbia issued emergency public health directives.

Public Health Officials Used Multiple Communication Strategies to Impart Key
Information

19National health organizations included the Association of State and
Territorial Health Officials, National Association of County and City
Health Officials, Council of State and Territorial Epidemiologists, and
Association of Public Health Laboratories.

20The Health Alert Network is an early-warning and response system
operated by CDC, which 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.

Table 3: Communication Methods Used by Various Health Departments to
Disseminate Influenza Information

                                            Public                            
                                           education                          
                  Mass   Health  Provider  campaign                      
                e-mails,  Alert  education (posters,   Media   Telephone Web
                 faxes   Network campaign   flyers)  publicity  hotline  site
California                                                            
State health                                                          
agency                                                                
San Diego                                                             
San                                                                   
Francisco                                                             
Florida                                                               
State health                                                          
agency                                                                
Miami-Dade                                                            
County                                                                
Maine                                                                 
State health                                                          
agency                                                                
Portland                                                              
Minnesota                                                             
State health                                                          
agency                                                                
Stearns                                                               
County                                                                
Washington                                                            
State health                                                          
agency                                                                
Seattle-King                                                          
County                                                                

Source: GAO.

Late-Season Actions Aimed to Boost Supply and Demand

At the latest part of the influenza vaccination period, from mid-December
2004 through January 2005, federal and state health officials took several
actions intended to further augment the vaccine supply and make vaccine
more accessible. Four areas were addressed: broadened recommendations for
groups to be vaccinated, modifications to the Vaccines for Children
program, purchase of foreign-made vaccine, and release of the federal
stockpile of influenza vaccine.

           o  CDC and states broadened the priority groups for influenza
           vaccination. On December 17, 2004, CDC announced broadened
           vaccination recommendations to include those aged 50-64 years and
           household contacts of high-risk individuals in locations where
           state and local health officials judged vaccine supply to be
           adequate. CDC's broadened recommendations became effective January
           3, 2005, allowing extra time for vaccination of individuals in the
           original priority groups and time for state and local health
           departments to prepare for increased requests for vaccine.21 As of
           January 3, 2005, however, according to information from the
           Association of State and Territorial Health Officials, 20 states
           had already expanded vaccination recommendations: 13 specified the
           additional groups identified by CDC, and 7 lifted all vaccination
           restrictions, allowing anyone wanting a vaccination to get one.22
           On January 27, 2005, CDC endorsed states' efforts to broaden
           vaccination recommendations to include all people wanting
           influenza immunization in states and localities where vaccine
           supply was sufficient to do so. Before that date, according to
           association officials, 27 states had already expanded
           recommendations to include everyone, although a few states waited
           longer to expand recommendations.
           o  CDC made vaccine from the Vaccines for Children program more
           widely available.23 CDC's ACIP passed a resolution for CDC's
           Vaccines for Children program, effective December 17, 2004, that
           expanded the groups of children eligible to receive the program's
           influenza vaccine to include program-eligible children outside of
           CDC's priority groups who were household contacts of people in
           high-risk groups. Later, on January 27, 2005, CDC authorized
           limited amounts of influenza vaccine from the Vaccines for
           Children program and held by the states to be transferred to state
           health departments for nonprogram use where the demand among
           program-eligible children had already been met. Public providers
           that had a reserve of program vaccine after vaccinating their
           program-eligible children could then use this vaccine for adults
           and children who were not eligible for the Vaccines for Children
           program.
           o  HHS purchased foreign-manufactured influenza vaccine for the
           U.S. market. After efforts initiated in early October to develop a
           plan to obtain foreign-made influenza vaccine that was not
           licensed for the U.S. market and make it available under an
           investigational new drug protocol, HHS in December 2004 purchased
           about 1.2 million doses from one manufacturer in Germany and, in
           January 2005, purchased about 250,000 doses from another
           manufacturer in Switzerland. CDC could then make this vaccine
           available to those states and localities wanting additional
           vaccine to alleviate shortages. According to HHS officials,
           however, none of the additional doses were used in the 2004-05
           influenza season.
           o  CDC made stockpiled vaccine available to providers. On January
           27, 2005, after the production of 3.1 million late-season doses
           designated for CDC's stockpile of influenza vaccine,24 CDC
           announced that that it would make this vaccine available to sanofi
           pasteur, which, in turn, could market and sell the vaccine to
           public and private providers and then replenish CDC's stockpile.
           This strategy allowed providers to order influenza vaccine
           directly from the manufacturer or a distributor, rather than go
           through state or local health departments. Providers who purchased
           these stockpiled doses would also be allowed to return unused
           vaccine for a credit and would have to pay only shipping costs for
           returned vaccine.

           Although the actions taken to address the influenza vaccine
           shortage helped achieve vaccination rates approaching past levels
           for certain priority groups (see fig. 5), a number of lessons
           emerged from federal, state, and local responses to the 2004-05
           influenza shortage. Some lessons were specific to that season's
           shortage, and others have wider ramifications for potential future
           shortages or a pandemic. The primary lessons can be grouped into
           three broad, interrelated categories: planning, timely action, and
           communication.

           Figure 5: Influenza Vaccination Rates for Selected Priority Groups

           Before October 5, 2004, CDC lacked a contingency plan specifically
           designed to respond to a scenario involving a severe influenza
           vaccine shortage at the start of the traditional fall vaccination
           period; the absence of a plan led to a delay in response. Faced
           with the unanticipated shortfall in the amount of influenza
           vaccine expected to be available for the 2004-05 influenza season,
           CDC revised recommendations and worked with sanofi pasteur to
           begin assessing available supply and to create a distribution plan
           for the remaining vaccine. Developing and implementing this plan
           took time and led to delays in response and some confusion at the
           state and local levels, particularly right after Chiron's October
           5, 2004, announcement. Public health officials in all five states
           we visited remarked that although phase I of CDC's redistribution
           plan quickly and effectively distributed some vaccine to public
           and private providers serving priority groups, the vaccine
           available in phase II of CDC's redistribution plan was too much,
           too late. Phase II ordering began on November 17, 2004, and
           continued into January 2005, but several weeks could elapse after
           orders were placed until vaccine was delivered. According to state
           and local public health officials we interviewed, by the time the
           vaccine was delivered through a cumbersome distribution process,
           demand for the vaccine had substantially waned, and public and
           private providers were left to redistribute the excess. The phase
           II distribution problem was compounded for state and local health
           officials because CDC restricted access to its secure data network
           to two people per state. This narrow restriction left several
           state and local public health officials, according to those we
           interviewed, without vital information about the supply or demand
           for vaccine.

           Our work showed that four areas of planning are particularly
           important for enhancing preparedness before a similar situation in
           the future: (1) defining the responsibilities of federal, state,
           and local officials; (2) using emergency preparedness plans and
           emergency health directives; (3) distinguishing between demand and
           need; and (4) identifying mechanisms for distributing and
           administering vaccine.

           o  Better defining responsibilities of federal, state, and local
           officials can minimize confusion. During the 2004-05 vaccine
           shortage, CDC worked with national organizations representing
           states and localities to coordinate roles and responsibilities.
           Several public health officials we spoke with reported that CDC
           effectively worked with sanofi pasteur and national organizations
           representing state and local health officials to coordinate
           responsibilities shortly after Chiron's announcement. Despite
           these efforts, however, problems occurred. For example, to
           identify national demand for vaccine, federal, state, and local
           health officials surveyed providers in states and localities to
           assess existing supply and additional need. 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 identical
           determination. This duplication of effort expended additional
           resources, burdened some long-term-care providers in the states,
           and created confusion.
           o  Emergency preparedness plans and emergency health directives
           help coordinate local response. State and local health officials
           in several locations we visited reported that using existing
           emergency plans or incident command centers helped coordinate
           effective local response 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 CDC's recommendations and in helping to
           prevent price gouging in those states whose directives addressed
           price gouging. Certain officials we spoke with, however, reported
           that although plans and directives helped, improvements were still
           needed. Some health officials indicated that as a result of the
           past influenza season, they were revising state and local
           preparedness plans or modifying command center protocols to
           prepare for future emergency situations. For example, in Maine,
           after experiences during the 2004-05 influenza season, state
           officials recognized the need to speed completion of their
           pandemic influenza preparedness plan. In addition, they said the
           vaccine shortage experience helped identify which officials should
           attend which meetings during a crisis to ensure the right people
           have the right information.
           o  Distinguishing between demand and need for vaccine can improve
           distribution. In discussing the adequacy of vaccine supplies,
           public health officials make a distinction between demand and need
           for vaccine by a high-risk group. In this context, demand is the
           number of high-risk individuals who want to receive an influenza
           vaccination, and need is the total number of high-risk individuals
           in an area or region, regardless of whether they want to receive a
           vaccination. Because some individuals in high-risk groups are
           unlikely to be vaccinated, estimating vaccine amounts on the basis
           of total need, rather than demand, can overstate the amount that
           will likely be used in any given location. Differentiating between
           demand and need would have helped states avoid substantially over-
           or underordering vaccine from CDC or a manufacturer. California
           state officials said that differentiating between demand and need
           earlier in the season could have reduced delays and confusion
           during the shortage. Certain states and localities we visited had
           taken time before the season to address contingencies for vaccine
           supply fluctuations. For example, Minnesota state officials used
           experiences in previous influenza seasons to build a state
           influenza plan that educated providers and local public health
           officials about the difference between demand and need. According
           to state officials, communicating this difference to local
           providers and health officials helped more accurately identify how
           much vaccine was in demand throughout the state.
           o  The distribution and administration of vaccine can be
           facilitated. One mechanism used in a majority of the states and
           localities we visited was building partnerships between public and
           private sectors. This mechanism was effective in both the
           distribution and the 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. In addition, several
           states and localities also partnered with other organizations,
           including home health organizations, to increase their capacity to
           administer vaccine to large numbers of people. For example, public
           health officials, including those in California and Florida,
           worked with national home health organizations to quickly immunize
           those in high-risk and other priority groups by holding mass
           immunization clinics. Other mechanisms we identified, aimed mainly
           at addressing the challenge of administering a limited amount of
           vaccine, included scheduling appointments and holding lotteries.
           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. Public health officials in Portland, Maine,
           emphasized the effectiveness of holding a lottery as a way to
           equitably administer limited amounts of vaccine to people and as
           an alternative to having large crowds show up for a limited number
           of doses.

           After the 2004-05 influenza season, CDC officials developed
           lessons learned from their experiences, including lessons on the
           importance of contingency planning and defining which groups have
           higher priority in the event of a vaccine shortage. In August
           2005, CDC issued interim guidelines to assist state and other
           immunization programs in planning for and dealing with an
           influenza vaccine shortage during the 2005-06 season.25 Also in
           August 2005, CDC published potential priority groups for
           vaccination in the event of a shortage. Because the total vaccine
           supply for the 2005-06 influenza season was not then known,
           however, CDC did not recommend setting priorities for injectable
           vaccine at that time.26 On September 2, 2005, CDC published
           priority recommendations for use of injectable vaccine through
           October 24, 2005.27

           During the 2004-05 influenza vaccine shortage, federal, state, and
           local officials needed to continually adapt to changing vaccine
           supply and demand, to make decisions, and to take action quickly.
           The actions they took after the traditional fall vaccination
           period, however, came too late to boost supply while demand was
           still high. These actions included making available
           foreign-manufactured vaccine that was not licensed for the U.S.
           market, expanding availability of vaccine from the Vaccines for
           Children program, and releasing vaccine reserved for the federal
           stockpile.

           HHS's decision to purchase influenza vaccine not licensed for the
           U.S. market and to make it available under an investigational new
           drug protocol was too late to mitigate the shortage's effects
           because of when such vaccines became available and because of
           cumbersome administrative requirements. Soon after Chiron's
           October 5, 2005, announcement, HHS started looking into foreign
           vaccine that was licensed for use in other countries but not in
           the United States. Nonetheless, by the time HHS purchased this
           vaccine in December 2004 and January 2005, there was little demand
           for it. CDC officials acknowledged that one lesson learned from
           experience in 2004-05 was that use of foreign-licensed vaccine
           under an investigational new drug protocol during the influenza
           season requires that vaccine be shipped no later than the
           beginning of October. Further, recipients of such vaccines may be
           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 and could dampen public enthusiasm for being
           vaccinated. Although about 1.5 million doses of this vaccine
           became available, none were used because demand had fallen, and
           injectable vaccine licensed for the U.S. market was still
           available.

           CDC's December 2004 and January 2005 implementation of decisions
           to make vaccine from the Vaccines for Children program more widely
           available was not timely and lacked flexibility. CDC explored
           options to use program vaccine to vaccinate three groups of
           people-children eligible for the Vaccines for Children program but
           not in a priority group, children not eligible for the program,
           and adults-but only in geographic areas where the needs of
           eligible children in high-risk groups had been met.28 But by the
           time CDC determined that demand from eligible children had been
           met and announced that it was taking steps to make more program
           vaccine available for others, many states' demand for additional
           vaccine had dropped. Because vaccine purchased under the Vaccines
           for Children program became available for nonprogram use so late,
           some states reported they were unable to vaccinate all their
           state's children in CDC's priority groups. In other states,
           vaccine purchased under the program remained unused after all
           program-eligible children were vaccinated, but completing the
           process to transfer the unused vaccine delayed some states from
           administering the remaining vaccine to individuals not eligible
           for Vaccines for Children. Since CDC expanded program vaccine
           availability too late, vaccine purchased under the Vaccines for
           Children program ultimately went unused. As a result, CDC is
           surveying epidemiologists, state health officials, and
           immunization managers on lessons learned to connect activities to
           outcomes, such as releasing program vaccine to increase
           immunization rates. Further, state health officials we interviewed
           reported that administrative difficulties in making vaccine
           available to a broader population hindered its ready use during
           the shortage. According to state health officials in California
           and Washington, if broadening Vaccines for Children eligibility
           had been more flexible and allowed more efficient transfer of
           vaccine to those not in the program, vaccine could have been made
           available sooner and more widely to people in priority groups.

           CDC's decision to release influenza vaccine produced for its
           national stockpile was also ineffective because the action came
           too late. The majority of doses reserved for the stockpile were
           not delivered until January 2005 because CDC wanted doses produced
           earlier in the season to be available to fill state orders. By the
           time the stockpiled doses were released back to the manufacturer
           for purchase by providers and others in January, national demand
           had shrunk. Of the 3.1 million doses of injectable vaccine
           released from the stockpile in January 2005, only approximately
           115,000 were ordered. Without exception, state health officials in
           the five states we visited reported that this vaccine became
           available too late in the season to be useful.

           Finally, certain states faced barriers when trying to buy
           available influenza vaccine from other states, preventing timely
           redistribution. During the 2004-05 shortage, some state health
           officials reported problems with their ability-both in paying for
           vaccine and in administering the transfer process-to purchase
           influenza vaccine. For example, 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
           flexibility 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, eliminating cost as a barrier
           in acquiring vaccine to distribute to the public.

           While part of the lesson learned about communication was positive,
           some aspects of this lesson pointed to need for improvement.
           Positives can be seen, for example, in the extent of CDC's
           communication. During the 2004-05 shortage, CDC communicated
           regularly through a variety of media as the situation evolved.
           Officials from most states and localities we talked with reported
           that CDC played an active role in communicating information
           despite a changing environment. Several state and local officials
           we spoke with said that biweekly conference calls were effective
           in providing updates and coordinating responsibilities. The state
           health officer from Alabama, for instance, noted the frequency and
           quality of the communications that CDC put forth during the
           influenza season.

           Despite these positives, when examining the 2004-05 influenza
           season, state and local officials identified areas of
           communication to improve for future seasons. During our visits to
           states and localities, we found four particularly important
           communication issues. These issues included maintaining
           consistency of communications to avert confusion, understanding
           the importance of changing messages under changing circumstances,
           using diverse media to reach diverse audiences, and educating
           providers and the public about prevention alternatives.

           o  Consistency among federal, state, and local communications is
           critical for averting confusion. Health officials in Minnesota,
           for example, reported that some confusion resulted when the state
           determined that the influenza vaccine supply was sufficient to
           meet demand and therefore made vaccine available to other groups,
           such as healthy individuals aged 50-64 years, earlier than
           recommended by CDC. Similarly, health officials in California
           reported that in mid-December, local radio stations in the state
           were running two public service announcements-one from CDC
           advising those aged 65 years and older to be vaccinated, and one
           from the California Department of Health Services advising those
           aged 50 years and older to be vaccinated. They emphasized that
           these mixed messages created confusion. In addition, some
           individuals seeking influenza vaccine in other regions 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
           were told to call their primary care provider, and when they
           called their primary care provider, they were told to call their
           local public health department. This inconsistency in information
           from authoritative sources led to confusion and possibly to
           high-risk individuals' giving up and not receiving an influenza
           vaccination.29 
           o  Modifying messages to respond to changing circumstances can
           prevent unintended consequences. Beginning in October, CDC
           communicated a message asking individuals who were not in a
           high-risk group or another priority group to forgo or defer
           vaccination, or to step aside, so that that those in priority
           groups could have access to available vaccine. According to CDC,
           this message resulted in an estimated 17.5 million individuals who
           specifically deferred vaccination to save vaccine for those in the
           priority groups. Public health officials we interviewed, however,
           lamented the fact that this nationwide effort did not also include
           a message to individuals who did step aside to check back with
           their providers or to seek an influenza vaccination later in the
           season. State and local officials suggested that CDC should have
           had a message to step aside until a certain estimated date, when
           more vaccine would be available and demand from individuals in the
           narrowed CDC priority groups would ease. These officials noted
           that many people in priority groups, including those aged 65 years
           and older who should have been vaccinated, stepped aside. These
           officials also said that they were concerned about other
           individuals, particularly those aged 50-64 years, who were not
           vaccinated during the moderate 2004-05 influenza season and, as a
           result, might think vaccination was not important enough to seek
           in future seasons.
           o  Using diverse media helps reach diverse audiences. During the
           2004-05 influenza season, public health officials reported the
           importance of using a variety of communication methods to help
           ensure that messages reached as many individuals as possible. For
           example, officials from the health department in Seattle-King
           County, Washington, reported that it was important to have a
           telephone 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. Further,
           public health officials in Miami-Dade County in 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 is important in alerting providers and the public
           about prevention alternatives. Educating health care providers and
           the public about all available influenza vaccines and forms of
           prevention may increase the number of vaccinated individuals and
           also reduce the spread of influenza. Experience with the nasal
           spray vaccine in 2004-05 illustrates the importance of education.
           Approximately 3 million doses of nasal spray vaccine were
           ultimately available during the season for vaccinating healthy
           individuals.30 According to public health officials we
           interviewed, however, some individuals were reluctant to use this
           vaccine because they feared that the vaccine was too new and
           untested or 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 500 doses were
           administered. 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.31

           According to CDC officials, as part of preparations for the
           2005-06 influenza season, the agency developed a draft
           communication plan-separate from the interim guidelines issued to
           states-from lessons learned, which includes messages for
           responding to the fluctuations in supply and demand anticipated
           throughout the season. As of August 2005, CDC officials said that
           this plan will remain in draft form because tactics will be
           changed and updated as circumstances change.

           Aided by a relatively moderate influenza season, efforts to
           mitigate the sudden and unexpected shortage of influenza vaccine
           for the 2004-05 season were largely successful, although the
           season was not without problems. Lacking a preseason plan to
           address a significant shortfall after the beginning of the
           traditional fall vaccination period, the federal government
           reacted to the shortage and its aftereffects as they unfolded
           throughout the season. This lack of preseason planning created
           confusion and delays during the optimal fall influenza vaccination
           window, when state and local public health agencies and health
           care providers most needed vaccine to protect individuals at high
           risk of severe complications. Conversely, federal efforts to boost
           supply late in the season had little effect, because demand fell
           off sharply in December and January, and vaccine became available
           too late. In some instances, uncoordinated communication from
           federal to state and local jurisdictions, and to providers and the
           general public, contributed to confusion, frustration, and
           individuals' failure to seek or receive an influenza vaccination.
           Drawing from experiences during the 2004-05 shortage, CDC has
           taken a number of steps, including issuing interim guidelines in
           August 2005, to assist in responding to possible future shortages.
           It is too early, however, to assess the effectiveness of these
           efforts in coordinating actions of federal, state, and local
           health agencies and others who play a part in the annual influenza
           vaccination process.

           In commenting on a draft of this report, HHS noted that the draft
           summarized in detail the activities undertaken by CDC and its
           public- and private-sector partners to deal with the influenza
           vaccine shortage of 2004-05, and the agency concurred with our
           finding that contingency planning will greatly improve response
           efforts. The agency also provided details on other actions, such
           as approval of additional influenza vaccines for the U.S. market,
           that were under way. HHS also agreed that adjustments to
           vaccination recommendations and vaccine supply ideally should
           occur earlier in the influenza season, but such adjustments cannot
           always be implemented in a shortage year. HHS's written comments
           appear in appendix I.

           As arranged with your office, unless you publicly announce the
           contents of this report earlier, we plan no further distribution
           of it until 30 days after its issue date. At that time, we will
           send copies of this report to the Secretary of HHS, the Directors
           of CDC and the National Vaccine Program Office, and other
           interested parties. We will also make copies available to others
           upon request. In addition, the report will be available at no
           charge on the GAO Web site at http://www.gao.gov .

           If you or your staff members have any questions, please contact me
           at (202) 512-7119 or [email protected]. Contact points for our
           Offices of Congressional Relations and Public Affairs may be found
           on the last page of this report. GAO staff members who made major
           contributions to this report are listed in appendix II.

           Marcia Crosse Director, Health Care

           Marcia Crosse, (202) 512-7119 or [email protected]

           In addition to the contact named above, Kim Yamane, Assistant
           Director; George Bogart; Ellen W. Chu; Nicholas Larson; Jennifer
           Major; Terry Saiki; and Stan Stenersen made key contributions to
           this report.

           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.

           Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts
           Have Improved Public Health Response Capacity, but Gaps Remain.
           GAO-03-654T . Washington, D.C.: April 9, 2003.

           Bioterrorism: Preparedness Varied across State and Local
           Jurisdictions. GAO-03-373 . Washington, D.C.: April 7, 2003.

           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.

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

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21See Centers for Disease Control and Prevention, "Updated Interim
Influenza Vaccination Recommendations, 2004-05 Influenza Season,"
Morbidity and Mortality Weekly Report, vol. 53, no. 50 (2004): 1183-1184.

22By December 15, 2004, nine states had begun offering influenza vaccine
to people aged 50 years and older and to household contacts of high-risk
individuals.

23In November 2004, CDC provided guidance for providers to borrow
influenza vaccine from the Vaccines for Children program, to immunize
children ineligible for the program, if, among other things, the providers
anticipated being able to replace the borrowed doses in the near term.

  Planning, Timely Action, and Communication Are Key to an Effective Response

24Before Chiron's announcement, CDC had planned to establish a stockpile
of approximately 4.5 million doses of injectable influenza vaccine
purchased from both Chiron and sanofi pasteur. The primary purpose of the
planned stockpile was to meet late-season, unmet pediatric demand.

Lesson Learned: Limited Contingency Planning Slows Response

Lesson Learned: Unless Expedited, Actions to Boost Supply Are Likely to Have
Little Effect

25CDC indicated that it had assembled a team in December 2004 to begin
contingency planning for the 2005-06 influenza season. See Centers for
Disease Control and Prevention, "Interim Guideline: Planning for a
Possible U.S. Influenza Vaccine Shortage, 2005-06 Season," August 4, 2005,
http://www.cdc.gov/flu/professionals/vaccination/pdf /vaccshortguide.pdf
(downloaded on Aug. 24, 2005).

26See Centers for Disease Control and Prevention, "Tiered Use of
Inactivated Influenza Vaccine in the Event of a Vaccine Shortage,"
Morbidity and Mortality Weekly Report, vol. 54, no. 30 (2005): 749-750.

27See Centers for Disease Control and Prevention, "Update: Influenza
Vaccine Supply and Recommendations for Prioritization during 2005-06
Influenza Season," Morbidity and Mortality Weekly Report, vol. 54, no. 34
(2005): 850.

28CDC indicated that because the Vaccines for Children program is an
entitlement, moving too rapidly to release vaccine to ineligible people
may risk denying vaccine to children for whom the law requires
availability.

Lesson Learned: Effective Response Requires Communication to Be Both Clear and
Consistent

29According 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 a 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.

                            Concluding Observations

30The 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.

31CDC posted guidance on its Web site in October 2004 about use of
antiviral medications and other ways to prevent the spread of influenza,
including covering the mouth when coughing, hand washing, and staying home
from work when ill. See http://www.cdc.gov/flu/protect/preventing.htm
(downloaded on Aug. 8, 2005).

                                Agency Comments

Appendix I: Comments from the Department of Health and Human Services
Appendix I: Comments from the Department of Health and Human Services

Ap Ac Appendix II: GAO Contact and Staff Acknowledgments

                                  GAO Contact

                                Acknowledgments

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September 2005

INFLUENZA VACCINE

Shortages in 2004-05 Season Underscore Need for Better Preparation

In early October 2004, the nation lost about half its expected influenza
vaccine supply when one of two major manufacturers announced it would not
release any vaccine for the 2004-05 season because of potential
contamination. The Centers for Disease Control and Prevention (CDC) had
earlier recommended vaccination for 188 million individuals, including
those at high risk of severe complications from influenza (such as seniors
and those with chronic conditions), and other groups (such as their close
contacts). Although health officials took actions to distribute the
limited supply of influenza vaccine, reports persisted of high-risk
individuals and others in priority groups who could not find a
vaccination, including those who were turned away and never returned when
supplies became available. Such reports raised questions about the
adequacy of U.S. preparedness to respond to significant vaccine shortages.

GAO was asked to examine actions taken at federal, state, and local levels
to ensure that high-risk individuals had access to influenza vaccine
during the shortage, including any lessons learned.

Federal, state, and local health officials took several actions beginning
in October 2004 to help ensure that individuals at high risk of severe
complications from influenza had access to vaccine. Federal officials, for
example, quickly revised vaccination recommendations to target available
vaccine to high-risk individuals and to other priority groups. Additional
actions were aimed to distribute vaccine expeditiously and to communicate
with providers and the public as events unfolded and vaccine supplies
changed. Beginning in mid-December, health officials took steps to
distribute additional vaccine, broadening recommendations on who should be
vaccinated.

Although these actions helped achieve vaccination rates approaching past
levels for certain priority groups, such as those aged 65 years and older,
several lessons emerged, including some that could help with future
shortages. First, unless planning for problems is already in place, action
is delayed. CDC's lack of a contingency plan contributed to delays and
uncertainty about how to ensure that high-risk individuals had access to
vaccine. Second, when actions occur late in the influenza season, they are
likely to have little effect. Third, effective response requires
communication that is both clear and consistent. CDC has taken a number of
steps, including issuing interim guidelines in August 2005, to respond to
possible future shortages. It is too early, however, to assess the
effectiveness of these efforts in coordinating actions of federal, state,
and local health agencies and others.

In commenting on a draft of this report, HHS concurred with GAO's finding
that contingency planning would improve response efforts, and the agency
indicated that additional preparations were under way.

Influenza Vaccination Rates for Selected Priority Groups
*** End of document. ***