October 2007 NVAC Meeting Minutes
The phase 1 input has been organized into a framework divided into research issues affecting a specific life stage and those issues that cut across life stages. Some of the key research themes gathered so far include
Specific vaccines; e.g., newly licensed vaccines; combination, annual, and pandemic influenza; bioterrorism and travel vaccines;
Vaccination practices; e.g., simultaneous vaccination, off-label use, clinical guidance for medical exemptions and causality assessment, reimmunization protocols;
Host factors,; e.g., gender, race, genetics, underlying conditions;
Clinical outcomes; e.g., demyelinating disorders, autoimmune disorders, allergic disorders, life-threatening disorders/death (including baseline rates);
Other areas; e.g., role in immune responses and vaccine adverse events, risk perception (e.g., autism).
To collect information for the agenda, ISO held an external scientific consultancy meeting with representatives from various specialties, including pediatric infectious diseases, adult infectious diseases, obstetrics and gynecology, epidemiology, genomics, and immunology. An Interagency Vaccine Group Meeting on the ISO Research Agenda included participants from NVPO, FDA, HRSA, NIH, DoD, and CDC. A meeting with vaccine manufacturer representatives is scheduled for November 16, 2007.
In response to a question, Ms. Kristin Pope explained that research on previously determined priorities was continuing while the new agenda was being developed and that ISO was looking at the whole system to see if current resources will meet emerging needs and to determine where gaps (e.g., research, staffing, funding) exist and where resources need to be shifted in order to make a more comprehensive agenda.
Dr. Broder noted that ISO has collected some non-research-related input and that NVPO may play a role in coordinating this information across agencies.
Ms. Trish Parnell asked if there were processes built into the development of the agenda for public review. Dr. Broder noted that the focus has been on scientific development and hoped that there would be a mechanism for public review through the NVAC review process. Dr. Bruce Gellin suggested that the NVAC wait until the agenda is completed to determine the best way to solicit and incorporate public input.
Dr. Dixie Snider noted that ISO would like NVAC’s assistance in developing a process that is fair, open, and worthy of the public’s trust. Dr. Pavia suggested that NVAC review the finalized agenda and produce a “next steps” White Paper.
Next Steps in Developing ISO Research Agenda
NVPO Sponsored ISO/Industry Meeting—Dr. Karen Broder, ISO/CDC
An NVPO-sponsored meeting with vaccine manufacturer representatives is scheduled for November 16, 2007. ISO staff will collect additional external input for the research agenda at this meeting. In general, participants will be asked to provide input on their areas of concern, clinical outcomes they would like considered, and their ideas on research prioritization. A briefing book will be sent out to participants prior to the meeting.
Addition of Consultants for Safety Subcommittee—Dr. Dan Salmon, NVPO