National Vaccine Advisory Committee (nvac)

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Vaccine Safety and Communication Subcommittee - Dr. Jerome Klein

Dr. Klein noted that the subcommittee discussed an update, presented by Dr. Roger Bernier and Dr. Melinda Wharton, of the IOM Committee on Review of the National Immunization Program’s Research Procedures and Data Sharing Program. The program, promoted by NIH and CDC, will make data available to the public.

Dr. Bernier noted that, because the program has been criticized, IOM has been asked by CDC to conduct an independent, third party review and to make recommendations about the data-sharing program. It was also asked to review and make recommendations about the handling of preliminary data from the Vaccine Safety Datalink (VSD). The IOM Task Order was signed on April 2004.

The program was the result of heightened public interest for giving independent investigators access to VSD data in order to replicate CDC analyses. There were several challenges in creating the VSD data-sharing program. 1) There was no formal CDC data-sharing program. 2) The program had to allow for transparency of VSD data, while maintaining privacy of personal medical records at MCOs. 3) Many datasets from previous published VSD studies had not been archived in a standard manner. To resolve some of these challenges, the concept of de-identifying the data was introduced. To protect privacy within the VSD data-sharing program, the program was developed within the existing mechanism of the NCHS Research Data Center (RDC). In August 2002, CDC issued guidelines for the data program.

The administration of the data-sharing program was moved from NIP to NCHS in Spring 2004. NCHS’s role in the application process is to verify that: 1) the proposals are complete; 2) the variables requested by external researchers to conduct new vaccine safety studies exist; 3) the requested final dataset for re-analysis of a VSD published study is available. If the proposal is complete and the data are available, the external researcher is provided with MCO IRB contact information for relevant sites for a second round of reviews.

The IOM committee is chaired by John Bailar, University of Chicago. There was a public meeting on data sharing held on August 23, 2004, including attendees from advocacy groups. Site visits, including RDC and MCOs, are underway, and a public meeting on the release of preliminary data is scheduled for October 21, 2004. The IOM report on the first part of the review is expected in November 2004; the second part is expected in February 2005.

NVAC Working Group on Public Participation – Ms. Ruth Katz

The members of the NVAC Working Group on Public Participation included Ruth Katz, David Johnson, and Mary Beth Koslap-Petraco. Charles Helms and Bruce Gellin served as ex-officio members. Ms. Katz thanked Sarah Landry for her help with the working group.

About a year ago, there was increased interest in enhancing public engagement in national vaccine policy. In June 2003, the Vaccine Policy Analysis Collaborative (VPACE) was brought to the attention of NVAC as a model for involving the public in setting national vaccine policy. VPACE served as a catalyst for the formation of this working group last spring. The purpose of this group was to learn more about enhancing public participation and to report its findings and recommendations to the full NVAC.

To learn more about government public participation activities, the working group held a two-day meeting to hear from experts about various approaches to engaging the public in decision-making. The working group found the presenters to be knowledgeable, thoughtful, creative, and committed to the goal of getting the public more involved in government-related decision-making. The presenters discussed how to engage very large groups, as well as how small groups work in the decision-making process. They discussed the use of using modern technology, such as the Internet, as well as the value of small roundtable discussions.

The working group reviewed the VPACE proposal as a mechanism to enhance public engagement in public policy. It also considered other potential models. The underlying premise for the working group was that the only issue before the group was how to, not whether to, better engage the public in national vaccine policy.

Ms. Katz, referring to the Executive Summary of the working group’s meeting, read the conclusions from the meeting:

  • There is a need for enhanced efforts to engage the broad public in vaccine policy discussions.

  • Both NVAC and NVPO have roles to play in supporting public engagement.

  • The public must be adequately represented.

  • In order to ensure that public engagement activities are based on an understanding of a strong scientific foundation, training of public representatives may need opt be provided.

  • A one-size-fits-all approach will not provide enough flexibility to address all vaccine topics.

  • The VPACE proposal is to be commended for drawing attention to the need for enhanced public engagement in vaccine issues.

The Wingspread Group, who put together the VPACE proposal, has received funding to look at issues related to the flu vaccine. The working group encourages them to move forward with this project and to provide NVAC with input.

The working group’s recommendations or next steps include:

  • Ensure that there is at least one member of the public on the full NVAC.

  • Continue to assess opportunities for public input in ongoing vaccine related activities.

  • Actively solicit attitudes, concerns, and suggestions from the public, providers, and industry about their perspectives, experiences, concerns, and perceptions of vaccines.

  • Assemble and measure knowledge and attitudes towards and concerns about vaccines by the U.S. public, and use that information to guide selection of issues for discussion by the working group.

  • Develop and promote communication with the general public through enhanced outreach activities (e.g., periodic reports and media releases, newsletters, hotlines, websites, and chat rooms.

  • Encourage other advisory committees and agencies involved with vaccines (e.g., ACIP and ACCV) work to effectively engage the public.

  • NVAC should work with the Deliberative Democracy Consortium in designing a broad-based public engagement program for vaccine policy.

The last recommendation will require dedicated resources. The working group learned that several countries include a line item in their budgets for public participation activities. However, the working group was not charged with making recommendations on funding issues.

Dr. Bernier commented on three key points from the Wingspread Working Group. First, the need for public participation is very real and compelling. Using the framework of social capital, there is a need to build and expend social capital to sustain the immunization program. Second, though there is some public engagement, there is a need for a new type of public engagement that is more inclusive, interactive, and useful to decision-makers. Third, there are advantages to both small (representatives) and large (direct public) groups, and both methods should be utilized to enhance public participation. The VPACE proposal was designed to dialogue with both small and large groups.

He added that the VPACE pilot is considering looking at the pandemic flu issue and asked NVAC to consider actively participating in the pilot.

Dr. Levin asked about the product of working with the Deliberative Democracy Consortium. Dr. Katz explained that the consortium would serve as a resource in providing access to various organizations that have different models for engaging the public.

Dr. Levin asked who would then make the decision on which model to use. Ms. Katz responded the consortium would assist in determining the best model for various goals. It would also help in determining the method in which the public participates in setting the agenda for various public participation activities. The consortium, as an outside organization, would also provide added credibility to the process. In essence, the consortium would act as a consultant to NVAC by directing NVAC to the appropriate organization for specific questions. Dr. Katz added that, in working with the consortium, NVAC should develop a list of goals, including keeping certain decision-making responsibilities within NVAC.

Dr. Guerra asked about how the public is defined and whether this initiative could promote better understanding of issues of disparity, in terms of race, class, ethnicity, culture, and tradition.

Dr. Bernier responded that the Wingspread Initiative included an examination of public diversity and had representatives from the minority groups. One Asian American participant noted that there is a fundamental issue of privilege, in terms of literacy and the ability to express your thoughts. These issues are barriers to creating a level playing field and a truly inclusive process.

Ms. Landry added that the working group was very sensitive to this issue of diversity. For example, the AmericaSpeaks model went to great lengths to get even undocumented immigrants to the table.

Dr. Katz commented that the issue of defining the public dominated discussions of the working group. Once the group is defined, there are additional issues in getting them to participate. It was determined that the defined public was largely determined by the specific issue. This is why the working group did not recommend any one model.

Dr. Helms noted that there were some concerns about the financial feasibility of working with the consortium. He asked the committee if it would approve the recommendations, while giving NVPO some flexibility in determining funding.

Ms. Katz suggested that NVAC meet with the Deliberative Democracy Consortium before making a final decision to determine funding requirements.

Dr. Whitley-Williams suggested that the final recommendation could be changed from “that NVAC work with” to “that NVPO explore with.” Ms. Katz concurred. Dr. Guerra suggested adding other groups, in addition to the consortium. Dr. Hinman suggested adding “on an ongoing basis” to the end of the fourth recommendation.

Dr. Guerra moved to accept the recommendations. The motion was seconded and all voted in favor.

NVAC Working Group on Vaccine Financing - Dr. Alan Hinman

The charge to the IOM Committee was to identify financial strategies designed to:

  • Achieve an appropriate balance of roles and responsibilities in public and private health sectors.

  • Integrate federal and state roles in supporting the purchase and administration of recommended vaccines.

  • Develop a framework for identifying pricing strategies that can contribute to achieving national goals for children and adults.

The Committee of 11 members held a series of meeting and commissioned papers, and came to the following conclusions.

  • Conclusion 1—“Current public and private financing strategies for immunization have had substantial success, especially in improving immunization rates for young children. However, significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations.”

  • Conclusion 2—“Substantial increases can be expected to occur in public and private health expenditures as new vaccine products become available. While these cost increases will be offset by the health and other social benefits associated with these advances in vaccine development, the growing costs of vaccines will be increasingly burdensome to all health sectors. Alternatives to current vaccine pricing and purchasing programs are required to sustain stable investment in the development of new vaccine products and attain their social benefits for all.”

  • Conclusion 3—“Many young children, adolescents, and high-risk adults have no or limited insurance for recommended vaccines. Gaps and fragmentation in insurance benefits create barriers for both vulnerable populations and clinicians that can contribute to lower immunization rates.”

  • Conclusion 4—“Current government strategies for purchasing and assuring access to recommended vaccines have not addressed the relationships between the financing of vaccine purchases and the stability of the US vaccine supply. Financial incentives are necessary to protect the existing supply of vaccine products, as well as to encourage the development of new vaccine products.”

  • Conclusion 5—“The vaccine recommendation process does not adequately incorporate consideration of a vaccine’s price and societal benefits.”

The committee identified two goals of financing strategies: 1) assuring access to recommended vaccines and 2) sustaining the availability of vaccines in the future. The funding strategy goals were to:

  • Eliminate individual financial barriers to immunization.

  • Increase incentives to the industry to invest in R&D and production capacity.

  • Reduce provider burden and improve provider compensation.

  • Minimize fragmentation of financing and delivery.

  • Maintain existing community and provider relationships.

  • Control escalation of costs and increasing fiscal burden on state budgets.

They considered the following seven alternative approaches to financing immunizations:

  1. Maintain the current system.

  2. Expand the VFC program to include additional eligibility categories.

  3. Provide universal coverage through federal purchase and supply of all recommended vaccines.

  4. Provide a federal block grant to the states for vaccine purchase.

  5. Use public vouchers to purchase recommended vaccines for disadvantaged populations.

  6. Create an insurance mandate that would require public and private health plans to cover all recommended vaccines.

  7. Combine features of the insurance mandate and voucher alternatives into a new funded mandate system.

Having considered these approaches, the IOM committee provided three recommendations:

    • Recommendation 1—“The committee recommends the implementation of a new insurance mandate, combined with a government subsidy, and voucher plan, for vaccines recommended by the Advisory Committee on Immunization Practices (ACIP).”

    • Recommendation 2—“The Secretary of the Department of Health and Human Services should propose changes in the procedures and members of ACIP so that its recommendations can associate vaccine coverage decisions with social benefits and costs, including consideration of the impact of the price of a vaccine on recommendations for its use.”

    • Recommendation 3—

      1. “As part of the implementation of recommendations 1 & 2, the National Vaccine Program Office should convene a series of stakeholder deliberations on the administrative, technical, and legislative issues associated with a shift from vaccine purchase to a vaccine mandate, subsidy, and voucher finance strategy. In addition, the Centers for Disease Control and Prevention (CDC) should sponsor a post-implementation evaluation study (in 5 years, for example).”

      2. “CDC should also initiate a research program aimed at improving the measurement of the societal value of vaccines, addressing methodological challenges, and providing a basis for comparing the impact of different measurement approaches in achieving national immunization goals.”

In response to the IOM Report, there were editorials in the New York Times and the Wall Street Journal. There was a briefing at the American Enterprise Institute. There was a forum at the National Partnership for Immunization. There was a pediatrics editorial comment. ACPM has issued a policy statement supporting the recommendations. There were a series of interviews with stakeholders and an NVAC workgroup was formed.

The initial environment scan of stakeholders was conducted between September 25 and October 3. Bruce Gellin, Alan Hinman, and Nicole Smith conducted informal interviews. They interviewed six vaccine companies, two federal government agencies, three public health agency organizations, three provider organizations, and one payer/insurer.

The following is a summary of the primary findings of the interviews.

  • There was commendation for IOM for highlighting the value of vaccines; highlighting the need to vaccinate adults, as well as children; attempting to ensure access to vaccines by all children; and for identifying factors contributing to instability in vaccine research, development, production, and supply.

  • There was skepticism that the recommended approaches would provide needed incentives to the manufacturers.

  • There was a concern about a dramatic shift to an unproven, new system.

  • There was concern about lack of detail on how the system would operate.

  • There was concern about the cost of the new system.

  • They questioned whether the system was broken enough to require this fix.

  • They felt that improvements in current system might go a long way, such as expanding VFC, removing price caps, giving providers choice, regulatory harmonization, and encouraging expansion of plan benefits.

The working group held a public meeting on June 28–29, 2004 in Washington, DC. There were 61 participants representing the perspectives of large manufacturers and biotech firms; federal, state, and local health departments; distributors and purchasers; healthcare providers; and consumers—there was no representative from the insurance industry.

At the meeting, participants were posed with three questions: what are the pros and cons are of the different options considered by IOM; what additional options that should be considered; and which option they support and why.

There was widespread agreement on:

  • The importance of vaccines and immunization

  • The exciting prospects for new vaccines

  • The fact that vaccines are undervalued

  • The need to assure access by everyone

  • The need to assure providers are adequately reimbursed for giving vaccines

  • The need to markedly improve efforts to vaccinate adolescents and adults

  • The need for regulatory harmonization

  • The need to strengthen liability protection

  • The need for better understanding of insurance and health plan coverage

  • The need for better understanding of factors responsible for low immunization coverage in adolescents and adults

No one felt that the IOM proposal for a mandate, subsidy, and voucher program was practicable. Many did not feel it would solve current problems and might be counterproductive. They were also concerned about how, and by whom, societal benefits would be calculated. Many favored improvements to the current system, including:

  • Expanding VFC coverage for underinsured children

  • Removing VFC price caps

  • Vaccine for Adults entitlement

  • Increased support for childhood immunization through Section 317

  • Specific support for adolescent and adult immunization through Section 317

Based on the meeting discussions, the working group proposes the following as NVAC’s response to the IOM report. NVAC does not:

  • Feel it is advisable to adopt the IOM recommendation to replace the current system with an insurance mandate and system of subsidies and vouchers.

  • Support the recommended changes in composition or charter of the ACIP.

The working group proposes that NVAC make the following recommendations:

  • Expanded and stable funding through Section 317 for program infrastructure and operations as well as vaccine purchase.

  • Expanded funding through Section 317 to support adolescent and adult immunization programs and vaccine purchase.

  • Rapid appropriation through Section 317 when new vaccines are recommended for universal use.

  • The expansion of VFC to include underinsured children in all public health clinics, to remove price caps, and to give providers choice of vaccines.

  • Regulatory harmonization to facilitate the introduction into the United States of vaccines licensed in other countries that comply with FDA-approved harmonized standards.

  • A further exploration of regulatory and other factors impeding vaccine research and development to alleviate barriers.

  • Increased communication between industry and FDA throughout the process of vaccine research and development.

  • Promoting “first dollar” insurance coverage for immunization and promoting re-calculation of capitation rates when new vaccines are recommended.

  • Assuring adequate reimbursement for administration of vaccines.

  • Expanded discussion about need, desirability, and feasibility of a Vaccines for Adults (or Vaccines for All) program to ensure that adults have access to vaccines, regardless of whether they have insurance.

The next step is for NVAC to approve, endorse, or adopt the working group report (with any needed revisions based on discussion). The working group also needs guidance as to whether its report should be submitted for publication.

Dr. Johnson noted that he was one of the interviewed stakeholders. One thing emphasized in the presentation is the unanimous opinion of all of the stakeholders that vaccines have been undervalued. One industry concern continues to be about the single entity purchase power. As this purchase power increases, price tends to be artificially held down, further undervaluing the vaccines. He suggested ending the first bullet on page 10 of the working group report with “as well as for vaccine purchase within existing guidelines,” since there are limitations with contract with 317 funds.

Dr. Hinman responded that the working group would accept that suggestion. Dr. Johnson then suggested dropping the last three words (“and vaccine purchase”) on the second bullet. Though vaccine purchase is being expanded, the primarily goal is infrastructure support. Dr. Hinman noted that he is not sure if the working group, which included industry representatives, would agree. He suggested replacing it with “including vaccine purchase.” Dr. Johnson responded that this suggestion was reasonable.

Dr. Johnson suggested changing the fourth bullet to read, “expansion of VFC to include underinsured children in all public health clinics, removing price caps, and giving all participating providers and clinics a choice of vaccines.” Dr. Hinman accepted this suggestion.

Dr. Gellin asked what they should do about the lack of representation from the insurance industry. Dr. Hinman commented that it should be noted that the report does not include input from insurance, though they were invited to participate. They were on the agenda for the public meeting, but the representative got ill and did not attend. The working group was informed that a statement would be provided, which it has not received. Additionally, there have been at least two failed attempts by NVPO to contact insurance.

Dr. Johnson suggested changing wording in the last bullet from “and feasibility of a Vaccines for Adults (or Vaccines for All) program” to “and feasibility of various initiatives (e.g., Vaccines for Adults program),” so as not to restrict what is considered in discussions. Dr. Hinman accepted this suggestion.

Dr. Guerra noted that there are circumstances that require children to be updated with their immunization to comply with various rules and regulations. This has to be done in a way that is convenient and affordable. Dr. Hinman responded that they could add “assure easy access” to the recommendations.

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