1. Pandemic Vaccines Current and Future Issues 30 January 2007 Beijing Keiji Fukuda Global Influenza Programme

2. Current Situation Limited global vaccine production capacity & demand –Primarily for seasonal influenza –Pandemic-related stockpiles –Several companies developing H5N1 vaccines Wide interest in expanding capacity –Anticipated gap in supply and demand during pandemic situation –Beneficial for reducing burden of seasonal influenza Global Pandemic Influenza Vaccine Plan –Provides global strategy for increasing supply and global distribution and access –Initial funding received and work underway with 6 manufacturers

3. Current Situation WHO Executive Board virus and genetic sequence sharing resolution –Will require passage at 2007 World Health Assembly –Provides basis for related international best practices –Balanced assessment and focus on concerns of affected countries, under resourced countries and international community Implementation of International Health Resolutions –Conceptual and legal framework for facilitating detection and response to disease threat

4. Pandemic Influenza Vaccines Key Conceptual Issues Pre-pandemic? –Protect specific populations against avian influenza? –Protection against future pandemic "Primer"? Fully immunizing schedule? During pandemic? –Protection of individuals? Prevent infection? Disease? Serious disease? –Induction of herd immunity?

5. Pandemic Influenza Vaccines Product Issues Non-replicating –Subunit hemagglutinin? –Whole virus? –Conserved protein / "universal"? –Adjuvant? Replicating –Live? –DNA?

6. Pandemic Influenza Vaccines Development / Regulatory / Production Issues Animal models for testing and evaluation? Immunty & efficacy –Correlates of immunity (Antibody titre of 1:40? Live vaccine? Etc) –Efficacy against broader range of strains Growth substrate? –Eggs / cells Reduction in time to high production –Regulatory –Technical Intellectual property related

7. Pandemic Influenza Vaccines National Issues Production capacity? –Drivers for demand? –Sustainable? Other production bottlenecks? –Ancillary essential products? Who will receive First? Delivery? Administration? Liability? Monitoring of adverse effects?

8. Pandemic Influenza Vaccines Global Issues Translating rapid virus & genetic sequence data best practices into actual practice –Strain selection –Benefits for developed versus underdeveloped –Research-related –Public health versus commercial / intellectual property approaches Technology transfer, capacity development & sustainability –Health rationale –Economics –Implementation of Global Action Plan

9. Conclusions Several options for the future Least good option –No action –Focus on issues in isolation Key steps –Distinguish political, economic & technical issues from each other –Solution that are integrated at several levels