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October 2007 NVAC Meeting Minutes

Dr. Salmon discussed the expansion of the Safety Subcommittee to include experts in immunology, epidemiology, biostatistics, genomics, toxicology, pharmacology, neurology, internal child/health medicine, and others to provide a broad panel for the NVAC review of the ISO research agenda. Invitations have been sent to representatives from the various fields, and many have accepted.

Inventory of Federal Vaccine Safety Activities—Dr. Dan Salmon, NVPO

NVPO is coordinating an inventory of Federal vaccine safety activities to compile the “story” of the Federal Government’s role in immunization safety. The inventory will detail the processes required for a vaccine to be licensed, concentrating on the work of Federal agencies, but also including FDA’s guidance and oversight of the work completed by the pharmaceutical industry. The inventory is intended for the public and will be written at a level accessible to an educated public without a science background. The document is in final draft form. Once the inventory goes through clearance (approximately 6 to 8 weeks), Constella staff will format it into a more user-friendly document.

The Subcommittee on Vaccine Safety will review the document, critique the safety system as a whole, make recommendations related to improvements (e.g., linking databases, addressing gaps and redundancies), and include a vision for the near future. This review will be presented in the form of a White Paper.

Discussion

Committee members discussed the need for sharing the inventory’s safety message with a broader audience and suggested secondary products that may include versions written at appropriate reading levels and with an appropriate amount of detail for target audiences; e.g., parents, pregnant women, older adults.

On September 27, 2007, the FDA Amendments Act of 2007 was signed into legislation. Dr. Pavia noted that it would be useful to have a summary of this legislation presented at the February 2008 NVAC meeting.

Next Steps in Federal Vaccine Safety Infrastructure and Role for the NVAC—Dr. Andrew Pavia, NVAC

Dr. Pavia discussed a new framework for working on the goals of NVAC—instead of static Subcommittees, goal-specific work would be conducted in Working Groups that would meet for finite periods of time; i.e., until goal is achieved.

Discussion

Subcommittee members were positive about this potential transition and suggested a consensus process for selecting priorities.

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