The NVPO Unmet Needs Program: Looking Back and Moving Forward

1. National Vaccine Advisory Committee Meeting, September 2006 The NVPO Unmet Needs Program: Looking Back and Moving Forward Ben Schwartz National Vaccine Program Office

2. Outline • Program overview • Evaluation of outcomes, 1995-2002 • FY 2006 priorities and funded projects • NVAC/Agency/NVPO Working Group on the Unmet Needs Program • FY 2007 Working Group suggested priority categories • Next steps

3. NVPO Unmet Needs Program • Provides support for high priority vaccine and immunization projects • Based on National Vaccine Plan & current HHS, NVPO, and NVAC priorities • “Seed money” and “catalytic funding” • Addresses new and emerging issues that fall outside regular agency funding cycle • Applicants include scientists/project officers from HHS agencies, DoD, and USAID

4. NVPO Unmet Needs Program • Projects funded for a maximum of 2-years • Intramural and extramural • Research and conferences • Domestic and international • $4 to $5 M provided annually for new and continuation projects • Funding decisions made competitively based on a defined review process

5. Goals of the National Vaccine Plan • Goal 1: Develop new and improved vaccines • Goal 2: Ensure the optimal safety and effectiveness of vaccines and immunization • Goal 3: Better educate the public and members of the health professions on the benefits and risks of immunization • Goal 4: Achieve better use of existing vaccines to prevent disease, disability, and death

6. Evaluation of Unmet Needs Projects Funded in 1995-2002 • Survey of project PIs • 114/178 responses (64%) • Objective outcomes • 68% peer-reviewed publications • 38% continued project with other funding; 37% developed follow-up project • 20% retained staff after project • 67% of projects provided training for fellows/post-docs • 42% extramural collaboration (14% interagency collab.)

7. Evaluation of Unmet Needs Projects Funded in 1995-2002 • Subjective outcomes • 98% fully/partially successful (met all/some objectives) • 40% enhanced collaboration between agencies • 90% unlikely to have been funded without this program • Major impacts • Improved assessment/safety of cell substrates • Addressed specific vaccine safety concerns • Contributed to vaccine development • Contributed to new vaccine recommendations • Assessed impacts of new vaccines

8. Evaluation of Unmet Needs Projects Funded in 1995-2002 • Program concerns • Several projects were funded for continuing activities based on new proposals submitted after funding for a prior project period ended • Some projects fall within priority categories but do not address highest priority near term issues affecting HHS and NVPO • One funded project was not done because the PI left the agency

9. FY 2006 Unmet Needs Priority Categories • Adolescent and adult vaccination • New and future vaccines • Pandemic and annual influenza • Vaccine safety • Vaccine supply and financing • Economic analysis of vaccines and vaccination programs

10. FY06 Unmet Needs-Funded Projects * 6 projects on New Vaccines (2 adolescent); 8 projects on Future Vaccines ** 4 projects funded with HHS pandemic influenza resources *** Some projects address multiple priority categories

11. Unmet Needs Program: Taking Stock and Moving Forward • Important issues for HHS and NVAC – such as vaccine financing – are not being addressed by funded projects • Current priority categories are broad and funded projects may not be closely linked with current HHS and NVAC issues • The approach to selecting projects for funding can be improved

12. NVAC/Agency/NVPO Working Group on the Unmet Needs Program • 3 representatives from each group • NVAC: Dekker, Freed, Humiston • Agency: Baylor, Curlin, Schuchat • NVPO: Bart, Gellin, Schwartz • Working Group objectives • Improve the program focus • Propose FY07 priority categories • Suggest changes to improve the review process

13. Unmet Needs Working Group: Options to Improve Program Focus • Narrow priority categories • Solicit proposals on specific topics • Identify a focus area for interagency collaborative research • Increase NVAC subcommittee roles in defining project foci and developing project proposals • Issue program announcements from NVPO for focused research

14. Working Group Recommendations • Narrow program priorities and align more closely with current HHS and NVAC priorities • Obtain input from NVAC subcommittees on priority issues to address • Consider multi-agency collaborative research focus for FY 08

15. Working Group Suggested Priority Areas for FY07 • Vaccine financing • Vaccine safety • For currently licensed and recommended vaccines (excluding traveler’s vaccines) • Adolescent vaccination (program/policy focus) • Public engagement on vaccine financing, safety, and adolescent vaccination • Improved methods for VPD detection • Laboratory tests for improved diagnosis and strain typing of agents targeted by current U.S. recommended vaccines (excluding traveler’s vaccines)

16. FY 07 Unmet Needs Review Process • Evaluation is ongoing • Likely direction of changes • More limited agency input on own proposals • Consider agency not scoring own/other’s proposals • Increase NVAC participation • Adhere to standardized scoring by evaluation category • Potential changes • Longer technical proposal (possibly with short initial concept and development of full proposals for selected projects)

17. Issues for NVAC • Comment on proposed priority categories for FY07 • Subcommittees propose questions/issues for research within priority categories • Suggest modifications to the review process • Volunteer to participate in proposal reviews