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October 2007 NVAC Meeting Minutes - page 29 / 40





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October 2007 NVAC Meeting Minutes

In terms of the ISO research agenda, Dr. Broder provided the Subcommittee with an update as to the group’s activities. Based on a recommendation from the IOM, the ISO is going through a process to develop a research agenda to focus on the vaccine safety datalink. During ISO’s meeting with external consultants and the interagency vaccine group meeting, the ISO discussed what their research agenda would focus on. They are looking at research issues that should be explored and not at the larger vaccine safety infrastructure. NVPO is sponsoring a meeting with vaccine companies on November 16 where representatives from the companies that manufacture vaccines that are routinely recommended in the United States will review and comment on what ISO has so far. CDC will then develop a draft research agenda, which will be given to the NVAC Subcommittee on Vaccine Safety for their comment.

In terms of NVPO’s current vaccine safety activities, NVPO is in the process of developing a comprehensive paper to review what is done by the Federal Government to ensure the optimal safety of vaccines. The document should be ready for wider distribution within the next few months. Questions arose as to the intended audience of the document. Therefore, the Subcommittee discussed the possibility of having something more useful for the general public or for healthcare workers to use to address patients’ questions regarding vaccine safety.

The next step for the Subcommittee is to review this document as well as the 1999 Vaccine Safety Action Plan and provide feedback. The Subcommittee may develop a White Paper that would outline what the safety system should look like according to the Subcommittee and NVAC. To address these tasks, several consultants were invited to join the Subcommittee.

Strategic Issues in Vaccine Research Program—FY08 Review Process—Dr. Benjamin Schwartz

This year the NVPO had five priority categories for the program. A total of 42 proposals were received this year, 20 of which address the priority of standardizing immunological assays, 9 of which address adolescent and adult immunizations, 5 of which address vaccine safety, and 5 of which address vaccine financing. Most of the proposals come from the various components at CDC and FDA, and one proposal came from USAID.

The first phase of the review process includes a number of reviewers from NVAC, the Federal agencies, and the NVPO reading and scoring these proposals. The second phase will include an in-person meeting that will take place in Washington, DC, tentatively on December 5. Last year, NVPO was late getting money out to the agencies; therefore, this year they are pushing for a quicker process.


In response to a question about the abstracts, Dr. Schwartz explained that he would need to e-mail the NVAC participants directly with their specific assignments as to which proposals to review. He also hoped that more NVAC participants would be willing to participate in the review process. He emphasized that participants can be involved in either phase 1 or phase 2 or in both phases.

Final Discussion and Public Comment—Dr. Guthrie S. Birkhead

Dr. Gordon provided the Committee with information from another conference he attended with Dr. Almquist on public trust in vaccines. He explained that the dialogue between those who support vaccines and those who do not, such as the autism groups, was constructive. He also informed the Committee that transcripts from these conversations were available. Dr. Birkhead asked if a specific report or recommendations were going to come from this conference. Dr. Gordon responded that a report would be available but that recommendations are not usually made.

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