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

1 National Pandemic Influenza Plans

2 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)

3 Integrated Pandemic Influenza Product Portfolio Approach VaccinesAntiviralsDiagnostics/ Respiratory Devices Advanced Development Cell-based Antigen-sparing Next Generation Recombinant Peramivir AV MedKits Diagnostics Point of Care Clinical Lab Simple Ventilators Next Generation Stockpile Acquisitions H5N1 Pre-Pandemic Vaccine Stockpiles Tamiflu & Relenza Federal Stockpiles State Stockpiles Masks & Respirators Infrastructure Building Retrofit Existing Mfg Facilities Build New Cell-based Mfg Facilities Egg-based Supply Intl. Vaccine Cap.

4 H5N1 Vaccine Stockpile Inventory: 2008 *Adjusted number for usage and potency loss Most vaccine is stored in the US as bulk concentrates H5N1 Vaccine StrainClade Totals A/VTN/1203/ A/Indo/05/ A/BHG/QL/1A/ A/Anhui/1/ Totals Ag-Alone Formulation (90 ug/dose) 0.2 M2.9 M7.0 M11.1 M * M AdjuvantAS M Totals Oil-in- Water Adjuvant Formulation (7.5 ug/dose) 2.7 M34.3 M84 M133.2 M14.4 M268 M * Adjusted for usage and potency

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

6 H1N1 Vaccine Strategy

7 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

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

9 H1N1 Vaccine Production Options

10 H1N1 Vaccine Production Options

11 H1N1 Vaccine Procurements to Date

12 H1N1 Vaccine Distribution Options LOCALS STATES CDC BARDA General PublicPrivate ProvidersCSL ElderlyOther Public SitesMedImmune Healthcare Workers County Public Health Depts McKesson and othersGlaxoSmithKline Critical WorkforcePODsNovartis ChildrenState Health Deptssanofi pasteur 300 million40, , distrb. sites5 American PublicStates & Locals Sites Wholesale Distributors Vaccine Manufacturers! ! !

13 H1N1 Pandemic Influenza Medical 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? Increase Supplies of Critical Materiel Demand for Healthcare Services Current Healthcare Capacity ? ? ? ? ? ? WHEN? PATHOGENICITY? ANTIGENICITY?