Implementing Expanded Seasonal Influenza Vaccination: Federal Perspective

1
Implementing Expanded Seasonal Influenza
Vaccination Federal Perspective

• Jeanne M. Santoli (jsantoli_at_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
• CDCs annual campaign

3
Approved Influenza Vaccines and Supply
Projections, United States 2008-09 Season
Vaccine Trade name Manufacturer Presentation Age group Projected Production (Doses)
TIV Fluzone sanofi pasteur .25 mL prefilled syringe 0.5 mL prefilled syringe 0.5 mL vial 5.0 mL multi-dose vial 6-35 mo gt 36 mo gt 36 mo gt 6 mo 50 m
TIV Afluria CSL 5.0 multi-dose vial 0.5 mL prefilled syringe gt 18 years 6 m
TIV Fluvirin Novartis Vaccine 5.0 mL multi-dose vial 0.5 mL prefilled syringe gt 4 years 40 m
TIV Fluarix Glaxo SmithKline 0.5 mL prefilled syringe gt 18 years 35-38 m 1/3 Fluarix, 2/3 Flulaval
TIV Fluluval Glaxo SmithKline 5.0 mL multi-dose vial gt 18 years 35-38 m 1/3 Fluarix, 2/3 Flulaval
LAIV FluMist MedImmune 0.2 mL sprayer 2-49 years 12 m
Total Projected Production Total Projected Production Total Projected Production Total Projected Production Total Projected Production 143-146 m
As reported May 12, 2008 at the National
Influenza Vaccine Summit, Atlanta, GA.
4
Influenza Vaccine Production and Distribution,
US, 1980-2007
Doses Produced (millions) Dose Distributed (millions) Difference (millions)
1980 15.7 12.4 3.3
1990 32.3 28.3 4.0
1995 71.5 54.9 16.6
1999 77.2 76.8 0.5
2000 77.9 70.4 7.5
2001 87.7 77.7 10.0
2002 95.0 83.0 12.0
2003 86.9 83.1 3.8
2004 61.0 57.0 4.0
2005 86.0 81.2 7.0
2006 120.9 102.5 18.4
2007 140.6 112.8 27.8
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
2007-08 Season 2008-09 Season
Doses licensed for use in children 6-35 months of age 12 m 20 m
Total doses 30 m 50 m
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
Vaccinate all 6-23 month olds recommendation
Encourage vaccination of 6-23 month olds
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 lt 6 yrs participated in
  an IIS
• 84 of grantees report maintaining vaccination
  data in IIS for persons 11-18 yrs

IIS ProgressUS, 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 projectsso
  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

• CDCs 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/f
  lu/NIVW/NIVW2008-index.htm
• Collaboration with Families Fighting Flu to
  sponsor Childrens 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