Influenza Vaccine: Issues Related to Production, Distribution, and Public Health Messages
Published: 2007-10-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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. 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—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.
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. 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, public health officials,  medical supply distributors, 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. 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. 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, 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—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.
subsections: section_title: Background
paragraphs: 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.
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.  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. The live  attenuated vaccine, in contrast, is approved for use only among healthy  individuals aged 2 through 49 years who are not pregnant. 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):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. 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. 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. 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.  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.  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.  The vaccine must be kept refrigerated within a prescribed temperature  range.
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. 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, a completely  universal influenza vaccine may be years away.
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. 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.
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). For the 2007–08 influenza  season, six U.S.-licensed manufacturers are expected to produce an  estimated 132 million doses of seasonal influenza vaccine.
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. 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.  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. 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.
section_title: Manufacturing Challenges, Limitations in Production Capacity, and Fluctuating Demand for Vaccine May Limit the Quantity of Vaccine Produced or Delay When Vaccine Reaches Providers
paragraphs: 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.
subsections: section_title: Manufacturing Challenges May Limit the Quantity of Seasonal Influenza Vaccine Produced or Delay When Vaccine Reaches Providers
paragraphs: 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.
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. 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. 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. In September 2007, the  manufacturer reported that it had resolved the observances contained in  the warning letter.
section_title: Production Capacity May Limit the Quantity of Seasonal Influenza Vaccine Produced and May Delay When Vaccine Reaches Providers
paragraphs: 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.
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.
section_title: Demand for Influenza Vaccine Affects the Quantity of Seasonal Influenza Vaccine Produced
paragraphs: 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.
section_title: Distribution Routes May Affect When Seasonal Influenza Vaccine Reaches Individual Providers
paragraphs: 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. 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, 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.
section_title: Issues Related to Vaccine Distribution May Affect Vaccine Availability for High- Risk and Other Target Groups
paragraphs: 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.
subsections: section_title: High-Risk and Other Target Groups Receive Vaccinations at Various Locations Where Different Types of Providers Administer Vaccine
paragraphs: 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).
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).
section_title: Manufacturers and Medical Supply Distributors Ship Vaccine Using a Variety of Distribution Practices
paragraphs: 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.
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. 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.
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.
section_title: CDC Data Indicate State and Local Health Departments Generally Received a Smaller Amount of Vaccine Than Other Providers in Early Fall
paragraphs: 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). 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.
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.
section_title: CDC and State Health Officials Have Undertaken Efforts to Help Monitor the Availability of Vaccine
paragraphs: 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.” 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, 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.
section_title: CDC and Others Have Produced Public Health Messages, and CDC Has Taken Some Steps to Assess Its Messages
paragraphs: 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.
subsections: section_title: CDC and Others Have Produced and Disseminated Influenza- Related Public Health Messages
paragraphs: 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, has involved senior HHS officials from CDC and the  Centers for Medicare & Medicaid Services 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.
section_title: CDC Has Taken Some Steps to Assess Its Public Health Messages
paragraphs: 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. 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. 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. 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.
section_title: Elements Important for Producing Effective Public Health Messages Face Impediments to Implementation
paragraphs: 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. 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.
section_title: Agency Comments
paragraphs: 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 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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. 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.  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.
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. 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. 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; and that varied in whether they used CDC’s Flu Vaccine Finder  and have proposed innovative approaches for distributing influenza  vaccine.
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.
section_title: Appendix II: Manufacturers of Seasonal Influenza Vaccine for the U.S. Market, 2000– 01 through 2007–08 Influenza Seasons
paragraphs: 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).
section_title: Appendix III: Advisory Committee on Immunization Practices (ACIP) Recommendations
paragraphs: 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). 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).
section_title: Appendix IV: Cumulative Percentage of Vaccine Distributed by Provider Type during 2006–07 Influenza Season
paragraphs: 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.
section_title: Appendix V: CDC’s Flu Vaccine Finder
paragraphs: 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. 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. 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.    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. The requested weekly information includes:    National Drug Code number of vaccine distributed,    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:  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.
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.
section_title: Related GAO Products
paragraphs: 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.