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The NVPO Unmet Needs Program: FY 2006 Update

National Vaccine Advisory Committee Meeting, June 2006. The NVPO Unmet Needs Program: FY 2006 Update. Ben Schwartz National Vaccine Program Office. Presentation Objectives. Describe Unmet Needs program Objectives Approach Priorities Funded projects Obtain NVAC input

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The NVPO Unmet Needs Program: FY 2006 Update

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  1. National Vaccine Advisory Committee Meeting, June 2006 The NVPO Unmet Needs Program: FY 2006 Update Ben Schwartz National Vaccine Program Office

  2. Presentation Objectives • Describe Unmet Needs program • Objectives • Approach • Priorities • Funded projects • Obtain NVAC input • Potential program modifications to better support NVPO & NVAC needs and priorities • Priority issues for FY’07

  3. NVPO Unmet Needs Program • Provides support for high priority vaccine and immunization projects • Based on National Vaccine Plan (1994) & 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. NVPO Unmet Needs Program: Proposal Evaluation Process • Agency review and ranking • Preliminary review • Proposal scored by 2 agency, 2 NVAC, and 1 NVPO reviewer • Technical review panel meeting • Agency, NVAC, NVPO representatives • Discuss proposals in rank order from preliminary review • All participants score all proposals

  6. NVPO Unmet Needs Program: Proposal Evaluation Criteria • Evaluation criteria • Agency priority (5 pts) • Interagency collaboration (5 pts) • Importance (25 pts) • Methods (30 pts) • Feasibility (20 pts) • Personnel (10 pts) • Budget <$180,000 (2.5 pts) • Addressing an NVPO priority is considered in scoring “importance”

  7. 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

  8. Unmet Needs Program Priority Categories, 2004-06

  9. NVPO/NVAC Priorities & Unmet Needs Funding Priorities

  10. “You Can Lead a Horse to Water”: Priority Categories Addressed by Unmet Needs Proposals, FY’06 More than one category may apply

  11. New Unmet Needs Proposals Funded in FY’05 and FY’06 Year N FY05 22 FY06 14

  12. FY’06 Funded Projects: New and Future Vaccines • New Vaccines • MCV4 effectiveness in adolescents • Rotavirus VE and impact on serotype distribution • Baseline HPV incidence and prevalence using VSD data • Future vaccines • Vaccines against enteric diseases (meeting) • Second generation Shigella soneii vaccine development • Effect of S. pneumoniae serotype replacement on formulation of next generation vaccines • Genotype specific in vitro assays for hepatitis C

  13. FY’06 Funded Projects: Other Priorities • Pandemic influenza • Development of methods for rapid production of strain-specific reagents • Improving reliability of reverse genetic methods • Pre-clinical development of cross-protective vaccine • Other (safety & adolescent vaccination) • Development of biomarkers of neurotoxicity in new vac. • Development of rapid methods to assess adjuvant effectiveness and safety • Assessing vaccination status of 13 year old adolescents

  14. Future Vaccine Proposals Funded in FY05 • Epidemiological studies • Burden of severe pertussis infection • Cross-reactivity of emerging lyssaviruses (rabies) • CMV disease burden surveillance • Vaccine development • Influenza vaccine – DNA prime, adenoviral boost • Evaluation of Sabin IPV vaccines • Novel PE antigens of mycobacteria • Vaccine evaluation • New assay for antibody response to HPV vaccine

  15. NVAC and CMV Unmet Needs Project • Vaccine development to prevent CMV disease: Report from NVAC (Arvin et al, CID 2004) • Recommend expanded epidemiological surveillance including population-based data • 2005 Unmet Needs project: Development of new assay and baseline congenital CMV surveillance • Yr 1: development of PCR assay using dried blood spots • Yr 2: population-based study in CA evaluating rates of congenital CMV by racial/ethnic group • Cost :~$140,000 per year

  16. NVAC and Polio and Rabies Unmet Needs Projects • Polio • NVAC working groups: lab containment (report 1/04); polio vaccine stockpile (report 2/04) • NVAC presentations: lab containment (2/04); outbreak of vaccine derived poliovirus infection (2/06) • Unmet needs project FY’05: Preclinical evaluation of efficacy of improved IPV vaccine • Rabies • NVAC presentation: emerging lyssaviruses (2/05) • Unmet needs project FY’05: Surveillance for emerging lyssaviruses and cross-reactivity of vaccine and RIGs

  17. How can the Unmet Needs program be improved to better meet the needs of NVPO and NVAC?

  18. Potential Modifications to the Unmet Needs Program

  19. Discussion Questions • How can the Unmet Needs program be improved to better address the needs of NVPO and NVAC? • Priorities? • Type of solicitation? • Type of projects submitted? • Type of projects funded? • Evaluation process?

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