1. 1 Prioritization of Vaccine Targets for Development CDR Angela Shen National Vaccine Program Office June 2, 2010 NVAC

2. 2 Presentation Outline Background National Vaccine Plan Priorities Steering Committee Discussion

3. 3 Background-1985 effort 1 IOM report contracted by NIAID Divided into two volumes, domestic and global priorities Used a cost effectiveness and decision analysis approach to create a prioritization list of vaccines targeted for development

4. 4 1985 Ranking of Vaccine Priorities

5. 5 Background- 1999 effort 2 Designed as a quantitative model rather than an actual ranked list Only considered vaccines of domestic importance and included therapeutic vaccines Prioritized into four levels based on cost per quality-adjusted life year saved

6. 6 Vaccine categorized 4 levels 1– saves money and QALYs (cost-effective) 2-<USD 10,000 per QALY saved 3->USD 10,000 per QALY saved 4->USD100,000 per QALY saved

7. 7 1999 Vaccine Priorities Level 1Level II CytomegalovirusChlamydia Group B streptococcusHelicobacter pylori Influenza virusHepatitis C Diabetes therapeutic vaccineHerpes simplex Multiple sclerosis- therapeuticHuman papillomavirus Rheumatoid arthritis-therapeutic Melanoma therapeutic vaccine Streptococcus pneumoniaeMycobacterium tuberculosis Neisseria gonorrhea Respiratory syncytial virus

8. 8 1999 Vaccine Priorities Level IIILevel IV Group A streptococcusBorrelia burgdorferi Group B streptococcus (low utilization) Coccidioides immitis ParainfluenzaEscherichia coli RotavirusEpstein-Barr Histoplasma capsulatum Neisseria meningitides type B Shigella

9. 9 National Vaccine Plan Provides strategic direction and a coordinated approach for preventing infectious diseases to improve the public’s health through vaccination.

10. 10 National Vaccine Plan- Goal 1 Develop new and improved vaccines  Prioritize the needs for developing new vaccines for domestic and global health priorities.  Support research to develop new vaccine candidates and improve current vaccines to prevent infectious diseases, particularly those determined to be priorities.  Support research on novel and improved vaccine delivery methods.  Increase understanding of how the host immune system influences vaccine response.  Support development of vaccine candidates and the scientific tools needed to evaluate these candidates for licensure  Strengthen the science base for the development and licensure of safe and effective vaccines

11. 11 HHS Interagency Priorities Steering Committee (PSC) Charge: To develop an evidence- based approach for prioritizing new and improved vaccine candidates by targeted diseases and to develop specifications for high priority vaccines to accelerate their development.

12. 12 PSC (cont.)  BARDA/ASPR  CDC  DoD  FDA  NIH  NVPO  USAID Comprised of representatives from federal agencies involved in vaccine research and development:

13. 13 PSC Prioritization Discussion In order to develop a prioritization framework the committee heard presentations on:  Past national prioritization efforts  BARDA’s prioritization process  DoD’s prioritization process Also held discussions with vaccine manufacturers to gain stakeholder input in the process

14. 14 Draft Scope of Work

15. 15 Draft Scope of Work (cont.) End product of Priorities Steering Committee, a contract to the Institute of Medicine to develop:  Quantitative, methodologic framework  Catalog of vaccines Separated into categories of short, medium and long term implementation Includes a comprehensive description of the vaccine and major barriers to development

16. 16 Framework for Evidence-based Vaccine Prioritization 1)Evidence-based catalog list of vaccine targets 2)BARRIERS TO DEVELOPMENT Major barriers to development ???? Epidemiology Type & breadth of market Scientific knowledge base ???? Federal Government Vaccine Companies AcademiaOthers Technical feasibility Likelihood of utilization Mortality/ morbidity ???? STAKEHOLDER INPUT OUTPUT CRITERIA SUPPORTING DATA

17. 17 Importance of Stakeholder Input Many stakeholders are involved Important to gather stakeholder input in evaluating a process for prioritizing the needs for new vaccines NVAC represents many of these stakeholders

18. 18 Questions to NVAC How should vaccine targets be categorized?  Domestic/global  Pediatric, adolescent, adult (across lifespan)  Countermeasure  Maternal  ??? What criteria should inform input?  Epidemiology  Type of Market  ???

19. 19 Discussion

20. 20 References 1.IOM. New vaccine development: Establishing priorities. 1985. http://www.nap.edu/openbook.php?book search=1&term=new%20vaccine%20de velopment&record_id=920. http://www.nap.edu/openbook.php?book search=1&term=new%20vaccine%20de velopment&record_id=920 2.IOM. Vaccines for the 21 st century. 1999. http://www.nap.edu/openbook.php?reco rd_id=5501&page=1. http://www.nap.edu/openbook.php?reco rd_id=5501&page=1