Preview of the 2004-2005 Influenza Preview of the 2004-2005 Influenza Season:Season:

Programmatic Challenges and Programmatic Challenges and OpportunitiesOpportunities

Preview of the 2004-2005 Influenza Preview of the 2004-2005 Influenza Season:Season:

Programmatic Challenges and Programmatic Challenges and OpportunitiesOpportunities

Jeanne M. Santoli, MD, MPHJeanne M. Santoli, MD, MPH

National Immunization ProgramNational Immunization Program

OverviewOverview

TimelineTimeline

ChallengesChallenges– New recommendationNew recommendation– Vaccine supplyVaccine supply

OpportunitiesOpportunities– Potential “spillover” benefits of expanded Potential “spillover” benefits of expanded

pediatric influenza immunizationpediatric influenza immunization

Next stepsNext steps

2004-05 Timeline2004-05 Timeline

December 2003:December 2003: “Pre-booking” for influenza “Pre-booking” for influenza vaccine vaccine began (non-CDC orders)began (non-CDC orders)

March-May 2004:March-May 2004: Federal influenza vaccine Federal influenza vaccine contracts contracts negotiatednegotiated

May 2004:May 2004: Federal immunization grantees Federal immunization grantees began placing vaccine began placing vaccine

ordersorders

August 2004:August 2004: ACIP to make assessment of need ACIP to make assessment of need for tiered vaccinationfor tiered vaccination

September 2004:September 2004: Vaccine delivery and vaccination Vaccine delivery and vaccination typically begin. typically begin.

March 2005:March 2005: Vaccination season endsVaccination season ends

Primary Changes/Updates to Primary Changes/Updates to Influenza RecommendationsInfluenza Recommendations

1.1. Annual vaccination of healthy 6-23 mo children and close Annual vaccination of healthy 6-23 mo children and close contacts of those aged 0-23 mo. contacts of those aged 0-23 mo.

2.2. Inactivated vaccine preferred over LAIV for close contacts Inactivated vaccine preferred over LAIV for close contacts (includes HCWs) of severely immunosuppresssed persons (includes HCWs) of severely immunosuppresssed persons in the 7 days following vaccination.in the 7 days following vaccination.

3.3. Severely immunosuppressed persons should not administer Severely immunosuppressed persons should not administer LAIV.LAIV.

4.4. 2004-05 trivalent vaccine strains: 2004-05 trivalent vaccine strains: A/Fujian/411/2002 (H3N2)-like, A/Fujian/411/2002 (H3N2)-like, A/New Caledonia/20/99 (H1N1)-like, A/New Caledonia/20/99 (H1N1)-like, B/Shanghai/361/2002-likeB/Shanghai/361/2002-like

5.5. CDC and other agencies will assess vaccine supply during CDC and other agencies will assess vaccine supply during the manufacturing period and make recommendations in the the manufacturing period and make recommendations in the summer about the need for tiered vaccination. summer about the need for tiered vaccination.

Source: CDC. Prevention and Control of Influenza. MMWR 2004; 53:1-40.

Pediatric Influenza Vaccination—Pediatric Influenza Vaccination—What is the Baseline?What is the Baseline?

9-10% --9-10% -- children 1-6 years with asthma in 4 large children 1-6 years with asthma in 4 large HMOs during 1995-1996; 61% of unvaccinated HMOs during 1995-1996; 61% of unvaccinated children had a missed opportunity--visit between 9/1 children had a missed opportunity--visit between 9/1 and 12/31/95 and 12/31/95 (Kramarz, 2000)(Kramarz, 2000)

7-9% --7-9% -- children 2-16 years with asthma who were children 2-16 years with asthma who were enrollees in NY CHIP plan enrollees in NY CHIP plan (Szilagyi, 2000)(Szilagyi, 2000)

31% --31% -- hospitalized children 6mo-18 years with high hospitalized children 6mo-18 years with high risk conditions risk conditions (Poehling, 2001)(Poehling, 2001)

25% -- 25% -- children with mod-severe asthma in an children with mod-severe asthma in an allergy/immunology clinic allergy/immunology clinic (Chung, 1998)(Chung, 1998)

80% --80% -- children 6mo-18 years with cystic fibrosis children 6mo-18 years with cystic fibrosis (CF) at a CF center in Utah during 1997-98 (CF) at a CF center in Utah during 1997-98 (Marshall, 2002)(Marshall, 2002)

No national data existNo national data exist

Feasibility Studies: Feasibility Studies: How Long Does it Take to Vaccinate?How Long Does it Take to Vaccinate?

Szilagyi, et al 2003Szilagyi, et al 2003 Time and motion study of 92 Time and motion study of 92 influenza vaccinations during vaccine-only visits in 7 influenza vaccinations during vaccine-only visits in 7 primary care practices in Rochester, NY during 2000-primary care practices in Rochester, NY during 2000-01 influenza season01 influenza season– Key findingsKey findings

Influenza vaccination and total visit times had median values of Influenza vaccination and total visit times had median values of 2 minutes and 14 minutes, respectively2 minutes and 14 minutes, respectively

80% patient time spent waiting (exam room + waiting areas)80% patient time spent waiting (exam room + waiting areas) Vaccinating 100 children would require 13 hours (4 half-day Vaccinating 100 children would require 13 hours (4 half-day

sessions), 12 hours of additional staff nurse time, and 10 sessions), 12 hours of additional staff nurse time, and 10 minutes of physician/nurse practitioner exam timeminutes of physician/nurse practitioner exam time

– RecommendationsRecommendations Consideration of influenza vaccination Consideration of influenza vaccination sessions, extended hourssessions, extended hours

Feasibility Studies: Feasibility Studies: Visits NeededVisits Needed

Szilagyi, et al 2003Szilagyi, et al 2003 Analysis of insurance Analysis of insurance claims from 3 influenza seasons (1998-2001) claims from 3 influenza seasons (1998-2001) by 6-23 month olds in 5 managed care plans by 6-23 month olds in 5 managed care plans (commercial and Medicaid) in upstate NY(commercial and Medicaid) in upstate NY– Assumption: vaccination during Oct-DecAssumption: vaccination during Oct-Dec– Key findingsKey findings

74% of children need 1 or more additional visit(s) if only 74% of children need 1 or more additional visit(s) if only well visits usedwell visits used

46% of children need 1 or more additional visit(s) if all 46% of children need 1 or more additional visit(s) if all visits are usedvisits are used

Longer vaccination seasons resulted in less children Longer vaccination seasons resulted in less children needing additional visitsneeding additional visits

– Recommendations Recommendations Consideration of longer Consideration of longer vaccination season, use of all visits for vaccination season, use of all visits for vaccinationvaccination

Ongoing Intervention Studies, IOngoing Intervention Studies, I

Zimmerman, et al Zimmerman, et al Intervention study in 9 Intervention study in 9 inner city health centers in Allegheny inner city health centers in Allegheny County, PA. Provider education and County, PA. Provider education and technical assistance on determining eligible technical assistance on determining eligible patients and implementing interventionspatients and implementing interventions– Key findings Key findings

Influenza vaccine coverage (first dose) Influenza vaccine coverage (first dose) – Pre-intervention : 0-8%Pre-intervention : 0-8%

– Post-intervention : 15-49%Post-intervention : 15-49%

Coverage with other vaccines not adversely affectedCoverage with other vaccines not adversely affected

Ongoing Intervention Studies, IIOngoing Intervention Studies, II

Kempe, et alKempe, et al RCT trial of registry-based RCT trial of registry-based recall for influenza vaccination of healthy 6-recall for influenza vaccination of healthy 6-21 month old children in 5 private practices 21 month old children in 5 private practices in Denver during the 2003-04 influenza in Denver during the 2003-04 influenza seasonseason– Influenza vaccine coverage among intervention Influenza vaccine coverage among intervention

groups ranged from 44-75%groups ranged from 44-75% As of 12/31/03As of 12/31/03

– Intervention group: 60.4%Intervention group: 60.4%– Control group: 55.9%Control group: 55.9%– Intervention – control: 4.5% (p = 0.001)Intervention – control: 4.5% (p = 0.001)

Prior to publicity about epidemicPrior to publicity about epidemic– Intervention – control: 9.3% (p < 0.0001)Intervention – control: 9.3% (p < 0.0001)

Evaluation Questions Evaluation Questions

Nearly a dozen studies about influenza vaccination Nearly a dozen studies about influenza vaccination in children 6-23 mo are planned or underway to in children 6-23 mo are planned or underway to assess:assess:

vaccine effectiveness and impact vaccine effectiveness and impact vaccination coveragevaccination coverage location and timing of vaccination location and timing of vaccination ““prevalence” of provider recommendation to parents prevalence” of provider recommendation to parents barriers faced by providers during the 2003-04 barriers faced by providers during the 2003-04

influenza seasoninfluenza season parental reasons for declining vaccinationparental reasons for declining vaccination burden of hospital-acquired influenza infections burden of hospital-acquired influenza infections

among childrenamong children

Vaccine SupplyVaccine Supply

Estimation of demand for vaccine Estimation of demand for vaccine during 2004-05 influenza season are during 2004-05 influenza season are complicated bycomplicated by– Unknown impact of experiences during the Unknown impact of experiences during the

2003-04 influenza season2003-04 influenza season– Variation in vaccine formulation Variation in vaccine formulation

preferencespreferences ThimerosalThimerosal

Reduced yield of preservative-free Reduced yield of preservative-free vaccinevaccine

Influenza Vaccine Doses Produced for the U.S. Market, Influenza Vaccine Doses Produced for the U.S. Market, 1999-2003*1999-2003*

YearYear Doses Produced Doses Produced (millions)(millions)

Doses Distributed Doses Distributed (millions)(millions)

19991999 77.277.2 76.876.8

20002000 77.977.9 70.470.4

20012001 87.787.7 77.777.7

20022002 95.095.0 83.083.0

2003**2003** 86.986.9 83.183.1

*Data provided by vaccine manufacturers**Estimated; includes both inactivated and live vaccines

2004-05 Federal Influenza Vaccine 2004-05 Federal Influenza Vaccine ContractsContracts

ManufacturerManufacturer Product Product namename

FormulationFormulation Dose priceDose price Contract Contract maximummaximum

Aventis Aventis PasteurPasteur

FluzoneFluzone®® Preservative-Preservative-freefree

(6-35 mo)(6-35 mo)

$10/0.25 mL $10/0.25 mL dosedose

(single dose (single dose syringe)syringe)

3 million 3 million dosesdoses

Aventis Aventis PasteurPasteur

FluzoneFluzone®® Preservative-Preservative-containingcontaining

(6+ months)(6+ months)

$6.80/0.5 mL $6.80/0.5 mL dose dose

(multi-dose vial)(multi-dose vial)

3 million 3 million dosesdoses

ChironChiron FluvirinFluvirin®® Preservative-Preservative-containingcontaining

(4 + years)(4 + years)

$7.54/0.5 mL $7.54/0.5 mL dosedose

(multi-dose vial)(multi-dose vial)

750,000 750,000 dosesdoses

CDC actions CDC actions Pre-season Pre-season

– Develop estimates of grantee needDevelop estimates of grantee need– Monitor grantee ordersMonitor grantee orders– Hold orders for preservative-containing influenza Hold orders for preservative-containing influenza

vaccine with state dollarsvaccine with state dollars– Talk with manufacturers about modifying contract Talk with manufacturers about modifying contract

maximumsmaximums Develop allocation planDevelop allocation plan

During the seasonDuring the season– Work with manufacturers and distributors to track Work with manufacturers and distributors to track

supply on a weekly basissupply on a weekly basis

Influenza Vaccine StockpileInfluenza Vaccine Stockpile

VFC fundsVFC funds– $40 million dollars in the FY 2004 budget$40 million dollars in the FY 2004 budget

– $40 million dollars requested in the FY $40 million dollars requested in the FY 2005 budget2005 budget

Mix of inactivated vaccine productsMix of inactivated vaccine products Contracting process underwayContracting process underway NIP/NCID working to develop “release NIP/NCID working to develop “release

models” models”

Opportunity: Opportunity: Growing the Influenza Vaccine MarketGrowing the Influenza Vaccine Market

GroupGroup Population (millions)Population (millions)

2001-02 2002-032001-02 2002-03

Adults Adults > > 65 y65 y 35.435.4 35.635.6

Adults 50-64 y (excluding high risk Adults 50-64 y (excluding high risk persons)persons)

19.619.6 20.120.1

High risk person 6 mo-64 y High risk person 6 mo-64 y 39.239.2 39.739.7

Pregnant womenPregnant women 22 22

Healthy children aged 6-23 mHealthy children aged 6-23 m 00 5.95.9

Household contactsHousehold contacts 62.262.2 75.575.5

Health care personnel < 65 yHealth care personnel < 65 y 77 77

Total target groupsTotal target groups 165.4165.4 185.8185.8

Source: James Singleton, NIP/CDC

Opportunity: Opportunity: Changing the CultureChanging the Culture

Link with routine childhood Link with routine childhood immunizationimmunization

Potential to address misperceptions of Potential to address misperceptions of vaccine safetyvaccine safety

Increased awareness of importance of Increased awareness of importance of parental vaccination to protect young parental vaccination to protect young childrenchildren

Themes from the 2004 Influenza Themes from the 2004 Influenza Summit (Atlanta, GA)Summit (Atlanta, GA)

Develop a crisis plan, including monitoring vaccine Develop a crisis plan, including monitoring vaccine supply at levels lower than the manufacturersupply at levels lower than the manufacturer

Create year-long, coordinated approach to influenza Create year-long, coordinated approach to influenza communicationscommunications

Continue efforts to improve influenza vaccine uptake Continue efforts to improve influenza vaccine uptake for current risk groups and extend vaccination for current risk groups and extend vaccination season when appropriateseason when appropriate

Improve health care worker vaccination ratesImprove health care worker vaccination rates Advocate for public/private funding for influenza Advocate for public/private funding for influenza

vaccination, particularly for under/uninsured adultsvaccination, particularly for under/uninsured adults Consider a broader concept of influenza prevention Consider a broader concept of influenza prevention

as part of Summit activitiesas part of Summit activities Explore universal vaccinationExplore universal vaccination

AcknowledgementsAcknowledgements

Carolyn BridgesCarolyn Bridges Rex EllingtonRex Ellington Marika IwaneMarika Iwane Dennis O’MaraDennis O’Mara Donna RickertDonna Rickert Lance RodewaldLance Rodewald Jim SingletonJim Singleton Nicole SmithNicole Smith Ray StrikasRay Strikas Anjella Vargas-RosalesAnjella Vargas-Rosales Greg WallaceGreg Wallace Rick ZimmermanRick Zimmerman