1. Planning for the 2005-2006 Influenza Season National Vaccine Advisory Committee February 8, 2005 Washington, DC Lance E. Rodewald, MD Director, Immunization Services Division National Immunization Program, CDC

2. Topics  Lessons to apply  Steps being taken  Questions for discussion

3. Key Lessons from Previous Seasons  Maximize available information  Plan for multiple contingencies  Plan around limitations – Recommendations – Delivery system  Plan with stakeholders

4. 2005-06 Influenza Season Planning Group  Scope – next season; non-pandemic  Charge – Identify priority activities for CDC – Determine who will lead / produce the activity – Develop time line – Monitor completion  Comprehensive and strategic representation  Primary planning group for CDC

5. Scenarios as Basis of Plans  Variables – Number of manufacturers – Vaccine type – Production projections – Licensure status  Scenario output – Timing, number, type of doses available – Rough probability of occurrence

6. Production Projection Monitoring  Critically important activity  NVPO to lead monitoring with FDA and CDC  Sequential milestones drive projections and allow more efficient planning  Information must be actionable

7. Prioritization Recommendations for Influenza Vaccine  Last season, priorities developed in an emergency ACIP session  Priorities were important and effective, but imperfect  Flexibility for local circumstances turned out to be crucial  Widespread desire to create prioritizations ahead of time

8. Prioritization Considerations and Process  ACIP considering evidence for groups – Hospitalization rate – Mortality rate – Group size – Usual coverage achieved – Vaccine effectiveness  Studying multi-tiered approach  Emphasizing role for LAIV  Presentation for ACIP vote this week  Weighing publication options

9. Vaccine Pre-Booking  Non-binding orders  Helps manufacturers determine their market size  Influences vaccine contracts, such as CDC’s contract  Has had problems with double booking in the past

10. Vaccine Distribution Policies  Predominant strategy is partial orders to all customers – Advantage: more vaccination early – Was important last season  Timing and prioritization important  Manufacturers and distributors have their own policies  Tracking of distribution – role of information

11. Planning for IND Vaccine in Routine Program  Challenges – IND not optimized for routine use – Need to use IRB – Need for Co-PIs to expand access – Insurance carriers experience limited – Public and provider acceptance unknown  Planning strengths – Example INDs to modify – Identification of many set-up problems

12. Contracting for Vaccine  Estimations of need  Public / private balance of purchase  Stockpiling strategy

13. Monitor Antigen-Sparing Studies  Several under study / review  Some can impact the coming season  Important to develop new knowledge needed for future years

14. Other Activities  Communications  Antiviral medication  Infection control  Evaluation  Monitoring legislative endeavors

15. What Could Better Planning Improve?  Contracting  Pre-book and distribution  IND vaccine use  Recommendations  Communication

16. Questions for Consideration (1)  What influenza vaccine environmental changes would more effectively promote vaccine use?  What strategies should be used to ensure a safety net for influenza vaccine supply?  How can IND vaccine be used most effectively?

17. Questions for Consideration (2)  What are the optimal roles for local / state / federal public health, and how can they be seamlessly integrated?  How can we enhance public health’s responsiveness to crises?

18. Extra slides

19. Long-Term Considerations  Solidifying vaccine financing  Increasing number of mfgs  Supporting effective public health immunization workforce  Pandemic influenza