The Quest for a Malaria Vaccine APPMG-BEAD Meeting February, 2006 Dr. Melinda Moree, Director PATH Malaria Vaccine Initiative

Existing Malaria Interventions

Vaccines A material originating from a microorganism or other parasite that induces an immunologically mediated resistance to disease. Successful Vaccines…. Induce the right type of immune response (antibody—T cells) Induce an immune response to the right antigens Induce an immune response that persists

Estimated and Reported Polio Cases, 1985-2002 * data as of 12 February 2003 Source: V&B/WHO 12 Feb 2003 data from 191 WHO member states

Why is public sector involvement critical? Perception 1: Classical market forces are insufficient to drive malaria vaccine development Perception 2: Malaria vaccines are not technically feasible

Deaths from HIV/AIDS, TB & Malaria

Vaccine Economics 88% 12% $4.9 B $1.2 B Low Income High Income Volume 100% 88% 12% $4.9 B $1.2 B Low Income 50% High Income Volume Revenue Mercer Management Consulting Report to GAVI 2002

Model of net cash flow over product lifetime Profitable vaccines +$ Malaria Vaccines Preclinical Clinical Licensure -$ Model of net cash flow over product lifetime

MISSION To accelerate the development of malaria vaccines and ensure their availability and accessibility for the developing world.

Developing any vaccine is hard Laboratory Pre-clinical Phase 1a, 2a Phase 1b Phase 3 Phase 2b Can take 10-20 years to develop a product. Cost hundreds of millions of dollars.

Developing a Malaria Vaccine is Hard Virus ~100 genes Bacteria ~2000 Genes Parasites (P. falciparum) 5200 genes

The Parasite

Pre-erythrocytic Development: 13 Clinical trial: 4 Product-like: 8 (vaccines to prevent infection and impact clinical disease) Development: 13 Clinical trial: 4 Product-like: 8

Blood-stage (vaccines to lessen disease) Development: 37 Clinical trial: 9 Product-like: 28

Mosquito-stage (vaccines to prevent transmission) Development: 2 Clinical trial: 0 Product-like: 2

Multi-stage Development: 6 Clinical trial: 2 Product-like: 2

Development: 58 Clinical Trials: 15 Product like: 40 The Global Malaria Vaccine Development Effort Development: 58 Clinical Trials: 15 Product like: 40

MVI Vaccine Development Projects Oxford Walter Reed GSK ICGEB GenVec MVDB +8 MVI is currently supporting 9 malaria vaccine development projects. This support spans 5 continents, and involves the development of 13 individual vaccines. Within the next year 6 clinical trials are anticipated with over half of these taking place in Africa. The red stars represent the vaccine developers… MOUSE CLICK … while the blue stars represent the chief partners that are receiving MVI support. QIMR Monash La Trobe

Proof of Concept

MAL026 Proof of Concept for RTS,S Malaria Vaccine

Can We Afford a Malaria Vaccine?

The Vision A world in which people are free from malaria

Advance Market Commitments Donor governments agree to buy vaccine IF it meets certain specs IF it’s developed and IF countries demand it…create a market incentive for development. Malaria – Unique case as little developed-country market. Gordon Brown, UK Chancellor of Exchequer – UK ready to implement APC for malaria - 2004 G8 Governments and Ministers of Finance - July 2005 – Committed to pursue further. Italy leading with WB support.

What Would an AMC do for Malaria Vaccines? Manage risk and increasing predictability: Signaling to manufacturers Signaling to countries to allow early and forwarding planning Synergy with strong push funding: Increases speed of testing products Ensures that products are consistent with priorities and realities in developing world Draw additional manufacturers Speed second and third generation products more quickly

Estimates of AMC Amounts and Associated Impact Preliminary estimates for size of malaria vaccine AMC (MVI, Italian MoF/World Bank); $4.5-5 billion in future dollars ($2.4-2.6 billion in net present value at 6% interest) Works out to $300-330M/year over 15 years Preliminary estimates of social impact, conservatively (MVI): 2-3 MM deaths prevented over life of AMC at very cost-effective levels (on order of $2500/death averted)

Dr. Melinda Moree PATH Malaria Vaccine Initiative mmoree@malariavaccine.org Tel: +1 206 285 3500