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October 2007 NVAC Meeting Minutes - page 32 / 40





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October 2007 NVAC Meeting Minutes

Dr. Gordon pointed out that the report draft contains no reference to the online version of the 1995/1999 compendium of adjuvants. He indicated that these might provide additional current references. He also stated that a new compendium was needed and asked those attending if they could provide working lists currently in use in their agencies for review and possible publication.

Dr. Baylor pointed out that a footnote was needed to table 4, stating that only antigen/adjuvant vaccine formulations with publicly available information are listed.

Next, Dr. Dekker asked for input regarding the research agenda outlined in the current document. Dr. Schwartz stated that a possible expansion of item 1, perhaps as item 1b, is stimulating research on adjuvant employment issues and effector mechanisms. Dr. Baylor said the newer adjuvants call for a new approach and that their possible pharmacologic activities could have an impact on translational studies.

Dr. York stated that there was a need for information on immune responses in various age groups. Dr. Hosbach added that information on risks versus benefits was needed, and sourcing and scalability issues should be considered. While some of these had been addressed, proprietary concerns prevented resolution of others.

The discussion concluded with Dr. Dekker indicating that she would provide the current draft document to any attendees, including non-Subcommittee members, who requested it in an effort to ensure the final report would represent a “best effort” by the Subcommittee. The agency representatives were asked to provide their summaries of currently sponsored research as soon as possible for inclusion into the draft in order to inform the recommendations.

The Development Effort for a New National Vaccine Plan—Dr. Ray Strikas, NVPO

Copies of the current draft of the National Vaccine Plan Update: Priority Issues, dated October 18, 2007, were distributed along with The Goals, Objectives, and Strategies of the National Vaccine Plan, Chapter IV of the 1994 plan. As attendees reviewed the documents, Dr. Strikas pointed out that the current draft included only input from Federal Government agencies. He added that this draft had yet to address any safety issues and addressed international issues only in the most limited sense.

Dr. Gordon said that one objective for the current discussion was to identify the role for the Subcommittee in the development process. Clearly, he said, one issue is prioritization.

In response to a question of the timeline for the accomplishment of plan goals, Dr. Strikas indicated it to be 2012 through 2015 based on approval of the plan in 2009. Dr. Dekker observed that this timeline would help in efforts of prioritization and determination of specificity.

Dr. Wallace stressed that it was important to establish specific criteria for prioritization. Dr. Gordon observed that the prioritization methods employed in creation of the 1986 IOM report on priorities for vaccine development were particularly effective and might be a good place to start. He suggested that the plan now being drafted should call for an annual addendum.

Dr. Hosbach reminded those attending that the National Vaccine Plan would have a significant impact on industry. Dr. Strikas responded that one specific intent of IOM involvement in the new plan’s creation was to ensure that manufacturers had some input to—and a degree of ownership in—the final result. In response to Dr. Baylor’s question of whether the 1994 National Vaccine Plan significantly impacted the industry, Dr. Gordon said yes although the 1985 IOM report’s impact was even greater.

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