Guidelines

1
Pandemic Vaccines Current and Future Issues 30
January 2007BeijingKeiji FukudaGlobal
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 VaccinesKey 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 VaccinesProduct Issues

• Non-replicating
• Subunit hemagglutinin?
• Whole virus?
• Conserved protein / "universal"?
• Adjuvant?
• Replicating
• Live?
• DNA?

6
Pandemic Influenza VaccinesDevelopment /
Regulatory / Production Issues

• Animal models for testing and evaluation?
• Immunty efficacy
• Correlates of immunity (Antibody titre of 140?
  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 VaccinesNational 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 VaccinesGlobal 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