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Report to the Committee on Oversight and Government Reform, House of 
Representatives: 

United States Government Accountability Office: 

GAO: 

October 2007: 

Influenza Vaccine: 

Issues Related to Production, Distribution, and Public Health Messages: 

Seasonal Influenza Vaccine: 

GAO-08-27: 

GAO Highlights: 

Highlights of GAO-08-27, a report to the Committee on Oversight and 
Government Reform, House of Representatives. 

Why GAO Did This Study: 

Annual vaccination is the main method for preventing seasonal 
influenza, which typically occurs in the United States from late fall 
to early spring. Manufacturers produce vaccine through a lengthy and 
complex process. Manufacturers and medical supply distributors then 
ship vaccine to providers such as physicians. Each year, the Department 
of Health and Human Services’s (HHS) Centers for Disease Control and 
Prevention (CDC) recommends who should be targeted for vaccination, 
including those at higher risk for influenza-related complications or 
medical care—for example, adults aged 50 years and older, young 
children, and some individuals with chronic medical conditions. CDC 
bases its recommendations on those made by the agency’s Advisory 
Committee on Immunization Practices (ACIP). 

GAO examined: (1) factors that affect the quantity of vaccine produced 
and when it reaches providers, (2) issues related to making vaccine 
available to high-risk and other target groups, and (3) public health 
messages produced and disseminated by CDC and others to promote 
vaccination. 

GAO reviewed relevant documents and interviewed officials from CDC, 
other public health entities, manufacturers, and medical supply 
distributors, and examined data on vaccine doses produced and shipped. 

What GAO Found: 

Several factors affect the quantity of vaccine produced for a given 
influenza season and when it reaches providers who administer the 
vaccine. One factor is the difficulty of manufacturing a new vaccine 
each year, which includes adherence to a relatively inflexible and 
sequential process, challenges of growing new virus strains, and 
maintaining safety and quality control practices to produce a sterile 
vaccine. Other factors include limitations in the production capacity 
of manufacturers and demand for vaccine throughout the influenza 
season. In addition, the distribution route the vaccine takes from the 
manufacturer to the provider can also affect how much time elapses 
before the vaccine reaches individual providers. 

Issues related to making vaccine available to high-risk and other 
target groups recommended by CDC and ACIP include the locations in 
which these individuals receive vaccinations, how vaccine is 
distributed to providers, and the timing of vaccine distribution to 
different types of providers. According to data from CDC, individuals 
in high-risk and other target groups have received influenza 
vaccinations at various locations where different types of providers 
administer the vaccine, including physicians’ offices, workplaces, 
clinics, or other settings. Certain types of providers, such as 
physicians, reported that they received their vaccine orders after 
other types of providers, such as mass immunizers that provide 
vaccinations at retail stores. Available data for the 2006–07 influenza 
season indicated, however, that most types of providers received 
vaccine in similar time frames. CDC officials acknowledged that 
individual providers’ experiences at the local level could vary. In an 
effort to help state and local health officials manage the availability 
of vaccine for high-risk or other target groups, CDC and state health 
officials have undertaken several efforts, including the creation of 
monitoring tools and the implementation of a state-specific vaccine 
distribution program. 

CDC and others have produced and disseminated public health 
messages—such as press releases and public service 
announcements—designed to promote seasonal influenza vaccination. These 
include messages designed to maintain public demand for vaccination 
later in the influenza season and to encourage preferential vaccination 
of certain groups during times of vaccine shortage or delay. CDC has 
taken steps to assess its influenza-related public health messages 
before disseminating them to the public and has conducted limited data 
collection afterwards. Although no comprehensive evaluations have been 
conducted to assess the impact of influenza-related messages after 
dissemination, CDC and other officials GAO interviewed identified key 
elements, such as clear and consistent messages, that they believe are 
important to producing effective public health messages. However, there 
are impediments to effectively implementing these elements, such as the 
need to modify messages during the season as circumstances change. 

We provided a draft of this report to HHS for comment. The department 
provided technical comments, which we incorporated as appropriate. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.GAO-08-27]. For more information, contact Marcia 
Crosse at (202) 512-7114 or crossem@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Manufacturing Challenges, Limitations in Production Capacity, and 
Fluctuating Demand for Vaccine May Limit the Quantity of Vaccine 
Produced or Delay When Vaccine Reaches Providers: 

Issues Related to Vaccine Distribution May Affect Vaccine Availability 
for High-Risk and Other Target Groups: 

CDC and Others Have Produced Public Health Messages, and CDC Has Taken 
Some Steps to Assess Its Messages: 

Agency Comments: 

Appendix I: Scope and Methodology: 

Appendix II: Manufacturers of Seasonal Influenza Vaccine for the U.S. 
Market, 2000-01 through 2007-08 Influenza Seasons: 

Appendix III: Advisory Committee on Immunization Practices (ACIP) 
Recommendations: 

Appendix IV: Cumulative Percentage of Vaccine Distributed by Provider 
Type during 2006-07 Influenza Season: 

Appendix V: CDC's Flu Vaccine Finder: 

Appendix VI: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Number of U.S.-Licensed Manufacturers of Seasonal Influenza 
Vaccine and Number of Doses Produced and Distributed, 2000-01 through 
2006-07 Influenza Seasons14: 

Table 2: Manufacturers of Seasonal Influenza Vaccine for the U.S. 
Market, 2000-01 through 2007-08 Influenza Seasons: 

Table 3: ACIP Influenza Vaccination Recommendations, 2000-01 through 
2007-08 Influenza Seasons: 

Table 4: Target Groups ACIP Recommended for Influenza Vaccination for 
the 2000-01 Influenza Season, before and after October 2000: 

Table 5: Target Groups ACIP Recommended for Influenza Vaccination for 
the 2004-05 Influenza Season, before and after October 2004: 

Table 6: Estimates of ACIP Target Group Populations Sizes, 2006: 

Table 7: Percentage of Cumulative Number of Doses Distributed by Month 
and Provider Type, 2006-07 Influenza Season: 

Figures: 

Figure 1: Month of Peak Influenza Activity, 1976 through 2006: 

Figure 2: Seasonal Influenza Vaccine Production Cycle: 

Figure 3: Distribution of Influenza Vaccine Doses in Millions by Month, 
2000-01 through 2006-07 Influenza Seasons: 

Figure 4: Potential Impact of Different Distribution Routes of Vaccine 
Orders from Manufacturer to Provider: 

Figure 5: Locations Where Adults Aged 65 Years and Older and Aged 50 
through 64 Years Reported Receiving Most Recent Influenza Vaccination, 
2004: 

Figure 6: Locations Where High-Risk Adults with Certain Chronic 
Conditions Reported Receiving Most Recent Influenza Vaccination, 2002: 

Figure 7: Percentage of Cumulative Number of Vaccine Doses Distributed, 
by Provider Type and Month, 2006-07 Influenza Season: 

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: 

United States Government Accountability Office: 

Washington, DC 20548: 

October 31, 2007: 

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

On average each year in the United States, seasonal influenza--which is 
caused by influenza viruses--is associated with more than 200,000 
hospitalizations and 36,000 deaths. Particular groups of individuals 
are at increased risk for influenza-related complications or at higher 
risk for medical care--including those aged 50 years and older, 
pregnant women, young children, and individuals with chronic medical 
conditions. The primary method for preventing influenza in these 
groups, and in the general population, is annual vaccination with 
influenza vaccine.[Footnote 1] The influenza season in the United 
States generally occurs from late fall to early spring, with infections 
typically peaking in January or February. October through November is 
considered to be the best time for influenza vaccination; in most 
years, however, vaccination in December or later can still be 
beneficial. Because circulating influenza virus strains change, a new 
vaccine is created each year based on the three influenza virus strains 
that the Department of Health and Human Services's (HHS) Food and Drug 
Administration (FDA) determines to be likely to cause serious illness 
in the United States that year.[Footnote 2] The vaccine is produced 
through a lengthy and complex process that involves growing the 
influenza virus strains in millions of chicken eggs. 

HHS's Centers for Disease Control and Prevention (CDC) and its Advisory 
Committee on Immunization Practices (ACIP) make recommendations on 
which groups should be targeted for annual influenza vaccination in the 
United States. Individuals in this target population for the 2007-08 
influenza season include those in high-risk groups[Footnote 3]--such as 
adults aged 50 years and older, children aged 6 to 59 months, pregnant 
women, and persons aged 6 months and older with certain chronic medical 
conditions--and individuals in other target groups, such as health care 
workers and others in close contact with those at high risk. CDC 
officials have raised concerns that, should shortages or delays in 
distribution of vaccine occur, vaccine would not be available for 
individuals in high-risk or other target groups during the time when 
demand for vaccination among these groups has traditionally been 
highest. In addition, these officials raised concerns, when vaccine has 
been more plentiful, that not all individuals in the target population 
for whom annual vaccination is recommended have been seeking or 
receiving vaccination. For example, only about half of those in groups 
at higher-risk for influenza-related complications and only about one- 
fifth of those in other target groups received influenza vaccination, 
according to CDC estimates.[Footnote 4] 

We previously reported on manufacturing difficulties experienced during 
the 2000-01 influenza season that illustrated the challenges in 
producing a new influenza vaccine each year on a timely basis. We 
reported on the delays in shipment and resulting initial vaccine 
shortage experienced for that season, and we also reported on the 
vaccine shortage experienced for the 2004-05 influenza season.[Footnote 
5] You observed that, despite changes since the 2000-01 season, 
concerns about the reliability of influenza vaccine supply and 
distribution persist. This report discusses (1) factors that affect the 
quantity of seasonal influenza vaccine produced and when vaccine 
reaches providers who administer vaccine, (2) issues related to making 
vaccine available for high-risk and other target groups, and (3) public 
health messages produced and disseminated by CDC and others to promote 
seasonal influenza vaccination. 

To address these objectives, we reviewed relevant documents and 
interviewed officials from CDC and FDA; national associations 
representing state and local health officials,[Footnote 6] public 
health officials, medical supply distributors,[Footnote 7] physicians, 
and long-term care providers; and all five manufacturers of seasonal 
influenza vaccine for the U.S. market for the 2007-08 influenza season 
as of August 31, 2007.[Footnote 8] We also selected judgmental samples 
of (1) medical supply distributors; (2) mass immunizers--organizations 
that conduct influenza vaccination clinics at workplaces, retail 
stores, long-term care facilities, and other locations; and (3) state 
health departments.[Footnote 9] For each organization in our samples, 
we reviewed relevant documents and interviewed officials. 

To determine the quantity of seasonal influenza vaccine produced and 
when vaccine reaches providers who administer vaccine, we examined data 
from CDC regarding the number of influenza vaccine doses produced and 
distributed each month for the 2000-01 influenza season through the 
2006-07 influenza season. We also reviewed data from CDC on the 
cumulative percentage of doses manufacturers and medical supply 
distributors reported shipping each month to different types of 
providers for the 2006-07 influenza season. To identify the locations 
in which high-risk groups receive their vaccinations, we reviewed data 
from CDC's Behavioral Risk Factor Surveillance System,[Footnote 10] a 
poll contracted by CDC, and other surveys CDC administered on 
immunization practices. To identify efforts undertaken by CDC and state 
health officials to help state and local officials manage availability 
of vaccine for high-risk and other target groups, we reviewed data from 
and documentation of the Internet-based distribution database that CDC 
created--the Flu Vaccine Finder, a component of CDC's Secure Data 
Network[Footnote 11]--and interviewed health department officials from 
our sample of states. We assessed the reliability of these data and 
determined they were sufficiently reliable for our purposes. 

To examine public health messages that CDC and others have produced and 
disseminated to promote seasonal influenza vaccination, we reviewed 
influenza vaccination communication plans produced by CDC and research 
and surveys conducted by CDC. We conducted our work in accordance with 
generally accepted government auditing standards from May through 
October 2007. 

Results in Brief: 

Several factors--including challenges in manufacturing a new vaccine 
each year, limitations in the production capacity of manufacturers, and 
fluctuating demand for vaccine by providers and patients--affect the 
quantity of vaccine produced for a given influenza season and when it 
reaches providers who administer the vaccine. Manufacturing challenges 
inherent to the production of seasonal influenza vaccine include the 
necessity of adhering to a relatively inflexible and sequential process 
involving multiple players including the World Health Organization, 
CDC, FDA, and manufacturers; difficulties growing new virus strains; 
and problems associated with maintaining safety and quality control 
practices to produce a sterile vaccine. Each of these manufacturing 
challenges has the potential to affect all manufacturers; however, in 
any given year, the degree to which these challenges affect the 
quantity of vaccine that an individual manufacturer produces or when 
that manufacturer's vaccine is shipped to providers may vary 
significantly. Overall production capacity--that is, the maximum amount 
of vaccine that manufacturers can produce, package, and ship at any 
given time--may also limit the quantity of vaccine produced and can 
delay when vaccine is available to providers. Another limiting factor 
is demand for vaccine throughout the influenza season. Because demand 
for vaccine is highest in October and November and then tapers off in 
December and later, manufacturers may decide to stop production if they 
do not believe there is sufficient demand later in the season, thereby 
limiting the quantity produced for that influenza season and how late 
in the season it is available. For individual providers who administer 
influenza vaccinations, the distribution route the vaccine takes from 
the manufacturer to the providers can also affect how much time elapses 
before the vaccine reaches them. 

Issues related to making vaccine available to high-risk and other 
target groups include the locations in which these individuals receive 
vaccinations, how vaccine is distributed to providers, and the timing 
of vaccine distribution to different types of providers. According to 
data from CDC, individuals in high-risk and other target groups have 
received influenza vaccinations at various locations where different 
types of providers, including physicians, hospitals, pharmacies, state 
and local health departments, and mass immunizers, administer vaccine. 
All manufacturers we spoke with and more than half of the medical 
supply distributors we interviewed reported that, for the 2007-08 
influenza season, they plan to continue or begin distributing vaccine 
to all types of providers in multiple shipments--that is, they plan to 
fill a portion of each customer's order as vaccine becomes available-- 
so that all customers may have at least some vaccine available for high-
risk or other target groups. Other medical supply distributors reported 
shipping vaccine using a variety of other distribution practices, such 
as filling vaccine orders in the order in which they were received. As 
a result of these distribution practices, it is possible that some 
providers receive vaccine and offer vaccinations to anyone who wants it 
before other providers have received enough vaccine to vaccinate their 
patients in high-risk or other target groups. In recent years, certain 
types of providers, such as physicians and state and local health 
departments, reported they received their vaccine orders later than 
other types of providers, such as mass immunizers that provide 
vaccinations at retail stores. National data collected by CDC for the 
2006-07 influenza season indicated that, in aggregate, most types of 
providers, including private providers such as physicians, received 
vaccine in similar time frames. However, the data also indicated that 
state and local health departments received a smaller percentage of the 
doses distributed in the early fall than later in the season. CDC 
officials acknowledged that individual providers' experiences at the 
local level could vary. In an effort to help state and local health 
officials manage the availability of vaccine for high- risk and other 
target groups, CDC and state health officials have undertaken several 
efforts, including the creation of monitoring tools and the 
implementation of a state-specific vaccine distribution program. 

CDC and others have produced and disseminated public health messages 
designed to promote seasonal influenza vaccination and CDC has taken 
some steps to assess its messages. Efforts to communicate public health 
messages undertaken by CDC and others--including state and local health 
departments and provider associations--include production and 
dissemination of press releases, educational materials, and public 
service announcements designed to promote vaccination, as well as 
messages aimed at maintaining public demand later in the season and 
encouraging preferential vaccination of certain groups during times of 
vaccine shortage or delay. CDC has taken steps to assess its influenza- 
related public health messages before disseminating them to the public 
and has collected some data afterwards. Although no comprehensive 
evaluations have been conducted, CDC and other officials we interviewed 
identified elements, such as clear and consistent messages, that are 
important to effective public health messages promoting influenza 
vaccination. However, there are impediments to effectively implementing 
these elements, such as the need to modify messages during the season 
as circumstances change. 

We provided a draft of this report to HHS for comment. The department 
provided technical comments, which we incorporated as appropriate. 

Background: 

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 seasonal 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. 

Vaccination, administered annually to provide protection against 
particular influenza virus strains expected to be prevalent that year, 
is the primary method for preventing seasonal influenza and its more 
severe complications. After vaccination, the body takes about 2 weeks 
to produce the antibodies that protect against infection. Traditionally 
CDC has recommended vaccination begin around October each year. 
However, because influenza seasons most often peak in January or 
February, in most years vaccination in December or later can still be 
beneficial. As shown in figure 1, the influenza season peaked in 
January or February in nearly two-thirds of the past 30 seasons. 

Figure 1: Month of Peak Influenza Activity, 1976 through 2006: 

This figure is bar chart showing month of peak influenza activity, 1976 
through 2006: 

November: 3%; 
December: 13%; 
January: 19; 
February: 45; 
March: 13; 
April: 3; 
May: 3. 

[See PDF for image] 

Source: CDC, "Prevention and Control of Influenza: Recommendations of 
the Advisory Committee on Immunization Practices (ACIP), 2007, 
"Morbidity and Mortality Weekly Report, vol. 56 (2007): 5. 

Notes: The peak month of activity was defined as the month with the 
greatest percentage of respiratory specimens testing positive for 
influenza virus. Percentages do not add to 100 percent due to rounding. 

[End of figure] 

Two types of vaccine are recommended for protection against seasonal 
influenza in the United States: (1) an inactivated virus vaccine 
injected into muscle or (2) a live attenuated vaccine administered as a 
nasal spray.[Footnote 12] The injectable vaccine--which represents the 
vast majority of influenza vaccine administered--can be used to 
immunize healthy individuals aged 6 months and older and those at 
increased risk of complications or more likely to require medical care, 
including high-risk individuals.[Footnote 13] The live attenuated 
vaccine, in contrast, is approved for use only among healthy 
individuals aged 2 through 49 years who are not pregnant.[Footnote 14] 
This live attenuated vaccine represented less than 3 percent of the 
vaccine doses produced for sale in the United States for the 2006-07 
influenza season. 

Because of fluctuations in the most prevalent virus strains of seasonal 
influenza, a new influenza vaccine is produced each year. Seasonal 
influenza vaccine is produced by manufacturers each year in a lengthy 
and complex process that involves a sequential set of steps (see fig. 
2):[Footnote 15] 

1. Virus Strain Selection: In late winter each year, FDA determines the 
three influenza virus strains assessed to be most likely to cause 
serious illness in the United States the following influenza 
season.[Footnote 16] One or two of the three strains selected for 
inclusion in the vaccine are usually new compared to the prior season. 
For example, for the 2000-01 influenza season and all but one of the 
subsequent seasons, FDA has changed at least one strain selected for 
the vaccine--that is, at least one selected strain has differed from 
the strains included in the previous season's vaccine. For one season, 
the 2003-04 season, FDA selected the same three influenza virus strains 
for the vaccine that were included in the prior season's vaccine. 

2. Production and Purification: Manufacturers and FDA obtain samples of 
each of the three selected virus strains from one of the World Health 
Organization Collaborating Centres.[Footnote 17] The manufacturers then 
inject the virus samples of each selected strain into separate batches 
of fertilized eggs to amplify the amount of virus. The viruses grown at 
this stage are called seed viruses and are tested by FDA. After 
manufacturers develop an appropriate seed virus for each of the three 
virus strains, these seed viruses are injected into millions of fertile 
chicken eggs and allowed to replicate.[Footnote 18] Producing these 
fertile eggs is more difficult than producing eggs grown for human 
consumption and FDA requires that the fertile eggs meet particular 
sanitation and other requirements. Each virus strain is grown 
separately inside the eggs over the course of several days, after which 
it is harvested, inactivated, and purified.[Footnote 19] 

3. Testing, Filling, and Packaging: Using biological materials provided 
by FDA, manufacturers and FDA test the virus strains produced by the 
manufacturers to determine the purity and yield of the virus and to 
ensure that the potency of the virus is sufficient for immunization. 
The three virus strains are then combined to create the vaccine for 
that season. Once the vaccine is created, manufacturers fill vaccine 
doses into vials and syringes. Labels are applied denoting the vaccine 
lot number and expiration date. FDA may conduct additional testing 
before officially releasing each lot for distribution; according to 
FDA, the agency typically releases a lot within 3 weeks, provided the 
lot has satisfied FDA standards.[Footnote 20] 

4. Shipping to Customers: Manufacturers ship released vaccine to 
customers, which can include medical supply distributors, physicians, 
hospitals, state and local health departments, and mass 
immunizers.[Footnote 21] The vaccine must be kept refrigerated within a 
prescribed temperature range.[Footnote 22] 

Figure 2: Seasonal Influenza Vaccine Production Cycle: 

This figure is a chart with illustrations showing seasonal influenza 
vaccine production cycle: 

1. Virus Strain Selection: 

* FDA’s Vaccines and Related Biological Products Advisory Committee, 
using surveillance information from the World Health Organization and 
CDC, recommends three virus strains to include in the annual vaccine 
for the following influenza season.

*  After receiving the Advisory Committee’s recommendation, FDA selects 
three virus strains that manufacturers must include in the influenza 
vaccine for the following influenza season. 

* One of the three strains is usually new compared to the prior season. 

2. Production and Purification: 

* Manufacturers and FDA obtain samples of each of the three selected 
virus strains from one of the World Health Organization Collaborating 
Centres.[A] 

* The manufacturers then inject the virus sample of each selected 
strain into separate batches of fertilized eggs to amplify the amount 
of virus. The viruses grown at this step are called seed viruses and 
are tested by FDA. After manufacturers develop an appropriate seed 
virus for each of the three virus strains these seed viruses are 
injected into millions of fertile chicken eggs and allowed to 
replicate. 

* Each virus strain is grown separately inside the eggs over the course 
of several days. 

* The viruses are harvested from the eggs, inactivated, and 
purified.[B] 

3. Testing, Filling, and Packaging: 

* Using biological materials provided by FDA, manufacturers and the FDA 
test virus strains to determine the purity and yield of the virus and 
to ensure that the potency is adequate for immunization. Once the 
potency of each strain is determined to be adequate, manufacturers 
combine the three virus strains to create the vaccine for that season. 

* Manufacturers fill vaccine doses into vials and syringes,which are 
then sealed. Labels are applied denoting the vaccine lot number and 
expiration date. 

* FDA may conduct additional testing before officially releasing each 
lot for distribution; according to FDA, the agency typically releases a 
lot within 3 weeks, provided the lot has satisfied FDA standards.[C] 

4. Shipping to Customers: 

* Vaccine is shipped to customers, which can include medical supply 
distributors, physicians, hospitals, state and local health 
departments, and mass immunizers.

[See PDF for image] 

Source: GAO, Art Explosion. 

Notes: These steps describe the manufacturing process for the 
inactivated injectable vaccine, which represented over 97 percent of 
vaccine doses produced for sale in the United States for the 2006-07 
influenza season. Live attenuated vaccine administered as a nasal spray 
is produced in a similar process that follows a similar timeline. 

The months associated with these steps are approximate and may vary 
from influenza season to influenza season. 

[A] The four World Health Organization Collaborating Centres are 
located in Australia, Japan, the United Kingdom, and the United States. 
CDC is the Collaborating Centre in the United States. 

[B] In contrast, the live attenuated vaccine administered as a nasal 
spray is not inactivated. 

[C] Influenza vaccine is subject to official lot release by FDA. 
Manufacturers submit samples of each lot of vaccine, along with 
summaries of the history of manufacture and the results of all the 
tests performed, to FDA, which may then perform additional tests before 
officially releasing the lot for distribution. The manufacturer may not 
distribute the vaccine lot until FDA releases it. 

[End of figure] 

Vaccine production generally takes 6 or more months after virus strains 
have been selected, according to vaccine manufacturers, and vaccines 
for certain influenza virus strains have been difficult to mass- 
produce. Manufacturers are currently pursuing new production 
technologies, which may allow for more robust and reliable influenza 
vaccine production and may speed up the production process. For 
example, 

* One such production technology involves growing the influenza virus 
in cells rather than chicken eggs.[Footnote 23] While eggs must be 
ordered up to 1 year in advance for egg-based production, cells used in 
cell-based production are more readily available, allowing for faster 
start up of vaccine manufacturing--the required amount of cells can be 
produced from frozen cells in a few days to weeks. In addition, cell- 
based production may present fewer contamination problems than egg- 
based production. 

* Another technology under development makes seed viruses using genetic 
techniques rather than through the current trial-and-error process in 
which the virus strains are grown and sampled for the desired 
characteristics. This technology may allow for more reliable production 
of seed viruses--an essential step in the vaccine production process. 

* Technology resulting in the development of a universal vaccine that 
would be effective against multiple virus strains would eliminate the 
need for current processes required to reformulate seasonal influenza 
vaccine each year. As a result, vaccine could be produced and available 
at any time of the year. However, despite recent increases in 
funding,[Footnote 24] a completely universal influenza vaccine may be 
years away.[Footnote 25] 

Manufacturers aim to make influenza vaccine available before the fall 
vaccination period when demand for vaccination has traditionally been 
the highest. At the end of the influenza season unused doses expire and 
cannot be used in subsequent years.[Footnote 26] For example, more than 
18 million doses left over from the 2006-07 influenza season expired in 
2007. Accordingly, manufacturers seek to match their vaccine production 
to expected demand for the vaccine so that no doses remain unsold at 
the end of the influenza season. 

Manufacturers sell vaccine directly to providers who administer 
vaccine, including physicians, hospitals, pharmacies, federal agencies, 
state and local health departments, and mass immunizers. In addition, 
manufacturers sell vaccine to medical supply distributors, who in turn 
sell it to providers and other customers such as other medical supply 
distributors. Providers administer vaccinations in a variety of 
locations, including physicians' offices, public health clinics, 
nursing homes, and nonmedical locations such as workplaces and retail 
stores. 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.[Footnote 27] 

The number of manufacturers of seasonal influenza vaccine for the U.S. 
market and the number of doses produced and distributed have changed 
over the past seven seasons (see table 1).[Footnote 28] For the 2007-08 
influenza season, six U.S.-licensed manufacturers are expected to 
produce an estimated 132 million doses of seasonal influenza vaccine. 

Table 1: Number of U.S.-Licensed Manufacturers of Seasonal Influenza 
Vaccine and Number of Doses Produced and Distributed, 2000-01 through 
2006-07 Influenza Seasons: 

Influenza season: 2000-01; 
Number of licensed manufacturers: 3; 
Total number of doses produced (in millions): 78; 
Total number of doses distributed (in millions): 70. 

Influenza season: 2001-02; 
Number of licensed manufacturers: 3; 
Total number of doses produced (in millions): 88; 
Total number of doses distributed (in millions): 78. 

Influenza season: 2002-03; 
Number of licensed manufacturers: 3; 
Total number of doses produced (in millions): 95; 
Total number of doses distributed (in millions): 83. 

Influenza season: 2003-04; 
Number of licensed manufacturers: 3; 
Total number of doses produced (in millions): 87; 
Total number of doses distributed (in millions): 83. 

Influenza season: 2004-05; 
Number of licensed manufacturers: 3[A]; 
Total number of doses produced (in millions): 61; 
Total number of doses distributed (in millions): 57. 

Influenza season: 2005-06; 
Number of licensed manufacturers: 4; 
Total number of doses produced (in millions): 92; 
Total number of doses distributed (in millions): 82. 

Influenza season: 2006-07; 
Number of licensed manufacturers: 5[B]; 
Total number of doses produced (in millions): 121; 
Total number of doses distributed (in millions): 103. 

Source: CDC and FDA. 

Notes: Table includes the number of doses produced by manufacturers and 
distributed to customers such as medical supply distributors, 
physicians, or other types of providers. 

[A] Of the three manufacturers of seasonal influenza vaccine for the 
2004-05 influenza season, two produced and distributed vaccine and one 
ceased production and did not distribute any vaccine for the U.S. 
market after its license was suspended by the United Kingdom in October 
2005. In addition to these three manufacturers, two foreign 
manufacturers' vaccines were purchased by HHS and made available in the 
United States under an investigational new drug protocol; however, none 
of these doses were distributed. 

[B] The manufacturers of vaccine licensed for the 2006-07 season and 
their vaccines were: GlaxoSmithKline Biologicals, a part of 
GlaxoSmithKline plc (Fluarix), ID Biomedical Corporation of Quebec, a 
subsidiary of GlaxoSmithKline plc (FluLaval), MedImmune Vaccines, Inc. 
(FluMist), Novartis Vaccines and Diagnostics Limited (Fluvirin), and 
sanofi pasteur (Fluzone). The policy of sanofi pasteur is to spell its 
name without capital letters. 

[End of table] 

Since influenza vaccine production and distribution are largely private-
sector activities, HHS and other federal entities have limited 
authority to control influenza vaccine production and 
distribution.[Footnote 29] CDC 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 those without insurance coverage for vaccinations. CDC 
also reserves stockpiles of certain vaccines for use in the event of a 
vaccine shortage or disease outbreak. 

For each influenza season, ACIP, after consulting with CDC, makes 
recommendations on who should be targeted for vaccination and, in some 
years, has modified its annual recommendations after issuing them in 
order to address vaccine shortage, such as during the 2004-05 
season.[Footnote 30] For the 2007-08 season, ACIP recommends 
vaccination for two categories of individuals: (1) high-risk 
individuals--that is, those persons at increased risk for medical 
complications or more likely to require medical care, such as children 
aged 6 to 59 months, pregnant women, persons aged 50 years or older, 
and persons with certain chronic conditions; and (2) close contacts of 
those at high risk--that is, persons who live with or care for persons 
at high risk, such as family members and health care workers. According 
to ACIP, approximately 73 percent of the U.S. population is included in 
one or more of these target groups. However, not everyone in these 
recommended target groups receives a vaccination each year--only an 
estimated one-third of them received vaccination, according to CDC 
estimates.[Footnote 31] For the 2007-08 season, in addition to 
recommending that providers vaccinate individuals in high-risk and 
other target groups, ACIP recommends that all persons, including school-
aged children, who want to reduce the risk of becoming ill with 
influenza or of transmitting influenza to others should be vaccinated. 

Manufacturing Challenges, Limitations in Production Capacity, and 
Fluctuating Demand for Vaccine May Limit the Quantity of Vaccine 
Produced or Delay When Vaccine Reaches Providers: 

Several factors may affect the quantity of vaccine produced for a given 
season and when it reaches providers who administer the vaccine. These 
factors include: challenges in manufacturing a new vaccine each year; 
limitations in the production capacity of manufacturers; and demand for 
vaccine by providers and patients that fluctuates throughout the 
season. For an individual provider, additional factors, including the 
route the vaccine takes from the manufacturer to the provider, can 
affect how much and when a particular provider receives vaccine. 

Manufacturing Challenges May Limit the Quantity of Seasonal Influenza 
Vaccine Produced or Delay When Vaccine Reaches Providers: 

Manufacturing challenges inherent to the production of a new seasonal 
influenza vaccine each year include the necessity of adhering to a 
relatively inflexible and sequential process involving multiple 
players, difficulties growing new virus strains, and problems 
associated with maintaining safety and quality-control practices to 
produce a sterile vaccine. Each of these challenges has the potential 
to affect all manufacturers; however, in any given year the degree that 
these challenges affect the number of doses that an individual 
manufacturer produces or when that manufacturer's vaccine becomes 
available may vary significantly. 

* Adherence to a sequential set of steps involving multiple players. 
Influenza vaccine is produced by manufacturers through a relatively 
inflexible process involving a sequential set of critical steps that 
are undertaken by multiple players including the World Health 
Organization, CDC, FDA, and manufacturers. Certain steps in the process 
must be completed before other steps can start and the timing and 
outcome of these steps can affect both the quantity of vaccine produced 
and when the vaccine reaches providers. For example, FDA typically does 
not have sufficient information until late each winter to identify the 
influenza virus strains likely to be prevalent during the upcoming 
season. As a result, FDA selects the three virus strains that will make 
up the vaccine for the upcoming season usually between late February 
and early March; once these selections are made, the manufacturers, 
using samples of each selected virus strain, develop seed viruses that 
are suitable for subsequent vaccine production. Manufacturers reported 
that the timeline for FDA's strain selection and the subsequent 
distribution of samples of strains to develop seed viruses does not 
allow them enough time to produce all three virus strains in time for 
the fall vaccination period. As a result, manufacturers consult with 
CDC and FDA, assess preliminary data, and complete their own analyses 
as to what FDA's choice of virus strains for the upcoming season might 
be. Manufacturers usually begin producing one of the influenza virus 
strains that they believe will be included in the vaccine in January in 
advance of FDA's strain selection.[Footnote 32] 

* Difficulties growing a new virus strain. Manufacturers have 
experienced delays in producing and distributing vaccine for several 
recent influenza seasons because of challenges inherent to growing 
influenza virus strains. For example, for the 2000-01 influenza season, 
difficulties experienced by two manufacturers growing a new virus 
strain contributed to an overall delay of about 6 to 8 weeks in 
distributing vaccine to most customers and an initial shortage of 
vaccine supply.[Footnote 33] For the 2006-07 influenza season, several 
manufacturers reported problems growing one of the two new virus 
strains that, for one major manufacturer, resulted in a delay of about 
3 weeks in vaccine production. Since this manufacturer was the only 
producer of vaccine licensed for children aged 6 through 47 months, the 
delay in its production may have affected some providers' ability to 
have vaccine available for this population. 

* Problems associated with maintaining safety and quality-control 
practices. Problems associated with maintaining safety and quality- 
control practices to produce a sterile vaccine can limit the quantity 
of seasonal influenza vaccine produced and when it reaches providers. 
In 2002, one manufacturer that had produced seasonal influenza vaccine 
for more than two decades exited the U.S. market after it was fined by 
FDA for failing to correct manufacturing deficiencies. In 2004, another 
manufacturer announced that because of potential contamination 
discovered when a small quantity of its vaccine failed sterility tests, 
it would not release any vaccine for the U.S. market. This manufacturer 
had been expected to produce approximately half of the estimated doses 
of influenza vaccine for the 2004-05 season.[Footnote 34] More 
recently, in May 2007, FDA issued a warning letter to a different 
manufacturer because of deviations from good manufacturing practices, 
including some which could potentially lead to sterility 
problems.[Footnote 35] In September 2007, the manufacturer reported 
that it had resolved the observances contained in the warning 
letter.[Footnote 36] 

Production Capacity May Limit the Quantity of Seasonal Influenza 
Vaccine Produced and May Delay When Vaccine Reaches Providers: 

Overall production capacity--that is, the maximum amount of vaccine 
that manufacturers can produce, package, and ship at any given time-- 
may limit the quantity of seasonal influenza vaccine produced and may 
delay when vaccine reaches providers. Manufacturers reported that, even 
in years with fewer manufacturing challenges, they are limited in the 
number of doses that they can produce and fill at a given time, and, 
therefore, not all doses of influenza vaccine are available by the 
beginning of each influenza season. Instead, manufacturers distribute 
vaccine as it becomes available beginning in late summer or in the fall 
and generally continuing into the winter, with the proportion of 
vaccine distributed each month varying from year to year (see fig. 3). 
Because vaccine is produced in batches over the course of several 
months, only a portion of the full year's production is available each 
month to vaccinate individuals against influenza. 

Figure 3: Distribution of Influenza Vaccine Doses in Millions by Month, 
2000-01 through 2006-07 Influenza Seasons: 

This figure is a line chart showing distribution of influenza vaccine 
doses in millions my month, 2000-01 through 2006-07. The X axis 
represents the month, and the Y axis represents vaccine doses 
distributed in millions. 

[See PDF for image] 

Source: CDC. 

[End of figure] 

More doses of influenza vaccine could be produced for each influenza 
season if either the current manufacturers increased their production 
capacity or if more manufacturers entered the U.S. market. All of the 
manufacturers of seasonal influenza vaccine for the U.S. market that we 
interviewed reported plans to increase production capacity for future 
seasons. In addition, on September 28, 2007, a sixth manufacturer, 
which has reported that it will eventually have the capacity to produce 
as many as 20 million doses of seasonal influenza vaccine for the U.S. 
market, received FDA approval for the 2007-08 season.[Footnote 37] 

Demand for Influenza Vaccine Affects the Quantity of Seasonal Influenza 
Vaccine Produced: 

Since demand for influenza vaccine typically peaks in October and 
November and then tapers off, manufacturers may decide to limit or stop 
production if they do not believe there is sufficient demand to sell 
all of the doses they have the capacity to produce--thereby limiting 
the quantity produced for that season and how late in the season it is 
available. For example, one manufacturer reported that it has capacity 
to produce more doses of influenza vaccine than its planned production 
for the 2007-08 season, but reported that production of the additional 
doses would be contingent in part on demand for doses later in the 
season. Even in seasons when there were vaccine shortages during the 
traditional fall vaccination period, some doses remained unsold at the 
end of the season. For example, even though there was an initial 
shortage of influenza vaccine for the 2000-01 season, after additional 
doses became available later in the season, approximately seven million 
doses of influenza vaccine went unsold. 

In past seasons when demand for influenza vaccine has occurred later in 
the season, supply has not always been available to meet it. For 
example, during the 2003-04 influenza season, there was late-season 
demand for seasonal influenza vaccine after reports of influenza- 
related deaths among children. However, there was not enough influenza 
vaccine available at the time to meet demand and individuals that 
wanted vaccine were not able to obtain it. To prevent this scenario 
from occurring again in subsequent seasons, beginning for the 2004-05 
season, CDC began contracting with manufacturers to produce a small 
quantity of influenza vaccine to be available later in the season to 
ensure that some vaccine would be available in the event of a late- 
season outbreak of influenza and related demand for vaccine. 

Distribution Routes May Affect When Seasonal Influenza Vaccine Reaches 
Individual Providers: 

In addition to the timing of the production and shipment of vaccine 
from the manufacturer, the distribution route that the vaccine takes 
from the manufacturer to a provider can also affect how much time 
elapses before the vaccine reaches individual providers who have 
ordered it. If, for example, a provider's order is routed through a 
medical supply distributor, it may take longer for vaccine to reach 
that provider than it would if a provider's order was routed directly 
from the manufacturer--a route with no stops to reach the provider. For 
the 2007-08 season, manufacturers of two of the five influenza vaccines 
licensed for the U.S. market as of August 31, 2007, reported plans to 
distribute the majority of their vaccine through medical supply 
distributors. The manufacturers of the three other vaccines told us 
they planned to distribute some vaccine through medical supply 
distributors. According to the Health Industry Distributors 
Association, the distribution route for about half of the vaccine sold 
for the 2006-07 influenza season was through medical supply 
distributors, 8 of every 10 of those doses went to a physician's office 
or a clinic, and medical supply distributors shipped vaccine to 
providers in 1 to 3 days after the distributors received the vaccine 
from the manufacturers. The association also estimated that the route 
for about half of the vaccine sold for the 2006-07 influenza season was 
shipped directly from the manufacturer to the provider.[Footnote 38] As 
shown in figure 4, if it takes from 1 to 3 days for manufacturers to 
distribute vaccine to their customers once it is ready for shipment, 
the route a provider's order takes--that is, whether it is routed 
directly from the manufacturer to the provider, which can take as 
little as 1 day,[Footnote 39] or whether it is routed through multiple 
medical supply distributors or a central location for distribution as 
is the case for some state health departments--affects the time that 
elapses from the date the manufacturer ships the vaccine until an 
individual provider receives it. 

Figure 4: Potential Impact of Different Distribution Routes of Vaccine 
Orders from Manufacturer to Provider: 

This figure is a chart showing potential impact of different 
distribution routes of vaccine orders from manufacturer to provider. 

[See PDF for image] 

Source: GAO. 

[End of figure] 

Issues Related to Vaccine Distribution May Affect Vaccine Availability 
for High-Risk and Other Target Groups: 

Issues related to making vaccine available for high-risk and other 
target groups include the locations where these groups are vaccinated, 
how vaccine is distributed to the providers who administer 
vaccinations, and the timing of vaccine distribution to different types 
of providers. According to data from CDC, individuals in high-risk and 
other target groups have received influenza vaccinations at various 
locations where different types of providers administer vaccine. 
Manufacturers and medical supply distributors we interviewed reported 
that, for the 2007-08 influenza season, they plan to distribute vaccine 
using a variety of distribution practices including shipping vaccine as 
it becomes available through multiple shipments and filling vaccine 
orders in the order in which they were received. In recent years, 
certain types of providers, such as physicians and state and local 
health departments, reported that they received their vaccine orders 
later than other types of providers, such as mass immunizers. National 
data collected by CDC for the 2006-07 influenza season indicated that 
in aggregate most types of providers, including private providers such 
as physicians, received vaccine in similar time frames. However, the 
data also indicated that state and local health departments received a 
smaller percentage of the doses distributed in the early fall than 
later in the season. CDC officials acknowledged that individual 
providers' experiences at the local level could vary. In an effort to 
help state and local health officials manage the availability of 
vaccine for high-risk or other target groups, CDC and state health 
officials have undertaken several efforts, including the creation of 
monitoring tools and the implementation of a state-specific vaccine 
distribution program. 

High-Risk and Other Target Groups Receive Vaccinations at Various 
Locations Where Different Types of Providers Administer Vaccine: 

Individuals in high-risk and other target groups receive influenza 
vaccinations at various locations where different types of providers, 
such as physicians, hospitals, pharmacies, and state and local health 
departments, administer vaccine. For example, CDC data from 2004 show 
that more than half of one population group considered at high-risk for 
complications in 2004--adults aged 65 years and older--and about a 
third of one target group recommended for vaccination in 2004--adults 
aged 50 through 64 years--received influenza vaccination at physicians' 
offices. A smaller proportion of adults in these groups received 
influenza vaccination at other locations, including workplaces and 
clinics (see fig. 5).[Footnote 40] 

Figure 5: Locations Where Adults Aged 65 Years and Older and Aged 50 
through 64 Years Reported Receiving Most Recent Influenza Vaccination, 
2004: 

This figure is a combination of pie charts showing locations where 
adults aged 65 years and older and aged 50 through 64 reported 
receiving most recent influenza vaccination in 2004: 

Adults aged 65 years and older: Physician's office: 52.6%; 
Adults aged 65 years and older: Clinic: 20.55; 
Adults aged 65 years and older: Other medically related place: 17.0%; 
Adults aged 65 years and older: Other nonmedically related place: 7.4%; 
Adults aged 65 years and older: Workplace: 2.0%. 

Adults aged 64 years and older: Physician's office: 34.9%; 
Adults aged 64 years and older: Clinic: 20.2%; 
Adults aged 64 years and older: Other medically related place: 19.85; 
Adults aged 64 years and older: Other nonmedically related place: 9.0%; 
Adults aged 64 years and older: Workplace: 16.2%. 

[See PDF for image] 

Source: CDC's National Adult immunization Survey Module, 2004. 

Notes: Percentages do not add to 100 percent because of rounding. For 
data on high-risk adults aged 65 years and older, the category "Other 
medically related place" includes hospitals (7.2 percent), pharmacies 
(6.1 percent), and other medically related places (3.7 percent); the 
category "Workplace" also includes home visits. For data on adults aged 
50 through 64 years, the category "Other medically related place" 
includes hospitals (9.2 percent), hospital vans or mobile units (2.0 
percent), pharmacies (4.7 percent), and other medically related places 
(3.9 percent); the category "Other nonmedically related places" 
includes other nonmedically related places (8.7 percent) and home 
visits (0.3 percent). 

[End of figure] 

CDC data from 2002 indicated that about half of individuals included in 
another target group recommended for vaccination--adults aged 18 to 64 
years with certain chronic conditions--also received vaccinations at 
physicians' offices, and the remaining individuals in this target group 
reported receiving vaccination at other locations such as workplaces 
(see fig. 6). 

Figure 6: Locations Where High-Risk Adults with Certain Chronic 
Conditions Reported Receiving Most Recent Influenza Vaccination, 2002: 

This figure is a pie chart showing locations where high-risk adults 
with certain chronic conditions reported receiving most recent 
influenza vaccination: 

Physician's office: 49.05; 
Workplace: 19.4; 
Other: 15.4; 
Clinic: 12.1; 
Retail store: 4.1%. 

[See PDF for image] 

Source: CDC's Behavioral Risk Factor Surveillance System, 2002. 

Note: Data are for high-risk adults aged 18 through 64 years with 
chronic conditions of diabetes or asthma or both. The category "Other" 
includes hospitals (5.1 percent), health departments (4.6 percent), 
other places (4.6 percent), and community centers (1.1 percent). 

[End of figure] 

Manufacturers and Medical Supply Distributors Ship Vaccine Using a 
Variety of Distribution Practices: 

All manufacturers we interviewed and four of six medical supply 
distributors we spoke with reported that for the 2007-08 influenza 
season they will continue or begin distributing vaccine as it becomes 
available using multiple shipments. This distribution practice allows 
for all types of providers to have some vaccine available for their 
high-risk patients when vaccine is initially distributed. CDC 
encouraged distributing vaccine in multiple shipments--a practice 
referred to as multiphased shipments--for the 2005-06 influenza season, 
stating that this distribution strategy enables all types of providers 
to administer vaccine initially to those persons at high risk, even 
when supplies are limited.[Footnote 41] 

In addition to the practice of multiphased shipments, one manufacturer 
and two medical supply distributors took steps to collect information 
from their customers on the number of doses in an order that are 
intended for certain priority groups, such as high-risk individuals, so 
that the manufacturer and medical supply distributors could, if 
necessary, distribute vaccine to customers serving those groups on a 
priority basis. However, officials from medical supply distributors and 
CDC reported differing perspectives on the utility of this information 
for prioritizing distribution to those serving individuals in certain 
priority groups, including high-risk groups. For example, two of the 
six medical supply distributors we interviewed reported that they 
routinely collect information from their customers on the number of 
doses ordered that are intended for high-risk individuals and may use 
this information to determine distribution of the vaccine. One reported 
that its distribution practice is to give priority to those individual 
providers that are serving more high-risk individuals; the other 
medical supply distributor reported that it intends to use the 
information to prioritize orders only in the event of a vaccine 
shortage.[Footnote 42] CDC officials, however, reported that collecting 
such information from customers on their patients in priority groups 
was not useful for prioritizing distribution to those serving 
individuals in these groups. For the 2005-06 influenza season, CDC 
encouraged manufacturers and medical supply distributors to collect 
information from their customers on the number of doses being ordered 
for priority groups, but according to CDC officials, the manufacturer 
that produced most of the vaccine that season reported such information 
had limited utility for prioritizing orders; these officials reported 
that the manufacturer found that the vast majority of its customers 
reported that nearly all of the doses they ordered were for individuals 
in priority groups. As a result, CDC officials said they no longer 
recommend collecting such information.[Footnote 43] 

Other medical supply distributors reported using other distribution 
practices. For example, one medical supply distributor stated that it 
fills vaccine orders in the order in which it received the orders. 
Also, for the 2007-08 season, two of the six medical supply 
distributors we interviewed reported guaranteeing delivery of all 
vaccine ordered by a specific date to customers. As a result of these 
distribution practices, it is possible that some providers receive 
vaccine and offer vaccinations to anyone who wants them before other 
providers have received enough vaccine to vaccinate their patients in 
high-risk or other target groups. 

CDC Data Indicate State and Local Health Departments Generally Received 
a Smaller Amount of Vaccine Than Other Providers in Early Fall: 

In recent years, certain types of providers, such as physicians and 
state and local health departments, reported they received their 
vaccine orders after other types of providers, such as mass immunizers 
that provide vaccinations at retail stores. For example, 
representatives from one national association representing physicians 
and one national association representing state and local public health 
officials told us that in past seasons many physicians did not receive 
their vaccine orders until November or later but other types of 
providers--particularly those providing vaccinations in mass 
immunization clinics at retail stores--had vaccine earlier in the fall. 
As a result, association officials stated that these other types of 
providers were able to vaccinate anyone who wanted a vaccination before 
physician practices had received a sufficient number of doses for their 
patients. 

According to CDC, a large percentage of high-risk individuals receive 
their annual vaccination at physicians' offices. Some officials from 
national associations representing physicians asserted that physicians 
should receive priority in vaccine distribution. According to a 
national association representing physicians and officials from a state 
health department, physicians have reported that if they do not have 
vaccine when patients seek it, those patients may not return for 
vaccination when the physician has vaccine. According to a national 
association representing pediatricians, establishing a reliable place 
for vaccination is especially crucial for children, given the ACIP 
recommendation for the 2007-08 influenza season that children aged 6 
months through 8 years receive two shots 30 days apart in their first 
year of vaccination. In addition, according to this association, having 
unused doses can be a financial burden to these physicians, as they are 
responsible for paying for any vaccine orders they place and receive, 
regardless of whether they administer the vaccine or not. While CDC 
data indicated that most physicians CDC surveyed intend to continue 
administering influenza vaccine as a service to their patients, 
association officials reported that this financial burden may serve as 
an incentive for some individual physicians to discontinue purchasing 
and administering the vaccine in the future. 

State and local health officials and national associations representing 
them also reported that they believe state and local health departments 
generally have received their vaccine orders later in the season, and 
in some instances, after other types of providers. State and local 
health departments are responsible for distributing the influenza 
vaccine to those providers who vaccinate high-risk populations through 
the Vaccines for Children program, for example. Therefore, officials we 
spoke with asserted that state and local health departments should 
receive vaccine in the same time frames as other types of providers. 

According to CDC officials, with more than 200 million individuals in 
high-risk and other target groups who should be vaccinated between late 
fall and early spring each influenza season, all types of providers 
have an important role to play in providing vaccinations. Therefore, 
having multiple opportunities for vaccination available to individuals 
in high-risk and other target groups is especially important as ACIP 
considers continued expansion of its recommendations on which groups 
should be targeted for vaccination for each influenza season. For 
example, mass immunization clinics at retail stores play an important 
role in increasing influenza vaccination rates because they may provide 
access to the vaccine for a population that does not regularly see a 
physician or would not otherwise receive the vaccine, according to 
officials from CDC, a national association representing physicians, and 
state and local health departments. 

Despite reports from physicians and other types of providers indicating 
otherwise, national data for the 2006-07 influenza season indicate that 
most types of providers, including private providers such as 
physicians, received vaccine in a similar proportion over the months 
the vaccine was distributed (see app. IV and fig. 7).[Footnote 44] 
Specifically, CDC analyzed national data on the percentage of the total 
vaccine doses distributed as of each month--these data show that 
private providers, including physicians, received about 42 percent of 
the cumulative number of doses distributed as of each month, as well as 
about 42 percent of the total number of doses distributed for the 2006- 
07 season. However, the national data support the testimonies from 
state and local health officials that they received a smaller 
percentage of doses in the early fall than later in the influenza 
season. 

Figure 7: Percentage of Cumulative Number of Vaccine Doses Distributed, 
by Provider Type and Month, 2006-07 Influenza Season: 

This figure is a combination of bar charts showing percentage of 
cumulative number of vaccine doses distributed, by provider type and 
month, 2006-07 influenza season: 

Private providers[A]: Private providers received 42.3 percent of all 
vaccine distributed; 

Sept.: 41.0; 
Oct.: 43.2
Nov.: 43.1; 
Dec: 42.3; 
Jan.: 42.3. 

State and local health departments: State and local health departments 
received 11.6 percent of all vaccine distributed; 

Sept.: 6.6; 
Oct.: 7.2; 
Nov.: 10.1; 
Dec.: 11.6; 
Jan.: 11.6. 

Long term care facilities: Long term care facilities received 3.1 
percent of all vaccine distributed; 

Sept.: 4.7; 
Oct.: 4.0; 
Nov.: 3.7; 
Dec.: 3.1; 
Jan: 3.1. 

Other[B]: Other providers types received 43.1 percent of all vaccine 
distributed; 

Sept.: 47.7; 
Oct.: 45.6; 
Nov.: 43.0; 
Dec.: 43.0; 
Jan.: 43.1. 

[See PDF for image] 

Source: CDC. 

Notes: Because a different number of additional doses were distributed 
each month, it is possible for one type of provider to receive a higher 
percentage of all doses distributed as of the end of one month than the 
percentage of cumulative doses the provider received as of the end of 
the following month. According to CDC, data identifying distribution of 
vaccine to mass immunizers were not available within a single provider 
category; rather, because these types of providers are classified 
differently by different manufacturers and medical supply distributors, 
doses received by them are included within a number of provider type 
categories. 

[A] The category "Private providers" includes physicians, as well as 
outpatient clinics and facilities, health maintenance organizations, 
and surgery centers. 

[B] The category "Other" includes vaccine doses distributed to medical 
supply distributors (15.6 percent), hospitals (9.9 percent), the 
federal government (5.1 percent), pharmacies (3.5 percent), other 
private provider types (2.9 percent), corporations (2.5 percent), the 
military (2.2 percent), correctional facilities (0.0 percent), and 
other public provider types (1.4 percent). These percentages indicate 
the total percentage of all vaccine doses distributed to the provider 
type during the 2006-07 influenza season. The decrease in the 
percentage of the cumulative number of doses distributed to provider 
types in the "Other" category from September to October reflects the 
higher percentage of doses medical supply distributors received in 
September, which then decreased later in the season. See app. IV for 
complete data on the percentage of the cumulative number of vaccine 
doses distributed by month to all types of providers during the 2006-07 
influenza season. 

[End of figure] 

CDC officials acknowledged that the aggregated, national data on 
vaccine distribution to private providers such as physicians do not 
reflect physicians' testimonies and that individual providers' 
experiences at the local level may vary significantly. In addition, 
several factors, such as size of order, with whom an order is placed, 
and the distribution route, may influence the perception that other 
types of providers received their vaccine orders before physicians. For 
example, the policy of some manufacturers and medical supply 
distributors to distribute the vaccine in multiphased shipments 
sometimes results in only a small number of vaccine doses being 
allocated to an individual provider per shipment. As a result, 
providers, including physicians, may choose to ask the medical supply 
distributors to delay shipment until a greater number of doses are 
available to fill the providers' order so, for example, a physician's 
office could hold a vaccination clinic. Manufacturers may also choose 
to fill a percentage of larger orders first and delay shipping smaller 
orders until later--a practice, according to one manufacturer, that is 
often easier to do because of the logistics of shipping. In addition, 
officials from one national association representing physicians 
reported that it is likely that the route through which smaller 
physicians' offices receive vaccine may entail an additional layer of 
distribution, such as multiple medical supply distributors, thus 
extending the time for the vaccine to reach an individual provider. In 
contrast, many mass immunizers that hold clinics in retail stores may 
receive vaccine more quickly than physicians if the mass immunizers 
place, and subsequently receive, large vaccine orders directly from the 
manufacturer or a national medical supply distributor. 

Officials from CDC and state health departments had little explanation 
as to why state and local health departments received more of their 
vaccine orders late in the season. One official from a state health 
department stated that her department received its vaccine order for 
the 2006-07 season late because the manufacturer with whom the 
department ordered experienced production problems. However, officials 
from CDC and two state health departments we spoke with were unable to 
speculate as to the reason for this distribution pattern, and CDC 
officials reported that the agency is researching why this occurred. 

CDC and State Health Officials Have Undertaken Efforts to Help Monitor 
the Availability of Vaccine: 

In order to help state and local health officials manage the 
availability of vaccine for high-risk or other target groups, CDC and 
state health officials have undertaken several efforts. These efforts 
include the creation of monitoring tools and the implementation of a 
state-specific vaccine distribution program. 

When faced with a shortage of vaccine for the 2004-05 season, CDC 
created a tool, the Flu Vaccine Finder, "to provide information to 
enhance visibility of influenza vaccine distribution for state and 
local health officials and to assist in their management of influenza 
vaccine availability issues and challenges."[Footnote 45] This tool, 
which has been modified for subsequent seasons, continues to be used by 
CDC and state health officials. For the 2006-07 season, CDC collected 
information to be included in the Flu Vaccine Finder on a weekly basis 
throughout the influenza season from all manufacturers and seven major 
medical supply distributors on all vaccine distributed. Specifically, 
the information collected included a product identifier,[Footnote 46] 
state and zip code to which the vaccine was distributed, number of 
doses distributed, and type of provider to whom the vaccine was 
distributed. For the 2005-06 and 2006-07 influenza seasons, the Flu 
Vaccine Finder also included a listing of doses that had been already 
ordered from a subset of manufacturers and medical supply distributors. 

CDC officials reported that the agency has used the Flu Vaccine Finder 
data to conduct a limited amount of routine analyses. Specifically, the 
agency routinely conducts two analyses using the data: total 
distribution of vaccine by month and total distribution of vaccine by 
provider type. In addition, according to CDC, data from the Flu Vaccine 
Finder have been used by some state officials to find out information 
on the number of vaccine doses distributed to a state or locality by 
provider type and vaccine availability by zip code. State health 
officials have also used the data to monitor the number of doses of 
vaccine distributed to certain types of providers, such as hospitals 
and local health departments, and to locate providers following vaccine-
related adverse events. For example, CDC officials stated that one 
state health department used the Flu Vaccine Finder data coupled with 
the state's data on the number of long-term care beds to determine if 
the state's long-term care facilities had received enough vaccine to 
vaccinate their population. However, according to CDC, 40 of the 56 
states and urban areas that are eligible to use the Flu Vaccine Finder 
have requested access to it for the 2007-08 influenza season, 
suggesting that not all state officials have found this to be a useful 
tool or are aware of this resource. To encourage use of the Flu Vaccine 
Finder, CDC officials reported that they are designing a Flu Vaccine 
Finder guidance document to share with users of the Flu Vaccine Finder, 
outlining some of the analyses states have performed using Flu Vaccine 
Finder data to help monitor vaccine distribution within states. 

State health officials suggested changes to the Flu Vaccine Finder, 
which they reported would make the Flu Vaccine Finder a more useful 
tool for monitoring vaccine distribution. Their suggestions included 
adding data on the specific providers receiving the vaccine, county- 
level data, data identifying all types of providers, and making the 
data more timely: 

* Data on specific providers receiving the vaccine. The 2006-07 version 
of the Flu Vaccine Finder included data on the zip code to which a 
manufacturer or medical supply distributor delivered a vaccine 
shipment; however, according to state and local health officials we 
spoke with, the Flu Vaccine Finder did not indicate the name or address 
of the particular provider that received the vaccine. State health 
officials reported that the provider who administered the vaccine may 
be in a different zip code from the location of where the vaccine was 
originally shipped. Officials also stated that knowing which specific 
providers have vaccine and where the vaccine was administered is 
helpful for determining which populations have access to the vaccine 
and which areas or providers are in need. 

* Addition of county-level data. According to CDC, state health 
officials stated that to make the Flu Vaccine Finder more useful to 
them, data on the number of doses distributed by county, rather than by 
zip code, would be helpful because some state health officials reported 
that public health activities are organized at the county level. One 
state official reported having to create its own zip code-to-county 
crosswalk in order to complete county-level data analysis--an imperfect 
process since some zip codes may cross county lines. 

* Data identifying all types of providers. The Flu Vaccine Finder does 
not have a provider type category for mass immunizers; rather, because 
these providers are classified differently by different manufacturers 
and medical supply distributors, doses received by them are included 
within a number of provider type categories, according to CDC. As a 
result, an official from one state health department reported being 
unable to tell how many vaccine doses have been shipped to mass 
immunizers, giving them an incomplete picture as to how the available 
vaccine was distributed in their state. 

* More timely data. CDC officials stated that the Flu Vaccine Finder 
data are generally a week old when they become available to users 
because of the time necessary for CDC to collect the data from 
manufacturers and medical supply distributors and upload these data 
into the system. State health officials reported that having real-time 
data would be helpful to effectively determine which types of providers 
are in need of vaccine at a given point in time. 

Some state health officials reported that they have utilized other 
mechanisms, such as surveying individual providers in their 
jurisdictions, to determine which providers have received a sufficient 
vaccine supply to vaccinate their high-risk and other target groups and 
which providers are in need. For example, one state, Minnesota, created 
its own database to monitor vaccine distribution in the state during 
the 2004-05 season. State health officials surveyed the individual 
providers in each of the state's public health jurisdictions on their 
vaccine supply, and then entered the information into a database. This 
database then provided information for state officials to determine the 
need for and availability of vaccine across the state. Health officials 
from other states have reported administering informal surveys of 
individual providers on their vaccine supply during times of shortage. 
State health officials reported using the information on vaccine supply 
to facilitate voluntary redistribution--that is, providers with excess 
vaccine supply were identified by health officials and asked to give 
their left over doses to providers who needed it most, such as occurred 
during the 2004-05 influenza season. According to a representative from 
a national association representing state and territorial health 
officials, these informal surveys were very time and resource 
intensive, however. 

One state, Rhode Island, created its own vaccine distribution program 
to manage the availability and distribution of vaccine in the state. 
Specifically, Rhode Island is implementing a program for the 2007-08 
season in which the state health department will manage the purchasing 
and distribution of vaccine among the state's providers for vaccination 
of adults. Specifically, the state health department plans to purchase 
and distribute about 250,000 influenza vaccine doses among 
participating providers free of charge to vaccinate adults who have 
health insurance or are working for or insured through a Rhode Island 
company.[Footnote 47] 

CDC and Others Have Produced Public Health Messages, and CDC Has Taken 
Some Steps to Assess Its Messages: 

CDC and others have produced a variety of public health messages 
designed to promote influenza vaccination, including messages to 
encourage preferential vaccination of certain high-risk and other 
target groups during times of vaccine delay or shortage. CDC has also 
taken some steps to assess its messages. For example, CDC has tested 
its messages prior to dissemination and collected some data to give the 
agency a sense of the impact its messages may be having on the public 
after dissemination. However, CDC and others have not conducted 
comprehensive evaluations on the impact of messages after 
dissemination. Although no comprehensive evaluations have been 
conducted, CDC and other officials we interviewed identified key 
elements, such as clear and consistent messages, that they believe are 
important to producing effective public health messages. However, there 
are impediments to effectively implementing these elements. 

CDC and Others Have Produced and Disseminated Influenza-Related Public 
Health Messages: 

CDC has produced and disseminated public health messages designed to 
promote seasonal influenza vaccination. These messages provide 
information to the public and others--including providers and other 
public health entities--about influenza and aim to motivate 
individuals, particularly those in high-risk and other target groups, 
to receive influenza vaccination. CDC uses diverse means to convey its 
messages to the public, such as press releases, information posted on 
CDC's Web site, print materials, and media campaigns. CDC has also 
created messages designed to reach specific populations, such as 
materials printed in Spanish or public service announcements 
disseminated via Spanish-language radio. 

Other public health entities also produce and disseminate their own 
messages to promote seasonal influenza vaccination. For example: 

* Some state and local public health departments produce and 
disseminate print material, Web site information, and press releases, 
and inform the public through media and other means about the 
importance of vaccination. 

* Provider associations, such as the American Medical Association and 
the American Academy of Pediatrics, produce and disseminate policy 
statements and other guidelines that adhere to ACIP recommendations for 
influenza vaccination, according to representatives of these 
associations we interviewed. 

* The American Lung Association, in collaboration with one major 
vaccine manufacturer, runs a Web-based educational initiative to 
encourage vaccination. 

* CDC and others participate in an influenza season press kickoff event 
held early each fall. This event, hosted by the National Foundation for 
Infectious Diseases,[Footnote 48] has involved senior HHS officials 
from CDC and the Centers for Medicare & Medicaid Services[Footnote 49] 
and has involved the participation of provider associations, such as 
the American Medical Association and the American Academy of 
Pediatrics. 

For the 2006-07 influenza season, CDC and other partners--including the 
Association of State and Territorial Health Officials, National 
Association of County and City Health Officials, and Association of 
Immunization Managers--implemented a National Influenza Vaccination 
Week during the last week of November in 2006 to promote influenza 
vaccination. Throughout the week, CDC and other partnering 
organizations disseminated print materials and television and radio 
public service announcements encouraging late-season vaccination. CDC 
also contacted providers of influenza vaccine to encourage them to 
continue vaccination into December and beyond by recommending 
vaccinations to their patients and scheduling additional vaccination 
clinics and longer hours at these clinics. CDC officials reported that 
the agency plans to make National Influenza Vaccination Week an annual 
event. 

During times of vaccine shortage or delay, CDC has produced and 
disseminated modified public health messages to encourage 
prioritization of available vaccine to allow those groups identified by 
ACIP--including some but not all of ACIP's initial target population of 
high-risk individuals--to be preferentially vaccinated before others. 
For example, during the vaccine shortage of the 2004-05 season, CDC 
held frequent press conferences beginning in October 2004 asking 
individuals who did not belong to one of these groups identified by 
ACIP to step aside and defer vaccination so that those in ACIP- 
identified priority groups would have vaccine available to 
them.[Footnote 50] 

CDC Has Taken Some Steps to Assess Its Public Health Messages: 

CDC has taken steps to assess its influenza-related public health 
messages before disseminating them to the public through focus groups 
and other activities, and has collected some data to give the agency a 
sense of the impact its messages may be having on the public after 
dissemination. For example, CDC has monitored media coverage of its 
messages and--in response to a recommendation we made in 2001-- 
collected data to assess the public's recall of the content and source 
of the messages disseminated for the 2000-01 season. CDC and others 
have not, however, conducted comprehensive evaluations to assess the 
impact of influenza-related messages after they are disseminated to the 
public. 

CDC officials involved in communicating the agency's influenza-related 
public health messages told us the agency tests its messages before 
they are disseminated to the public using focus groups and other 
similar methods. For example, CDC conducts in-depth interviews with 
providers, and leads focus group discussions with target audiences, 
such as African-American seniors, Hispanics, and seniors with chronic 
conditions. CDC officials reported that the goal of these efforts is to 
help determine if the agency's influenza-related public health messages 
are easily understood by these audiences. These officials told us the 
feedback they receive is used to revise the messages as necessary 
before disseminating them to the public. 

CDC officials we interviewed also reported that the agency has 
collected some data to provide a sense of the impact its messages may 
be having on the public. For example, due to the influence that media 
reports can have on public demand for vaccination, CDC officials 
reported that the agency monitors media sources--such as newspapers, 
press releases, and wire services--during the influenza season to 
assess the volume and content of influenza-related stories in the news. 
CDC has also monitored the number of calls to the agency's information 
hotline following influenza-related public health campaigns. The agency 
also collected limited information related to its public health 
messages in response to our recommendation that CDC assess the relative 
success of its past outreach and education efforts to help the agency 
prepare for potential delays or shortages of vaccine in subsequent 
seasons.[Footnote 51] Specifically, CDC conducted a mail survey in June 
2001 that, in part, assessed the public's recall of the content and 
source of the influenza-related public health messages disseminated 
that year.[Footnote 52] Based on the survey results, CDC officials 
concluded that the importance of continuing to vaccinate persons in 
December or later should be emphasized more strongly in the future, 
especially when vaccine is not available earlier in the season. 

CDC has not conducted comprehensive evaluations to assess the impact of 
the influenza-related messages it uses on promoting vaccination after 
these messages are disseminated to the public. CDC officials reported 
that the agency does not conduct formal impact analyses of its 
influenza-related public health messages after these messages are 
disseminated--such as analyses to determine what messages successfully 
influence changes in behavior. These officials, who are responsible for 
producing and disseminating influenza-related messages, commented that 
it would be difficult to discern the impact of public health messages 
disseminated by CDC and others because these messages are just one 
factor among many that can influence vaccination. Given the complexity 
of such an evaluation, these officials noted that CDC resources 
available for influenza-related communications do not support formal 
impact analyses. One of these officials estimated that, to complete a 
post-dissemination evaluation of CDC's influenza-related messages, it 
would cost five times CDC's total budgeted amount for seasonal 
influenza-related public health communications. For fiscal year 2007, 
this budgeted amount was an estimated $1.5 million.[Footnote 53] In 
addition to CDC officials, officials we interviewed representing state 
and local health departments, national associations representing 
physicians, and a public health association reported that they had not 
conducted, nor were they aware of, studies examining the impact of the 
influenza-related public health messages they or others produced. 

Elements Important for Producing Effective Public Health Messages Face 
Impediments to Implementation: 

Although no comprehensive evaluations have been conducted to assess the 
impact of influenza-related public health messages on vaccination, CDC 
and other officials identified elements they believe, based on their 
experience, are important to producing public health messages regarding 
seasonal influenza vaccination that will have an impact on promoting 
vaccination. These elements included clear and consistent messages, 
messages encouraging late-season vaccination, and the importance of 
recommendations from health care providers in creating public demand 
for vaccination. However, there are impediments to effectively 
implementing these elements. 

* Clear and consistent messages. Officials we interviewed from CDC and 
state and local health departments stressed the importance of 
consistent influenza-related messages disseminated to the public. For 
example, officials from CDC and state health departments stressed the 
importance of consistency in messages coming from different public 
health entities. Similarly, we reported in 2005 on the importance of 
clear and consistent messages in averting public confusion regarding 
who should be vaccinated and when they should receive the 
vaccine.[Footnote 54] For example, we reported that during the 2004-05 
influenza season, health officials in California told us, at one time, 
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. These 
officials emphasized that these mixed messages created confusion. In 
addition to consistency in messages coming from different public health 
entities, officials we interviewed from CDC, as well as national 
associations representing physicians, stressed the importance of 
consistency in messages sent by any one public health entity because 
inconsistency during an influenza season and between seasons may also 
create confusion. For example, some individuals in target groups who 
heeded CDC's messages to step aside during the 2004-05 season still 
thought it was not appropriate for them to get vaccinated after CDC 
stopped disseminating these messages later in the season. CDC has 
recognized the importance of clarity and consistency in influenza- 
related public health messages in its communications plans for the 2007-
08 influenza season. A CDC official involved in communicating the 
agency's messages acknowledged past inconsistencies in messages 
disseminated by different public health entities but noted that many 
public health entities look to CDC to take the lead with public health 
messages and the result, overall, was a high level of consistency in 
the messages disseminated from different entities. This official also 
stated, however, that it is difficult to maintain a consistent message 
during or between influenza seasons, because messages need to adapt to 
the dynamic and complex situations that comprise influenza seasons. For 
example, messages need to be modified to account for changes in ACIP 
recommendations, which could result in the public hearing differing 
messages before and after these ACIP revisions are made. 

* Messages encouraging late-season vaccination. CDC and other health 
officials we interviewed reported that public demand for influenza 
vaccination typically wanes after November. According to these and 
other officials, they believe interest wanes in part because the public 
has been conditioned by prior messages from CDC and other public health 
entities to believe that they must receive vaccination before late 
November for it to be effective. CDC and other officials representing 
state health departments we interviewed, as well as national 
associations representing physicians, reported that it is important 
that public health messages effectively encourage late-season 
vaccination so that as many people as possible can be protected against 
influenza and related complications. These efforts are also important 
to help minimize surplus vaccine left over at the end of influenza 
season. The experience by some states during the 2006 National 
Influenza Vaccination Week, however, illustrates the difficulties 
encountered when trying to coordinate promotion of late-season 
vaccination with vaccine availability. Specifically, officials from 
three of the six states we interviewed reported the timing of the 
National Influenza Vaccination Week--which was held from November 27 to 
December 3, 2006--was problematic for their state because it occurred 
before an adequate vaccine supply was available. For example, officials 
from the Minnesota Department of Health told us that they were unable 
to participate in National Influenza Vaccination Week because local 
health departments in the state had not yet received vaccine by that 
week. An official from the Texas Department of State Health Services 
told us the department received approximately half of its vaccine in 
the 2 weeks immediately preceding National Influenza Vaccination Week-
-probably too late for many providers in the state to participate in 
the initiative, this official said. An official from the Washington 
State Department of Health told us the department did not receive the 
bulk of its vaccine until during that week. 

* Recommendations from health care providers influence demand. CDC 
officials we interviewed reported that the agency has consistently 
found that a recommendation from a physician or other health care 
provider is the most important factor in an individual's decision to 
get vaccinated. Officials representing state health departments and 
national associations representing physicians also acknowledged the 
importance of providers' recommendations. CDC officials reported that 
the agency has made efforts to encourage providers to recommend 
vaccination to their patients, including providing patient education 
tools that physicians can use when discussing vaccination with their 
patients. However, despite these efforts, available data suggest that 
getting providers to recommend vaccination for their patients has been 
difficult. For example, a January 2007 phone survey of adults conducted 
for CDC by an independent research organization found that less than 40 
percent of respondents reported that their physician or other health 
care worker discussed getting an influenza shot with them. 

Agency Comments: 

We provided a draft of this report to HHS for comment. The department 
provided technical comments, which we incorporated as appropriate. 

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 Health and Human Services and other 
interested parties. We will also provide copies to others upon request. 
In addition, the report will be available at no charge on the GAO Web 
site at [hyperlink, http://www.gao.gov]. We will also make copies 
available to others upon request. 

If you or your staff members have any questions about this report, 
please contact me at (202) 512-7114 or crossem@gao.gov. Contact points 
for our Offices of Congressional Relations and Public Affairs may be 
found on the last page of this report. GAO staff who made contributions 
to this report are listed in appendix VI. 

Signed by: 

Marcia Crosse: 

Director, Health Care: 

[End of section] 

Appendix I: Scope and Methodology: 

In conducting this study, we reviewed relevant documents and 
interviewed officials from the Department of Health and Human 
Services's (HHS) Centers for Disease Control and Prevention (CDC) and 
Food and Drug Administration (FDA) and manufacturers of all five 
seasonal influenza vaccines licensed for the U.S. market for the 2007- 
08 season as of August 31, 2007.[Footnote 55] We also reviewed relevant 
documents and spoke with officials from the American Public Health 
Association, the National Foundation for Infectious Diseases, and three 
national associations representing state and local public health 
officials: the Association of Immunization Managers, Association of 
State and Territorial Health Officials, and National Association of 
County and City Health Officials.[Footnote 56] We reviewed relevant 
documents and spoke with officials from the Health Industry 
Distributors Association, a national association representing medical 
supply distributors, as well from national associations representing 
physicians and long-term care providers, including the American Medical 
Association, American Academy of Pediatrics, the National Center for 
Assisted Living, and the American Health Care Association. We also 
reviewed documents related to the 2007 National Influenza Vaccine 
Summit.[Footnote 57] 

We also selected judgmental samples of (1) medical supply distributors; 
(2) mass immunizers--organizations that conduct mass immunization 
clinics at workplaces, retail stores, long-term care facilities, and 
other locations; and (3) state health departments. For each 
organization in our samples, we reviewed relevant documents and 
interviewed officials. We selected the samples to reflect a mix of 
medical supply distributors, mass immunizers, and states; however, our 
samples were not statistically representative and cannot be generalized 
to all medical supply distributors, mass immunizers, or states. 

For our judgmental sample of medical supply distributors, we selected 
six medical supply distributors that plan to distribute influenza 
vaccine for the 2007-08 season.[Footnote 58] These six distributors 
represented a mix of organizations that distributed seasonal influenza 
vaccine to different markets (i.e., physician offices, hospitals, long- 
term care facilities); distributed different types of influenza vaccine 
products; and varied in whether they guaranteed delivery of the vaccine 
by a specific date, provided data to CDC for its Flu Vaccine Finder, 
and participated in the Flu Vaccine Business Practices 
Initiative.[Footnote 59] In addition, we interviewed one medical supply 
distributor who distributed the influenza vaccine in prior seasons, but 
has decided not to for the 2007-08 influenza season. 

For our judgmental sample of mass immunizers, we selected four mass 
immunizers who represented a mix of organizations that vaccinated 
individuals in different regions of the country; provided seasonal 
influenza vaccine in a variety of delivery locations (i.e., places of 
work, retail stores, other nonmedical settings); and were based on 
different business models (for-profit and nonprofit). We also 
interviewed representatives from entities that contract with mass 
immunizers to provide vaccinations including one retail store, one long-
term care and assisted living facility, and one workplace. 

For our judgmental sample of state health departments, we selected six 
states that represented a mix of states from different regions of the 
country; with different population sizes; with varied influenza 
vaccination success;[Footnote 60] and that varied in whether they used 
CDC's Flu Vaccine Finder and have proposed innovative approaches for 
distributing influenza vaccine.[Footnote 61] 

To determine the quantity of seasonal influenza vaccine produced and 
when vaccine reaches providers who administer vaccine, we examined data 
from CDC regarding the number of influenza vaccine doses produced and 
distributed each month for the 2000-01 influenza season through the 
2006-07 influenza season. We also reviewed data from CDC on the 
cumulative percentage of doses manufacturers and medical supply 
distributors shipped each month to different types of providers for the 
2006-07 influenza season. To identify the locations in which high-risk 
groups receive their vaccinations, we reviewed data from CDC's 
Behavioral Risk Factor Surveillance System--a state-based system of 
health surveys that collects information on health risk behaviors, 
preventive health practices, and health care access primarily related 
to chronic disease and injury. We also reviewed data from a Gallup poll 
conducted on behalf of CDC, as well as CDC's National Adult 
Immunization Survey. In addition, to identify efforts undertaken by CDC 
and state health officials to help state and local officials manage 
availability of vaccine for high-risk and other target groups, we 
reviewed data from and documentation of the Flu Vaccine Finder, the 
Internet-based distribution database that CDC created to assist state 
and local health officials in their management of influenza vaccine 
availability issues, and interviewed health department officials from 
our sample of states. We assessed the reliability of these data by 
interviewing officials from CDC, manufacturers, and medical supply 
distributors knowledgeable about the data and by reviewing documents 
related to the data. On the basis of our assessment, we determined the 
data were sufficiently reliable for our purposes. 

To identify actions CDC and others have taken to communicate public 
health messages that promote seasonal influenza vaccination, we also 
reviewed influenza vaccination communication plans produced by CDC and 
research and surveys conducted by CDC. 

We conducted our work in accordance with generally accepted government 
auditing standards from May through October 2007. 

[End of section] 

Appendix II: Manufacturers of Seasonal Influenza Vaccine for the U.S. 
Market, 2000-01 through 2007-08 Influenza Seasons: 

The manufacturers of seasonal influenza vaccine for the U.S. market 
have changed between the 2000-01 influenza season, when there were 
three manufacturers, and the 2007-08 influenza season, for which there 
were six licensed manufacturers as of September 28, 2007 (see table 2). 

Table 2: Manufacturers of Seasonal Influenza Vaccine for the U.S. 
Market, 2000-01 through 2007-08 Influenza Seasons: 

Manufacturer: sanofi pasteur (Aventis Pasteur Inc.)[B]; 
Influenza season: 2000-01: [Check]; 
Influenza season: 2001-02: [Check]; 
Influenza season: 2002-03: [Check]; 
Influenza season: 2003-04: [Check]; 
Influenza season: 2004-05[A]: [Check]; 
Influenza season: 2005-06: [Check]; 
Influenza season: 2006-07: [Check]; 
Influenza season: 2007-08: [Check]. 

Manufacturer: Wyeth Laboratories, Inc; 
Influenza season: 2000-01: [Check]; 
Influenza season: 2001-02: [Check]; 
Influenza season: 2002-03: [Check]; 
Influenza season: 2003-04: [Empty]; 
Influenza season: 2004-05[A]: [Empty]; 
Influenza season: 2005-06: [Empty]; 
Influenza season: 2006-07: [Empty]; 
Influenza season: 2007-08: [Empty]. 

Manufacturer: Novartis Vaccines and Diagnostics Limited (Chiron 
Vaccines Limited; 
PowderJect Pharmaceuticals plc; 
Medeva Pharma Limited; 
Evans Vaccines Limited)[C]; 
Influenza season: 2000-01: [Check]; 
Influenza season: 2001-02: [Check]; 
Influenza season: 2002-03: [Check]; 
Influenza season: 2003-04: [Check]; 
Influenza season: 2004-05[A]: [Check][D]; 
Influenza season: 2005-06: [Check]; 
Influenza season: 2006-07: [Check]; 
Influenza season: 2007-08: [Check]. 

Manufacturer: MedImmune Vaccines, Inc.[E]; 
Influenza season: 2000-01: [Empty]; 
Influenza season: 2001-02: [Empty]; 
Influenza season: 2002-03: [Empty]; 
Influenza season: 2003-04: l[F]; 
Influenza season: 2004-05[A]: [Check]; 
Influenza season: 2005-06: [Check]; 
Influenza season: 2006-07: [Check]; 
Influenza season: 2007-08: [Check]. 

Manufacturer: GlaxoSmithKline Biologicals; 
Influenza season: 2000-01: [Empty]; 
Influenza season: 2001-02: [Empty]; 
Influenza season: 2002-03: [Empty]; 
Influenza season: 2003-04: [Empty]; 
Influenza season: 2004- 05[A]: [G]; 
Influenza season: 2005-06: [Check]; 
Influenza season: 2006-07: [Check][H]; 
Influenza season: 2007-08: [Check][H]. 

Manufacturer: ID Biomedical Corporation of Quebec; 
Influenza season: 2000-01: [Empty]; 
Influenza season: 2001-02: [Empty]; 
Influenza season: 2002-03: [Empty]; 
Influenza season: 2003-04: [Empty]; 
Influenza season: 2004-05[A]: [Empty]; 
Influenza season: 2005-06: [Empty]; 
Influenza season: 2006-07: [Check][H]; 
Influenza season: 2007-08: [Check][H]. 

Manufacturer: CSL Limited; 
Influenza season: 2000-01: [Empty]; 
Influenza season: 2001-02: [Empty]; 
Influenza season: 2002-03: [Empty]; 
Influenza season: 2003-04: [Empty]; 
Influenza season: 2004-05[A]: [Empty]; 
Influenza season: 2005-06: [Empty]; 
Influenza season: 2006-07: [Empty]; 
Influenza season: 2007-08: [Check]. 

Source: CDC and FDA. 

Notes: Table shows manufacturers of seasonal influenza vaccine licensed 
for the U.S. market for the 2007-08 season as of September 28, 2007. 

[A] For the 2004-05 season, in addition to the three manufacturers, two 
foreign manufacturers' vaccines were made available by FDA under an 
investigational new drug protocol. Although HHS purchased about 1.5 
million doses of this vaccine, no doses were distributed that season. 

[B] Aventis Pasteur Inc., became sanofi pasteur in January 2005. 

[C] In 2006, Novartis Vaccines and Diagnostics Limited acquired Chiron 
Vaccines Limited. In 2003, Chiron Vaccines Limited acquired PowderJect 
Pharmaceuticals plc. In 2001, PowderJect acquired Medeva Pharma 
Limited; Medeva had previously acquired Evans Vaccines Limited. 

[D] Chiron's license was suspended by the United Kingdom in October 
2004 because of contamination at its manufacturing facility there and 
Chiron ceased production of the vaccine for the U.S. market for the 
2004-05 season. 

[E] MedImmune Vaccines, Inc. manufactures live attenuated vaccine 
administered as a nasal spray, sold under the trade name FluMist. All 
other manufacturers produce inactivated virus vaccine administered as 
an injection. 

[F] Wyeth Laboratories, Inc. distributed MedImmune's FluMist vaccine 
during the 2003-04 season. 

[G] GlaxoSmithKline Biologicals's vaccine was not licensed for the 
United States for the 2004-05 season, but the manufacturer's vaccine 
was made available for that season by FDA under an investigational new 
drug protocol. Although HHS purchased about 1.2 million doses of 
GlaxoSmithKline's vaccine, no doses were distributed that season. 

[H] ID Biomedical Corporation of Quebec, the licensed manufacturer of 
one influenza vaccine (FluLaval), is a subsidiary of GlaxoSmithKline 
plc. GlaxoSmithKline Biologicals, also part of GlaxoSmithKline plc, is 
the licensed manufacturer of another influenza vaccine, Fluarix. 

[End of table] 

[End of section] 

Appendix III: Advisory Committee on Immunization Practices (ACIP) 
Recommendations: 

In spring or summer each year, ACIP, after consulting with CDC, makes 
recommendations on which population groups should be targeted for 
annual influenza vaccination. Since publishing its recommendations for 
the 2000-01 season, ACIP has changed its recommendations on who should 
be targeted for vaccination, primarily expanding the groups it has 
recommended (see table 3).[Footnote 62] ACIP has also modified its 
recommendations to address a vaccine shortage or delay; for two 
seasons, ACIP published revised recommendations that narrowed the 
groups that should receive priority for available vaccine (see tables 4 
and 5). For the 2006-07 season, approximately 73 percent of the U.S. 
population--an estimated 218 million individuals--were included in 
ACIP's target groups (see table 6). 

Table 3: ACIP Influenza Vaccination Recommendations, 2000-01 through 
2007-08 Influenza Seasons: 

[See PDF for image] 

Source: GAO analysis of CDC's Morbidity and Mortality Weekly Reports, 
2000 through 2007. 

Notes: A check mark [Check] indicates vaccination was recommended for 
that group for that season. 

[A] The check marks in this column represent those target groups ACIP 
recommended for vaccination for the 2000-01 influenza season prior to 
ACIP issuing revised recommendations in October 2000. 

[B] The check marks in this column represent those target groups ACIP 
recommended for vaccination for the 2004-05 influenza season prior to 
ACIP issuing revised recommendations in October 2004. 

[C] For the 2006-07 through 2007-08 seasons, ACIP also recommended that 
healthy children aged 6 months through 8 years who had not been 
previously vaccinated receive two doses of vaccine. 

[D] ACIP generally refers to persons at increased risk for influenza- 
related complications as the "high-risk" groups within the target 
population and the other persons in the target population for annual 
vaccination as the "other target groups." For the 2007-08 influenza 
season, ACIP also considers as part of the "high-risk" groups those 
persons at higher risk for influenza-associated clinic, emergency 
department, or hospital visits--including adults aged 50 through 64 
years and children aged 24 to 59 months. 

[E] For the 2002-03 and 2003-04 seasons, ACIP encouraged vaccination of 
healthy children aged 6 to 23 months when feasible because they are at 
increased risk for influenza-related hospitalization. For the 2007-08 
season, ACIP recommended vaccination of children aged 6 to 23 months 
because they are at increased risk for influenza-related 
hospitalization. 

[F] For the 2000-01 through 2005-06 seasons, adults aged 50 through 64 
years were recommended for vaccination because of an elevated 
prevalence of chronic medical conditions in this age group. For the 
2006-07 and 2007-08 seasons, adults aged 50 through 64 years and 
healthy children aged 24 to 59 months were recommended for vaccination 
because of a higher risk for medical care--that is an increased risk of 
influenza-associated clinic, emergency department, or hospital visits. 

[End of table] 

Table 4: Target Groups ACIP Recommended for Influenza Vaccination for 
the 2000-01 Influenza Season, before and after October 2000: 

Target groups: Pregnant women in second or third trimester during the 
influenza season; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Adults aged 65 years and older; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Residents of nursing homes and other chronic-care 
facilities; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Persons aged 6 months through 64 years with certain 
chronic medical conditions; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Health care workers; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Household contacts of persons at high-risk; 
April 2000[A]: [Check]; 
October 2000[B]: [Check]. 

Target groups: Adults aged 50 through 64 years; 
April 2000[A]: [Check]; 
October 2000[B]: [Empty]. 

Source: CDC, "Prevention and Control of Influenza: Recommendations of 
the Advisory Committee on Immunization Practices (ACIP)," Morbidity and 
Mortality Weekly Report, vol. 49, no. RR-3 (2000) and CDC, "Updated 
Recommendations From the Advisory Committee on Immunization Practices 
in Response to Delays in Supply of Influenza Vaccine for the 2000-01 
Season," Morbidity and Mortality Weekly Report, vol. 49, no. 39 (2000): 
888-892. 

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

[A] ACIP advised that in addition to the groups for which vaccination 
is recommended, all persons, including school-aged children, who want 
to reduce the risk of becoming ill with influenza or of transmitting 
influenza to others, should be vaccinated, depending on vaccine 
availability. 

[B] The revised recommendations, published after a delay in influenza 
vaccine availability, also stated that special efforts should be made 
in December and later to vaccinate adults aged 50 through 64 years. 

[End of table] 

Table 5: Target Groups ACIP Recommended for Influenza Vaccination for 
the 2004-05 Influenza Season, before and after October 2004: 

Target groups: Children aged 6 to 23 months; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: All women who will be pregnant during the influenza 
season; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Adults aged 65 years and older; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Residents of nursing homes and other chronic-care 
facilities; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Persons aged 6 months and older with certain chronic 
medical conditions; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Health care workers; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Persons aged 2 to 64 years who are household contacts of 
persons at high-risk[C]; 
May 2004[A]: [Check]; 
October 2004[B]: [Empty]. 

Target groups: Persons aged 2 to 64 years who are household contacts of 
children younger than 6 months[C]; 
May 2004[A]: [Check]; 
October 2004[B]: [Check]. 

Target groups: Adults aged 50 through 64 years who are not household 
contacts of high-risk individuals; 
May 2004[A]: [Check]; 
October 2004[B]: [Empty]. 

Source: CDC, "Prevention and Control of Influenza: Recommendations of 
the Advisory Committee on Immunization Practices (ACIP)," Morbidity and 
Mortality Weekly Report, vol. 53, no. RR-6 (2004) and CDC, "Interim 
Influenza Vaccination Recommendations, 2004-05 Influenza Season," 
Morbidity and Mortality Weekly Report, vol. 53, no. 39 (2004): 923-924. 

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

[A] ACIP advised that in addition to the groups for which vaccination 
is recommended, all persons, including school-aged children, who want 
to reduce the risk of becoming ill with influenza or of transmitting 
influenza to others, should be vaccinated, depending on vaccine 
availability. 

[B] These revised recommendations were published in response to a 
shortage of influenza vaccine. 

[C] These groups belonged to a single category in ACIP's May 2004 
recommendations. 

[End of table] 

Table 6: Estimates of ACIP Target Group Populations Sizes, 2006: 

Target group: Persons at increased risk for influenza-related 
complications: Children aged 6 to 23 months; 
Population in millions: 6.0; 
Percent of total U.S. population: 2.0%. 

Target group: Persons at increased risk for influenza-related 
complications: All women who will be pregnant during the influenza 
season; 
Population in millions: 4.0; 
Percent of total U.S. population: 1.3. 

Target group: Persons at increased risk for influenza-related 
complications: Adults aged 65 years and older; 
Population in millions: 37.2; 
Percent of total U.S. population: 12.5. 

Target group: Persons at increased risk for influenza-related 
complications: Persons aged 24 months through 64 years with certain 
chronic medical conditions; 
Population in millions: 44.0; 
Percent of total U.S. population: 14.8. 

Target group: Persons at increased risk for influenza-related 
complications: Subtotal; 
Population in millions: 91.2; 
Percent of total U.S. population: 30.6. 

Target group: Persons with elevated prevalence of chronic medical 
conditions, or with increased risk for influenza-associated clinic, 
emergency department, or hospital visits: Adults aged 50 through 64 
years; 
Population in millions: 18.0; 
Percent of total U.S. population: 6.0. 

Target group: Persons with elevated prevalence of chronic medical 
conditions, or with increased risk for influenza-associated clinic, 
emergency department, or hospital visits: Children aged 24 to 59 
months; 
Population in millions: 7.1; 
Percent of total U.S. population: 2.4. 

Target group: Persons with elevated prevalence of chronic medical 
conditions, or with increased risk for influenza-associated clinic, 
emergency department, or hospital visits: Subtotal; 
Population in millions: 25.1; 
Percent of total U.S. population: 8.4. 

Target group: Persons who can transmit influenza to those at high risk; 
Population in millions: Household contacts of persons at high risk or 
children aged 24 through 59 months; 
Population in millions: 94.8; 
Percent of total U.S. population: 31.8. 

Target group: Persons who can transmit influenza to those at high risk; 
Population in millions: Health care workers; 
Population in millions: 7.0; 
Percent of total U.S. population: 2.4. 

Target group: Persons who can transmit influenza to those at high risk; 
Population in millions: Subtotal; 
Population in millions: 101.8; 
Percent of total U.S. population: 34.1. 

Target group: Total target population; 
Population in millions: 218.1; 
Percent of total U.S. population: 73.1%. 

Source: CDC analysis of United States Census Bureau data. 

Note: Population sizes are based on United States Interim population 
projections by age, sex, race, and Hispanic origin: 2000 to 2050 
(Population Projections Branch, United States Census Bureau, released 
May 11, 2004). Percentages are based on a total population estimate of 
about 298 million. 

[End of table] 

[End of section] 

Appendix IV: Cumulative Percentage of Vaccine Distributed by Provider 
Type during 2006-07 Influenza Season: 

For the 2006-07 influenza season, manufacturers distributed 103 million 
doses of vaccine to customers such as physicians, state and local 
health departments, or other types of providers who administer 
vaccinations. Manufacturers distributed vaccine as it became available, 
with the proportion of vaccine distributed each month varying. Table 7 
shows the cumulative percentage of vaccine distributed to different 
types of providers throughout the 2006-07 influenza season, according 
to CDC. 

Table 7: Percentage of Cumulative Number of Doses Distributed by Month 
and Provider Type, 2006-07 Influenza Season: 

Provider type: Corporations; 
September: 2.2%; 
October: 2.5%; 
November: 2.6%; 
December: 2.5%; 
January: 2.5%. 

Provider type: Correctional facilities; 
September: 0.0; 
October: 0.0; 
November: 0.0; 
December: 0.0; 
January: 0.0. 

Provider type: Distributors; 
September: 24.9; 
October: 16.2; 
November: 18.3; 
December: 15.7; 
January: 15.6. 

Provider type: Federal government; 
September: 1.1; 
October: 3.9; 
November: 3.3; 
December: 5.0; 
January: 5.1. 

Provider type: Hospitals; 
September: 9.2; 
October: 12.9; 
November: 10.4; 
December: 9.9; 
January: 9.9. 

Provider type: Long-term care facilities; 
September: 4.7; 
October: 4.0; 
November: 3.7; 
December: 3.1; 
January: 3.1. 

Provider type: Military; 
September: 0.6; 
October: 1.0; 
November: 0.8; 
December: 2.2; 
January: 2.2. 

Provider type: Other private provider types; 
September: 3.4; 
October: 2.9; 
November: 2.7; 
December: 2.8; 
January: 2.9. 

Provider type: Other public provider types; 
September: 1.3; 
October: 1.1; 
November: 1.1; 
December: 1.4; 
January: 1.4. 

Provider type: Pharmacies; 
September: 5.0; 
October: 5.1; 
November: 3.8; 
December: 3.5; 
January: 3.5. 

Provider type: Private providers[A]; 
September: 41.0; 
October: 43.2; 
November: 43.1; 
December: 42.3; 
January: 42.3. 

Provider type: State and local health departments; 
September: 6.6; 
October: 7.2; 
November: 10.1; 
December: 11.6; 
January: 11.6. 

Source: CDC. 

Notes: Percentages do not add to 100 percent because of rounding. Table 
indicates the cumulative number of doses distributed to provider types 
as of September 29, 2006; October 20, 2006; November 10, 2006; December 
22, 2006; and January 12, 2007. According to CDC, there was minimal 
change in percentage of doses distributed to provider types after 
January 12, 2007, and therefore CDC did not conduct analyses of the 
percentage of doses distributed beyond this date. Data identifying 
distribution of vaccine to mass immunizers were not available within a 
single provider category, according to CDC; rather, because these types 
of providers are classified differently by different manufacturers and 
medical supply distributors, doses received by them are included within 
a number of provider type categories. 

[A] The category "Private providers" includes physicians, as well as 
outpatient clinics and facilities, health maintenance organizations, 
and surgery centers. 

[End of table] 

[End of section] 

Appendix V: CDC's Flu Vaccine Finder: 

An effort by CDC to provide state and some local health officials with 
information to help them monitor where vaccine is distributed is the 
Flu Vaccine Finder component of the Secure Data Network.[Footnote 63] 
Initially created to address a severe vaccine shortage that occurred in 
the 2004-05 influenza season, the Flu Vaccine Finder "provides 
information to enhance the visibility of influenza vaccine distribution 
for state and local health officials to assist in their management of 
influenza vaccine availability issues and challenges." 

Fifty-six states, cities, and urban areas that are CDC immunization 
grantees--all 50 states and 6 cities and urban areas--are eligible to 
use the Flu Vaccine Finder, but to access it, grantees must request and 
receive access from CDC.[Footnote 64] CDC officials reported that for 
the 2007-08 influenza season, once CDC approval is received, each 
grantee is allowed to identify five individuals within their 
organization to be users of the Flu Vaccine Finder; these users have 
access to data for their state or jurisdiction. 

Since its inception, the Flu Vaccine Finder has evolved, specifically 
in the number and type of contributors of data and the type of 
information available: 

* 2004-05 influenza season. After one of the two major vaccine 
manufacturers exited the market for that influenza season in October 
2004 because of contamination at its manufacturing facility, a severe 
vaccine shortage occurred. In response, CDC developed the Flu Vaccine 
Finder as part of its plan to help state and local health officials 
direct available vaccine to certain high-risk groups. The Flu Vaccine 
Finder was first available to users in November 2004 and included data 
from the remaining major influenza vaccine manufacturer. In addition to 
providing information on where that manufacturer had shipped vaccine, 
users could also order vaccine through the Flu Vaccine Finder.[Footnote 
65] 

* 2005-06 influenza season. According to CDC officials, the Flu Vaccine 
Finder was expanded to include data from two manufacturers and seven 
major medical supply distributors for the 2005-06 season, and 
information on the number of doses that had been already ordered by 
users was also available. However, CDC discontinued the Flu Vaccine 
Finder's feature for ordering influenza vaccine that had been available 
during the 2004-05 influenza season. For this season, the Flu Vaccine 
Finder was available to users beginning in December 2005. 

* 2006-07 influenza season. Before the start of the 2006-07 season, CDC 
officials met with manufacturers and major medical supply distributors 
to receive feedback on the Flu Vaccine Finder and instruct them on the 
type of data CDC would be requesting from them and the process for 
submitting this information to CDC during the season. For this season, 
the Flu Vaccine Finder included data from seven major medical supply 
distributors, along with all U.S.-licensed manufacturers. Data, 
including a onetime listing of doses ordered in advance from those 
manufacturers and medical supply distributors who submitted the 
information, were available to users from September 2006 until the end 
of January 2007. 

* 2007-08 influenza season. CDC officials reported that the Flu Vaccine 
Finder will include data from at least the manufacturers of five 
licensed vaccines and six major medical supply distributors for this 
season. CDC officials also reported that they expect data will be 
available to users from September 2007 until the end of January 2008. 

For the 2007-08 season, CDC officials stated that they requested that 
manufacturers and medical supply distributors submit information weekly 
to CDC for the Flu Vaccine Finder on the vaccine doses they distributed 
for the season so far.[Footnote 66] The requested weekly information 
includes: 

* National Drug Code number of vaccine distributed,[Footnote 67] 

* state where influenza vaccine is distributed, 

* zip code where influenza vaccine is distributed, 

* number of doses distributed, 

* date the vaccine doses were shipped, and: 

* type of provider where vaccine is distributed. 

Manufacturers and medical supply distributors do not classify in a 
uniform way the types of providers to whom vaccine is distributed. 
Therefore, for use in the Flu Vaccine Finder, CDC recodes data 
submitted by manufacturers and medical supply distributors on the type 
of provider into one of the following categories:[Footnote 68] 

* corporation/occupational health, 

* correctional facility, 

* distributors, 

* federal government, 

* hospitals/emergency departments/dialysis centers, 

* long-term care, 

* military, 

* other private provider, 

* other public provider, 

* pharmacy, 

* private providers, and: 

* state/local health department. 

CDC officials reported that it typically takes about a week for the 
information submitted by manufacturers and medical supply distributors 
to be made available by CDC in the Flu Vaccine Finder. Users are able 
to view Flu Vaccine Finder data for their state or jurisdiction online 
as well as download data into a spreadsheet format which allows them to 
then perform their own analyses. The spreadsheet contains variables for 
which manufacturers and medical supply distributors submitted data. 
According to CDC officials, CDC does not conduct data reliability tests 
of the data in the Flu Vaccine Finder because the data represent a 
"census" of influenza vaccine distribution data and another data source 
does not exist for reliability testing. In addition, CDC officials 
reported that about 15 percent of doses distributed during the 2006-07 
season and captured by the Flu Vaccine Finder were shipped from 
manufacturers or medical supply distributors to other medical supply 
distributors for resale. CDC officials reported that the Flu Vaccine 
Finder does not capture to which types of providers the medical supply 
distributors then resell these doses. 

[End of section] 

Appendix VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov: 

Acknowledgments: 

In addition to the contact named above, Kim Yamane, Assistant Director; 
Ramsey Asaly; George Bogart; Jennifer DeYoung; Jawaria Gilani; and 
Cathleen Hamann made key contributions to this report. 

[End of section] 

Related GAO Products: 

Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza 
Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4, 2005. 

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

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

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

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

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

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

February 12, 2004. 

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

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

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

[End of section] 

Footnotes: 

[1] Influenza vaccination is performed by a diverse group of providers, 
including state and local health departments, other medical facilities, 
and mass immunizers--visiting nurse agencies or for-profit companies 
that contract with and conduct influenza vaccination clinics at 
workplaces, retail stores, long-term care facilities, and other 
locations. 

[2] FDA's determination of strains to be included in the seasonal 
influenza vaccine is based on a review of surveillance data, the 
availability of appropriate materials, and consultation with an FDA 
advisory committee. 

[3] Throughout this report, we use the term high-risk to refer to those 
groups of individuals ACIP has identified for the 2007-08 influenza 
season as being at increased risk for influenza-related complications 
or at higher risk for medical care--that is, for influenza-associated 
clinic, emergency department, or hospital visits. See Centers for 
Disease Control and Prevention, "Prevention and Control of Influenza: 
Recommendations of the Advisory Committee on Immunization Practices 
(ACIP), 2007," Morbidity and Mortality Weekly Report, vol. 56 (June 29, 
2007): 1-53. 

[4] See Centers for Disease Control and Prevention, "Estimates of 
Influenza Vaccination Target Population Sizes in 2006 and Recent 
Vaccine Uptake Levels," [hyperlink, 
http://www.cdc.gov/flu/professionals/vaccination/pdf/targetpopchart.pdf]
(downloaded April 2, 2007). 

[5] See GAO, Flu Vaccine: Supply Problems Heighten Need to Ensure 
Access for High-Risk People, GAO-01-624 (Washington, D.C.: May 15, 
2001); GAO, Influenza Vaccine: Shortages in 2004-05 Season Underscore 
Need for Better Preparation, GAO-05-984 (Washington, D.C.: Sept. 30, 
2005); and see Related GAO Products at the end of this report. 

[6] We also spoke with state and local health officials who are members 
of national associations representing state and local health officials. 

[7] Medical supply distributors purchase vaccine from manufacturers and 
resell it to customers such as physicians, hospitals, state and local 
health departments, other distributors, and others seeking vaccine in 
order to administer vaccinations. 

[8] For the 2007-08 influenza season, five vaccines were licensed by 
FDA for the U.S. market as of August 31, 2007: (1) Fluarix, 
manufactured by a part of GlaxoSmithKline plc, GlaxoSmithKline 
Biologicals, (2) FluLaval, manufactured by a subsidiary of 
GlaxoSmithKline plc, ID Biomedical Corporation of Quebec, (3) FluMist, 
manufactured by MedImmune Vaccines, Inc., (4) Fluvirin, manufactured by 
Novartis Vaccines and Diagnostics Limited, and (5) Fluzone, 
manufactured by sanofi pasteur. The policy of sanofi pasteur is to 
spell its name without capital letters. We interviewed officials and 
obtained information from GlaxoSmithKline Biologicals regarding both 
Fluarix and FluLaval; and interviewed officials and obtained 
information from MedImmune Vaccines, Inc., Novartis Vaccines and 
Diagnostics Limited, and sanofi pasteur regarding FluMist, Fluvirin, 
and Fluzone, respectively. On September 28, 2007, FDA approved an 
additional influenza vaccine, Afluria, manufactured by CSL Limited, for 
the U.S. market for the 2007-08 season. 

[9] We selected these samples to reflect a mix of distributors, mass 
immunizers, and states; however, our samples were not statistically 
representative and cannot be generalized. Our judgmental samples 
included six medical supply distributors that plan to distribute 
influenza vaccine for the 2007-08 season, four mass immunizers, and six 
state health departments. For additional information on our scope and 
methodology, see app. I. 

[10] The Behavioral Risk Factor Surveillance System is a state-based 
system of health surveys that collects information on health risk 
behaviors, preventive health practices, and health care access 
primarily related to chronic disease and injury. 

[11] The Secure Data Network is an ongoing project sponsored by CDC to 
allow CDC field staff, researchers, and public health partners to 
securely exchange confidential, proprietary, or sensitive data over the 
Internet. 

[12] A live attenuated vaccine contains attenuated, or weakened, 
influenza viruses. 

[13] Manufacturers may produce different formulations of the vaccine, 
and formulations are indicated for certain age groups. For example, for 
the 2006-07 influenza season, only one manufacturer made formulations 
of its injectable vaccine that were approved for use in children aged 6 
months through 3 years of age. For that age group, the manufacturer 
made formulations in multidose vials that contain a preservative, as 
well as in preservative-free single-use prefilled syringes. 

[14] On September 19, 2007, FDA expanded the group approved for use of 
the live attenuated vaccine FluMist from healthy individuals aged 5 
through 49 years to those aged 2 through 49 years. 

[15] These steps describe the manufacturing process for the inactivated 
injectable vaccine, which represented over 97 percent of vaccine doses 
produced for sale in the United States for the 2006-07 influenza 
season. Live attenuated vaccine administered as a nasal spray is 
produced in a similar process that follows a similar timeline. 

[16] FDA conducts this strain selection process in consultation with 
its Vaccines and Related Biological Products Advisory Committee. 
Surveillance information from the World Health Organization and CDC is 
evaluated, as is the availability of materials suitable for commercial 
production of vaccine. 

[17] The four World Health Organization Collaborating Centres are 
located in Australia, Japan, the United Kingdom, and the United States. 
CDC is the Collaborating Centre in the United States. 

[18] Manufacturers report that they usually begin production of one 
virus strain that they anticipate FDA will select for the following 
influenza season's vaccine--for example, a strain that was included in 
the prior season's vaccine--in January, prior to FDA's strain selection 
and distribution of that influenza season's strains. 

[19] In contrast, the live attenuated vaccine administered as a nasal 
spray is not inactivated. 

[20] Influenza vaccine is subject to official lot release by FDA. 
Manufacturers submit samples of each lot of vaccine, along with 
summaries of the history of manufacture and the results of all the 
tests performed, to FDA, which may then perform additional tests before 
officially releasing the lot for distribution. The manufacturer may not 
distribute the vaccine lot until FDA releases it. 

[21] Some customers may also be members of group purchasing 
organizations--entities that help health care providers realize savings 
and efficiencies by aggregating purchasing volume and using that 
leverage to negotiate discounts with manufacturers, distributors, and 
other vendors. 

[22] For the 2007-08 season, the live attenuated vaccine administered 
as a nasal spray also requires refrigeration within a prescribed 
temperature range. 

[23] While cell-based production methods are new for influenza 
vaccines, they have been used for other vaccines such as chickenpox, 
hepatitis A, polio, and shingles. HHS has awarded more than $1 billion 
in contracts to develop cell-based technologies for influenza vaccines. 

[24] For example, Dynavax Technologies Corporation was recently awarded 
a $3.25 million grant from the National Institutes of Health to 
continue development of a universal influenza vaccine. 

[25] In April 2007, the World Health Organization's Strategic Advisory 
Group of Experts on Immunization concluded that it was realistic to 
expect that vaccines offering protection against multiple influenza 
strains could be developed; however, no specific time frame was given. 
In May 2007, the World Health Organization reported that a universal 
vaccine might not be available in the next 5 to 10 years. 

[26] According to FDA, the expiration dating period for inactivated 
virus vaccine is set so that influenza vaccine for one influenza season 
cannot be confused with vaccine for subsequent seasons. 

[27] According to a Gallup poll conducted for CDC in 2005, adults 
received influenza vaccination in the following locations: physicians' 
offices (39 percent), workplaces (17 percent), other clinics or health 
centers (10 percent), stores or pharmacies (10 percent), health 
departments (8 percent), hospitals (6 percent), senior or recreational 
centers (4 percent), other locations (4 percent), and schools (2 
percent). 

[28] See app. II for a list of U.S.-licensed manufacturers of seasonal 
influenza vaccine from the 2000-01 season through the 2007-08 influenza 
season. 

[29] With specified exceptions, the Federal Food, Drug, and Cosmetic 
Act prohibits the resale of prescription drugs, including influenza 
vaccine, after their purchase by health care entities such as public or 
private hospitals. This prohibition does not apply to resale for 
emergency medical reasons. In addition, because the term "entity" does 
not include wholesale distributors, this prohibition does not apply to 
resale by wholesale distributors. See 21 U.S.C. §353(c)(3). 

[30] See app. III for additional information on ACIP recommendations 
for prevention and control of influenza and on the priority groups-- 
comprised of subsets of the high-risk and other target groups--that 
ACIP recommended receive priority for available vaccine during seasons 
with vaccine delays or shortage. 

[31] See app. III for information on the estimated population in each 
target group. The vaccination rates among the different high-risk and 
other target groups vary. For example, about 65 percent of adults aged 
65 years and older and about 42 percent of health care workers less 
than 65 years of age received vaccination, according to CDC estimates. 
See Centers for Disease Control and Prevention, "Estimates of Influenza 
Vaccination Target Population Sizes in 2006 and Recent Vaccine Uptake 
Levels." 

[32] If a manufacturer were to begin production of a virus strain in 
January that did not end up being one of the strains selected by FDA 
for the vaccine--a situation that manufacturers report has yet to 
occur--it is possible that the manufacturer would not have enough time 
to grow a different virus strain in time to distribute the vaccine for 
fall vaccination. 

[33] GAO-01-624. 

[34] GAO-05-984. 

[35] Good manufacturing practices include requirements applicable to 
the entire manufacturing process to help ensure that biological 
products, such as vaccines, are safe, pure, and potent. 

[36] The manufacturer had previously reported that it expected to 
address the problem without affecting the quantity of vaccine produced. 

[37] In October 2007, this manufacturer reported that it will make 
approximately 2 million doses immediately available to the U.S. market 
for the 2007-08 season. 

[38] Health Industry Distributors Association, "2006-07 Influenza 
Vaccine Production & Distribution Market Brief," (Alexandria, Va.: 
Health Industry Distributors Association, 2007) [hyperlink, 
http://www.hida.org/attachment.asp?attachment_id=10509] (downloaded 
Oct. 3, 2007). 

[39] An official from the American Medical Association participating in 
the National Influenza Vaccine Summit estimated it takes from 1 to 3 
days for a manufacturer to distribute vaccine to customers. 

[40] For the 2007-08 influenza season, ACIP considers both of these 
population groups as part of the high-risk groups. 

[41] CDC recommended this strategy because of uncertainty in the 
production of vaccine for that season. See CDC, "Influenza Vaccine 
Prebooking and Distribution Strategies for the 2005-06 Influenza 
Season," Morbidity and Mortality Weekly Report, vol. 54, no. 12 (2005): 
307-308. 

[42] The other four medical supply distributors we interviewed did not 
report that they plan to collect information from their customers on 
the number of doses ordered that are intended for high-risk or other 
target groups. 

[43] CDC recommended obtaining information on doses ordered for high- 
risk individuals for the 2005-06 season, following the significant and 
unexpected shortage of vaccine during the 2004-05 season. When that 
shortage occurred, CDC recommended vaccine distribution be prioritized 
to certain groups. CDC was only able to successfully facilitate the 
directed distribution and redistribution of vaccine so that the vaccine 
would be made available to those priority groups through extensive 
collaboration and information sharing between multiple parties 
including the major manufacturer of vaccine that season, and state and 
local health officials. For more information, see GAO-05-984. 

[44] According to CDC, data identifying distribution of vaccine to mass 
immunizers were not available within a single provider category; 
rather, because these types of providers are classified differently by 
different manufacturers and medical supply distributors, doses received 
by them are included within a number of provider type categories. 

[45] Jeanne M. Santoli, "Influenza Vaccine Distribution Data and Use of 
Data During the 2006-07 Season" (PowerPoint presentation at the 2007 
National Influenza Vaccine Summit, Atlanta, Georgia, April 2007). For 
more information on the flu vaccine distribution information collected 
by CDC and made available to states through the Flu Vaccine Finder, see 
app. V. 

[46] The Flu Vaccine Finder includes the National Drug Code number, a 
universal product identifier for human drugs which identifies the 
labeler, product, and trade package size. For example, for the 
influenza vaccine, the National Drug Code number identifies the 
manufacturer of the vaccine, the type of vaccine (preservative-free or 
preservative-containing), and the presentation of the vaccine (.25 
milliliters, .5 milliliters, etc., and single dose syringes or 
multidose vials). 

[47] Rhode Island's uninsured residents are eligible to receive 
influenza vaccinations through other programs administered by the 
state. 

[48] The National Foundation for Infectious Diseases is a nonprofit 
organization whose mission includes educating the public and health 
care professionals about infectious diseases, such as influenza. 

[49] The Centers for Medicare & Medicaid Services administers Medicare, 
the government-sponsored insurance program for persons aged 65 years 
and older and other qualified persons. The Medicare program pays for 
influenza vaccinations for Medicare beneficiaries and the Centers for 
Medicare & Medicaid Services partners with CDC to promote influenza 
vaccination among Medicare beneficiaries. 

[50] See GAO-05-984 and app. III for revisions to groups recommended 
for vaccination by ACIP during the 2004-05 influenza season vaccine 
shortage. 

[51] See GAO-01-624. 

[52] CDC conducted a mail survey in June 2001 of 3,719 individuals that 
assessed vaccination coverage levels, timing of vaccination, place of 
vaccination, reasons for not being vaccinated, and messages heard about 
vaccination. 

[53] This $1.5 million for fiscal year 2007 included additional funding 
for National Influenza Vaccination Week. 

[54] GAO-05-984. 

[55] For the 2007-08 influenza season, five vaccines were licensed by 
FDA for the U.S. market as of August 31, 2007: (1) Fluarix, 
manufactured by a part of GlaxoSmithKline plc, GlaxoSmithKline 
Biologicals, (2) FluLaval, manufactured by a subsidiary of 
GlaxoSmithKline plc, ID Biomedical Corporation of Quebec, (3) FluMist, 
manufactured by MedImmune Vaccines, Inc., (4) Fluvirin, manufactured by 
Novartis Vaccines and Diagnostics Limited, and (5) Fluzone, 
manufactured by sanofi pasteur. The policy of sanofi pasteur is to 
spell its name without capital letters. We interviewed officials and 
obtained information from GlaxoSmithKline Biologicals regarding both 
Fluarix and FluLaval; and interviewed officials and obtained 
information from MedImmune Vaccines, Inc., Novartis Vaccines and 
Diagnostics, Limited, and sanofi pasteur regarding FluMist, Fluvirin, 
and Fluzone, respectively. These five manufacturers also produced 
seasonal influenza vaccine for the U.S. market for the 2006-07 
influenza season. On September 28, 2007, FDA approved an additional 
influenza vaccine, Afluria, manufactured by CSL Limited, for the U.S. 
market for the 2007-08 season. 

[56] We also spoke with members of the Association of Immunization 
Managers and the National Association of County and City Health 
Officials who are state and local health officials. 

[57] The National Influenza Vaccine Summit participants include 
stakeholders interested in influenza prevention such as CDC, the 
American Medical Association, manufacturers, medical supply 
distributors, and others such as state health departments. The summit 
meets annually to address important issues in influenza immunization. 

[58] The Health Industry Distributors Association estimated that 25 
medical supply distributors distribute vaccine in the United States in 
2007. 

[59] Members of the Flu Vaccine Business Practices Initiative have 
voluntarily committed themselves to adhering to a set of "responsible 
business practices" including compliance with all of CDC's guidelines 
and initiatives, purchasing vaccine only from manufacturers or 
manufacturer-authorized medical supply distributors, and adhering to 
manufacturer vaccine storage and handling guidelines. This initiative 
is sponsored by the Health Industry Distributors Association. 

[60] To determine vaccination rates, we used immunization rates for 
adults aged 65 years and older for 2005 from CDC's Behavioral Risk 
Factor Surveillance System. 

[61] The six states we selected were Colorado, Maryland, Minnesota, 
Rhode Island, Texas, and Washington. 

[62] In addition, for the 2000-01 through 2007-08 seasons, ACIP has 
advised that, in addition to the high-risk and other target groups for 
whom providers are recommended to provide vaccinations, all persons, 
including school-aged children, who want to reduce the risk of becoming 
ill with influenza or of transmitting influenza to others, should be 
vaccinated, depending on vaccine availability. 

[63] CDC's Secure Data Network is an ongoing project sponsored by CDC 
to allow field staff, researchers, and public health partners to 
securely exchange confidential, proprietary, or sensitive data over the 
Internet. 

[64] Immunization grantees are recipients of grants from CDC's National 
Center for Immunization and Respiratory Diseases (formerly the National 
Immunization Program) that support effective immunization systems and 
high rates of coverage through scientific assistance for evaluation, 
delivery, communications, and partnership development. 

[65] For more information about CDC's two-part plan to help state and 
local officials direct vaccine to high-risk groups during the vaccine 
shortage in the 2004-05 season as well as the inception of the Flu 
Vaccine Finder, see GAO-05-984. 

[66] According to CDC officials, CDC requested that manufacturers do 
not provide data on doses shipped to medical supply distributors 
participating in the Flu Vaccine Finder in order to avoid a duplication 
of information from that being submitted by the six major medical 
supply distributors. 

[67] The National Drug Code number is a universal product identifier 
for human drugs which identifies the labeler, product, and trade 
package size. For example, for the influenza vaccine, the National Drug 
Code number identifies the manufacturer of the vaccine, the type of 
vaccine (preservative-free or preservative-containing), and the 
presentation of the vaccine (.25 milliliters, .5 milliliters, etc., and 
single dose syringes or multidose vials). 

[68] According to CDC, data identifying distribution of vaccine to mass 
immunizers were not available within a single provider category; 
rather, because these types of providers are classified differently by 
different manufacturers and medical supply distributors, doses received 
by them are included within a number of provider type categories. 

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