Global Health Policy: Vaccines Edwin J. Asturias Senior Investigator Colorado School of Public Health Department of Pediatrics Children s Hospital Colorado UNIVERSITY OF COLORADO COLORADO STATE UNIVERSITY UNIVERSITY OF NORTHERN COLORADO
Smallpox eradication
Eradication of Rinderpest (GREP) mortality of 80-90% Declared eradicated may 2011 Dr. Walter Plowright
Poliomyelitis: 1 in 200 paralyzed
Annual Global Polio Case Burden, 1985-2010 WHA Resolution to eradicate polio America s certified polio free Last case in China Last cases in Pacific & Euro regions Type 2 polio eradicated 99% REDUCTION in number of cases mopv vaccine bopv vaccine 97% reduction in endemic countries and 99% reduction in cases since 1988 One of 3 wild virus types (type 2) eliminated since 1999 Type 3 on the ropes with few cases and limited transmission in 2011 Source: WHO/Polio database, data as of December 2010 2011 Bill & Melinda Gates Foundation 5
World Situation of Wild Poliovirus 1, Previous 6 Months* *15 Feb 14 Aug 2012 Wild virus type 1 Wild virus type 3 Endemic country Country with WPV case in previous 6 months Country Onset of most recent case Number of Districts Virus Type W1 W3 TOTAL WPV Chad 14-Jun-12 3 4 4 Nigeria 23-Jul-12 38 45 14 59 AFR Total 23-Jul-12 41 49 14 63 Afghanistan 21-Jul-12 9 13 13 Pakistan 21-Jul-12 10 15 2 17 EMR Total 21-Jul-12 19 28 2 30 Total 23-Jul-12 60 77 16 93 1 Excludes viruses detected from environmental surveillance and vaccine derived polioviruses. Data in WHO HQ as of 14 Aug 2012
Timeline for Polio Eradication as outlined by WHO
EPI program success around the world Vaccine Preventable Disease Global cases (2008) Estimated Global Deaths (2004) Global Vaccine Coverage (2008) % Reduction from reported peak % Countries with ALL districts >80% coverage Diphtheria 7,088 5,000 82% 92.8% 26% Tetanus 16,628 163,000 82% 85.8% 26% Pertussis 151,568 254,000 82% 92.4% 26% Polio 1,731 <1000 83% 96.3% >75% Hepatitis B 600,000 69% NA NA Measles 281,972 *164,000 83% 93.6% 58% * 2008, >90% coverage http://www.who.int/immunization_monitoring/diseases/en/ Prepared by E. Asturias
Vaccines as a public health technology Life saving Cost-effective Equitable Return on investment + 18% But
23 million children still unimmunised Global number of under-five children unimmunised with 3 doses of DTP, 2011 Note: Revised figures for 2011 (July 2012) Source: WHO/UNICEF coverage estimates 2011 revision. July 2012
Major causes of death in neonates and children under five globally 2010 7.6 millions deaths a year in children < 5 year About one third of all child deaths linked to malnutrition Children in lowincome countries about 18 times more likely to die Crédit to Colin Mathers Unpublished -confidential
Vaccines for Used in Developing Country EPI Programs 1984 1. BCG 2. Diphtheria 3. Tetanus 4. Pertussis 5. Polio - OPV 6. Measles 7. (Yellow Fever) Added/Adding 1. Hepatitis B 2. H. influenzae type b (Hib) 3. Mumps 4. Rubella 5. Rotavirus 6. Pneumococcal 7. N. meningitidis 8. HPV 9. Malaria
About WHO WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters Shaping the health research agenda Setting norms and standards Articulating evidence-based policy options Providing technical support to countries Monitoring and assessing health trends.
UNIVERSITY OF COLORADO COLORADO STATE UNIVERSITY UNIVERSITY OF NORTHERN COLORADO
Immunization Policy Advisory Framework Safety Standards Practice Burden assessment/ modelling Other WHO Technical Advisory Committees Strategic Advisory Group of Experts (SAGE) Global policy recommendations & strategies Support regional/national challenges Regional Technical Advisory Group Regional policies & strategies Identify & set regional priorities Monitor regional progress National Policies & Strategies Prioritize problems & define optimal solutions Implement national programme & monitor impact Countries National Technical Advisory Group on Immunization
WHO Vaccine Position Papers Position papers = Key reference documents Developmental and review process (follow recommendations of SAGE, extensive peer review, evidence-base, periodic updating) Format Weekly Epidemiological Record Current structure (Intro, background (Disease epidemiology, the pathogen, disease), info on vaccines (composition, safety, immune response, efficacy and effectiveness, cost effectiveness and any other relevant issue), WHO position on vaccine use) Additional posting of information on the web: Grading of Recommendations Assessment, Development and Evaluation (GRADE) tables, references, summaries (one pager and PowerPoint presentation)
Global coverage estimates, 1990-2010 DTP3, Measles, HepB3, Hib3, PCV3 and Rota Source: WHO/UNICEF coverage estimates 2010 revision. July 2011 458,000 unvaccinated infants (DPT3) in EURO, 2010 29% live in countries eligible for GAVI Alliance funding
Supported by a $37 million 4-year grant from GAVI/GVF Haemophilus influenzae type b (Hib) is a bacterium which can cause meningitis and severe pneumonia 3 million cases of serious illness and 400,000 deaths each year in children under 5 years of age from Hib In 2006, only 26% of children worldwide received Hib vaccine 1/3 of the countries eligible for funding from the GAVI Alliance (i.e., Gross national income/capita <$1000 per year) are using Hib vaccines The Hib Initiative focuses on coordination, communication and research. Hib Initiative Activities 19
Global Alliance for Vaccines and Immunization
The Global Fund For Children s Vaccines GAVI Board Establishes Principles recommendations on fund allocation Contributors Gates Foundation USA, UK, Norway, Netherlands,... $$$ The Fund Independent Board for fundraising & management Working Capital Account (at UNICEF) for vaccine procurement and resource disbursement Three Sub-accounts: Immunization services Vaccines & Safe injection materials R & D (not yet active) Financial Tools: Vaccine Shares, matching grants procurement Strengthened Immunization Services and New Vaccines Delivered in Countries
GAVI: Five Strategic Objectives Improve access to sustainable immunization services Expand use of all existing cost-effective vaccines Accelerate introduction of new vaccines Accelerate R&D on vaccines for developing countries, (HIV/AIDS, malaria and tuberculosis) Make immunization coverage a centrepiece in international development efforts
Coverage of DTP3 Hepatitis B and Hib immunisation in GAVI-eligible countries 100% 90% Projections 80% 70% 60% 50% 40% 30% 20% 10% 0% 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 DTP3 HepB Hib Source WHO Report on GAVI Progress 2000-2006 & Projected Achievements 2007-2010, 15 November 2007
Current vaccines and vaccines on the horizon Future vaccines Malaria HIV/AIDS TB YF Traditional EPI Influenza Tetanus Polio Pertussis Diphtheria Source WHO, 2005 New and underused vaccines // JE Rubella Cholera Measles Typhoid Hib (conj) HepB 1960 1980 2000 Dengue Mening (conj) HPV Pneumo Rotavirus (conj) //
We still could reduce 1/5 of childhood deaths with current or upcoming vaccines
GAVI new vaccines support Vaccines currently supported Pentavalent Pneumococcal conjugate Rotavirus Measles second dose Meningococcal A conjugate (campaigns) Yellow Fever (routine & campaigns) Measles campaigns in selected countries and outbreak response Under review 2013 and later Japanese encephalitis Typhoid Dengue Malaria New in 2012: HPV (national introduction & demo project) Rubella (MR campaigns) Also: meningitis and yellow fever vaccine stockpiles
New Key GAVI policies Country eligibility policy: Threshold for 2012 is $1,520 GNI per capita (World Bank, Atlas method) updated annually New vaccine introduction grant and operational support for campaigns policy NEW! Co-financing policy
Vaccine introduction grant and operational support for campaigns policy Vaccine introduction grant levels Vaccines delivered to infants HPV vaccines GAVI support $0.80 per child in the birth cohort Or lump sum $100,000 $2.40 per girl Or lump sum $100,000 Applicable to Penta, Rota, Pneumo, M2D, Rubella routine, YF routine HPV Operational support for campaigns level GAVI support Applicable to All supported campaigns $0.65 per target person MenA campaign, YF campaign, MR campaign, measles campaigns
GAVI programmatic policies Co-financing Policy Objective: to enhance ownership and put countries on a trajectory towards financial sustainability to prepare for phasing out of GAVI support. All countries applying for NVS are required to co-finance a portion of the cost of requested vaccines* 3 country groupings according to GNI per capita: Country group GNI per capita threshold Co-financing requirement Low income currently <$1,005 $0.20 per dose Intermediary currently >$1,005 to <$1,520 Graduating Currently > $1,520 $0.20 per dose + 15% annual increase Gradual ramp up over five years to reach projected price after GAVI *The only exceptions from co-financing are vaccines for measles second dose, MenA and YF preventive campaigns and MR. Countries are however expected to pay a share of operational costs of campaigns.
UNICEF is the world s largest purchaser of vaccines for developing countries and a key partner in global immunisation efforts. Its supply division, based in Copenhagen, is responsible for global purchasing, including some $100 million per year spent on vaccines and safe injection equipment 31
Estimated Global Distribution of Rotavirusrelated Deaths (from Parashar, 2006) Europe 11,838 United States and Canada 125 Latin America 18,981 Africa 229,701 Asia 289,354 32
Forecasted Rotavirus Demand- Doses All Regions 33 Approximately 160 million doses in peak year 2021 for 64 GAVI-eligible countries
Who produces the vaccines of the world? 6.3 Billion Dose Global Market.9 B 3.6 B 1.2 B.4 B Source: WMA 2004, SP Internal Note: SP MSD sales split by origin
Who shares the market from the vaccines of the world?(2008) (2) (2) 15 B Global Market (1) (1) Based on reported FY2008 results and sanofi-aventis internal estimates for Others (2) Includes 50% of Sanofi Pasteur MSD joint venture sales
The free market has given rise to tiered pricing 36
Social Problems for the 21 st Century Safety and Acceptance Cost and Availability Sufficient Production 37
Global Immunization Vision and Strategy (GIVS) for the period 2006-2015 UNICEF/WHO initiative Reduce mortality due to vaccine-preventable diseases by 2/3 by 2015 Reach 90% coverage by 1015 Introduce new vaccines (which?) Can we afford GIVS? Wolfson et al. (2008) try to answer this!
Investment in vaccines by governments and the private sector Vaccines the number-one priority at the Gates Foundation Prevent the deaths of some 7.6 million children under 5 from 2010-2019 1.1 million children could be saved with the rapid introduction of a malaria vaccine beginning in 2014 Bill & Melinda Gates Foundation
Final Remarks on Vaccine Policy One of the most effective and equitable health preventive technologies Global Policy requires sound epidemiology, science, commitment and partnership Use of vaccines is key to their preventive success Addressing the safety and societal concerns is a priority