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Opportunities to Inform Recommendations of the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group
The National Vaccine Advisory Committee (NVAC), a Federal advisory committee to the Department of Health and Human Services (HHS), is seeking broad public input into the scientific research agenda that is being developed by the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO). Comments and input from members of the general public, citizens groups, parents, physicians, nurses and other health care providers, public health practitioners, academics, and policy makers will contribute to NVAC recommendations to CDC/ISO on the scientific agenda.
As a key component of a broad vaccine safety system, CDC’s ISO has significant responsibility for monitoring the safety of vaccines after they are licensed and used among children and adults in the United States (http://www.cdc.gov/vaccinesafety). ISO’s scientific agenda identifies vaccine safety issues to consider for scientific study over the next five years, in addition to any new questions that may arise. Since not all questions and issues can be addressed at once, setting priorities is important.
ISO’s draft scientific agenda can be found at: http://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf and the addendum at http://www.cdc.gov/vaccinesafety/00_pdf/draft_recommendations_add_080410.pdf
Public Comment Opportunity on the CDC Immunization Safety Office (ISO) Draft Scientific Agenda Now Available
The NVAC Vaccine Safety Working Group is seeking public comment on the CDC ISO draft Scientific Agenda as an important part of its review process. An opportunity to submit written comments is now available. You can view the Federal Register notice (PDF - 60KB) requesting comments from the public. The comments being sought include people’s concerns about vaccine safety; their values — why some concerns may be more important than others; specific suggestions on the scientific agenda; and any other information, including personal stories. The deadline to receive comments is 5 p.m. on February 2, 2009.
All public comments received by 5 pm on January 26, 2009, will be given to NVAC Vaccine Safety Working Group members and a summary of those comments will be presented at a public meeting on February 4th (for more information, please see below). Comments received after this date but before the deadline also will be given to NVAC Vaccine Safety Working Group members but may not be included in the meeting presentation due to time constraints.
Public and stakeholder input
Approaches currently being planned for public and stakeholder input include:
- Providing written comments — which can be done by any interested individual or organization
- Participating in an all-day dialogue that will include a cross-section of the general public from three communities (“public engagement”)
- Participating in a meeting of representatives from organizations that have a primary focus on vaccines and/or vaccine safety issues (“stakeholder engagement”)
- Attending a February 4, 2009, meeting of the NVAC Vaccine Safety Working Group
How will HHS and CDC/ISO use the public and stakeholder input?
NVAC is reviewing the ISO scientific agenda and providing recommendations to strengthen the content and establish priorities for their research. Public and stakeholder input will be important to the development of the NVAC recommendations, contributing along with the expertise of the NVAC and Vaccine Safety Working Group members. In addition, the public and stakeholder input will be heard directly by CDC/ISO through their participation in the meetings and will inform their thinking as the scientific agenda is finalized.
Who is planning the public and stakeholder engagement activities?
Planning for the public and stakeholder engagement meetings is being coordinated by a steering committee that includes NVAC members (including the public representative), a member of HHS’ Advisory Commission on Childhood Vaccines (ACCV) who is a parent of a vaccine-injured child, representatives from HHS, CDC, the Association of State and Territorial Health Officials (ASTHO) and the National Association of County and City Health Officials (NACCHO). The steering committee is representative of the groups that are sponsoring the meetings and that will use the results, and brings public perspectives to the planning process. The Keystone Center (www.keystone.org), a non-profit organization with extensive experience bringing together diverse groups around health and environmental policy issues is serving as a neutral convener for the public and stakeholder meetings and is working with the steering group to plan these meetings.
Community dialogues — a sampling of public values and perspectives on vaccine safety
Public engagement meetings will take place in Birmingham, Alabama, on December 13; Ashland, Oregon, on January 10; and Indianapolis, Indiana, on January 17. These locations were chosen in order to hear from people in different parts of the country and who may have different perspectives on vaccine safety (for example, parents in Ashland more often seek exemptions to school immunization laws for their children than do parents in the other communities). Each of the meetings will include up to about 75 community members. Participants will be sought through outreach from a variety of community networks, including health care providers, school-based and home-school-based organizations, alternative medicine providers, and the local media. Because the purpose of these meetings is to hear from a broad cross-section of community members, participation will be limited to people who live in the local area and who register in advance of the meeting, with emphasis on parents or guardians of children under 18 years old. Public meetings will last a full day and include educational presentations, small group deliberations, and full group discussions. The primary objective will be to identify participants’ values and concerns which will contribute to prioritization of scientific activities in the ISO agenda.
A stakeholder dialogue — deliberation among representatives of organizations interested in vaccines and vaccine safety
The stakeholder engagement meeting will take place on January 22 and/or 23, 2009, at a site that has not yet been determined. Identifying participants for this meeting is challenging because of the wide range of interests of stakeholders and the desire to keep the size manageable so that the dialogue can be deliberative and productive. Ideally, participants in this meeting should have the following attributes:
- Interest and knowledge in vaccines and vaccine safety issues
- Comfort in discussing science as well as values
- Ability to work with people who have very different views
- Willingness to focus on the specific task at hand - feedback on the ISO scientific agenda, discussion of priorities and gaps, and discussion of the values that underpin stakeholder positions.
Recognizing the challenges in designing this meeting, the steering committee recommended that preliminary conversations take place with a number of stakeholders who are active on issues around vaccines and vaccine safety. These interviews are not meant to be a comprehensive inventory of perspectives on the issues or include all potential participants, but rather to provide a better understanding of the diversity of viewpoints around vaccine safety. These discussions, which are being planned and carried out on behalf of NVAC Vaccine Safety Working Group by neutral facilitators from The Keystone Center, also will seek input regarding participation for the meeting and how the agenda might be structured. It is important to emphasize that participation in a preliminary discussion is neither a prerequisite nor a guarantee of participation at the meeting. Representatives of organizations and individuals who are interested in being considered as a stakeholder participant should visit The Keystone Center site at www.keystone.org/information/.
NVAC Vaccine Safety Working Group — an open meeting
The NVAC Vaccine Safety Working Group will meet in Washington, DC, on February 4, 2009, to hear the results of the public and stakeholders meeting, and a summary of the written comments. This information will inform their deliberations and recommendations on the ISO scientific agenda. The meeting is open to the public and there will be some opportunity for public comment. Because space is limited, registration will be required. To register, please contact Ms. Kirsten Vannice at HHS’ National Vaccine Program Office (kirsten.vannice@hhs.gov).
HHS commitment to conversation
HHS is committed to obtaining broad public input on vaccine safety and the vaccination program. Since 2000, CDC and HHS have sponsored public and stakeholder engagement on vaccine safety, pandemic influenza — the latter including consideration of priorities for vaccination, community strategies, and protecting vulnerable populations. HHS will seek further opportunities to build trust and transparency in vaccination program policy through additional public outreach.
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