Implementing Expanded Seasonal Influenza Vaccination: Federal Perspective

1. Implementing Expanded Seasonal Influenza Vaccination: Federal Perspective Jeanne M. Santoli (jsantoli@cdc.gov) Immunization Services Division National Center for Immunization and Respiratory Diseases July 14, 2008

2. Outline • Vaccine supply • Vaccine financing • Vaccine coverage • Vaccine safety monitoring • Public health infrastructure • Supporting activities • New knowledge • CDC’s annual campaign

3. Approved Influenza Vaccines and Supply Projections, United States 2008-09 Season *As reported May 12, 2008 at the National Influenza Vaccine Summit, Atlanta, GA.

4. Influenza Vaccine Production and Distribution, US, 1980-2007

5. Influenza Vaccine Production and Distribution, US, 1980-2007

6. Sufficiency of Supply • ~ 27 million doses of vaccine were not distributed in 07-08 • A mismatch between supply and demand not surprising when both supply and recommendations are changing • There have been steady increases in doses distributed over past several years: • 81 million doses (2005-06) • 103 million doses (2006-07) • 113 million doses (2007-08) • Given projected production for upcoming season and data about uptake of new vaccine recommendations, including uptake of recent expanded flu recommendations, we anticipate that supply will likely be sufficient to meet demand

7. Production Projections for Thimerosal-free or Preservative-free Influenza Vaccines, United States *Represents production capacity for products as reported by the influenza vaccine manufacturers prior to the 2007-08 season. **Represents production capacity, as reported on May 12, 2008 by influenza vaccine manufacturers at the National Influenza Vaccine Summit in Atlanta, GA. NOTE: Translation of capacity into actual production depends upon production yields, lot release, and demand for product.

8. Financing for Flu Vaccine • VFC resolution adopted Feb 2008 to cover expanded recommendations • Vaccine available on CDC contracts has increased steadily • Approximately 12.5 million doses across all products in 08-09 • Issue of low administration fees for VFC impacts influenza vaccination as well as other routine vaccines • Section 317 Report calls for increased funding for underinsured children and adolescents to cover routine vaccines, including influenza • Private insurance coverage for flu vaccine • Time lag for new vaccines vs. expanded recs?

9. Influenza Vaccination Coverage Among Children 6-23 Months of Age, National Immunization Survey, 2002-2006 “Encourage vaccination of 6-23 month olds” “Vaccinate all 6-23 month olds” recommendation

10. How do we measure seasonal flu coverage in children? • National Immunization Survey • Provider-verified • Routinely assesses • Children 19-35 months (state level) • Children 13-17 years (state level beginning 08) • National Health Interview Survey • All ages, national data, self reported • BRFSS • Self reported • Child flu vaccination module available in 2006 • Immunization Information Systems • Provider verified • Small area/practice level estimates possible • Status of IIS varies by region

11. Vaccine Safety Monitoring • ACIP Influenza Working Group reviewed available vaccine safety data as part of deliberation process • Available data suggest widespread use of TIV/LAIV would be safe • Existing systems are in place for initial safety monitoring • Additional efforts needed to optimize safety monitoring in non-traditional or non-healthcare settings

12. Public Health Infrastructure for Influenza Vaccine Delivery • Broad interest in use of venues that are unrelated to vaccination or healthcare to capture school-aged children • In contrast to traditional or non-traditional medical settings, these venues will require staff to deliver vaccines • Delivery will likely either be public health staff or overseen by public health staff • Current public health infrastructure is likely insufficient to play these roles across the US

13. A Second Public Health Infrastructure Issue • Use of non-traditional and/or non-healthcare venues increases need for information- sharing to preserve continuity of care • Immunization information system (IIS) development in the US continues, traditional focus has been on younger children • In 2006, 65% of children < 6 yrs participated in an IIS • 84% of grantees report maintaining vaccination data in IIS for persons 11-18 yrs IIS Progress—US, 2006, MMWR March 21, 2008 Vol57/N0 11, pp 289-91.

14. New Knowledge • Two RFAs focused on school-based vaccination were posted by CDC this year • One RFA focuses specifically on influenza vaccination • Goal was to identify sustainable projects—so involvement of billing entity was required • RFAs targeted toward state and local health departments • Another RFA focuses on strategies for private providers to use a longer vaccination season to vaccinate their patients

15. Promotion of the Expanded Seasonal Recommendations • CDC’s traditional seasonal campaign enhanced with new materials for providers and public • Highlight benefits of decreased school absenteeism, more time for learning • Routine childhood and pre-teen/adolescent materials updated to include influenza recommendations for these children • NIVW to be sponsored December 8-14, 2008; more information is available at: http://www.cdc.gov/flu/NIVW/NIVW2008-index.htm • Collaboration with Families Fighting Flu to sponsor Children’s Vaccination Day during NIVW

16. Summing Up • Manufacturers project a large supply of vaccine for 08-09 season • Vaccine financing issues similar to other childhood vaccines • Underinsured children/adolescents are the primary gap • Vaccine coverage is low in young children • Enhancements to current systems for monitoring vaccine coverage and safety are needed as current mechanisms are not optimized to the newly added agegroup and potential new venues • Increased public health infrastructure is needed to support implementation of expanded recommendations • Knowledge gaps around immunization delivery exist and efforts are being made to fill them

17. Acknowledgments • Karen Broder • Gary Euler • John Iskander • Lance Rodewald • Tammy Santibanez • Kris Sheedy • Abigail Shefer • Greg Wallace • Karen Wooten