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

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 Priority category Number of Projects FundedSubmitted (rate) Adol & adult vaccination 110 (10%) New & future vaccines 14*48 (29%) Pandemic & annual flu 7**21 (33%) Vaccine safety 311 (27%) Vaccine supply & finance 0 1 (0%) Vaccine economic studies 0 8 (0%) TOTAL25 93 (25%)*** * 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 1. Vaccine financing 2. Vaccine safety For currently licensed and recommended vaccines (excluding traveler’s vaccines) 3. Adolescent vaccination (program/policy focus) 4. Public engagement on vaccine financing, safety, and adolescent vaccination 5. 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