From development to delivery: Decision-making for the introduction of a new vaccine

Transcription

1 From development to delivery: Decision-making for the introduction of a new vaccine Prince Mahidol Award Conference Bangkok, Thailand 1-2 February 2007 Dr. J.M. Okwo-Bele Department of Immunization, Vaccines and Biologicals WHO Geneva

2 Global Immunization Vision and Strategy Realizing the Vision for all vaccines Protecting more people. Introducing new vaccines. Integrating immunization with other interventions. Immunizing in a context of global interdependence Reaching the unreached Immunization benefits to older age groups Fully informed national decision and policy Vaccines are an element of comprehensive strategy Financing and Supply Information exchange

3 % coverage Global Immunization coverage DPT3, For 2005 Global annual surviving infants cohort = 126 million % 56 DPT3 coverage million children vaccinated million unvaccinated Global African American Eastern Mediterranean European South East Asian Western Pacific Source: WHO/UNICEF coverage estimates , August WHO Member States. Date of slide: 4 September 2006

4 Countries with most unvaccinated children DPT (in millions) India Nigeria China Indonesia Pakistan Ethiopia DR Congo Sudan Bangladesh Philippines Source: WHO/UNICEF coverage estimates , August 2006

5 Reported DPT3 Coverage in AFR Jan-Aug 2005 & Jan-Aug ND ND 25% 70% 59% 74% 63% 71% EMRO >= 80% 50-79% <50% >= 90% 75% 52% ND: No data Source: 2006 EPI Monthly report 5

6 The vaccines pipeline Available by > 2011 HIV/AIDS Future Malaria TB Underutilized Vaccines YF Influenza JE Rubella Cholera Typhoid Hib (conj) HepB Dengue Mening (conj) HPV Rotavirus Pneumo (conj) Traditional EPI Diphtheria Pertussis Tetanus Polio Measles Unfinished agenda // // Source: WHO, Aug 2006

7 Issues for national decision on the introduction of a vaccine Disease burden Public health priority Other interventions (including other vaccines) Policy issues Efficacy, quality and safety Vaccine X Economic and financial issues Vaccine presentation Programmatic issues Supply availability Programmatic strength Introduce the vaccine Wait for introduction

8 Some characteristics of two candidates HPV Vaccines Manufacturer Merck [Gardasil TM] GSK [Cervarix TM] Virus-like particles (VLPs) of genotypes Schedule in trials Countries/regions included in phase II trials Countries/regions included in phase III trials Substrate Quadrivalent - 6/11/16/18 0,2,6 months Brazil; Europe; USA N America; Latin America; Europe; Asia- Pacific Yeast [S. cerevisiae] Bivalent - 16/18 0,1,6 months Brazil; North America N America; L America; Europe; Asia-Pacific Baculovirus

9 Quadrivalent HPV Vaccine (Merck) Summary High efficacy in 16 to 26 year-old females who are naïve to the respective vaccine HPV types HPV 16,18 related CIN 2/3 HPV 6,11,16,18 related CIN, external genital lesions Most reported data on clinical efficacy are from a mean of 1.5 years follow-up Efficacity data available through 5 years from Phase II trial No evidence of therapeutic efficacy Safe; side effects mainly local reactions

10 Bivalent HPV Vaccine (GSK) Summary High efficacy in 15 to 25 year-old females who are naïve to the respective vaccine HPV types HPV 16,18 related CIN 2/3; incident persistent infections Efficacy data available through 4.5 years from Phase II trial Evidence for cross protection against two, non-vaccine HPV types Antibody titers substantially higher than after natural infection; highest in those vaccinated at younger ages 100% HPV-16/18 seropositivity through follow-up period No vaccine-related serious adverse events

11 Additional clinical development Merck vaccine [Gardasil TM] - Efficacy study in males underway - Efficacy study in women > 26 years under way - Studies of administration at the same time as other vaccines - Safety and immunogenicity in HIV-infected persons and other immunocompromised groups GSK [Cervarix TM] - Efficacy, Immunogenicity bridging and safety studies in women > 26 years - Studies of administration at the same time as other vaccines - Safety and immunogenicity in African populations, including HIV infected women

12 Status of HPV vaccines utilization Merck vaccine licensed in >40 countries (end 2006) Distributed through private sector Recommended for use in United States in: Girls aged years Catch-up in years girls Cost $360 (private) Three doses 0, 2, 6 months

13 Action areas toward a policy for use of HPV vaccines at global level 1. Safety and efficacy Independent review by GACVS 2. Regulatory approval Expert Committee on Biological Standardization (ECBS) WHO vaccine Pre-qualification for UN/GAVI procurement 3. Cost-effectiveness analysis 4. Programmatic feasibility Demonstration projects (PATH - delivery systems; cultural issues; etc.) 5. Experts endorsement WHO SAGE; TAG; WHA Resolutions 6. Financing and Supply issues GAVI Alliance

14 Conclusions Enormous potential of Immunization programmes HPV vaccines have huge public health benefits Several steps to be completed to effectively make it available to the neediest, including: Obtain geographically representative evidence of efficacy and safety Adapt immunization strategies to HPV optimal schedule Develop a healthy HPV vaccines market Ensure effective partnership at global and country levels

15 Acknowledgements Teresa Aguado Nora Dellepiane Tracey Goodman Patrick Lydon Jos Vandelaer Patrick Zuber

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17 The Cost of Reaching GIVS goals $11-15 billion funding gap for immunization ( ) Scaling Up Systems 16% Campaigns 5% Basic Vaccines 7% Underused & New Vaccines 28% National Gov. 26% $35 billion needs $11-$15 billion gap Unfunded 43% Trad. Donors 17% Maintaining System 44% Source: GIVS Costing Analysis (WHO-UNICEF, 2005) GAVI & IFFim 14%

18 Trend in Immunization Funding: analysis of data from FSPs of 50 GAVI eligible countries $6.0 $5.0 Immunization Funding per Infant $4.0 $3.0 $2.0 $1.0 Baseline Year with GAVI $0.0 Government GAVI Multilaterals Bilaterals Other donors