1. HHS Pandemic Influenza Vaccine Program VRBPAC Meeting Robin Robinson, Ph.D. Director, BARDA Deputy Assistant Secretary, ASPR November 14, 2012

2. U.S. Pandemic Influenza Plans Laid the Pathway for Pandemic Vaccines

3. 2 Vaccine Strategic Goals Were Specific on Expectations Goal #1: Establish & maintain dynamic pre- pandemic influenza vaccine stockpiles available for 20 M persons (2 doses/person): H5N1 stockpiles 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) www.pandemicflu.gov

4. 3 Seasonal Influenza Preparednes s Pandemic Influenza Preparedness for other hazards Vaccine Development, Planning, & Infrastructure Must Address Both Seasonal and Pandemic Influenza Unifying Principle

5. Pandemic Influenza Vaccine Implementation Goals Fortify existing influenza vaccine capabilities Support development of better influenza vaccines that afford greater surge manufacturing capacity ─Cell-based Vaccines ─Recombinant and Molecular Vaccines ─Adjuvants for Dose- and Antigen-sparing ─Universal Influenza Vaccines Establish pre-pandemic influenza vaccine stockpile Expand domestic manufacturing capacity ─Retrofit existing facilities ─Establish new facilities

6. 5 National Pandemic Influenza Vaccine Development Strategy Is Multi-Step & Integrated Approach Cell-based Vaccines Egg-based Vaccines Recombinant- based Vaccines Universal Vaccines Antigen-Sparing Vaccine Technology “More and better vaccines sooner”

7. 6 2009 Pandemic Influenza Scenario Relied on Existing Capabilities Antigen-Alone Egg-based Vaccines Pan Flu Illnesses 22-24 weeks Unabated Pandemic Wave Idealized Pandemic Wave

8. 7 New Vaccines & Domestic Facilities Will Help Close the U.S. Pan Flu Vaccine Gap this Decade Egg- & Cell- based Vaccines with Adjuvants Recombinant Vaccines with Adjuvants Pre-pandemic Vaccines 16-20 weeks 12 -16 weeks Pan Flu Illnesses

9. 8 Universal Flu Vaccines Will Transform Seasonal & Pandemic Influenza Preparedness Egg- & Cell- based Vaccines with Adjuvants Recombinant Vaccines with Adjuvants Universal Vaccines 16-20 weeks 12 -16 weeks “Priming Dose” “Booster Dose” Pan Flu Illnesses

10. HHS Has Supported Development of Multiple Antigen-sparing Flu Vaccine Adjuvant Technologies Supported multiple projects in 2007-09 (H5N1) & in 2009 (H1N1) for advanced development of pandemic influenza vaccines with adjuvants towards US-licensure Vaccine candidates are at various stages of development with Q-Pan representing one mature vaccine candidate Multiple study results (academia, USG, & vax mfg.) have shown that different oil-in-water emulsion adjuvants confer additional properties onto flu vaccines ─antigen- & dose-sparing effects ─cross-strain protection ─prolonged prime-boost immunity Mix-N-Match studies showed that H1 and H5 vaccine antigens from one manufacturer combined with adjuvants from other manufacturers are immunogenic

11. HHS Has Established H5N1 Vaccine Stockpile Available for Deployment HHS/BARDA established & manages H5N1 vaccine antigen (4 strains) and adjuvant (2) stockpiles stored and routinely tested at domestic vaccine manufacturing sites U.S. pan flu preparedness stockpiling goal met in 2008 Stockpile needs evaluated annually using CDC’S Influenza Risk Assessment Tool (e.g., H3N2v – 2012) Potency of bulk vaccine antigen lots remains >75% after 5-8 years & bulk adjuvant lots near 100% after 4-5 years Pre-EUA packages submitted by BARDA in 2012 to FDA for stockpiled vaccines with adjuvants Vaccine distribution through central distribution system managed by CDC

12. Licensure of H5N1 Vaccine with Adjuvant Caps Development & Initiates Further Partnering Milestone achievement for U.S. pandemic preparedness realized with licensure of H5N1 vaccine with adjuvant USG (CDC, FDA, BARDA, DoD, & others) and flu vaccine manufacturers will continue partnering on post-licensure activities for seasonal and H5N1 flu vaccines. ─seasonal flu vaccine safety & performance tracking ─planning future U.S. tracking systems for influenza vaccine safety and effectiveness ─executing these tracking systems during inter-pandemic periods and influenza pandemics