The National Vaccine Advisory Committee (NVAC)
Annual Influenza Report
February 9, 2005
The NVAC directs the NVPO to conduct a critical comprehensive after-action report of all aspects of each year's national influenza vaccination program. This report should include, but not be limited to, assessments by the CDC, ASTHO, CSTE, the ACIP, vaccine manufacturers, the National Influenza Vaccine Summit and representatives of providers and the public. Lessons learned as well as items for improvement should be featured. The results should be completed before the annual June meeting of the NVAC and should be subsequently delivered to the Assistant Secretary for Health and interested parties.
Strengthening US vaccine supply: understanding barriers to entering the U.S. Market
February 9, 2005
The NVAC establish a working group to explore the legislative and regulatory changes that would be required to allow licensure of vaccines licensed for use in other industrialized countries in order to meet vaccine needs in the US. The working group should provide recommendations back to NVAC at its September 2005 meeting.
Immunization Infrastructure Funding
May 14, 1999
WHEREAS, current funding for immunization infrastructure from Fund 317 has been reduced and currently provides only $130 million, and
WHEREAS, state and local public health agencies have demonstrated a need for at least $195 million for infrastructure, and
WHEREAS, immunization infrastructure is essential to the provision of immunizations, and
WHEREAS, in the absence of adequate infrastructure funding, states and localities will be forced to reduce essential public health services, and
WHEREAS, those service reductions are likely to include WIC linkages, expanded clinic hours, registry development, immunization personnel and outreach, and reminder and recall systems, and
WHEREAS, the above services contribute to the improved immunization rates for children and the Department of Health and Human Services has expressed a commitment to the “Strategies for Sustaining Success” process,
Be it, therefore, resolved by the NVAC that current FY99 funding through Fund 317 for infrastructure is woefully inadequate and that $65 million additional infrastructure funding is essential for FY99 to maintain and improve the progress achieved in childhood immunization rates. The President’s proposed FY2000 budget falls $75 million below the level necessary to avoid further reductions in the above named public health services, NVAC recommends that the Assistant Secretary for Health convey to the Secretary of the Department of Health and Human Services and the President the need to consider the findings of the Institute of Medicine committee relevant to this issue, when available.
May 14, 1999
Hepatitis B is a common and dangerous infection. Currently used hepatitis B vaccines are highly safe and effective, and offer the hope of preventing many deaths that would otherwise occur due to cirrhosis or liver cancer.
Infants and young children who become infected with hepatitis B have the highest risk of developing later cirrhosis or liver cancer. Recommendations for use of hepatitis B vaccine reflect years of thoughtful discussion of the scientific evidence and are widely supported by medical, public health, and government advisory panels and expert groups.
Although vaccines are among the safest and most effective medical intervention, and pose vastly less risk than the diseases they prevent, no medical intervention—indeed, no human activity—is entirely risk-free.
Vaccines are extensively tested prior to licensure, but even a study involving ( for example) 100,000 participants is incapable of detecting a problem that arises only a few times per million uses. Thus, despite the most rigorous pre-licensure testing, it will always remain true that a rare adverse effect might become apparent only after a vaccine is in widespread use. At the same time, adverse events that occur after vaccination, but that are known also to occur in unvaccinated persons, may have nothing to do with vaccination.
Our current ability to detect and understand the casual mechanisms or rare and very rare adverse events that are temporarily related to vaccination is too limited. It is essential to have additional resources allocated to conduct clinical, epidemiological, and laboratory studies that will enable better understanding of potential or perceived rare adverse events.
In light of the foregoing, therefore, be it resolved that the NVAC supports maintaining current recommendations for hepatitis B vaccine, which are based on the best available knowledge. At the same time, NVAC also supports the allocation of additional resources for further understanding and prevention of potential rare adverse events, as outlined in the Department of Health and Human Services Vaccine Safety Action Plan which has been endorsed by the NVAC.
Vaccine Safety Action Plan
January 12, 1999
The NVAC recognizes that the success of immunization programs is preventing infectious diseases is critically dependent on ensuring the optimal safety of vaccines. As stated in NVAC’s January 22, 1996, resolution, the NVAC firmly believes that the development of action steps to achieve the Task Force on Safer Childhood Vaccines Report’s goals of education, research and surveillance are crucial for children and families in the United States.
The NVAC strongly endorses the Vaccine Safety Action Plan. While the Plan focuses on Federal activities, NVAC encourages collaboration with non-Federal government and private sector involvement. The NVAC will also assist in the expeditious development of priorities and relevant time lines for the Plan’s action steps. Therefore, NVAC recommends that additional funds be allocated for implementing the Vaccine Safety Action Plan independent of existing agency funding for immunization activities.
September 29, 1998
WHEREAS, a pocket of need may be broadly defined as an undervaccinated population, and
WHEREAS, adolescents are undervaccinated with hepatitis B vaccine as well as other recommended vaccines, and
WHEREAS, racial/ethnic disparities exist for the risk of acquiring hepatitis B virus (HBV) infection, therefore
Be it resolved that:
NVAC recognizes adolescents as an age-defined pocket of need and recommends targeted hepatitis B vaccination activities for adolescents, and
NVAC recommends that the Assistant Secretary for Health focus specifically on improving vaccination coverage of adolescents against HBV infection when designing and implementing strategies to eliminate racial/ethnic disparities in disease incidence.
Resources to Support Vaccine Safety
September 29, 1998
WHEREAS, the Food and Drug Administration’s Center for Biologic Evaluation and Research (CBER) budget is decreasing at a time of increasing complexity of the technology in vaccine development; and
WHEREAS, the decrease in personnel and research resulting from these budget reductions threatens the availability of safe and effective vaccines in the United States
Then, be it resolved that the NVAC recommends that the Secretary for Health and Human Services and the National Vaccine Program Office explore means to ensure that CBER has the resources necessary to continue their mission of assuring that safe and effective vaccines are available and that the health of the public is not jeopardized.
Pandemic Influenza Preparedness
May 8, 1998
The National Vaccine Advisory Committee (NVAC) proposes the formation of an Ad Hoc Working Group to provide consultation, advice, and recommendations to NVPO and NVAC on critical policy issues that relate to pandemic preparedness.
The Ad Hoc Working Group should be composed of individuals from diverse backgrounds.
Vaccination Coverage Among Adults
May 8, 1998
WHEREAS, vaccine preventable diseases continue to occur in our nation’s adolescents and result in unnecessary morbidity and mortality, and
WHEREAS, adolescent vaccination rates remain low especially for hepatitis B and varicella vaccine while childhood vaccination rates are at an all time high, and
WHEREAS, there are multiple barriers to improving adolescent vaccination rates, including cost and lack of routine health care, and
WHEREAS, there is a need to target those adolescents at high risk of undervaccination, therefore
Be it resolved that:
NVAC recommends the assessment, evaluation and documentation of existing strategies to improve adolescent vaccination coverage, and
NVAC recommends that the Assistant Secretary for Health seek new resources to improve vaccination coverage among adolescents.
National Workshop on Adult Immunizations in Non-Traditional Settings
September 9, 1997
WHEREAS, levels of adult immunization in the United States, although improving, are still less than optimal, and
WHEREAS, survey data indicate that improving vaccination levels is particularly difficult among underserved inner city and minority populations, and
WHEREAS, there has been increasing attention to immunization outreach programs carried out by non-physician providers in non-traditional sites, therefore
Be it resolved that:
The NVPO work with relevant governmental and non-governmental organizations to convene a national workshop within 6 months to gather information on the extent, benefits, and risks, if any, and of adult immunization outreach programs outside of traditional health care settings with special emphasis on the utility of suck programs for improving immunization rates in underimmunized adults, and provide NVAC with a written report by 9/98.
Use of Vaccine Injury Compensation Trust Fund Resources for National Vaccine Safety Activities
September 9, 1997
Recognizing the need for additional, stable, ongoing financial support for national vaccine safety activities including surveillance, assessment, and prevention of vaccine-associated adverse events, the NVAC recommends that the Secretary of Health and Human Services propose legislation amending the Public Health Service Act to allow limited and judicious use resources from the Vaccine Injury Compensation Trust Fund for purposes of expanding national vaccine safety activities, which are key to both fair compensation and prevention of vaccine-associated adverse events.
Further, recognizing the important role played by the National Vaccine Injury Compensation Program in providing payment to individuals entitled to compensation for vaccine-related adverse events, use of the resources must not interfere with the Program’s capacity to adequately provide such payments.
Working Group on Adult Immunization
Adult Immunization – Adverse Events and Liability
Recommendation #1 - May 1, 1997
WHEREAS, Adult Immunization, a report by NVAC, was issued in January, 1994, calling attention to the high cost in morbidity, mortality and health care dollars of vaccine-preventable diseases in adults in the United States; and
WHEREAS, in January 1994, the Assistant Secretary for Health requested the National Vaccine Program Office to consult with Federal agencies about implantation; and
WHEREAS, NVAC’s Working Group on Adult Immunization is overseeing a survey conducted by the National Vaccine Program Office to assess the degree to which the 5 goals, 18 recommendations and 72 strategies of Adult Immunization are being addressed by Federal agencies and thereby evaluate the current Federal effort; and
WHEREAS, the goals of the survey would be facilitated by reactivating the Interagency Committee on Immunization which in the past regularly enhanced access, information flow, and coordination between the National Vaccine Program Office and designated agency staff not only in regard to adult immunization, but also in regard to all immunization activities;
Then, be it therefore resolved that NVAC urges the Assistant Secretary for Health to give priority to carrying out a comprehensive study and analysis of existing data on adverse events and liability, and how these factors impact adult immunization, the purpose of such an analysis being to guide policy decisions regarding incorporation of adult vaccines within NVICP in a timely manner.
Recommendation #2 - May 1, 1997
WHEREAS, the cost in morbidity, mortality, and health care dollars of vaccine preventable disease in adults in the United States is substantial; and
WHEREAS, in the 1994 NVAC report, Adult Immunization, emphasis was placed on preserving and strengthening the capacity of the nation’s vaccine manufacturers to meet current and future needs for adult vaccines; and
WHEREAS, one strategy in the report to accomplish this recommendation is to explore the advantages and disadvantages of incorporating accepted vaccine-related adverse events which follow adult immunization into the National Vaccine Injury Compensation Program (NVICP); and
WHEREAS, various options for vaccine injury compensation are under consideration in the national plan for Influenza Pandemic Preparedness; and
WHEREAS, a comprehensive analysis of adverse events following administration of adult vaccines, has not been carried out,
Then be it therefore resolved:
The NVAC recommends that the Assistant Secretary for Health give priority to carrying out a comprehensive study and analysis of existing data on adverse events and liability, and how these factors impact adult immunization, the purpose of such an analysis being to guide policy decisions regarding incorporation of adult vaccines within NVICP in a timely manner.
Tuskegee Study – Presidential Apology
January 14, 1997
WHEREAS, public confidence and trust are central to the success of immunization programs, the NVAC has considered many issues concerning trust in health care settings and discussed the study of untreated syphilis in which that trust was abrogated. Given the enormous negative impact of the Tuskegee Study on the public perception of governmental health programs, the NVAC recommends to the Secretary of the Department of Health and Human Services that she advise the President of the great value to be gained from a Presidential apology on behalf of the government and the American people. AN apology is appropriate and would accelerate the healing process needed to restore and maintain trust in our public health programs.
WHEREAS, the critical importance of a strong surveillance system is well recognized to optimize vaccine safety, and that active surveillance systems such as large linked data bases need to be maintained and expanded, the NVAC hereby resolves that the Secretary of the Department of Health and Human Services should pursue the establishment of a $.05 flat tax per antigen that would be earmarked to improve the understanding of vaccine safety.
Vaccines for Developing Countries
May 7, 1996
The NVAC recognizes the US Agency for International Development’s (USAID’s) contribution to research directed at the development and testing of vaccines for childhood meningitis, pneumonia, and diarrhea in developing countries, and commends USAID for promoting epidemiologic and etiologic research collaborations with international institutions such as World Health Organization, United Nations International Children’s Emergency Fund (UNICEF), and United Nations Development Program (UNDP), domestic agencies such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and with US vaccine manufacturers. NVAC encourages USAID to continue support for the development, testing, and introduction of these vaccines in developing countries and to expand efforts in the future for new vaccines, including combination vaccines.
Task Force on Safer Childhood Vaccines – Final Report and Recommendation
January 22, 1996
The NVAC applauds the effort of the Task Force on Safer Childhood Vaccines in producing its recent landmark report, identifying key issues and enhancing collaboration on behalf of vaccine safety. The Committee urges the Secretary of the Department of Health and Human Services to expeditiously approve the Report, and encourages implementation through immediate development of a work plan with definitive task and time line delegated to member agencies of the Task Force.
We firmly believe that such action steps under the Report’s identified priorities of education, research and surveillance are critical to ensuring vaccine safety for children and families in the United States.
Surveillance – Adverse Events Following Immunization
January 22, 1996
The NVAC, in recognizing the critical importance of the collection and analysis of both passive and active surveillance information on potential adverse events and effects of childhood and adult vaccines, recommends that the Secretary of the Department of Health and Human Services seek, identify, and establish a source of stable funding for Large Linked Data Base studies, as well as other active surveillance efforts. This action is essential to the success of national vaccine safety efforts, and the Committee believes that comprehensive surveillance data will improve the communication of vaccine risk to both providers and parents.
The NVAC recognizes the tremendous effort by the Public Health Service, including the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), US Agency for International Development (USAID), and the National Vaccine Program Office (NVPO) through the Inter-Agency Group, in promoting the development of safe and effective acellular pertussis vaccines for use in infants in the United States. The NVAC especially wishes to acknowledge Dr. John LaMontagne, Dr. George Curlin, and Dr. David Klein for their leadership in the National Institute of Allergy and Infectious Diseases (NIAID)-supported efficacy trials in infants in Sweden and Italy.
September 25, 1995
WHEREAS, welfare reform is a topic of urgent national concern which has prompted the President and Secretary of Health and Human Services to institute policies designed to encourage the States to experiment broadly with welfare reform initiatives; and
WHEREAS, many States have requested and received waivers to implement such initiatives; and
WHEREAS, many of these initiatives have included incentives and/or sanctions intended to improve the immunization rates for young children; and
WHEREAS, Congress has announced its intention to institute extensive and, in some cases, sweeping, changes in welfare programs, including the transfer of authority for such programs to the States:
Be it hereby resolved by NVAC that: the Secretary consider requesting all relevant Federal agencies involved with welfare reform to monitor the possible impact of these reforms on the immunization status of children and adults, to coordinate planning and development of welfare reform activities with respect to this issue, and to provide joint guidance to appropriate State agencies on vaccine coverage for such welfare reform proposals.
In adopting this resolution, NVAC offers its assistance in the development of any necessary and appropriate guidelines.
September 28, 1995
WHEREAS, endemic Hepatitis A imposes a significant burden on the health of adults and children, and
WHEREAS, that health burden translates into a substantial direct and indirect cost to the health care delivery system as well as to communities,
Be it resolved that the NVAC recommends that the Assistant Secretary for Health request that the Advisory Committee on Immunization Practices consider relevant data on the efficacy and potential benefit for recommending use of Hepatitis A vaccine in endemic areas and coverage provided through the Vaccine for Children program.
Vaccine Coverage Rates
September 28-29, 1995
#1 Be it resolved,
That NVAC expresses appreciation for and applauds the efforts of Dr. Walter Orenstein and staff, Centers for Disease Control and Prevention, National Immunization, for their outstanding work in fostering the improvement of vaccine coverage rates for preschool-aged children nationwide between 1990 and 1994.
#2 Be it resolved,
That NVAC recommends to the Assistant Secretary for Health that formal recognition be extended to those states and cities that have demonstrated excellent progress in preschool-aged vaccine coverage, based on the results of the National Immunization Survey.
Special Recognition of Chester Robinson, D.P.A.
May 12, 1995
The NVAC recognizes and commends Dr. Chester Robinson for his commitment and dedication to the activities of the Committee and the National Vaccine Program. The Committee expresses its deep appreciation for his many tangible and intangible contributions to the attainment of our national goals to assure the availability of safe and effective vaccines and the delivery of immunization services to all children and adults.
In particular, the Committee recognizes Dr. Robinson’s:
- Contributions to the development of the National Vaccine Plan and National Vaccine Advisory Committee Subcommittee reports including reports on Immunization Information Systems, State and Local Impediments to the Delivery of Immunization Services, Adult Immunization, and Access to Immunization Services.
- Role in implementing many of the recommendations of the National Vaccine Advisory Committee’s Measles White Paper, particularly the development of the Interagency Committee’s on Immunization which produced the Public Health Service Action Plan to Improve Access to Immunization Services.
- Participation in a number of evaluation studies including one that addressed the vaccine information materials and another that assessed the economics of vaccine supply and distribution
- Administrative skills over the last two years, ensuring the smooth operation of the National Vaccine Program Office.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
Edgar K. Marcuse, M.D. Date: May 12, 1995
United States Vaccine Industry – Mercer Report
Resolutions made by Dr. Osborne as an addition and amendment to
Resolution on May 11, 1995
May 12, 1995
In addition, NVAC notes that in the course of conducting its study, Mercer Management Consultants, Inc., have identified a number of issues which, if addressed, could lead to increased vaccine company interest in vaccine development and to improved public-private sector collaboration for immunization. These include:
- Perceived barriers to full involvement of US companies in international markets.
- Opportunities for early discussion of vaccine development and use issues between government, other large volume purchasers, and vaccine companies.
- The need for comprehensive coverage of immunization in all health insurance plans.
- Approaches to maintaining overall national resources and commitment to vaccine development and use.
The NVAC further request the Assistant Secretary for Health to consult with Mercer and other relevant parties, and inform NVAC at a future meeting of the specific Public Health Service/Department of Health and Human Services plans to address these concerns.
United States Vaccine Industry – Mercer Report
May 11, 1995
Resolution made by Dr. Douglas:
We, the National Vaccine Advisory Committee, recommend to the Director, National Vaccine Program, that Mercer Consultants be instructed to examine the data of their recent report, and evaluate the effect of differing scenarios regarding the relative loss of private market due to the Vaccines for Children program and on vaccine company revenues on research and development.
Last revised: September 27, 2006