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H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009

H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009. National Pandemic Influenza Plans. U.S. Strategic Pan Flu Vaccine Goals. Vaccines

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H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009

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  1. H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009

  2. National Pandemic Influenza Plans

  3. U.S. Strategic Pan Flu Vaccine Goals • Vaccines • Goal #1: Establish and maintain a dynamic pre-pandemic influenza vaccine stockpile available for 20 M persons (2 doses/person) • Goal #2: Provide pandemic vaccine to all U.S. citizens within 6 months of a pandemic declaration: pandemic vaccine (600 M doses) National Strategy for Pandemic Influenza (Nov 2005) and HHS Pandemic Influenza Plan (Nov 2005) http://www.pandemicflu.gov

  4. Integrated Pandemic Influenza Product Portfolio Approach

  5. H5N1 Vaccine Stockpile Inventory: 2008 • *Adjusted number for usage and potency loss • Most vaccine is stored in the US as bulk concentrates * Adjusted for usage and potency

  6. U.S. Pandemic Influenza Vaccine Capacity Forecast: The Promise of Adjuvants

  7. H1N1 Vaccine Strategy

  8. H1N1 Vaccines • National Strategy for Pandemic Influenza (Nov. 2005) goal is to provide vaccine to everyone in U.S. within 6 months of pandemic onset • H1N1 Vaccine Strategy follows pandemic playbook for vaccine development, production, and administration with multiple decisions and on/off ramps • Clinical studies will inform vaccine formulation and safety profile • Licensure of antigen-alone formulations may be afforded as strain changes • Emergency Usage Authorization may afford vaccine administration with adjuvant • Scenario-sensitive vaccine production & administration approach • Disease severity affects selection of vaccine type • Virus antigenicity as compared to vaccine immunogenicity (well-matched?) • Key decision issues: • Prioritization of vaccine for special populations (e.g., children, etc. ) • Vaccine type • Thimerosal preservative • Oil-in-water adjuvant • Post-immunization adverse event safety monitoring

  9. H1N1 Vaccine Products Scenario A Standard vaccine – U.S.-licensed Multi-dose vial sanofi pastuer MedImmune CSL GSK Scenario B Standard vaccine – U.S.-licensed Vaccine + adjuvant - EUA GSK 3.4% GSK Novartis sanofi pastuer Novartis MedImmune CSL sanofi pastuer CSL Novartis

  10. H1N1 Vaccine Production Options

  11. H1N1 Vaccine Production Options

  12. H1N1 Vaccine Procurements to Date

  13. H1N1 Vaccine Distribution Options Vaccine Manufacturers Wholesale Distributors States & Locals Sites American Public 5 30-50 distrb. sites 40,000 - 90,000 300 million sanofi pasteur State Health Depts Children Novartis PODs Critical Workforce GlaxoSmithKline McKesson and others County Public Health Depts Healthcare Workers ! ! ! MedImmune Other Public Sites Elderly CSL Private Providers General Public BARDA CDC STATES LOCALS

  14. H1N1 Pandemic InfluenzaMedical Countermeasure Supply-Demand Gap Closure Reduce Demand: Pandemic Vaccines, Community Mitigation, Antivirals, Masks Increase Capacity: Ventilators, Oxygen, Antivirals, Pandemic Vaccines, Masks Egg- based Vaccines + Adjuvants? WHEN? PATHOGENICITY? ANTIGENICITY? Demand for Healthcare Services Increase Supplies of Critical Materiel ? ? ? Current Healthcare Capacity

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