Planning for the 2005-Planning for the 2005-2006 Influenza Season:2006 Influenza Season:Will it be Rain, Shine, or Will it be Rain, Shine, or

Hurricane?Hurricane?

Planning for the 2005-Planning for the 2005-2006 Influenza Season:2006 Influenza Season:Will it be Rain, Shine, or Will it be Rain, Shine, or

Hurricane?Hurricane?National Vaccine Advisory Committee

June 7, 2005Washington, DC

Raymond A. Strikas, MDRaymond A. Strikas, MDImmunization Services DivisionImmunization Services Division

National Immunization ProgramNational Immunization Program

Key Lessons from 2004Key Lessons from 2004 Plan with partnersPlan with partners

Implement public sector direction of allocation/distribution with Implement public sector direction of allocation/distribution with partnerspartners

Offer flexibility to local areas in recommendations’ implementationOffer flexibility to local areas in recommendations’ implementation

Provide real-time information (e.g., BRFSS)Provide real-time information (e.g., BRFSS)

Plan for contingencies – multiple scenariosPlan for contingencies – multiple scenarios

Using IND vaccine routinely problematicUsing IND vaccine routinely problematic

Extending vaccination season difficultExtending vaccination season difficult

Improve vaccine manufacturing capacityImprove vaccine manufacturing capacity

Planning StrategyPlanning Strategy

Supply-based scenariosSupply-based scenarios

MonitoringMonitoring

Insurance policiesInsurance policies

CommunicationsCommunications

Three ScenariosThree ScenariosThree ScenariosThree Scenarios

BaseBase

BestBest

WorstWorst

Base Case Scenario: RainBase Case Scenario: Rain

Base Case Scenario: Base Case Scenario: 63M Doses63M Doses

TIVTIV– sanofi pasteur onlysanofi pasteur only– 60 M doses60 M doses

50M by end of November50M by end of November 10M by end of year10M by end of year

LAIVLAIV– MedImmuneMedImmune– 3 M doses3 M doses

Depends on vaccine virus growth Depends on vaccine virus growth characteristicscharacteristics

Best Case Scenario: ShineBest Case Scenario: Shine

Best Case Scenario: Best Case Scenario: >> 63M Doses>> 63M Doses

TIVTIV

– sanofi pasteursanofi pasteur 50 to 60 M doses50 to 60 M doses

– Chiron in U.S. market: 25M-30M dosesChiron in U.S. market: 25M-30M doses

– GSK licensed: 10 M dosesGSK licensed: 10 M doses

LAIV: 3 M dosesLAIV: 3 M doses

Worst Case Scenario: Worst Case Scenario: HurricaneHurricane

Worst Case Scenario: Worst Case Scenario: << 63M Doses<< 63M Doses

Sanofi pasteur production failureSanofi pasteur production failure

No other TIV manufacturer in the U.S. No other TIV manufacturer in the U.S. marketmarket

Result – substantially fewer TIV doses Result – substantially fewer TIV doses than last seasonthan last season

Planning ActivitiesPlanning Activities

2005-06 Influenza Season 2005-06 Influenza Season Planning GroupPlanning Group

Scope – next season; non-pandemicScope – next season; non-pandemic

ChargeCharge– Identify priority activities Identify priority activities – Determine who will lead / produce the activityDetermine who will lead / produce the activity– Develop time lineDevelop time line– Monitor completionMonitor completion

Comprehensive and strategic representationComprehensive and strategic representation

Primary planning group for CDC, in Primary planning group for CDC, in collaboration with NVPO, FDA, ASTHO, collaboration with NVPO, FDA, ASTHO, NACCHO, AIMNACCHO, AIM

Supply Projection MonitoringSupply Projection Monitoring

Adjusts scenario likelihoods Adjusts scenario likelihoods

NVPO, FDA, and CDC activityNVPO, FDA, and CDC activity

Process: calls to manufacturersProcess: calls to manufacturers– Production milestones Production milestones

– Regulatory milestonesRegulatory milestones

Prioritization Recommendation Prioritization Recommendation DevelopmentDevelopment

Last season, priorities developed in an Last season, priorities developed in an emergency ACIP sessionemergency ACIP session

ACIP Influenza Working Group met in ACIP Influenza Working Group met in January to sub-prioritize for next seasonJanuary to sub-prioritize for next season– Four work groupsFour work groups

Disease impact (Kathy Neuzil Lead)Disease impact (Kathy Neuzil Lead) Disease reduction from vaccination (Kristin Nichol Lead)Disease reduction from vaccination (Kristin Nichol Lead) Herd Immunity (Arnold Monto Lead)Herd Immunity (Arnold Monto Lead) Economic aspects (Lisa Prosser Lead)Economic aspects (Lisa Prosser Lead)

ACIP approved the sub-prioritization ACIP approved the sub-prioritization recommendations in Februaryrecommendations in February

Proposed ACIP Priority Groups for Influenza Proposed ACIP Priority Groups for Influenza Vaccination, 2005-06Vaccination, 2005-06

1a: <20 million persons1a: <20 million persons

>65 years with medical >65 years with medical conditionsconditions

Nursing home residentsNursing home residents

1b: ~70 million persons1b: ~70 million persons

Persons 2-64 years with Persons 2-64 years with high risk conditionshigh risk conditionsPregnant womenPregnant womenPersons without high risk Persons without high risk conditions conditions >>65 years65 yearsChildren 6-23 months oldChildren 6-23 months old

1c: ~12 million persons1c: ~12 million persons

Health care workersHealth care workers

Close contacts to Close contacts to children <6 months of agechildren <6 months of age

2:  ~98 million persons2:  ~98 million personsContacts of all other high risk personsContacts of all other high risk persons

Healthy persons 50-64 yearsHealthy persons 50-64 years

3: ~96 million persons3: ~96 million persons

Healthy persons 2-49 years of age (everybody else)Healthy persons 2-49 years of age (everybody else)

ConceptsConcepts

No use of tiering when supply is adequateNo use of tiering when supply is adequate

However, proposed tiering to be published if However, proposed tiering to be published if necessarynecessary

Three tiers based on U.S. rates of influenza-Three tiers based on U.S. rates of influenza-associated mortality & hospitalizationassociated mortality & hospitalization

During influenza vaccine shortagesDuring influenza vaccine shortages

– Will recommend tiered vaccination approachWill recommend tiered vaccination approach

– Tier 1 should be vaccinated preferentially, Tier 1 should be vaccinated preferentially, followed by Tier 2, and then Tier 3. followed by Tier 2, and then Tier 3.

ConceptsConcepts

If local vaccine supply is extremely limited,If local vaccine supply is extremely limited,

– vaccinate Tier 1A before all other groups. vaccinate Tier 1A before all other groups.

Otherwise, Tiers 1A, 1B, & 1C Otherwise, Tiers 1A, 1B, & 1C

– Considered equivalentConsidered equivalent

– Should vaccinate simultaneously. Should vaccinate simultaneously.

Encourage LAIV for eligible persons in Tier 1C, Encourage LAIV for eligible persons in Tier 1C, Tier 2, & Tier 3 Tier 2, & Tier 3

Local application of tiering based on local supplyLocal application of tiering based on local supply

Pre-Booking and Pre-Booking and DistributionDistribution

Two-Tiered TIV Pre-BookingTwo-Tiered TIV Pre-Booking

Proposed by sanofi pasteurProposed by sanofi pasteur

Request # doses for targeted groups Request # doses for targeted groups and total # of doses to purchase and total # of doses to purchase

Allows public health considerations Allows public health considerations into vaccine salesinto vaccine sales

Vaccine DistributionVaccine Distribution

Predominant strategy has been partial Predominant strategy has been partial orders to all customersorders to all customers– Advantage: more vaccination earlyAdvantage: more vaccination early– Was important last seasonWas important last season

Two-tiered pre-booking allows public Two-tiered pre-booking allows public health targeting into initial distributionhealth targeting into initial distribution– Initial distribution to targeted populationsInitial distribution to targeted populations– May smooth distribution and allow May smooth distribution and allow

targeted individuals first access to vaccinetargeted individuals first access to vaccine

IND Vaccine in Routine IND Vaccine in Routine ProgramProgram

ChallengesChallenges– IND not optimized for routine useIND not optimized for routine use

– Need to use IRBNeed to use IRB

– Co-PI Co-PI

– Insurance carriers experience limitedInsurance carriers experience limited

A need for routine IND vaccine use A need for routine IND vaccine use argues for different mechanisms to use argues for different mechanisms to use imported (unlicensed) vaccineimported (unlicensed) vaccine

Two Vaccine Insurance PoliciesTwo Vaccine Insurance Policies

Vaccine stockpileVaccine stockpile– Purpose: late season demand in excess of Purpose: late season demand in excess of

vaccine supplyvaccine supply– For all three scenariosFor all three scenarios– Supported by VFC programSupported by VFC program

Monovalent bulk production solicitationMonovalent bulk production solicitation– Purchases maximum number of doses for given Purchases maximum number of doses for given

amount of fundingamount of funding– For use in worst case scenarioFor use in worst case scenario– Takes time to combine and packageTakes time to combine and package– Could be licensed or unlicensedCould be licensed or unlicensed

Live Attenuated Influenza Live Attenuated Influenza VaccineVaccine

Useful in all three scenariosUseful in all three scenarios

Each LAIV dose spares a TIV doseEach LAIV dose spares a TIV dose

Even in subprioritization situation, LAIV Even in subprioritization situation, LAIV has many useshas many uses– Health care workersHealth care workers– MilitaryMilitary– Household contactsHousehold contacts

Planning DecisionsPlanning Decisions

Supply-Based Scenarios Supply-Based Scenarios 2005-062005-06

ScenarioScenario Total Total dosesdoses

LikelihoodLikelihood ActionsActions

BaseBase ~63 M~63 M ModerateModerate Tough it out—no INDTough it out—no INDDual pre-bookDual pre-bookDual distributionDual distributionPrioritize vaccinePrioritize vaccine

BestBest >> 63 M>> 63 M Most likelyMost likely Promote vaccine usePromote vaccine use

WorstWorst << 63 M<< 63 M UnlikelyUnlikely Prioritize vaccinePrioritize vaccineActivate insurance Activate insurance policypolicyConsider IND vaccineConsider IND vaccine

2005-06 Season Concerns2005-06 Season Concerns

Will demand suffer setback from this Will demand suffer setback from this past season?past season?

Will private providers retain interest in Will private providers retain interest in vaccinating?vaccinating?

Will we be able to communicate the Will we be able to communicate the complex messages required for complex messages required for scenario-based planning?scenario-based planning?

Longer Term ConsiderationsLonger Term Considerations

Increasing vaccine demand, group by group, Increasing vaccine demand, group by group, with an enhanced public health workforcewith an enhanced public health workforce

Developing science basis for broader Developing science basis for broader recommendations (e.g., cost effectiveness)recommendations (e.g., cost effectiveness)

Stabilizing and diversifying vaccine supplyStabilizing and diversifying vaccine supply

Selective use of tiering strategiesSelective use of tiering strategies

Pandemic preparednessPandemic preparedness