2):1. 3. 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. 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. 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. 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. 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. 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. For example, one medical supply distributor stated that it fills  vaccine orders in the order in which it received the orders. 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. 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 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. 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. However, there are impediments to effectively  implementing these elements. Clear and consistent messages. Agency Comments

We provided a draft of this report to HHS for comment. The department  provided technical comments, which we incorporated as appropriate. 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. 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. The spreadsheet contains variables for which  manufacturers and medical supply distributors submitted data.
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.