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Autism Speaks Participates in NVAC's Vaccine Safety Writing Group Meeting

The National Vaccine Advisory Committee (NVAC), and specifically NVAC's Vaccine Safety Working Group, has asked for public and stakeholder input regarding ISO's draft Scientific Agenda. In an effort to do this, The Keystone Center has worked with a steering committee of NVAC's Vaccine Safety Working Group to design and facilitate input to this process.

On February 20-21, a small writing group* was convened in Salt Lake City to accomplish the following:

Identify any potential gaps in the draft Immunization Safety Office's Scientific Agenda
Develop draft prioritization criteria that can be applied to the ISO Scientific Agenda
Develop relative weights for the prioritization criteria (above).

The writing group included individuals and members of groups whose primary interests are focused on vaccine-related issues, state and local public health and immunization officials, pediatricians, federal agency officials, and members of NVAC and their Safety Working Group. The participants were selected by The Keystone Center and invited to participate in order to draft documents for a stakeholder meeting open to all stakeholders on March 16, 2009 in Washington, DC. If you are interested in attending this meeting, register with Kirsten Vannice at 202-690-5566 or by e-mail at kirsten.vannice@hhs.gov.

Participants attended the writing group meeting with the understanding that:

The work produced would remain in draft form for the March meeting, when all interested stakeholders will have an opportunity to share their views on the specific draft products from the writing group, as well as the ISO Scientific Agenda more broadly.
There were many other stakeholders whose participation could have been appropriate for this meeting, but it was important to keep the writing group to a manageable size given the goal of drafting documents for consideration at the March 16 meeting.
Their participation should not imply to others at the meeting that they think the vaccine safety system generally works or is fundamentally flawed. Rather, their participation indicates their willingness, for the purposes of the writing session, to focus on the draft ISO Scientific Agenda and the associated prioritization criteria.

The writing group agreed to issue the following statement (in the box below) about their work together:

On February 20/21, The Keystone Center convened a writing group meeting on behalf of the National Vaccine Advisory Committee Vaccine Safety Working Group, to discuss prioritization of the draft Immunization Safety Office agenda items, and to draft materials in preparation for a larger stakeholder meeting in the near future.

Each member of the writing group came to the meeting from a unique constituency, and we have made a good faith effort to provide draft prioritization criteria for vaccine safety research. While differences of opinion remain, we have worked together to find common ground where we can, and to respect our differences where we cannot.

Two draft products are the result of our meeting together:

Draft Prioritization Criteria. The draft prioritization criteria generated represents a consensus on important prioritization criteria, although we may differ in our evaluation of specific projects using these criteria. We agree that these are the important parameters to consider in prioritizing future projects within the ISO. We hope that these criteria may be useful more broadly in the vaccine safety research system.
Draft Gaps in the ISO Agenda. This list represents additional gaps identified by members of the writing group. As part of the discussion on gaps in the Scientific Agenda, we also drafted a recommendation to establish and charge an expert panel with evaluating study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. This draft charge is responsive to issues raised at community meetings in Alabama, Oregon, and Indiana as well as the Interagency Autism Coordinating Committee request for collaboration with the National Vaccine Program Office.

We worked in good faith and are hopeful that these draft products will help to advance important conversations in vaccine safety. We collectively understand that participation in this effort does not imply that groups or individuals give up their rights or authorities by participating in this two-day meeting. In the case of NVAC and government officials, we understand that they will consider this effort, in addition to many others, as they approach their advisory and decision-making obligations.

The Writing Group Members

All meeting participants signed onto this statement with the exception of Melinda Wharton, ISO Acting Director. Given she is the final recipient of the NVAC's advice, she felt it more appropriate to issue a separate statement.

Melinda Wharton, Acting Director of the Immunization Safety Office, issued the following statement:

As Acting Director of the Immunization Safety Office, I was honored to be included in the meeting of the Vaccine Safety Writing Group, held in Salt Lake City, February 20-21, 2009. ISO has solicited input into the draft scientific agenda from both internal and external experts and other stakeholders, and is anticipating receiving very useful guidance from the National Vaccine Advisory Committee (NVAC). We are sure that the Writing Group's recommendations will be useful to NVAC and the NVAC Vaccine Safety Working Group. The discussions at the Writing Group meeting were constructive and collegial, and we are glad that we were able to participate. We look forward to additional discussions with other stakeholders and receiving recommendations from NVAC later this year.

Melinda Wharton, M.D., MPH
Acting Director, Immunization Safety Office, Centers for Disease Control and Prevention

DRAFT OUTPUTS OF THE WRITING GROUP MEETING

Draft outputs from the meeting include:

These documents are for consideration by a larger group of stakeholders on March 16.

*Writing Group Members -- Peter Bell, Autism Speaks; Sallie Bernard, Safe Minds; Joseph A. Bocchini, Jr., Louisiana State University; Guthrie Birkhead, Chair, National Vaccine Advisory Committee (NVAC); Anna Buchannan, ASTHO; Tawny Buck, Vaccine Safety Advocate; Chris Carlson, NVAC Safety Working Group Member; Tracy Cron, participant in Birmingham Community Meeting; Vicky Debold, National Vaccine Information Center; Margaret Dunkle, George Washington University; Bruce Gellin, National Vaccine Program Office (NVPO); Lance Gordon, NVAC Member; Alan Greene, Stanford University School of Medicine; Dennis Johnson, Children's Health Foundation; Barbara Loe Fisher, National Vaccine Information Center; James Mason, NVAC Member; Debbie McCune Davis, Arizona Partnership for Immunization; Andrew Pavia, NVAC Member, Chair of NVAC Safety Working Group; Jim Shames, Jackson County, OR; David Sundwall, Utah Department of Health; Collette Young; OR Public Health Division; Melinda Wharton, Immunization Safety Office (ISO); Heather Zwickey, National College of Natural Medicine; Robert Bednarczyk, NY Department of Public Health; Roger Bernier, Centers for Disease Control (CDC); Dan Salmon, NVPO, Ben Schwartz, NVPO; Elizabeth Skillen, CDC.

FOR MORE INFORMATION

For more information regarding this session or the planning of the March 16 session, please feel free to contact with Janesse Brewer of The Keystone Center at jbrewer@keystone.org or by telephone at 970-513-5847.