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8. How would you compare these strategies in terms of effectiveness, cost, and practicality to a likely vaccine?

9. What are the known components of immunity for this organism (antibody to what antigens, T-cells, B-cells, etc.)?

10. What are the critical determinants of an immune response associated with protection against infection?

11. What are the correlates of immunity (e.g., surrogates for protection) that may be useful or necessary for vaccine development?

12. To your knowledge, is vaccine development for this disease occurring now? If so, describe the type of vaccine (what antigen, live or killed, subunit, naked DNA, etc.).

13. Who (individual, group, company) is working on this vaccine?

14. How far has vaccine development progressed (preclinical, clinical trials: Phase I, II, or III)?

15. When could Phase III trials be expected to start for such a vaccine?

16. When could such a vaccine be expected to be licensed for use?

17. If a vaccine is not in development, what new knowledge is necessary to undertake vaccine development?

18. Who should develop it (e.g., industry, government, military)?

19. What are the barriers to success in developing a vaccine (money for research, scientific knowledge, correlates of immunity, lack of animal model, public perceptions, etc.)?

20. Please estimate future R&D funding (public and private) needed to achieve licensure of a vaccine and postmarketing costs.

21. Is this vaccine likely to be part of a combination vaccine (with other antigens)?

22. For an anticipated vaccine, please estimate its likely efficacy, likely cost per dose, and number of doses needed for complete immunization (initial series, frequency of boosters).



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