1. Planning for the 2005-2006 Influenza Season: Will it be Rain, Shine, or Hurricane? National Vaccine Advisory Committee June 7, 2005 Washington, DC Raymond A. Strikas, MD Immunization Services Division National Immunization Program

2. Key Lessons from 2004  Plan with partners  Implement public sector direction of allocation/distribution with partners  Offer flexibility to local areas in recommendations’ implementation  Provide real-time information (e.g., BRFSS)  Plan for contingencies – multiple scenarios  Using IND vaccine routinely problematic  Extending vaccination season difficult  Improve vaccine manufacturing capacity

3. Planning Strategy  Supply-based scenarios  Monitoring  Insurance policies  Communications

4. Three Scenarios BaseBestWorst

5. Base Case Scenario: Rain

6. Base Case Scenario: 63M Doses  TIV – sanofi pasteur only – 60 M doses  50M by end of November  10M by end of year  LAIV – MedImmune – 3 M doses  Depends on vaccine virus growth characteristics

7. Best Case Scenario: Shine

8. Best Case Scenario: >> 63M Doses  TIV – sanofi pasteur  50 to 60 M doses – Chiron in U.S. market: 25M-30M doses – GSK licensed: 10 M doses  LAIV: 3 M doses

9. Worst Case Scenario: Hurricane

10. Worst Case Scenario: << 63M Doses  Sanofi pasteur production failure  No other TIV manufacturer in the U.S. market  Result – substantially fewer TIV doses than last season

11. Planning Activities

12. 2005-06 Influenza Season Planning Group  Scope – next season; non-pandemic  Charge – Identify priority activities – Determine who will lead / produce the activity – Develop time line – Monitor completion  Comprehensive and strategic representation  Primary planning group for CDC, in collaboration with NVPO, FDA, ASTHO, NACCHO, AIM

13. Supply Projection Monitoring  Adjusts scenario likelihoods  NVPO, FDA, and CDC activity  Process: calls to manufacturers – Production milestones – Regulatory milestones

14. Prioritization Recommendation Development  Last season, priorities developed in an emergency ACIP session  ACIP Influenza Working Group met in January to sub-prioritize for next season – Four work groups  Disease impact (Kathy Neuzil Lead)  Disease reduction from vaccination (Kristin Nichol Lead)  Herd Immunity (Arnold Monto Lead)  Economic aspects (Lisa Prosser Lead)  ACIP approved the sub-prioritization recommendations in February

15. Proposed ACIP Priority Groups for Influenza Vaccination, 2005-06 1a: <20 million persons  >65 years with medical conditions  Nursing home residents 1b: ~70 million persons  Persons 2-64 years with high risk conditions  Pregnant women  Persons without high risk conditions >65 years  Children 6-23 months old 1c: ~12 million persons  Health care workers  Close contacts to children <6 months of age 2: ~98 million persons  Contacts of all other high risk persons  Healthy persons 50-64 years 3: ~96 million persons  Healthy persons 2-49 years of age (everybody else)

16. Concepts  No use of tiering when supply is adequate  However, proposed tiering to be published if necessary  Three tiers based on U.S. rates of influenza- associated mortality & hospitalization  During influenza vaccine shortages – Will recommend tiered vaccination approach – Tier 1 should be vaccinated preferentially, followed by Tier 2, and then Tier 3.

17. Concepts  If local vaccine supply is extremely limited, – vaccinate Tier 1A before all other groups.  Otherwise, Tiers 1A, 1B, & 1C – Considered equivalent – Should vaccinate simultaneously.  Encourage LAIV for eligible persons in Tier 1C, Tier 2, & Tier 3  Local application of tiering based on local supply

18. Pre-Booking and Distribution

19. Two-Tiered TIV Pre-Booking  Proposed by sanofi pasteur  Request # doses for targeted groups and total # of doses to purchase  Allows public health considerations into vaccine sales

20. Vaccine Distribution  Predominant strategy has been partial orders to all customers – Advantage: more vaccination early – Was important last season  Two-tiered pre-booking allows public health targeting into initial distribution – Initial distribution to targeted populations – May smooth distribution and allow targeted individuals first access to vaccine

21. IND Vaccine in Routine Program  Challenges – IND not optimized for routine use – Need to use IRB – Co-PI – Insurance carriers experience limited  A need for routine IND vaccine use argues for different mechanisms to use imported (unlicensed) vaccine

22. Two Vaccine Insurance Policies  Vaccine stockpile – Purpose: late season demand in excess of vaccine supply – For all three scenarios – Supported by VFC program  Monovalent bulk production solicitation – Purchases maximum number of doses for given amount of funding – For use in worst case scenario – Takes time to combine and package – Could be licensed or unlicensed

23. Live Attenuated Influenza Vaccine  Useful in all three scenarios  Each LAIV dose spares a TIV dose  Even in subprioritization situation, LAIV has many uses – Health care workers – Military – Household contacts

24. Planning Decisions

25. Supply-Based Scenarios 2005-06 Scenario Total doses LikelihoodActions Base ~63 M Moderate  Tough it out—no IND  Dual pre-book  Dual distribution  Prioritize vaccine Best >> 63 M Most likely  Promote vaccine use Worst << 63 M Unlikely  Prioritize vaccine  Activate insurance policy  Consider IND vaccine

26. 2005-06 Season Concerns  Will demand suffer setback from this past season?  Will private providers retain interest in vaccinating?  Will we be able to communicate the complex messages required for scenario-based planning?

27. Longer Term Considerations  Increasing vaccine demand, group by group, with an enhanced public health workforce  Developing science basis for broader recommendations (e.g., cost effectiveness)  Stabilizing and diversifying vaccine supply  Selective use of tiering strategies  Pandemic preparedness