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The National Vaccine Advisory Committee (NVAC)

The Action Plan

This Adult Immunization Action Plan describes five major goals for adult immunization in the United States. These are:

I. Increase the demand for adult vaccination by improving provider and public awareness.

II. Increase the capacity of the health care delivery system to effectively deliver vaccines to adults.

III. Expand financing mechanisms to support the increased delivery of vaccines to adults.

IV. Monitor and improve the performance of the nation's immunization program.

V. Enhance the capability and capacity to conduct research on (1) vaccine-preventable diseases of adults, (2) adult vaccines, (3) adult immunization practices, (4) new and improved vaccines, (5) international programs for adult immunization.

The findings that underlie these goals and the action steps recommended for their implementation are described in this report. A complete listing of agency-specific action steps can be found in Appendix A.

Overall coordination of this effort will be the responsibility of the National Vaccine Program Office (in conjunction with the Interagency Vaccine Group) with the support of the Assistant Secretary for Health who is the statutory Director of the National Vaccine Program.

The task that lies ahead is complex, and the effort and resources needed to achieve success will be substantial, yet even within existing resources progress can be made. In undertaking this work we should remind ourselves that our nation's programs for childhood immunization have reduced the costs of health care and dramatically improved the well-being of all our children. We can and should expect no less from our efforts to immunize adults.

Introduction

The potential for prevention of infectious diseases through vaccination is clearly demonstrated by the success of the childhood immunization programs in the U.S. As a result of broad use of vaccines:

  • Diphtheria and childhood tetanus have practically disappeared.
  • Fatal cases of pertussis (whooping cough) are rare.
  • No cases of indigenous poliomyelitis have been reported since 1979.
  • The occurrence of measles has also been substantially reduced, despite resurgence in 1989-1991.
  • Cases of rubella during pregnancy are rarely observed, resulting in few reports of congenital rubella syndrome.
  • Childhood mumps cases are also rarely encountered by physicians.
  • Finally, within the past few years we have witnessed an extraordinary decline in the occurrence of Haemophilus influenzae type b (Hib) meningitis, formerly the leading cause of bacterial meningitis in children, an event solely attributable to the introduction and widespread use of Hib vaccines.

These achievements reflect the creativity of our scientists, the enterprise of our vaccine manufacturers, and the commitment of our health-care community to help ensure the health and well-being of all our children.

A similar level of commitment is needed to improve the health of adults. An estimated 90% or more of all costs of treating adult pneumococcal infections are the result of hospital care. The overall societal costs of moderately severe influenza outbreaks may be $10 billion or more, not including the value of years of life lost. Annually, hepatitis B virus-related acute and chronic liver disease causes up to 5000 deaths and produces medical and work-related loss costs of approximately $700 million. Outbreaks of measles, rubella, and mumps have disrupted college campuses, the work place, and institutions such as prisons.

Despite these enormous costs, vaccines already available to prevent influenza, invasive pneumococcal infection, and hepatitis B are underutilized, although use of the influenza vaccine has been improving over the last eight to nine years. It is estimated that at least 45,000 adult deaths occur as a result of these vaccine-preventable diseases each year. By contrast, fewer than 1,000 persons in the United States die of vaccine-preventable diseases of childhood.

This contrast does not reflect a lack of concern or commitment. Among the many worthy efforts developed to prevent morbidity and mortality due to these adult vaccine-preventable diseases are the following:

  • Recommendations for use of influenza, pneumococcal, and hepatitis B vaccines have been widely disseminated in the Morbidity and Mortality Weekly Report from the Advisory Committee on Immunization Practices, and in the Guide for Adult Immunization from the American College of Physicians and the Infectious Disease Society of America.
  • A number of DHHS initiatives have resulted in: the development of a pandemic influenza preparedness plan and a strategic plan for emerging infections.
  • In 1987, the Department of Health and Human Services stated that hepatitis B vaccine should be provided at no charge to workers at risk of occupational exposure to hepatitis B virus.
  • In 1988, the Health Care Financing Administration in collaboration with the Centers for Disease Control and Prevention launched its Medicare Influenza Vaccine Demonstration providing reimbursement for the cost of vaccine and vaccine administration.
  • The U.S. Preventive Services Task Force has also recommended vaccination of adults when appropriate during periodic health examinations.
  • The National Coalition for Adult Immunization published Standards for Adult Immunization Practice and successfully worked with Congress to establish National Adult Immunization Awareness Week each October.
  • The American Lung Association and American Thoracic Society launched demonstration projects for influenza vaccination throughout the country.
  • The American College Health Association issued recommendations for vaccines that should be required for college matriculation.
  • The American Hospital Association recommended hepatitis B, rubella, and measles vaccination for health-care workers and hospital-based vaccination programs for patients.
  • The OSHA Blood borne Pathogens Rule (1991) requiring employers to vaccinate and educate employees at no cost.

Each year, tens of millions of adults in the U.S. receive influenza vaccine. The overall immunization rate has at least doubled, from 20%-30% up to 50%-60%, in a little more than a decade. Over the four-year period of the Medicare influenza vaccine demonstration project alone (1988 to 1992), close to $69 million were spent in a multifaceted program that increased vaccination rates among Medicare enrollees to 59% and demonstrated the cost-effectiveness and

health benefits of influenza vaccine. Both influenza and pneumococcal vaccines are now covered under Medicare and providers are reimbursed for both vaccine cost and administration charges.

As these efforts unfolded, our nation has undergone transformations that affect everything we do: how we communicate, work, learn, think, perceive our world, and live. This has had profound effects on health care, from the way an individual schedules an office visit to the way the nation approaches the delivery of health care. This Adult Immunization Action Plan acknowledges those changes and proposes a coordinated, economical, and effective approach to the challenges of vaccine-preventable diseases.

The choice our nation faces is not simply one of deciding whether to pay for adult immunization. It is whether to pay more for the costs of treating cases of preventable disease, or less for preventing these diseases from occurring in the first place. The evidence to date indicates that adult immunization is highly cost-effective. Our burgeoning elderly population poses special challenges and although we already know that influenza and pneumococcal vaccines are more cost-effective than all other preventive, screening, and treatment interventions that have been studied, we have yet to realize the potential for expanded use of existing vaccines, including use of currently licensed vaccines that are not currently recommended for adults (e.g., varicella and acellular pertussis). Nationwide emergence of drug-resistant S. pneumoniae strains are making treatment of pneumococcal infections much more expensive and the potential for severe complications far greater. Epidemiologic studies have clearly demonstrated the substantial risk of serious sequelae following hepatitis B virus infection, including hepatocellular carcinoma, hepatic failure, and chronic hepatitis.

These findings add urgency to our need for implementation of effective prevention strategies. This effort must be built on sound, scientific research at all levels, from the laboratory where existing vaccines will be improved and new vaccines created, to the field where innovative programs for vaccine delivery and reimbursement will be evaluated.

As the National Vaccine Advisory Committee noted in its report, improving adult immunization requires greater awareness of the diseases that can be prevented and of the effectiveness and safety of the vaccines that can be used. It requires closer working relationships among health-care professionals, vaccine manufacturers, and payers for health-care services.

This Adult Immunization Action Plan presents both a blueprint for DHHS action and a commitment of the Department to work in partnership with other federal and state agencies and the private sector to effect these changes. It offers suggestions on how we might extend to greater numbers of adults the protection against vaccine-preventable diseases that we currently provide to our children. In this Plan, the DHHS Workgroup on Adult Immunization describes five major goals for adult immunization in the U.S. In addition, specific action steps to accomplish each goal are provided. None of the goals will be reached without giving attention to all.

The Action Plan is far-reaching in scope but will focus on achieving the Healthy People 2000 National Health Promotion and Disease Prevention Objectives for adult immunization. Within these objectives, initial priorities for action will be aimed at ensuring that adults aged 65 and over are vaccinated for influenza and pneumococcal diseases, immunizing adults aged less than 65 at high risk for influenza and pneumococcal disease, and immunizing all those at risk for hepatitis B infection.

The Action Plan that follows is composed of five goals. Each goal is followed by a short discussion of its importance and its contribution to increasing immunization coverage among adults. A series of specific action steps follows and is intended to define an implementation plan to accomplish each goal.

Many of the action steps contained in Appendix A provide for mechanisms to monitor progress and evaluate specific activities. The use of national and local surveys, surveillance for disease, and specific epidemiologic studies will help to assess changes in vaccine coverage levels as well as changes in vaccine delivery practices. The National Vaccine Program Office (NVPO) will be responsible for the management of the initiative and will ensure the continuous monitoring of the impact of the plan at both the national and local levels. Each of the action steps has at least one designated lead agency which will be responsible for coordinating the activities of the participating agencies as they develop a work plan to ensure accomplishment of the action step. For action steps with more than one lead agency, NVPO will assist in coordinating the activities. The NVPO will also ensure the plan is linked to other public (through the Interagency Vaccine Group comprised of representatives from major government agencies involved in vaccine research, development, and delivery) and private sector activities (through the National Vaccine Advisory Committee) in order to help ensure its successful implementation.

GOAL I: INCREASE THE DEMAND FOR ADULT VACCINATION BY IMPROVING PROVIDER AND PUBLIC AWARENESS.

Discussion

In today's health-care environment, individuals have both the opportunity and the obligation to play a proactive role in sound health-care decisions, in partnership with health professionals. It has therefore been increasingly necessary to target health messages to the public simultaneously with messages to health-care professionals. Increasing the demand for adult vaccination must begin with improving the awareness by both health-care providers and the general public regarding the health impact of vaccine-preventable diseases and their costs. Both health-care providers and the general public have limited perceptions of adult vaccine-preventable diseases as significant health problems. Given the much greater incidence of cardiovascular and neoplastic diseases, this perception is not surprising.

It will be equally important to improve understanding of the safety and effectiveness of adult vaccines. For example, doubts linger in the minds of some providers and the public about the efficacy and safety of pneumococcal vaccine. Although pneumococcal vaccine efficacy against nonbacteremic pneumonia is controversial, effectiveness against invasive disease is proven and shown to be cost-effective. This knowledge must be shared in such a way that it leads to changes in behavior: health-care providers offering vaccines and adults expecting, asking for, and accepting recommended vaccines.

Programs to increase awareness must address behaviors that affect vaccine delivery at every level: the individual, the institution, the provider, and society at large. Communication efforts should focus on the provider, the individual, the family, the workplace, community and retirement centers, and health-care settings. Traditional methods for sharing information, such as television, radio, newspapers, and mailings, should be used, as well as newer technology like the Internet.

The National Coalition for Adult Immunization has already established partnerships with health care provider organizations and private sector organizations such as the American Association of Retired Persons and will be a critical partner in educating the public and professional about the benefits of adult immunization.

Action Steps

a. Plan, develop, and implement on a regular basis, effective training and informative programs on adult immunization for health-care providers (including students in medical schools, nursing schools, and allied health professional schools) to improve their immunization practices.

Lead: CDC, HCFA, HRSA

Participating Agencies: AHCPR, OASPA, ACF, AoA, FDA, IHS, OCR, OMH, SAMHSA

b. Plan, develop, and implement effective information programs that educate the public on the importance of preventing vaccine-preventable diseases among adults and the safety and benefits of immunizations.

Lead: CDC, HCFA, HRSA

Participating Agencies: AoA, AHCPR, OASPA, ACF, IHS

c. Conduct studies to: identify barriers to immunization services and assess knowledge and attitudes of providers. Develop and implement strategies based on the results to decrease barriers and increase access to immunization services.

Lead: CDC

Participating Agencies: AHCPR, HCFA, HRSA

d. Implement effective media campaigns to encourage adults in target populations to be vaccinated

Lead: OPHS/NVPO

Participating Agencies: ACF, AoA, CDC, HCFA, HRSA, OASPA, OMH

GOAL II: ENHANCE THE CAPACITY OF THE HEALTH CARE DELIVERY SYSTEM TO EFFECTIVELY DELIVER VACCINES TO ADULTS.

Discussion

Ironically, the majority of adults who develop vaccine-preventable illnesses have been in the care of a physician prior to their illness (in offices, clinics, hospitals) and could have been vaccinated at that time but were not. The costs of these "missed opportunities" are very high. Efforts to improve adult immunization must be focused on developing workable systems for regularly offering vaccines to patients, including workers and students-in-training (e.g., medical and nursing students ) at risk, whether their care is received in specialist settings, institutions, hospitals, health departments, nursing homes, clinics, managed-care, or other settings. Such systems should include practice guidelines featuring adult immunization , and assessing adult immunization coverage levels should become a common feature of quality assurance and accreditation programs.

Federal agencies must also assume increased responsibility for assuring that adults are appropriately immunized and provide leadership in developing and monitoring systems that ensure eligible adults are offered vaccines they need, particularly in federally supported programs. Record-keeping among providers, providing records to vaccinees, and maintaining accessible vaccination records will be critical issues as people receive vaccination services in settings other than their medical home-base. The use of non-traditional providers to administer vaccines to adults needs to be assessed as a means to increase immunization coverage. Although agencies may be designated below as having lead for certain action steps, cross-agency collaboration and the establishment of partnerships outside of the Federal government will be essential to many activities.

Because managed care systems are a substantial component of the United States health care industry, immunization performance measures are needed to improve quality of care, provide uniform assessment criteria, and enhance reporting of quality of care measures.

Vaccine-preventable disease is an important cause of costly hospitalization, especially among the elderly. Despite the burden of disease, vaccines that are recommended for adults are not used optimally. As noted in Goal I, awareness among providers and the public must be increased. In addition, other reasons have been given to explain this:

  • The childhood vaccination schedule is standardized and nearly universal (all vaccines for all children), but adult immunization is selective (different vaccines have different target groups). For example, diphtheria, pertussis, and tetanus (DPT) vaccinations are required of most children (some states do not require pertussis) entering kindergarten, but influenza vaccination is targeted to senior citizens and people at risk of complications of the disease.
  • The sizes of the adult target populations for individual vaccines vary. For some vaccines, the target populations are very large, even much larger than the target population for childhood vaccination.
  • Except for the blood-borne pathogen standard for at-risk workers, there is no statutory requirement for adult immunization as there is for childhood immunization.
  • Unlike the child health-care practices in most communities, few widespread and well-organized programs exist in the private or public sector for vaccinating adults.
  • Until recently, the reimbursement system for adult immunization has been neglected by both government and private insurers, leaving responsibility for paying for vaccination largely in the hands of each individual. Compared with adults, children have more opportunities to obtain inexpensive or free vaccines from public health clinics. Public availability of vaccines, together with responsible parenting and school entry vaccination requirements, have given our nation a high level of childhood immunization.

Action Steps

a. Enhance adult immunization activities at state and local levels.

Lead: CDC

Participating Agencies: HCFA, HRSA, IHS, OMH

b. Ensure adults are appropriately vaccinated in all health-care delivery settings (both publicly and privately supported) including workers who may be at risk for occupational exposure to vaccine-preventable diseases.

Lead: CDC

Participating Agencies: HCFA, HRSA, IHS, OMH, OSG

c. Ensure that guidelines and standards for adult immunization practices are developed in collaboration with health professional organizations and implemented in all practice settings.

Lead: CDC

Participating Agencies: AHCPR, HCFA, HRSA, IHS, OMH, OSG

d. Assess our national manufacturing capacity to meet our demands for vaccine in both public and private settings.

Lead: FDA

Participating Agencies: CDC

e. Provide appropriate data to the nation's vaccine companies to better determine current and future needs for adult vaccines.

Lead: CDC

Participating Agencies: FDA, HCFA, HRSA, IHS, NIH, NVPO

GOAL III: EXPAND FINANCING MECHANISMS TO SUPPORT THE INCREASED DELIVERY OF VACCINES TO ADULTS.

Discussion

Federal reimbursement for influenza vaccination was specifically prohibited by Medicare regulations until 1993. Since then, financing for influenza vaccine has been available through Medicare, and considerable progress has been made in vaccinating high-risk groups. Vaccination services against pneumococcal disease have been funded through Medicare since 1981, but the program has not been extensively implemented. Although the recommended vaccines for adults are very inexpensive and remarkably cost-effective compared with most other health-care services, they are often ignored by providers and patients alike. Managed care offers a significant opportunity to enhance the delivery of clinical preventive services. Increasing adult immunization will require adequate public and private financing mechanisms to support vaccine delivery.

Business and labor leaders and state health insurance regulators should encourage inclusion of adult immunization as a covered benefit for those insured under employee and other policies.

Action Steps

a. Provide adequate reimbursement to providers for the costs of vaccine and vaccine administration by all publicly funded and private health insurance programs.

Lead: HCFA

Participating Agencies: NVPO, CDC, HRSA, IHS

b. Ensure inclusion of appropriate adult immunization services as covered preventive benefits.

Lead: NVPO

Participating Agencies: HCFA, CDC, IHS, OS

GOAL IV: MONITOR AND IMPROVE THE PERFORMANCE OF THE NATION'S IMMUNIZATION PROGRAM.

Discussion

Optimal disease surveillance is needed to ensure that the impact of immunization programs on disease incidence can be evaluated, so changes in trends in disease incidence can be detected. Ethnographic and other types of research on patient acceptability of immunization need to be conducted. As a result of this information, public health prevention strategies can be appropriately altered to improve effectiveness of new strategies implemented. Development of improved diagnostic tests would enhance disease surveillance. In addition, surveillance of immunization use must continuously assess progress in immunization coverage rates. We must ensure that immunization programs are achieving coverage and disease reduction goals within target populations, including patients who are traditionally under served and who require special efforts to ensure that they are offered immunizations.

Action Steps

a. Ensure continuing surveillance for adult vaccine-preventable diseases.

Lead: CDC

Participating Agencies: HCFA, HRSA, NIH, NVPO

b. Monitor overall immunization rates to ensure immunization programs are achieving coverage goals with a special emphasis on coverage goals within underserved and vulnerable populations.

Lead: CDC

Participating Agencies: HCFA, HRSA

GOAL V: ENHANCE THE CAPABILITY AND CAPACITY TO CONDUCT RESEARCH ON (1) VACCINE-PREVENTABLE DISEASES OF ADULTS, (2) ADULT VACCINES, (3) ADULT IMMUNIZATION PRACTICES, (4) NEW AND IMPROVED VACCINES, (5) INTERNATIONAL PROGRAMS FOR ADULT IMMUNIZATION.

Discussion

Greater understanding of the biology of disease agents and their interactions with hosts will guide new approaches for vaccine development. Research on how vaccines are used in practice will assure that they are given to everyone who will benefit. The complexities of developing new and improved vaccines for vaccine-preventable diseases of adults and at-risk populations requires extensive collaboration between individuals and institutions in the public and private sectors.

The Institute of Medicine - Vaccine Development: Establishing Priorities for the United States for the 21st Century, scheduled to be published in the fall of 1997, evaluates priorities and identifies gaps in research and development efforts to improve the safety, immunogenicity, efficacy, and ease of delivery of vaccines for infections, as well as non-infectious targets like cancer and autoimmune diseases. One important direction would be to simplify adult immunization schedules by reducing the number of dosages needed for a vaccine to be effective or to develop mucosal delivery methods that eliminate the need for injections. Likely targets for development or improvement are new vaccines against respiratory syncytial virus, influenza, pneumococcus, Epstein-Barr virus, hepatitis B and hepatitis C, and Helicobacter pylori, varicella vaccine to prevent shingles and post-herpetic neuralgia, and the evaluation of acellular pertussis vaccine in adults to determine its impact on the epidemiology of adult pertussis disease. Another important activity would be to reconcile any differences that exist in vaccine recommendations, particularly as new vaccines are licensed and recommended for use.

Another critical activity will be to study and identify successful methods for increasing adult immunizations coverage among vulnerable, and hard to reach populations. In addition, we need to ensure the safety and efficacy of all vaccines in these populations. These issues should be considered when designing and conducting clinical trials of new vaccines.

The increasingly global economy presents unprecedented opportunities for both the spread and control of vaccination-preventable diseases; therefore, any approach to vaccination must incorporate a global perspective. Research on adult vaccines and their use in other countries will expand our understanding of the possibilities for better control of infectious diseases of adults throughout the world.

Action Steps

a. Identify and work to eliminate barriers (technical/scientific, legal, financial, etc.) to efficient development of new vaccines.

Lead: FDA, NVPO

Participating Agencies: NIH

b. Ensure continued support for research on vaccine-preventable diseases of adults.

Lead: NIH, CDC

Participating Agencies: FDA, HRSA, NVPO

c. Ensure the efficacy, safety, clinical and cost effectiveness of adult vaccines are adequately studied and supported.

Lead: CDC, FDA, NIH

Participating Agencies: HRSA, NVPO

d. Ensure studies of immunization practices in adults and those at high risk of vaccine-preventable diseases are conducted.

Lead: CDC

Participating Agencies: HRSA, NVPO

e. Ensure vaccines are improved and new and more effective ones are developed.

Lead: NIH, CDC

Participating Agencies: FDA, NVPO

f. Ensure adequate support for research on international programs for adult immunization.

Lead: CDC, NIH

Participating Agencies: NVPO

 

Last revised: August 19, 2005

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