Influenza Vaccine:

Issues Related to Production, Distribution, and Public Health Messages

GAO-08-27: Published: Oct 31, 2007. Publicly Released: Nov 15, 2007.

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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.

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.

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