Pandemic Vaccines Current and Future Issues

30 January 2007Beijing

Keiji FukudaGlobal Influenza Programme

Pandemic Vaccines Current and Future Issues

30 January 2007Beijing

Keiji FukudaGlobal Influenza Programme

Current SituationCurrent 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

Current SituationCurrent 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

Pandemic Influenza VaccinesKey Conceptual Issues

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?

Pandemic Influenza VaccinesProduct Issues

Pandemic Influenza VaccinesProduct Issues

Non-replicating – Subunit hemagglutinin?– Whole virus?– Conserved protein / "universal"?– Adjuvant?

Replicating– Live?– DNA?

Pandemic Influenza VaccinesDevelopment / Regulatory / Production Issues

Pandemic Influenza VaccinesDevelopment / 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

Pandemic Influenza VaccinesNational Issues

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?

Pandemic Influenza VaccinesGlobal Issues

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

ConclusionsConclusions

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