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The National Vaccine Advisory Committee (NVAC)

Appendices

APPENDIX A:  Specific Agency Action Steps

Administration for Children and Families (ACF)

Make information regarding adult immunization goals of Healthy People 2000 available to all its program leadership groups as background information in developing outreach and education efforts to targeted groups in their various program areas.

Goal: Ia

Implementation Year: FY 1997

Facilitate and sponsor workgroups and seminars (through meetings, conferences, training, technical assistance workshops, and regional office-sponsored meetings) to educate staff and program leadership and to help them understand barriers and factors related to adult immunization in ACF's target populations.

Goal: Ia

Implementation Year: FY 1998

Target information and education efforts to other groups including: child welfare workers, foster parents, adoptive parents, Head Start parents, Head Start teachers and staff, social workers, family service workers, runaway and homeless youth, youth workers and shelter staff, transitional living youth, parents of children with developmental disabilities, domestic violence victims, domestic violence workers and staff, and Indian Child Welfare workers and staff.

Goal: Ib

Implementation Year: FY 1998

Work with Community Action Agencies to provide information concerning factors which create barriers or promote access which would be useful both in development of education/outreach materials and of delivery strategies addressing low-income populations.

Goal: Ic

Implementation Year: FY 1998

Work with programs such as the Child Care Bureau, the Office of Family Assistance, the Office of Community Services, Family and Youth Services Bureau, the Head Start Bureau, the Administration of Developmental Disabilities, the Office of Child Support Enforcement, the Administration of Native Americans, and the Office of Refuge Resettlement in the implementation of effective media campaigns and to provide appropriate information on an ongoing basis.

Goal: Id

Implementation Year: FY 1998

Work closely with external partners and national networks in the implementation of effective media campaigns.

Goal: Id

Implementation Year: FY1997

Administration on Aging (AoA)

Increase the demand for adult immunization by improving provider and public awareness through the mandates of the Older Americans Act.

Goal: Ia,b,d

Agency for Health Care Policy and Research (AHCPR)

Assist the Centers for Disease Control and Prevention's Task Force on Community Preventive Services to develop evidence-based recommendations for a variety of provider- and system-based interventions (e.g., community programs, health care regulations) to improve vaccination practices for adults.

Goal: Ia,b; IId

Implementation Year: FY 1997, 1998

Through its grant for the study, Improving Disease Prevention in Primary Care, AHCPR will promote an agenda for preventive services so the health maintenance organizations Blue Plus and Health Partners can stimulate its contracted primary care clinics to deliver routinely the medical preventive services in the Healthy People 2000 goals. Preventive services to be tested include influenza and pneumococcal immunization in those 65 and older. The intervention will consist of training and consultation with the clinics to ensure that as patients appear for normal office visits, they are screened and receive recommendations, assistance, and follow-up.

Goal: Ia; IIb

Study period: 7/93 to 6/98

Highlight the importance of influenza, pneumococcal, and hepatitis B vaccines for all adults aged 65 and older and for other adults with selected medical problems as part of a consumer brochure from the U.S. Preventive Services Task Force.

Goal: Ib

Implementation Year: FY 1997, 1998

Examine data obtained through the Outcomes of Lower Respiratory Illness in Nursing Home Residents study and assess patient histories of pneumococcal and influenza immunization.

Goal: IIc

Study period: 10/96 to 9/99.

Office of the Assistant Secretary for Planning and Evaluation (ASPE)

Collaborate with Department agencies in completing adult immunization action steps.

Goal: I-V

Implementation Year: Ongoing

Office of Public Health and Science (OPHS)

In collaboration with the Office of the Assistant Secretary for Public Affairs, the National Vaccine Program Office, the Assistant Secretary for Health and Science communications staff, and the Public Affairs offices of all agencies

Design a public and provider adult immunization awareness campaign to publicize adult immunization and Medicare coverage of influenza and pneumococcal immunizations.

Goal: Ia,b

Implementation Year: FY 1997

Continue to promote the activities of National Adult Immunization Awareness Week.

Goal: Ia,b

Implementation Year: Ongoing

Distribute information on adult immunizations on the Internet.

Goal: Ia,b

Implementation Year: FY 1997

Create a comprehensive press strategy for the future.

Goal: Ib,d

Implementation Year: FY 1998

Amplify media activities in radio and print markets.

Goal: Ib,d

Implementation Year: FY 1997

Centers for Disease Control and Prevention (CDC)

The Message

Assess the content needs for the training and informational programs to answer the question, "What skills in adult immunization are needed by the public health work force?" both in response to new directives and information that needs to be promulgated by CDC and through direct contact with the public health work force.

Goal: Ia

Implementation Year: FY 1998

Determine the best media for reaching the audience, be it satellite video-conferencing, audio-conferencing, videotape, multimedia, Internet training, print-based, etc.

Goal: Ia

Implementation Year: FY 1998

Develop, produce, market, distribute, and evaluate media program objectives and programs.

Goal: Ia

Implementation Year: FY 1998/1999

Promote adult immunization services and information dissemination via a national public education campaign on adult vaccine-preventable diseases.

Goal: Ib,d

Implementation Year: FY 1998

Enhance local demand for immunization services through the use of culturally sensitive education- and age-appropriate materials.

Goal: Ib, IIb

Implementation Year: FY 1998

Educate health-care providers to recognize that any contact with a provider should be considered an opportunity to provide needed vaccines.

Goal: IIb

Implementation Year: FY 1997

Include information on misconceptions regarding contraindications to vaccination in educational programs on adult immunization.

Goal: IIb

Implementation Year: FY 1997

Assist in revising and distributing to public clinics, professional associations, and large managed-care organizations the "Standards for Adult Immunization Practice" developed by the NCAI.

Goal: IIc

Implementation Year: FY 1998

Continue dialogue with consumer groups concerned about or opposed to certain aspects of the development, manufacturing, or use of various adult vaccines.

Goal: IId

Implementation Year: Ongoing

Capacity Building

Work with major health-care provider organizations to include: (a) training on adult immunization in continuing medical education activities and (b) assessment of adult immunization knowledge and practices in certification and recertification activities.

Goal: Ia

Implementation Year: FY 1997

Identify states that have developed and implemented impressive adult immunization program activities, which can be used as models.

Goal: Ia,c

Implementation Year: FY 1997

Provide increased staff and support to expand adult immunization activities and assistance to state and local immunization programs.

Goal: IIa

Implementation Year: FY 1999

Provide federal grants to support vaccine purchase and program services, promotion, and evaluation at the state and local level.

Goal: IIa

Implementation Year: FY 1999

Encourage all immunization grant projects to use grant funds to establish immunization services for adults.

Goal: IIa

Implementation Year: FY 1997

Set up demonstration projects (to be carried out with state and local immunization grantees) to develop, pilot-test, and evaluate various approaches to raising and measuring immunization coverage.

Goal: IIa

Implementation Year: FY 1999

Encourage immunization grant projects to develop partnerships with private providers and managed-care organizations to assure delivery of vaccination services to all adults.

Goal: IIa, b, c

Implementation Year: FY 1997

Develop and promote use of software and other strategies to assess immunization coverage of adults and practices that contribute to missed opportunities in provider offices and other sites where adult vaccination services are offered.

Goal: IIb

Implementation Year: FY 1999/2000

Develop model legislation for state and/or local governments that could be used to enact legislation to mandate availability of immunization services for certain adults, including special populations, such as persons attending colleges, nursing home residents, and health-care workers.

Goal: IIb

Implementation Year: FY 1998

Encourage the Joint Commission on the Accreditation of Health Care Organizations and other accrediting organizations to require hospitals, nursing homes, managed-care organizations and clinics and physicians' offices to develop and monitor systems for assuring adult immunization.

Goal: IIb,c

Implementation Year: FY 1997

Support state and local administrative and legislative policies that encourage health-care institutions to offer vaccines to adults.

Goal: IIc

Implementation Year: FY 1997

Coordinate Federal efforts to collaborate with major health-care provider organizations to develop policies among their members that will facilitate adequate delivery of adult immunization.

Goal: IIc

Implementation Year: FY 1997

Encourage health-care provider organizations to review their current immunization policy and implement appropriate revisions, including directives on immunization of adults, especially high-risk groups.

Goal: IIc

Implementation Year: FY 1997

Provide clear guidance to industry about the clinical and public health needs for the specific vaccines to ensure sufficient quantities of vaccine.

Goal: IId

Implementation Year: FY 1997/1998

Research, Evaluation, and Surveillance

Collaborate with other agencies to develop research activities to determine factors influencing vaccination of groups with lower vaccination levels than overall population rates (e.g., African Americans).

Goal: IIb; IVb

Implementation Year: FY 1998

Explore experience and legal basis and/or impediments for adult vaccine administration in atypical settings (e.g., shopping centers) or by non-traditional personnel.

Goal: IIb

Implementation Year: FY 1997

Revise the immunization grant program announcement to require that grantees adopt a mechanism for evaluating adult immunization services in public sector clinics and private settings.

Goal: IIc, Vc

Implementation Year: FY 1999

Collaborate with other Federal agencies to assist managed-care plans to improve quality of vaccination services and to develop performance measures and uniform assessment criteria.

Goal: IIc

Implementation Year: FY 1999

Provide a clear definition and harmonization of vaccine use recommendations for adults. Goal: IIc

Implementation Year: FY 1997/1998

Catalog geographic, social, financial, and logistical impediments, if any, to the effective distribution of each adult vaccine to appropriate target groups, especially those considered to be "vulnerable;" explore potential for alternative means of vaccine distribution when indicated.

Goal: IId

Implementation Year: FY 1997/1998

Develop more precise estimates of the number of persons in various target groups for each vaccine.

Goal: IIe

Implementation Year: FY 1998

For each licensed vaccine indicated for adult use, determine (1) epidemiologic or programmatic circumstances, if any, in which current vaccine supplies would fail to meet the demand; (2) technologic or other impediments that would preclude the manufacturer from temporarily or permanently increasing production capacity.

Goal: IIe

Implementation Year: FY 1997/1998

Catalog potential for natural or man-made public health emergencies involving emerging or reemerging infectious diseases or biologic agents; determine extent to which investigational vaccines could be manufactured by industry on an emergency basis.

Goal: IIe

Implementation Year: FY 1997/1998

Conduct adult-disease outbreak investigations at the request of Federal agencies and state and local health departments.

Goal: IVa

Implementation Year: Ongoing

Expand and improve surveillance for adult vaccine preventable diseases including influenza, pneumococcal disease, hepatitis A, hepatitis B, measles, mumps, rubella, diphtheria, tetanus, and pertussis (see Surveillance Work Plan--Appendix D)

Goal: IVa

Implementation Year: FY 1999/2000

Expand and improve existing surveillance for vaccine-associated adverse events to provide population-based incidence rates of adverse events linked to specific vaccines (see Surveillance Work Plan--Appendix D)

Goal: IVa

Implementation Year: FY 1998

Conduct surveillance using Emerging Infection Program sites and other mechanisms to identify diseases for which vaccine development should be targeted. (See Surveillance Work Plan -- Appendix D)

Goal: IVa

Implementation Year: FY 1997

Improve the capacity to assess immunization coverage levels in adults (see Surveillance Work Plan--Appendix D)

Goal IVb

Implementation Year: FY 1998

Develop new approaches for more effective control of influenza through improved immunogenicity and cross-protective efficacy, as well as use of novel vaccine strategies. Goal: Va

Implementation Year: FY 1998

Conduct research and development assessments for existing and potential vaccine-preventable diseases.

Goal: Va

Implementation Year: FY 1997/1998/1999/2000

Participate in studies of adult vaccine efficacy, safety, and clinical effectiveness.

Goal: Vb

Implementation Year: FY 1997/1998/1999/2000

Refine our current understanding of the human response to influenza infection and vaccination with an emphasis on elucidating the long-term effects of annual vaccination.

Goal: Vb,c

Implementation Year: FY 1999/2000

Conduct reviews of existing literature regarding knowledge, attitudes, practices, and other factors that may influence the demand for vaccination services by consumers and health-care providers; additional studies should be designed and carried out as needed.

Goal: Vc

Implementation Year: FY 1997/1998

Improve existing vaccines and develop novel vaccines.

Goal: Vd

Implementation Year: FY 1997/1998/1999/2000

Provide surveillance and public health information to focus vaccine research and development.

Goal: Vd,e

Implementation Year: Ongoing

Food and Drug Administration (FDA)

Disseminate information through its Medical Bulletin (for health-care professionals), FDA Consumer, a monthly column in the Journal of the American Medical Association, and regular mailings to health professionals and consumer organizations concerning the broad range of FDA activities. FDA has a Web page and also conducts a variety of workshops, conferences, hearings, and other meetings with its constituencies, including health-care professionals, consumers, industry, and others. A special focus on adult immunization will be developed where most appropriate.

Goal: Ia,b

Implementation Year: FY 1998

Continue to provide guidance to industry through written guidelines, "Points to Consider," conference calls, meetings, workshops, symposia, and other forums.

Goal: IId; Vb

Implementation Year: Ongoing

Continue to conduct laboratory-based research to modify or develop alternative methods in an effort to speed up rate-limiting steps in manufacturing protocols.

Goal: IId; Vd

Implementation Year: Ongoing

Continue to conduct laboratory-based research to simplify testing and validation procedures.

Goal: IId; Vb

Implementation Year: Ongoing

Continue to provide "regulatory relief" to vaccine manufacturers with well-established track records through simplification and streamlining of reporting requirements and testing procedures, when indicated, as part of the ongoing FDA reform process.

Goal: IId

Implementation Year: Ongoing

For each licensed vaccine indicated for adult use, determine impediments that would preclude the manufacturer from temporarily or permanently increasing production capacity.

Goal: IId

Implementation Year: FY 1998

Identify areas where ACIP recommendations and FDA labeling differ, clarify the basis for the differences, and seek to resolve these differences.

Goal: IId

Implementation Year: FY 1997/1998

Surveillance: Adverse Events

Goal: IVa

Implementation Year: FY 1997/1998/1999/2000

Revise VAERS form and instructions to improve quality of data collected.

Consider population-based studies, phone surveys, and other methodologies to collect additional data necessary to develop specific incidence/prevalence rates of illness.

Consider reporting of vaccine-associated adverse events as part of a pilot project for surveillance of occupational health problems.

Health Care Financing Administration (HCFA)

Increase the awareness and the demand for influenza and pneumococcal vaccinations among Medicare beneficiaries and their providers through direct mailings, outreach, distribution of posters, and public service announcements. Providers targeted include health departments and other mass immunizers, hospitals, physicians offices, nursing homes, and managed care plans.

Goal: Ia,b

Implementation Year: FY 1997

Provide technical assistance to providers and Medicare-eligible adults to increase participation and improve support of adult-immunization activities.

Goal: Ia; IIIa

Implementation Year: FY 1997

Encourage professional review organizations and carriers to work with local organizations representing vulnerable populations to increase immunization awareness.

Goal: Ib

Implementation Year: FY 1997/1998/1999/2000

Work with voluntary organizations (e.g., Americorp, Job Corps) to promote adult immunization to the aged and people with disabilities.

Goal: Ib

Implementation Year: FY 1997/1998

Develop a comprehensive marketing strategy designed to target the Medicare population with messages on Medicare-covered services.

Goal: Ib, IIIa

Implementation Year: FY 1998/1999

Combine the analysis of Medicare and Medicaid data with aggressive networking and survey data from other sources to assess community access and awareness of adult immunization.

Goal: Ic

Implementation Year: FY 1997/1998

Work with minority organizations and other groups to understand the attitudes, knowledge, and beliefs regarding vaccination among Medicare beneficiaries and providers.

Goal: Ic

Implementation Year: FY 1997/1998

Increase role in financing adult immunization activities through a variety of means, including: increasing vaccine administration fees, instituting high-performance provider recognition awards, developing "prevention package" mailings to newly enrolled beneficiaries, orchestrating National Immunization Days, including reminder tear-out sheets in the Medicare Handbook, and other activities as appropriate.

Goal: IIa; IIa,b

Implementation Year: FY 1997/1998

Encourage providers, including managed-care providers, to have accurate and accessible medical records, periodic reminder systems, and other administrative strategies and organizational arrangements to guarantee regular offering of vaccines to all beneficiaries in their practice.

Goal: IIb

Implementation Year: 1997

Collaborate with other agencies to develop research activities to determine factors influencing vaccination of groups, such as African Americans, who have lower vaccination rates than does the overall population.

Goal: IIb,c

Implementation Year: FY 1997/1998

Urge specialist physicians (e.g., cardiologists, pulmonologists, hematologists, obstetrician/gynecologists, endocrinologists, oncologists, and nephrologists in dialysis centers) who are the principal providers of health-care to beneficiaries, to offer vaccinations or refer patients for vaccinations when indicated.

Goal: IIc

Implementation Year: FY 1997

Urge hospitals that provide care to beneficiaries to offer adult immunization services on inpatient units, at discharge, and in emergency departments and outpatient clinics.

Goal: IIc

Implementation Year: FY 1997

Assure that nursing homes and other community and home health-care providers administer and document recommended adult vaccines to all beneficiaries.

Goal: IIc

Implementation Year: FY 1997

Work with other agencies and organizations to ensure that the primary care of beneficiaries includes periodic assessment of their needs for vaccines based on age, occupation, situation, and lifestyle.

Goal: IIc

Implementation Year: FY 1997

Develop and evaluate specific programs for vaccinating hard-to-reach beneficiaries at increased risk for vaccine-preventable diseases.

Goal: IIc

Implementation Year: FY 1998

Enroll public clinics as Medicare providers of vaccination services and encourage them to implement mass vaccination campaigns.

Goal: IIc

Implementation Year: FY 1997

Facilitate productive working relationships among state Medicare agencies and health departments.

Goal: IIc

Implementation Year: FY 1997

With other agencies, conduct a program management review in every state, including methods for tracking immunization and reimbursement among Medicare-eligible adults. Goal: IIc, IIIa, IVa

Implementation Year: FY 1998

Develop (with AHCPR)

and implement guidelines and standards for adult immunization practice as part of quality assurance programs.

Goal: IId

Implementation Year: FY 1997

Disseminate educational information on Medicare billing and provider enrollment procedures to national health-care organizations that serve vulnerable populations.

Goal: IIIa

Implementation Year: FY 1997/1998/1999/2000

Enhance program activities in order to increase participation of Medicare-eligible adults. Goal: IIIa

Implementation Year: FY 1998

Encourage providers to take advantage of Medicare reimbursement for the cost and administration of influenza and pneumococcal vaccinations and simplify provider enrollment billing and enrollment processes.

Goal: IIIa

Implementation Year: FY 1997

Monitor and improve the performance of the delivery system through a number of sources including Medicare claims data and CDC's NHIS and BRFSS.

Goal: IVa

Implementation Year: FY 1998

Work with CDC to develop thematic maps that will use outcome and demographic data to identify areas for intervention.

Goal: IVa

Implementation Year: FY 1998

Work with the managed-care industry on including a pneumococcal immunization measure in HEDIS 3.0.

Goal: IVa

Implementation Year: FY 1998

Health Resources and Services Administration (HRSA)

Inform state and local health departments, MCH programs, and CMCH and HCH providers of the importance of adult immunization, and educate them on appropriate immunization practices.

Goal: Ia

Implementation Year: Ongoing

Distribute consumer information materials developed as part of HCFA's flu campaign to providers and consumers.

Goal: Ia,b

Implementation Year: Ongoing

Collaborate with CDC and State Health Officials to conduct regional workshops for State Health Departments, Immunization Directors, and Medicare/Medicaid Directors to facilitate State strategies for improving the delivery and financing of adult immunization services.

Goal: Ia; IIIa

Implementation Year: FY 1998/1999

Encourage HRSA-supported programs to develop linguistically- and culturally-appropriate community based strategies to increase vaccine coverage of adult target populations.

Goal: Ib

Implementation Year: FY 1997/1998/1999/2000

Identify States and/or community-based agencies who have developed and implemented impressive adult immunization program activities which can be used as models.

Goal: Ib, IIb

Implementation Year: FY 1997

Encourage HRSA-funded providers to have appropriate management and clinical information systems that will ensure effective tracking and regular offering of vaccines to adult patients.

Goal: IIb,c

Implementation Year: FY 1997/1998

Collaborate with other agencies to develop clinical research activities to determine factors influencing vaccination of minority and other high risk groups, who have lower vaccination levels than overall population rates.

Goal: IIb,c

Implementation Year: FY 1998

Extend the Together for Tots program to include promotion of immunizations for adolescents and adults.

Goal: IIb,c

Implementation Year: FY 1998/1999

Encourage grantees at federal, state and local health care institutions to develop community outreach programs and monitoring systems for assuring that eligible adults are offered the vaccines they need.

Goal: IIc

Implementation Year: FY 1997/1998

Encourage the implementation of guidelines and standards for adult immunization practice as part of the grantees quality assurance plans.

Goal: IId

Implementation Year: FY 1997/1998

Support the capacity of vaccine companies to meet current and future needs for adult vaccines.

Goal: IId

Implementation Year: Ongoing

Review existing liability procedures involving the use of investigational vaccines in adults; explore the feasibility, indications and costs for government coverage in selected

instances where liability concerns may impede the development and use as an adult vaccine which is projected to have a significant public health benefit.

Goal IId; Vb

Implementation Year: FY 1998

Evaluate influenza and pneumococcal vaccines for inclusion in the National Vaccine Injury Compensation Program.

Goal: Vb

Implementation Year: FY 1997

Contribute data from health centers which may increase our knowledge of the safety of adult vaccines and to help assess the epidemiology of immunization practices.

Goal: Vb,c

Implementation Year: FY 1998

Indian Health Service (IHS)

Promote adult immunization education activities in IHS and tribal service units.

Goal: Ia,b

Implementation Year: FY 1997

Require each IHS Area to review its current influenza and pneumococcal vaccination policies and to assure that all at-risk clients are offered services.

Goal: IIc

Implementation Year: FY 1998

Institute policies and program guidelines to assure that every IHS service unit will achieve the Healthy People 2000 objectives for adult immunization.

Goal: IIc

Implementation Year: FY 1998

Require each IHS Area to assess its current hepatitis B virus immunization activities and implement policies and procedures to ensure that all current recommendations of the ACIP are being executed.

Goal: IIc

Implementation Year: FY 1998

National Institutes of Health (NIH)

Conduct and support research to improve the efficacy of vaccines routinely recommended for use in adults and the elderly:

Novel pneumococcal vaccines: conjugate vaccines, novel adjuvants

Novel influenza vaccines: nasally administered live influenza vaccine

Goal: V

Implementation Year: Ongoing

Conduct and support research to assess the potential use of "children's" vaccines in adults and the elderly:

Safety and efficacy of acellular pertussis vaccine in adults

Safety, immunogenicity, and efficacy of single-dose tetanus toxoid vaccines

Efficacy of varicella vaccine in adults to prevent shingles and post-herpetic neuralgia

Goal: V

Implementation Year: Ongoing

Conduct and support fundamental research to define protective immunity:

Mechanisms of immunity

Improve understanding of the immunobiology of the senescent immune response

Correlates of protection against infectious diseases

Protective antigens as the basis of new vaccine approaches

Goal: V

Implementation Year: Ongoing

Conduct and support research and development of classical and novel vaccine approaches and routes of administration for improved and new vaccines in adults and the elderly:

Live attenuated, inactivated, subunit, vector-based, DNA vaccines

Mucosal (oral, intranasal), intradermal, microencapsulation, adjuvant absorbed

Immunoenhancers (adjuvants and cytokines) that are safe and stimulate the senescent immune system

Edible vaccines produced in transgenic plants

Novel vaccines for cancer and autoimmunie diseases

Goal: V

Implementation Year: Ongoing

Support research toward development of diagnostic tests and relevant animal models for infectious diseases and cancer.

Goal: V

Implementation Year: Ongoing

Extend the spectrum of diseases defined as "vaccine-preventable" or "vaccine-treatable" in adults and the elderly:

Support research on infectious etiology of chronic diseases (e.g., cancer, ulcers, autoimmune diseases, rheumatic diseases)

Helicobacter pylori (gastric ulcers, cancer)

Hepatitis B (liver cancer)

Epstein-Barr virus (nasopharyngeal cancer, Burkitt's lymphoma)

Human papilloma virus (cervical cancer)

Chlamydia pneumoniae (heart disease)

Support research on vaccine immunotherapy of cancer

Goal: V

Implementation Year: Ongoing

Support process development and pilot-lot manufacturing of promising vaccine candidates and immunotherapeutic agents (e.g., novel influenza vaccines, malaria vaccines, new approaches to cholera vaccine, immunotherapeutic agent against Shiga-like toxins).

Goal: V

Implementation Year: Ongoing

Define host factors that influence enhanced susceptibility to infectious diseases in adults and the elderly:

Natural history of the senescent immune system

Genetic and immunologic determinants

Goal: V

Implementation Year: Ongoing

Conduct clinical evaluations of promising vaccine candidates for adults and the elderly.

Goal: V

Implementation Year: Ongoing

Use a variety of mechanisms to continue essential partnerships with private-sector vaccine companies toward the development and evaluation of potential vaccine

candidates for adult and elderly populations.

Cooperative Research and Development Agreements

Material Transfer Agreements

Clinical Trials Agreements

Small Business Innovative Research Awards

Goal: V

Implementation Year: Ongoing

Continuing assessment of vaccine research and development priorities:

Institute of Medicine Study - Vaccine Development: Establishing Priorities for the 21st century

NIH Advisory Councils

Blue Ribbon Panel on Vaccine Research and Development

Jordan Report

Goal: V

Implementation Year: Ongoing

National Vaccine Program Office (NVPO)

Lead the Department in developing and executing the adult immunization action plan, convene the Department-level Adult Immunization Workgroup, and coordinating communication among the agencies.

Goal: I-V

Implementation Year: Ongoing

Continue to ensure active communication and collaboration among federal partners and with non-federal governmental (i.e., state and local health departments) and non-governmental (i.e., vaccine industry, professional organizations, academia) partners. Goal: I-V

Implementation Year: Ongoing

Continue to support the activities of private-sector coalitions and other not-for-profit associations, industry, and academia.

Goal: I-V

Implementation Year: Ongoing

Develop Department-level activities to integrate the Adult Immunization Initiative in prevention messages throughout the year and coordinate activities among Department and agency offices of public affairs, including integration with ongoing activities to promote childhood vaccination.

Goal: Ib

Implementation Year: FY 1997

Coordinate federal efforts to assist managed-care plans to improve quality of vaccination services and develop performance measures and uniform assessment criteria.

Goal: IIc

Implementation Year: FY 1998

Establish a Department initiative to encourage worksite health promotion by major employers, to include offering vaccination services at workplaces, whenever possible, and incorporating vaccination as a covered benefit of health and insurance programs.

Goal: IIc

Implementation Year: FY 1999

Promote greater collaboration between government and industry by streamlining and facilitating the use of CRADAs and other mechanisms to carry out vaccine-related research.

Goal: IId

Implementation Year: FY 1998

Review listings of high-priority vaccines (under development through the Institute of Medicine); attempt to determine the extent to which the development of any high-priority vaccine has been impeded by financial constraints; explore potential means for supplementing the research and development efforts of small biotechnology firms in instances where the addition of relatively small amounts of money or human resources could have a large effect on the likelihood of success.

Goal: IId

Implementation Year: FY 1998

Determine the degree to which financial incentives to vaccine manufacturers (e.g., through guaranteed purchase programs) or health-care providers may improve the utilization of adult vaccines.

Goal: IId

Implementation Year: 1998

Office for Civil Rights (OCR)

Assist HCFA in increasing public awareness and demand for influenza and pneumococcal vaccinations among Medicare beneficiaries and their providers through outreach, display of posters and materials at conferences and training sessions, and other forms of technical assistance.

Goal: Ia,b

Implementation Year: FY 1997/1998/1999

Establish partnerships with HCFA, ACF, FDA, CDC, OMH, and HRSA to assist in disseminating their information on adult immunizations to DHHS beneficiaries and recipients through program and community affiliations.

Goal: Ib

Implementation Year: FY 1997/1998/1999

Provide technical assistance to agency partners for development and dissemination of information in language and format accessible to at-risk populations with limited English proficiency and sensory impairment.

Goal: Ib

Implementation Year: FY 1997/1998/1999

Office of Intergovernmental Affairs (OIA)

Through Regional Offices and Regional Directors consult with national, state, county, and local government advocacy organizations (i.e., the National Governors Association,

U.S. Conference of Mayors) to facilitate policy that promotes the goal of the Adult Immunization Action Plan, facilitate (through Regional Health Administrators) DHHS adult immunization program collaboration at the regional level, and regularly inform State Health Officers of the expanded adult immunization program.

Goal: I-V

Implementation Year: FY 1997/1998

Through Regional Health Administrators facilitate DHHS adult immunization program collaboration at the regional level and regularly inform state health officers of the expanded adult immunization program.

Goal: I-V

Implementation Year: FY 1997/1998/1999/2000

Office of Minority Health (OMH)

Facilitate the exchange of adult immunization information among health-care providers serving Asian and Pacific Islanders, through a list server established under a cooperative agreement with APIAHF.

Goal: Ia

Implementation Year: FY 1997/1998

Facilitate the exchange of adult immunization information among home-health providers serving American Indian/Alaska Native populations through a home page established through a cooperative agreement with the Association of American Indian Physicians and through the IHS home page.

Goal: Ia

Implementation Year: 1997/1998

Provide a list of Webmasters at sites of interest to minority professionals and consumers, and use this to highlight the availability of adult immunization.

Goal: Ia

Implementation Year: FY 1997/1998

Facilitate the development and distribution of minority-targeted adult immunization materials to minority community-based organizations, state offices of minority health, minority health professional organizations, and local and private groups serving minority populations.

Goal: Ia,b

Implementation Year: Ongoing

Incorporate adult immunization information at online community access points through existing cooperative agreement with Asian Pacific Islander American Health Forum.

Goal: Ia,b

Implementation Year: 1997/1998

Collaborate with CDC, HCFA and other relevant agencies to work with minority community-based organizations to establish mass vaccination programs, and to improve access to adult vaccination programs.

Goal: Ia,b; IIc

Implementation Year: 1997/1998

Facilitate the development of relationships with non-traditional partners in the area of adult immunization activities (e.g., pharmacies, hospital emergency rooms, churches), to promote vaccination services.

Goal: Ia; IIc

Implementation Year: FY 1997/1998

Work with HCFA's Website influenza campaign by translating their consumer publications into Spanish.

Goal: Ib

Implementation Year: FY 1997

Identify and encourage community-based organizations and health-care facilities serving minority populations to promote adult immunizations.

Goal: Ib

Implementation Year: Ongoing

Office of the Surgeon General (OSG)

Provide public visibility to adult immunization issues, particularly as they relate to populations served by federal agencies.

Goal: Ia,b

Implementation Year: FY 1998

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborate to promote awareness of adult immunization recommendations by mental health and substance abuse service providers.

Goal: Ia

Implementation Year: 1997

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APPENDIX B:  Agency Immunization Functions

Administration for Children and Families (ACF): ACF provides national leadership and direction to plan, manage, and coordinate the nationwide administration of comprehensive and supportive programs for vulnerable children and families. These programs focus on the economic independence of families, the improved health, development, and well-being of children, youth, and families, and services tailored to the needs of special populations including refugees, Native Americans, persons with developmental disabilities, and persons with mental retardation. ACF recognizes that adult immunization can be a major factor in protecting and promoting the well-being of children and families.

Administration on Aging (AoA): AoA serves as the lead federal advocacy agency for older Americans, providing and overseeing home- and community-based services and programs through the mandate of the Older Americans Act. AoA's vast aging network is comprised of 57 State Units on Aging, 661 Area Agencies on Aging, 228 tribal organizations representing over 300 tribes, 27,000 service providers, and numerous volunteers. Included in the Older Americans Act legislation is a mandate to provide health promotion and disease prevention services. AoA, along with its aging network, has been an active participant in the Department's influenza and pneumonia immunization campaigns.

Agency for Health Care Policy and Research (AHCPR): AHCPR has conducted short-term studies to address issues and questions related to the quality and effectiveness of rural health services. The studies were aimed at assessing the impact of demographic and social characteristics on receipt of immunization and reimbursement mechanisms on access, utilization, and cost.

Centers for Disease Control and Prevention (CDC): The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability. As the nation's prevention agency, CDC accomplishes its mission by working with partners throughout the nation and the world. CDC conducts and supports surveillance and epidemiologic investigations of vaccine-preventable diseases. CDC provides medical and epidemiologic expertise to enhance immunization coverage of adults against vaccine-preventable diseases, such as influenza, pneumococcal disease, and hepatitis B. The overall strategy for addressing adult immunization includes developing nationwide and local prevention strategies including: reducing missed vaccination opportunities, promoting vaccination of patients, establishing and maintaining partnerships, evaluating prevention activities, developing and disseminating information, and responding to urgent threats to health.

Food and Drug Administration (FDA): FDA is involved in a wide variety of adult immunization activities. The FDA plans and conducts research related to the development, manufacture, and testing of vaccines, including those related to adult immunization such as autoimmune deficiency syndrome, hepatitis A, hepatitis B, influenza, pneumococcal disease, varicella, tetanus, and diphtheria toxoid. The FDA reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines, among other related products, for use in the prevention, treatment, and diagnosis of human disease.

Health Care Financing Administration (HCFA): The Health Care Financing Administration (HCFA) administers the Medicare and Medicaid programs, serving approximately 70 million poor, aged and disabled people in the United States. HCFA's mission is to assure health care security for beneficiaries by providing access to affordable and quality health care services, protecting the rights and dignity of beneficiaries, and providing clear and useful information to beneficiaries and providers to assist them in making health care decisions. HCFA's Consumer Information Program promotes covered preventive services to improve the health status of Medicare beneficiaries and Medicaid recipients. Influenza and pneumococcal vaccinations are among the covered preventive services that HCFA promotes. HCFA's Pneumonia/Flu 2000 campaign aims to reach and surpass the Healthy People 2000 goal rates for institutionalized and non-institutionalized beneficiaries through beneficiary and provider-based interventions. Beneficiary-based interventions aim to increase awareness and demand for vaccinations. HCFA initiated the Horizons Pilot Project with historically black colleges and universities to target African Americans beneficiaries, whose immunization rates are substantially lower than the majority population. HCFA's provider-based interventions encourage providers in all settings to include adult immunization in their practice and to take advantage of Medicare reimbursement for influenza and pneumococcal vaccinations. Using resources such as CDC's NHIS and BRFSS, and Medicare claims, HCFA monitors the immunization rates of the nation's elderly and targets under-served areas.

Health Resources and Services Administration (HRSA): HRSA guides health resources development and supports health services for disadvantaged and under served parts of the population. Several programs support activities that relate to immunization. HRSA's main contributions to adult immunization proceed through the Bureau of Primary Health Care provides comprehensive primary health-care services for poor and medically under served people through its CMHCs, HCH programs, and Health Care in Public Housing programs. Grantees provide preventive services, including age-appropriate immunization, to children and adults as an integral part of comprehensive health services for the populations they serve. The Bureau of Health Professions oversees the VICP, which monitors vaccine usage, safety of vaccines, and adverse events, and administers compensation for adverse events of common childhood vaccines. The Maternal and Child Health Bureau administers block grants to states to meet public health needs among mothers and children; immunization is one of the principal preventive services these promote.

Indian Health Service (IHS): The mission of IHS is to provide health care services to Native Americans. IHS plans to promote adult immunization education activities through the implementation of this plan in their health care delivery settings and among the populations they serve.

National Institutes of Health (NIH): The mission of NIH is to conduct research that will lead to an improvement in the nation's health. With respect to adult immunization, the NIH conducts and supports a broad portfolio of research leading to the development of new and improved vaccines for diseases that affect adults and the elderly. The National Institute of Allergy and Infectious Diseases has the lead for vaccine research; and with other interested Institutes, including the National Institute on Aging and the National Cancer Institute, supports and participates in a number of activities to advance this element of the vaccine research agenda. The Division of Microbiology and Infectious Diseases supports research and the necessary infrastructure to accelerate the development of candidate vaccines. The NIAID-supported Vaccine Evaluation Units, placed at research institutions across the U.S., conduct careful, clinical evaluation of candidate vaccines in adults and the elderly. A number of candidate vaccines, based on applications of new technologies, are being developed as part of the era of renaissance for vaccinology. NIH continues to participate in a number of planning and policy activities related to adult immunization. Through the NVPO, NIH participated in the National Vaccine Advisory Committee and the drafting of the paper on adult immunizations. It provides ongoing liaison to advisory groups, such as the ACIP, where issues relating to adult immunization are addressed.

National Vaccine Program Office (NVPO): The NVPO carries out the responsibilities of the National Vaccine Program (Office of the Secretary, DHHS) and develops strategies for optimally achieving prevention of human diseases through immunization and prevention of adverse reactions to vaccines. Another major responsibility of the Program is ensuring coordination and collaboration of vaccine activities within the Federal sector.

Office of the Assistant Secretary for Planning and Evaluation (ASPE): The Assistant Secretary for Planning and Evaluation is the principal advisor to the Secretary of DHHS on policy development issues, and is responsible for major activities in the areas of policy coordination, legislation development, strategic planning, policy research and evaluation, and economic analysis. ASPE develops or reviews issues from the viewpoint of the Secretary, providing a perspective that is broader in scope than the specific focus of the DHHS operating divisions, while working closely with them. ASPE assists these divisions in developing policies and planning policy research, evaluation, and data collection, within broad DHHS and administration initiatives. ASPE often serves a coordinating role for cross-cutting policy and management activities.

Office for Civil Rights (OCR): The primary mission of OCR is to eliminate unlawful discrimination and to ensure equal opportunities for the beneficiaries and potential beneficiaries of Federal financial assistance provided by DHHS. OCR investigates complaints of discrimination, conducts compliance reviews, and initiates outreach and technical assistance projects to eliminate discrimination. OCR's target populations are beneficiaries in health and social services programs, who may have been discriminated against on the basis of their race, color, national origin, age, sex, disability, or religion. Health and social services programs include extended-care facilities, nursing homes, hospitals, state agencies responsible for administering health care, Medicaid, community mental health centers, family health centers and clinics; physicians and other health-care professionals in private practice with patients assisted by Medicaid, state, and local public assistance agencies; adoption agencies, foster care homes, day-care centers, senior citizen centers; and nutrition programs. OCR develops and implements forums to inform state agencies, health-care providers, Operating Divisions, and Staff Divisions of OCR's jurisdiction and civil rights laws and to receive input on priority issues. In addition, OCR has established partnerships with OPDIVs/STAFFDIVs, and national, state, and local agencies to design technical assistance programs, where both beneficiary and recipient groups can work together on civil rights issues.

Office of the Inspector General (OIG): Under the authority of the Inspector General Act, the Office improves Department programs and operations and protects them against fraud, waste, and abuse. By conducting independent and objective audits, evaluations, and investigations, the Office provides timely, useful, and reliable information and advice to Department officials, the Administration, Congress, and the public.

Office of Intergovernmental Affairs (IGA), Office of the Secretary: The Office provides advice and counsel to the Secretary of DHHS on matters of intergovernmental affairs; intervenes on behalf of the Secretary and Deputy Secretary on critical governmental issues; advises on the impact of Departmental action on state, tribal, county, and local governments; provides leadership and promotes partnerships in intergovernmental matters of mutual concern to the Department and external state, tribal, county, and local advocacy organizations, other federal agencies, professional associations, and non-governmental special interest groups; and serves as the point of contact for the Secretary's Regional Offices, communicating policies, program decisions, and initiatives of the Administration.

Office of Minority Health (OMH): OMH has activities aimed specifically at increasing the demand for adult vaccination by improving provider and public awareness of the need for immunizations among the adult population. They facilitate the distribution of minority-targeted adult immunization materials to minority community-based organizations, state offices of minority health, minority professional health organizations, and local and private groups serving minority populations. OMH is actively involved with the Health Care Financing Administration's flu campaign and has provided support for the expansion of a number of BPHC (HRSA)/CDC hepatitis B demonstration projects.

Office of Public Affairs (OPA): OPA has been working to institute a system to annually publicize adult immunization and Medicare coverage of influenza and pneumococcal vaccinations. OPA has partnerships with HCFA, CDC, AoA, and HRSA. It has created a comprehensive press strategy for adult immunization for the coming years. In conjunction with other federal partners, OPA has been involved with the development and dissemination of numerous radio, television, and print media spots.

Substance Abuse and Mental Health Services Administration (SAMHSA): SAMHSA collaborates to promote awareness of adult immunization recommendations among mental health and substance abuse service providers.

 

APPENDIX C: Matrix(ces) of Federal Adult Immunization Activities

APPENDIX D:

Work plan for Surveillance -- Centers for Disease Control and Prevention

I. Surveillance for Disease and Immunization Coverage -- General Issues

Increase number of Emerging Infections Programs to 8-10 and ensure the scope of activities includes work on the evaluation of vaccine-preventable diseases of adults and to identify diseases of substantial public health magnitude for priority focus for new vaccine research and development.

Improve training of health-care providers regarding the importance of surveillance (improved manuals, Internet training), including criteria for testing patients for reportable diseases and reporting these diseases.

Conduct surveillance to assess the impact of immunization programs on disease incidence among adults and immunization coverage through surveillance and by use of CDC's National Center for Health Statistics' National Health Interview Survey (NHIS). Modify NHIS and Behavioral Risk Factor Surveillance System (BRFSS) to collect and report prevalence of specified health conditions, behaviors, or occupations that are indicators for influenza, pneumococcal, or hepatitis vaccines and ascertain population-based vaccination levels.

Improve time of availability of NHIS- and BRFSS-reported vaccination levels to less than one year after data are collected; data to be reported within 6 months of availability; reports to include vaccination levels in those at highest risk and currently under-immunized groups; if not possible, consider special adult vaccination survey(s).

Support work of CDC's Health Information and Surveillance Systems Board to integrate surveillance and health information systems at CDC.

Improve the timely dissemination of relevant surveillance information to health-care providers to assist in clinical decision-making.

Complete pilot-testing of software and data collection methods for vaccine preventable diseases and vaccination data in hospitals, and promote wide application of surveillance software.

Coordinate adult immunization activities with DHHS data council to ensure that developing standards permit capture of information on vaccine-preventable diseases and vaccine coverage in adults.

Urge managed-care organizations to monitor Health Plan Employer Data Information Set (HEDIS) influenza vaccination requirements with administrative systems rather than surveys. Add pneumococcal vaccination to HEDIS measures; other vaccines for adults to follow.

Assess the need for validation of vaccination status studies and implement annual validation for a sample, if necessary.

Consider development of mechanisms to monitor immunizations at workplaces and free-standing sites (e.g., grocery stores) during vaccine campaigns.

II. Surveillance for Adverse Events

Conduct population-based surveillance for vaccine-related adverse events through vaccine safety data link and other mechanisms.

Consider population-based studies, phone surveys, and other methodologies to collect data to develop age-specific incidence/prevalence rates of illness

Gather data on vaccine-associated adverse events as part of a pilot project for surveillance of occupational health problems

Revise the VAERS form and instructions to improve the quality of data collected.

III. Disease-specific surveillance issues

A. Influenza

Expand and standardize disease-based surveillance for influenza both in the United States and abroad with a special emphasis on expanding networks of sentinel physicians and on establishing HMO and occupational-based influenza surveillance.

Develop and extend existing influenza virologic surveillance systems in humans, both in the United States and abroad, and transfer technology through an aggressive program of laboratory training to laboratories participating in national and global surveillance for influenza.

Perform annual rapid assessments of influenza-vaccine effectiveness among vulnerable U.S. populations (e.g., persons 65 years of age or older, persons with high-risk medical conditions).

Evaluate and modify current state activity assessment levels for influenza.

Develop pandemic-specific contingency plans and study protocols to be implemented immediately upon declaration of a pandemic.

Develop a prototype national information system that is well-suited for rapid dissemination of critical information both during the interpandemic years and during a pandemic.

B. Pneumococcal Disease

Establish nationwide laboratory-based reporting for pneumococcal disease, with particular emphasis on drug-resistant pneumococcal infections.

Continue and enhance current active, population-based surveillance for invasive pneumococcal disease.

Establish sentinel surveillance and collection of pneumococcal isolates for serotyping to monitor changes in serotype distribution.

C. Hepatitis

Revise hepatitis data collection instruments (whether paper forms or computerized surveillance records) to improve the completeness and utility of surveillance data collected through the National Notifiable Diseases Surveillance System.

Enhance hepatitis surveillance to measure incidence, monitor risk factors, and evaluate vaccination impact, including prevention of occupational transmission.

D. Measles, Mumps, Rubella, Diphtheria, Tetanus, Pertussis

Monitor surveillance quality by tracking surveillance indicators for measles, mumps, rubella, tetanus, and diphtheria.

Improve complete reporting for measles, mumps, rubella, tetanus, pertussis (including pertussis as a cause of respiratory disease among adults), and diphtheria by training providers and extending infrastructure resources to state health departments.

Last revised: August 19, 2005

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