Planning for the 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

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

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

Three Scenarios BaseBestWorst

Base Case Scenario: Rain

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

Best Case Scenario: Shine

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

Worst Case Scenario: Hurricane

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

Planning Activities

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

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

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

Proposed ACIP Priority Groups for Influenza Vaccination, a: <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 years 3: ~96 million persons  Healthy persons 2-49 years of age (everybody else)

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.

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

Pre-Booking and Distribution

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

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

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

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

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

Planning Decisions

Supply-Based Scenarios 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

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?

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