1. Preview of the 2004-2005 Influenza Season: Programmatic Challenges and Opportunities Jeanne M. Santoli, MD, MPH National Immunization Program

2. Overview  Timeline  Challenges – New recommendation – Vaccine supply  Opportunities – Potential “spillover” benefits of expanded pediatric influenza immunization  Next steps

3. 2004-05 Timeline December 2003: “Pre-booking” for influenza vaccine began (non-CDC orders) March-May 2004: Federal influenza vaccine contracts negotiated May 2004: Federal immunization grantees began placing vaccine orders August 2004:ACIP to make assessment of need for tiered vaccination September 2004:Vaccine delivery and vaccination typically begin. March 2005: Vaccination season ends

4. Primary Changes/Updates to Influenza Recommendations 1. Annual vaccination of healthy 6-23 mo children and close contacts of those aged 0-23 mo. 2. Inactivated vaccine preferred over LAIV for close contacts (includes HCWs) of severely immunosuppresssed persons in the 7 days following vaccination. 3. Severely immunosuppressed persons should not administer LAIV. 4. 2004-05 trivalent vaccine strains:  A/Fujian/411/2002 (H3N2)-like,  A/New Caledonia/20/99 (H1N1)-like,  B/Shanghai/361/2002-like 5. CDC and other agencies will assess vaccine supply during the manufacturing period and make recommendations in the summer about the need for tiered vaccination. Source: CDC. Prevention and Control of Influenza. MMWR 2004; 53:1-40.

5. Pediatric Influenza Vaccination— What is the Baseline?  9-10% -- children 1-6 years with asthma in 4 large HMOs during 1995-1996; 61% of unvaccinated children had a missed opportunity--visit between 9/1 and 12/31/95 (Kramarz, 2000)  7-9% -- children 2-16 years with asthma who were enrollees in NY CHIP plan (Szilagyi, 2000)  31% -- hospitalized children 6mo-18 years with high risk conditions (Poehling, 2001)  25% -- children with mod-severe asthma in an allergy/immunology clinic (Chung, 1998)  80% -- children 6mo-18 years with cystic fibrosis (CF) at a CF center in Utah during 1997-98 (Marshall, 2002)  No national data exist

6. Feasibility Studies: How Long Does it Take to Vaccinate? Szilagyi, et al 2003 Time and motion study of 92 influenza vaccinations during vaccine-only visits in 7 primary care practices in Rochester, NY during 2000- 01 influenza season Szilagyi, et al 2003 Time and motion study of 92 influenza vaccinations during vaccine-only visits in 7 primary care practices in Rochester, NY during 2000- 01 influenza season – Key findings  Influenza vaccination and total visit times had median values of 2 minutes and 14 minutes, respectively  80% patient time spent waiting (exam room + waiting areas)  Vaccinating 100 children would require 13 hours (4 half-day sessions), 12 hours of additional staff nurse time, and 10 minutes of physician/nurse practitioner exam time – Recommendations Consideration of influenza vaccination sessions, extended hours

7. Feasibility Studies: Visits Needed Szilagyi, et al 2003 Analysis of insurance claims from 3 influenza seasons (1998-2001) by 6-23 month olds in 5 managed care plans (commercial and Medicaid) in upstate NY – Assumption: vaccination during Oct-Dec – Key findings  74% of children need 1 or more additional visit(s) if only well visits used  46% of children need 1 or more additional visit(s) if all visits are used  Longer vaccination seasons resulted in less children needing additional visits – Recommendations Consideration of longer vaccination season, use of all visits for vaccination

8. Ongoing Intervention Studies, I  Zimmerman, et al Intervention study in 9 inner city health centers in Allegheny County, PA. Provider education and technical assistance on determining eligible patients and implementing interventions – Key findings  Influenza vaccine coverage (first dose) – Pre-intervention : 0-8% – Post-intervention : 15-49%  Coverage with other vaccines not adversely affected

9. Ongoing Intervention Studies, II  Kempe, et al RCT trial of registry-based recall for influenza vaccination of healthy 6- 21 month old children in 5 private practices in Denver during the 2003-04 influenza season – Influenza vaccine coverage among intervention groups ranged from 44-75%  As of 12/31/03 – Intervention group: 60.4% – Control group: 55.9% – Intervention – control: 4.5% (p = 0.001)  Prior to publicity about epidemic – Intervention – control: 9.3% (p < 0.0001)

10. Evaluation Questions Nearly a dozen studies about influenza vaccination in children 6-23 mo are planned or underway to assess:  vaccine effectiveness and impact  vaccination coverage  location and timing of vaccination  “prevalence” of provider recommendation to parents  barriers faced by providers during the 2003-04 influenza season  parental reasons for declining vaccination  burden of hospital-acquired influenza infections among children

11. Vaccine Supply  Estimation of demand for vaccine during 2004-05 influenza season are complicated by – Unknown impact of experiences during the 2003-04 influenza season – Variation in vaccine formulation preferences  Thimerosal  Reduced yield of preservative-free vaccine

12. Influenza Vaccine Doses Produced for the U.S. Market, 1999-2003* Year Doses Produced (millions) Doses Distributed (millions) 199977.276.8 200077.970.4 200187.777.7 200295.083.0 2003**86.983.1 *Data provided by vaccine manufacturers **Estimated; includes both inactivated and live vaccines

13. 2004-05 Federal Influenza Vaccine Contracts Manufacturer Product name Formulation Dose price Contract maximum Aventis Pasteur Fluzone® Preservative- free (6-35 mo) $10/0.25 mL dose (single dose syringe) 3 million doses Aventis Pasteur Fluzone® Preservative- containing (6+ months) $6.80/0.5 mL dose (multi-dose vial) 3 million doses Chiron Fluvirin® Preservative- containing (4 + years) $7.54/0.5 mL dose (multi-dose vial) 750,000 doses

14. CDC actions  Pre-season – Develop estimates of grantee need – Monitor grantee orders – Hold orders for preservative-containing influenza vaccine with state dollars – Talk with manufacturers about modifying contract maximums  Develop allocation plan  During the season – Work with manufacturers and distributors to track supply on a weekly basis

15. Influenza Vaccine Stockpile  VFC funds – $40 million dollars in the FY 2004 budget – $40 million dollars requested in the FY 2005 budget  Mix of inactivated vaccine products  Contracting process underway  NIP/NCID working to develop “release models”

16. Opportunity: Growing the Influenza Vaccine Market Group Population (millions) 2001-02 2002-03 2001-02 2002-03 Adults > 65 y 35.435.6 Adults 50-64 y (excluding high risk persons) 19.620.1 High risk person 6 mo-64 y 39.239.7 Pregnant women 22 Healthy children aged 6-23 m 05.9 Household contacts 62.275.5 Health care personnel < 65 y 77 Total target groups 165.4185.8 Source: James Singleton, NIP/CDC

17. Opportunity: Changing the Culture  Link with routine childhood immunization  Potential to address misperceptions of vaccine safety  Increased awareness of importance of parental vaccination to protect young children

18. Themes from the 2004 Influenza Summit (Atlanta, GA)  Develop a crisis plan, including monitoring vaccine supply at levels lower than the manufacturer  Create year-long, coordinated approach to influenza communications  Continue efforts to improve influenza vaccine uptake for current risk groups and extend vaccination season when appropriate  Improve health care worker vaccination rates  Advocate for public/private funding for influenza vaccination, particularly for under/uninsured adults  Consider a broader concept of influenza prevention as part of Summit activities  Explore universal vaccination

19. Acknowledgements  Carolyn Bridges  Rex Ellington  Marika Iwane  Dennis O’Mara  Donna Rickert  Lance Rodewald  Jim Singleton  Nicole Smith  Ray Strikas  Anjella Vargas-Rosales  Greg Wallace  Rick Zimmerman