On May 20-21, 2003, the National Influenza Summit was held in Chicago, IL. This was the fourth in a series of meetings of health care professionals, provider organizations, health care purchasers, health plans, state and local health departments, hospital and long-term care facility managers, vaccine manufacturers and distributors, community immunization providers, coalitions and others committed to achieving the Healthy People 2010 influenza immunization objectives. Since its inception in 2001, the Summit has provided a forum for identifying and resolving challenges and barriers to increasing the use of influenza vaccine in accord with the recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC).

The Summit is administered by the CDC and the American Medical Association (AMA). Participants in the 2002 Summit meeting identified 50 topics ranging from vaccine pricing to use of vaccine in occupational settings to provider and public education needed to support an environment conducive to increasing the acceptance and use of influenza vaccine. Each of these issues was referred to one or more working group comprised of interested Summit participants. During the 2003 Summit, each of the working groups met, some for the first time, to review progress as well as ongoing or new challenges facing the influenza immunization community. Section 1, below, briefly summarizes the reports from the working groups, and Section 2 highlights some of the plenary presentations to Summit participants.

1. Working Group Reports

A. Communications (Vincenza Snow, MD, American College of Physicians, chair). The working group proposed that a single, consistent message about the value and benefit of influenza immunization be identified that could be targeted to both providers and the public. A timetable was established that calls for development of a communication plan by the end of June 2003. CDC will facilitate this process by providing working group members with forms on which to identify target audiences, messages and evaluation criteria. Because many groups have already begun communication planning for the 2003-2004 influenza season, the plan will likely have limited application this year, but may have greater utility in subsequent years.

B. Payment (Mitch Rothholz, RPh, American Pharmacists Association, chair). The working group has had some success in working with the Centers for Medicare and Medicaid Services (CMS) to streamline the process for addressing problematic claims with the intent of eliminating the need to re-file claims. Last year's payment coding problems have been resolved. CMS has increased the vaccine administration fee to be paid to providers this year, raising the possibility that this could contribute to increased vaccine use. It also is anticipated that the CMS allotment for vaccine purchase will be increased this year. The working group is exploring whether and how CMS payments may be made to non-traditional vaccine providers, and whether and how Health Insurance Portability and Accountability Act (HIPAA) compliance imposes costs that erode the increases in the vaccine purchase price and the administration fee.

C. Long-term Care (William Kavesh, MD, MPH, American Medical Directors Association, chair). The 2002 CMS directive regarding the establishment of standing orders for influenza (and pneumococcal) vaccine use in long-term care facilities is expected to increase vaccine use. However, because some states prohibit the use of standing orders, the impact will not be uniform among states. The working group is developing protocols for the implementation of standing orders. The group is also interested in educating nursing home managers about the value of immunizing staff and, possibly, visitors. The development of recommendations about immunizing nursing home staff is confounded by questions such as: Would the vaccine and its administration be paid for by the employer or by the worker's health plan? Similar questions apply to discussion of immunizing visitors. In both cases, influenza immunization would be advocated in terms of protecting nursing home residents.

D. Vaccine Reallocation (J.R. Ransom, MPH, National Association of County and City Health Officials and Claire Hannan, Association of State and Territorial Health Officials, co-chairs). The influenza vaccine supply problems during the 2000-2001 and 2001-2002 seasons revealed deficiencies in the immunization community's ability to determine the location of vaccine supplies. This lack of knowledge confounded the ability to shift vaccine from well supplied areas to less well supplied areas, and undermined efforts to assure equity in distribution. The working group is creating an electronic clearinghouse for information germane to vaccine distribution and allocation. The group is working with manufacturers to identify how to locate unused vaccine, and is exploring state regulations that may restrict interstate reallocation/transport of vaccine.

E. Occupational Vaccinators (Roslyn Stone, MPH, Corporate Wellness Inc. and Constance Hanna, MD, American College of Occupational and Environmental Medicine, co-chairs). In recent years, those who administer vaccines in occupational settings have had mixed success in deferring their programs until November or later. Indeed, retailers and restaurants were reluctant to set aside time and space during December for immunization due to the demands of their businesses. Similarly, there has been little interest in conducting clinics during January and those that did reported very poor participation. The working group discussed, and rejected, the idea of conducting two clinics per sponsor one for high priority individuals in October and a second one for healthy adults during November. From the perspective of the working group, initiating occupational immunization campaigns in mid-October rather than on November 1st would increase the likelihood of increasing vaccine use. The group noted that increases in vaccine and vaccine administration costs could limit further expansion of workplace influenza immunization programs.

F. Community-based Vaccinators (Jean Ellis, Visiting Nurse Association of America and Steve Wright, Maxim Health Services, co-chairs). The group discussed whether the adoption of no return policies by influenza vaccine producers has had an adverse effect on vaccine use. Sentiment among the group was divided, with some indicating that vaccine use has declined since implementation of these policies; others were skeptical. Vaccine manufacturers indicated that providers were reluctant to pay a premium price for vaccine that could be returned. The working group revisited a point raised during the 2002 Summit that suggested that purchase contracts should incorporate language indicating that providers intend to use the vaccine in accord with ACIP recommendations. The group agreed to the importance of adhering to ACIP guidance, but did not consider it appropriate to embody this in vaccine purchase contracts. The group expressed concern that compliance with HIPAA provisions could undermine efforts to achieve the Healthy People 2010 influenza immunization objectives, and will send a letter to the Office of Civil Rights asking for clarification/guidance regarding this concern. The working group also proposed that ACIP implement an alert system that would be triggered should supply concerns necessitate use of the two-tiered schedule.

G. Physicians (L.J. Tan, PhD, American Medical Association, chair). This working group determined that informing physicians about recent and pending CMS decisions regarding vaccine purchase and administration fees is a top priority. There is interest in re-engaging physicians that had ceased administering influenza vaccine in recent years because of payment issues. The AMA will develop a Web site for physicians to address these issues, and will develop brochures to encourage physicians and their office staff to be immunized annually. The group also will explore how physicians may be able to contribute to efforts to extend the immunization season. Several of the other physician organizations represented in this working group will also develop initiatives intended to inform their members about these and related issues.

H. Vaccine Distribution (Jennifer Alfisi, Health Industry Distributors Association, chair). The working group has developed draft guidelines for the storage and handling of influenza vaccine, largely in the context of vaccine reallocation. Their current efforts are directed toward developing a flow diagram "describing" how the vaccine is distributed. This information is critical to addressing how distribution and tracking might be improved. There also is interest in better defining the term distributor because it is currently applied to a wide variety of organizations and entities. The group anticipates developing a distribution plan that could be implemented in years when vaccine supplies are abundant and on schedule, and a second plan that could be used in years when vaccine delivery is delayed. These plans will be submitted to the ACIP for review.

I. Consumer Education (David Neumann, PhD, National Partnership for Immunization and Deborah Wexler, MD, Immunization Action Coalition, co-chairs). The group identified a number of organizations, corporations and others that have begun planning consumer education initiatives for the 2003-2004 influenza season. The group will gather information about these initiatives to identify opportunities for collaboration and to leverage resources committed to public education. The evaluation of the impact of such initiatives was discussed, and it was suggested that in addition to monitoring the number of media impressions, etc., the CDC's Immunization Hotline may be able to gather data regarding the numbers of calls received and the issues raised by callers in conjunction with various media campaigns. The group noted that while common themes might underlie all media campaigns, specific messages need to be crafted on a target audience-specific basis. The working group has and will continue to liaise with groups that serve high priority groups such as the American Association of Retired Persons and national organizations that focus on diabetes and heart, lung and liver disease.

2. Invited Presentations

The Summit featured a number of presentations that explored a variety of issues related to vaccine use, expectations about the influenza vaccine supply for 2003-2004, the application of new technologies to influenza vaccine production and the status of pandemic influenza planning in the U.S. The presentations are posted on the AMA Web site, http://www.ama-assn.org/ama/pub/article/1826-7688.html#slides.

Influenza vaccine use during the 2002-2003 season is believed to have declined somewhat relative to previous years despite the timely availability of an abundant supply of vaccine. Approximately 95 million doses of vaccine were produced during 2002-2003, and approximately 72 million doses were used. During 2000, vaccine uptake by high priority groups was estimated to be 46% overall, but was considerably less among high priority individuals between 18 and 49 years of age. Similarly, racial disparities in the use of influenza vaccine persist - during the first quarter of 2002, 69% of older whites, 50% of older African Americans and 47% of older Hispanics reported receiving an influenza immunization within the preceding 12 months. This under use of influenza vaccine illustrates the magnitude of the challenge the community faces with respect to achieving the Healthy People 2010 objectives. The ACIP recommends that approximately 185 million people should seek annual influenza immunization.

Increasing uptake of influenza vaccine by Medicare beneficiaries is a major goal of the Centers for Medicare and Medicaid Services (CMS). Working closely with Quality Improvement Organizations and other organizations nationwide, CMS has supported a variety of programs that seek to identify best practices as well as novel approaches that might contribute to achieving the Healthy People 2010 objectives. For the 2003-2004 influenza season, Medicare will pay nearly twice as much for vaccine administration as it did last year and likely will increase the amount paid for the vaccine itself. CMS is actively exploring approaches to reducing other barriers to influenza vaccine use such as payment for vaccine delivered through managed care and at non-traditional sites, improving communication with health care providers and other administrative changes.

The influenza vaccine being produced for the 2003-2004 season is identical in composition to that used during the 2002-2003 season. This will mark the second time that year-to-year antigenic drift was so negligible that the same strains could be used in the vaccine during two consecutive seasons. During early 2003, a new variant of the influenza virus was isolated from infected individuals, but an isolate suitable for vaccine production was not obtained until well after this year's vaccine production was initiated. This new variant is not considered to pose an increased threat to human health, nor is it considered to represent a pandemic strain.

Although the number of manufacturers of injectable influenza vaccine for use in the U.S. has fallen to two, vaccine production for the 2003-2004 season is on schedule and is expected to result in the production of about 80-85 million doses. However, because several critical steps remain in the vaccine production process, it is too soon to predict when vaccine distribution will begin. The much anticipated cold adapted influenza vaccine for intranasal administration has not yet been licensed, but is in commercial production in expectation that licensing will be completed prior to the advent of the 2003-2004 influenza immunization campaign.

Several European vaccine manufacturers have developed cell culture-based systems for producing influenza viruses for use in vaccines. Indeed, two vaccines produced through this technology are licensed for use in the Netherlands, but neither is used currently in the public health arena pending the establishment of commercial production facilities. In addition to eliminating the need to produce virus in chicken eggs, this technology, in combination with modern methods in molecular biology, may offer a means for accelerating the development, production and distribution of a vaccine against a truly pandemic strain of influenza.

Planning for an influenza pandemic has been in progress for nearly a decade. A number of states have created plans and submitted them to the Department of Health and Human Services. The National Vaccine Program Office (NVPO) is reviewing state plans and working to complete a national plan by the end of 2003. Insights gained through the efforts related to bioterrorism preparedness and smallpox immunization will be incorporated into the plan. Later this year, the plan will be circulated to Summit participants and others for review and comment. The NVPO envisions that the final product will be a living document that will further benefit from accumulating knowledge and experience.