Preparing to Protect: Flu Vaccines From Production to Consumption

1. Preparing to Protect: Flu Vaccines From Production to Consumption Kristin L. Nichol, MD, MPH, MBA Professor of Medicine, University of Minnesota Chief of Medicine, Minneapolis VA Medical Center 2007 National Health Policy Conference February 12, 2007 Washington DC

2. Prevention & Control of Seasonal Influenza is Important * Substantial annual burden of disease * Critical element for pandemic influenza strategy

3. Selected Challenges • Strategies targeting high risk groups have not been fully successful • Risk based recommendations difficult to implement • Ageism ? • Public financing not available for many 18 – 64 YO in target groups • Vaccine supply has not always been available in sufficient quantity or in a timely manner

4. US Influenza Vaccination Rates, 1997 – 2003 NHIS (low & stagnant) 2010 Goal Elderly 65+ 2010 Goal HR < 65 HR 50 - 64 HR 18 - 49 www.cdc.gov/flu/professionals/vaccination [accessed 8/23/06]

5. Influenza is the #1 Cause of Death Due to Vaccine Preventable DiseasesCases & Deaths, US 1989 - 1998 90% in the elderly 11k from 1989-98 (actual is 5x to 10x higher) MMWR 2001; 48 (RR-53); Thompson et al. JAMA 2003; 289: 179; Feikin DR, et al. Am J Public Health 2000; 90: 223-9.

6. VPD’s Take the Highest Death Toll Among Adults Annual VPD Deaths • Adults: 99% of VPD Deaths • 30,000 to 70,000 deaths each year • Children: 1% of VPD Deaths • 100 to 300 deaths each year VPD = Vaccine Preventable Disease Source: CDC, IOM

7. Vaccine Supply & Demand We Need More of Both Now to Assure Adequate Supplies for Seasonal Influenza and Capacity for Pandemic Influenza Supply Demand

8. Influenza Vaccine Production is an 8 to 9 Month Process Jan May Aug Dec Apr Sep Feb Mar Jun Jul Oct Nov Production of Concentrates Eggs Formulation-TestingFDA Release Filling-TestingPackaging Distribution Need to Know: Administration ACIP recommendations for use One or more strains in formula Precise formulation All strains in formula Courtesy of the Centers for Disease Control and Prevention. The characteristics of the strains circulating the previous season provide the basis for selecting virus strains for the next year’s vaccine.

10. Recent Experiences • Changing messages to the public: • Step in line (for high risk)  • Step aside unless really high risk  • Step in line (all) • Frustration among providers • No vaccine, late vaccine, uneven availability of vaccine (haves and have nots)

11. Timing of Influenza Vaccinations & the Challenge of Extending into Dec & BeyondMN Medicare Beneficiaries www.cms.hhs.gov/preventiveservices/2d3.asp

12. US Influenza Vaccine SupplyWill Demand Keep Up? Max Amount Ever Distributed * National Influenza Vaccine Summit, Jan 2006; sanofi pasteur estimates

13. 2006 – 07 Experience • “New challenges for officials: Maximizing takers for increased flu shot supply • This season may be one in which there is more than enough vaccine rather than a shortage” • AMNews Jul 10, 2006 • “Doctors wary about flu vaccine deliveries. • Supplies are supposed to be plentiful, but after several rough seasons, physicians are dubious” • AMNews, Oct 9, 2006 • “Distribution gaps appear in flu shot supply • Those involved in dispensing vaccines taking pains to explain the system’s complexities to physicians” • AMNews Nov 6, 2006

14. Selected Challenges • Strategies targeting high risk groups have not been fully successful • Risk based recommendations difficult to implement • Ageism ? • Public financing not available for many 18 – 64 YO in target groups • Vaccine supply has not always been available in sufficient quantity or in a timely manner

16. US Influenza Vaccination Rates, 1997 – 2003 NHIS (low & stagnant) www.cdc.gov/flu/professionals/vaccination [accessed 8/23/06]

17. VPD Deaths in Adults are Similar to Other Important Causes of Death in Adults Range of VPD deaths in adults Source: CDC, NCHS (online data for 2000).