National Vaccine Advisory Committee (nvac)

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National Vaccine Advisory Committee (NVAC)

October 5-6, 2004 meeting

Draft Minutes

Meeting Overview

Several working groups provided reports and recommendations, three of which were accepted by vote of the full Committee.

  • As requested by Acting Assistant Secretary for Health Dr. Christina Beato during the June 1-2, 2004 NVAC meeting, a Pandemic Influenza Working Group was formed to prepare comments for NVAC on the Department’s Pandemic Influenza Preparedness and Response Plan, as issued to the public in draft form on August 26, 2004. The full committee approved the Working Group’s comments and recommendations.

  • In response to Dr. Beato’s challenging request made during the Committee’s February 2004 meeting, an Influenza Working Group was formed with three subgroups to identify high priority issues and recommendations for improvement of the national influenza immunization program. A preliminary report of the working groups findings are expected shortly.

  • The Working Group on Enhancing Public Participation in Vaccine Policy Deliberations, chaired by Ruth Katz, MPH, JD, held a meeting on September 13-14, 2004 to consider options for enhancing public participation in vaccine policy deliberations and to evaluate the proposal from the Wingspread Public Engagement Planning Group for the Vaccine Policy Analysis Collaborative (VPACE) demonstration project. Responding to the Working Group’s charge, several recommendations developed by the Working Group, which were approved by the full Committee.

  • In response to the IOM’s request, as presented in their report “Financing Vaccines in the 21st Century,” the Vaccine Financing Working Group held a 2-day stakeholder forum on June 28-29, 2004 to examine the administrative, technical, and legislative issues associated with a possible shift from vaccine purchase to a vaccine mandate, subsidy, and voucher financed strategy. Attendees represented manufacturers, Federal agencies, public health agencies, and providers. Insurers were invited to the table, but were unable to attend and have not provided a payer’s opinion. As a result of that forum, the Working Group developed a number of recommendations they feel could contribute to the stabilization of the current immunization financing system, which were approved by the full Committee.

  • The Working Group on Public Health Options for Implementing Vaccine Recommendations has continued its work on the development of a decision making framework that could be utilized by state authorities in the implementation of vaccine recommendations. This framework emphasizes the public process, the thorough consideration of public health, public policy, and operational environments, and a closer examination of exemptions, particularly the effects of non-medical exemptions and the process for obtaining such an exemption.

The Vaccine Safety & Communication Subcommittee received a presentation by Dr. Melinda Wharton, NIP, about the IOM review of the NIP Vaccine Safety Datalink data sharing program. The IOM’s final reports are expected to be released in November 2004 (reviewing and presenting recommendations on the program) and in February 2005 (reviewing and presenting recommendations for the handling of preliminary data obtained by Datalink). While the Immunization Coverage & Future Vaccines Subcommittees held a joint meeting to begin the planning of a National Stakeholder Meeting on Strategies to Increase the Uptake of New Vaccines for Adolescents, currently proposed to be held in June 2005. The goals of such a meeting would be to identify the strengths and weaknesses of key implementation strategies and issues; identify approaches that will effectively and efficiently increase the proportion of adolescents who receive vaccines; develop plans to implement these approaches; and to identify research initiatives in support of the successful introduction of these new vaccines and to accelerate the development of vaccines in the ‘pipeline.’

Other presentations of interest included the following: a review of the 2004-2005 Influenza Season (Drs. Steven Cochi, Eddie Wilder, and Alan Janssen, NIP), National Children’s Health Study (Dr. Peter Scheidt, NIH), an update of the READII program (Tamara Kicera, NIP), and an overview of project Bioshield (Monique Mansoura, OPHEP).

Agency and committee updates were presented by: NIP/ACIP (Dr. Steve Cochi - CDC), ACCV/DVIC (Dr. Geoff Evans - HRSA), FDA/VRBPAC (Dr. Gary Overturf – University of Mexico, VRBPAC Chair and NVAC liaison), NIH (Dr. George Curlin – NIAID).

Committee Members in Attendance

    Dr. Charles M. Helms—Chair

    Dr. Ann Margaret Arvin

    Dr. Fernando A. Guerra

    Dr. Alan Richard Hinman

    Dr. David Johnson

    Ruth Katz

    Dr. Jerome O. Klein

    Mary Beth Koslap-Petraco

    Dr. Richard Raymond

    Dr. William Schaffner

    Dr. Patricia N. Whitley-Williams

    Dr. Adele Young

    Executive Secretary

    Dr. Bruce Gellin, NVPO

    Liaison Representatives

    Dr. Gary D. Overturf, VRBPAC/FDA

    Dr. Myron Levin, ACIP/CDC

    Ex-Officio Members

    Dr. Steve Cochi, Acting Director, NIP/CDC

    Dr. George Curlin, Special Advisor, NIH

    Col. Renata J. M. Engler, Chief, Allergy/Immunology Dept., Walter Reed, DoD

    Dr. Geoffrey Evans, Medical Director, VICP/HRSA

    Dr. James Randolph Farris, Regional Administrator, Region VI, CMS

    Emily Marcus Levine, Senior Attorney, OGC/DHHS

    Committee Members Absent

    Dr. Gary Freed

    Dr. Steven Black, Liaison, AAHP and Director, Vaccine Study Center, Kaiser Permanente

    Jackie Noyes, Liaison, Advisory Commission on Childhood Vaccines

    Dr. Norman Baylor, Microbiologist, CBER/FDA

    Neal Brandes, USAID

    Invited Speakers

    Dr. Cristina Beato, Acting Assistant Secretary of Health, DHHS

    Alan P. Janssen, Office of Health Communication, NIP/CDC

    Ms. Tamara J. Kicera, NIP/CDC

    Dr. Monique K. Mansoura, Office of Research and Development Coordination, DHHS

    Dr. Benjamin Schwartz, NVPO

    Dr. Peter Scheidt, National Children’s Health Study, NIH

    Dr. Eddie Wilder, Public Health Advisor, Immunization Services Division, NIP/CDC

    Dr. Donald Williamson, NVAC Working Group on Public Health Options for Implementing Vaccine Recommendations

    Day 1 – October 5, 2004

Welcome from the National Vaccine Advisory Committee Chair – Dr. Charles Helms

Dr. Helms thanked NVAC members and noted that Dr. Bruce Gellin was “putting out a fire” and would join them when he could. He suggested they begin the meeting to stay on schedule. Dr. Helms then introduced himself and asked the attendees to introduce themselves.

Dr. Helms gave a brief report to update the committee. He brought members’ attention to the solicitation for nominations for NVAC. He noted that committees such as NVAC are ongoing because of the participation of expert individuals whose presence on such committees can increase productivity and improve advice offered to the government.

Dr. Helms noted that they have been very busy in response to Dr. Beato’s request for a preliminary report from the Influenza Working Group, as well as many other things that would be reported on during the meeting. The DHHS Draft Pandemic Influenza Preparedness and Response Plan is now publicly available and comments are being solicited. In addition, Dr. Alan Hinman, who chairs the Working Group on Pandemic Influenza, created to provide NVAC comments on the plan, will be presenting some of these comments for deliberation. The Influenza Working Group will give a presentation on its preliminary report and Dr. Hinman would also be reporting on the follow-up on the IOM report on vaccine financing. Ruth Katz will also give an important presentation on a recent meeting held by the Working Group on Public Participation, which she chairs.

Dr. Helms noted that there would be a special joint meeting of the Immunization Coverage and Future Vaccines Subcommittees to discuss a possible stakeholder meeting on adolescent immunization. Upcoming Influenza Season
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