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Contributions of GAVI and The Vaccine Fund toward global control of Hepatitis B Mark Contributions of GAVI and The Vaccine Fund toward global control of Hepatitis B Mark Kane, MD, MPH Children’s Vaccine Program (CVP) Program for Appropriate Technology in Health

Un homme enceinte s’accouche dans son tombeau* *A pregnant man delivers in his grave Un homme enceinte s’accouche dans son tombeau* *A pregnant man delivers in his grave

Cancer rates, Gambian males 1986 -96 incidence per 100, 000 140 120 100 80 Cancer rates, Gambian males 1986 -96 incidence per 100, 000 140 120 100 80 all cancer liver cancer 60 40 20 0 014 1519 2024 2529 3034 3539 4044 age 4549 5054 5559 6064 65+ (GHIS Reports)

Geographic Pattern of Hepatitis B Prevalence HBs. Ag Endemicity 8% and above = High Geographic Pattern of Hepatitis B Prevalence HBs. Ag Endemicity 8% and above = High 2% - 8% = Intermediate Below 2% = Low

Burden of Hepatitis B disease • 2, 000 million with markers of current or Burden of Hepatitis B disease • 2, 000 million with markers of current or past infection • 350 million chronic carriers • 15%-25% will die from chronic liver disease (cirrhosis or liver cancer) • About 1 million deaths / year preventable with vaccine

Hepatitis B carrier prevalence before and after immunization Hepatitis B carrier prevalence before and after immunization

Hepatitis B carrier prevalence before and after immunization Hepatitis B carrier prevalence before and after immunization

 • World Health Assembly, 1992: Hepatitis B vaccine should be integrated into national • World Health Assembly, 1992: Hepatitis B vaccine should be integrated into national immunization programmes in all countries by 1997 • WHO 9 th Programme of Work (1996 -2001): Among children, new hepatitis B virus carrier incidence will be reduced at least 80% through integration of hepatitis B vaccine into national immunization programmes

HB vaccine: Universal Immunization Policy 1999 National program HB vaccine: Universal Immunization Policy 1999 National program

Impact of income on program implementation: Hepatitis B Coverage >70% HBs. AG > = Impact of income on program implementation: Hepatitis B Coverage >70% HBs. AG > = 5% Brunei Hep B in EPI Hep B unavailable Hong Kong Singapore Saudi Arabia $6000 Taiwan Rep of Korea Bulgaria South Africa Jordan Fiji DPR Korea Mongolia Zimbabwe Thailand Philippines Indonesia Log GNP/Capita $500 Togo Zambia Benin China Uganda Malawi Log Population Ghana Kenya 10 Million Viet Nam Tanzania 50 Million

The Three Gaps • ACCESS – 30 million children un-immunized per year – stagnant The Three Gaps • ACCESS – 30 million children un-immunized per year – stagnant or falling coverage in some regions • EQUITY – many immunized children in developing countries lack important newer vaccines (hep B, Hib) and receive unsafe injections • INVESTMENT – too little investment in vaccines which primarily impact developing countries

The GAVI Network World Bank WHO National NGOs Bilaterals Immunizatio n UNICEF Foundations Services The GAVI Network World Bank WHO National NGOs Bilaterals Immunizatio n UNICEF Foundations Services Academia Industry Technical Organizations

The Vaccine Fund • The Vaccine Fund has been established with an initial gift The Vaccine Fund • The Vaccine Fund has been established with an initial gift of $750 million over 5 years from the Bill & Melinda Gates Foundation; additional donations have been committed by Norway, Netherlands, USA, Denmark, Sweden, Canada and the UK. Firm commitments now exceed $1 Billion. • The Fund has three separate sub-accounts for: 1) procurement of new vaccines and safe syringes 2) support to strengthen access and infrastructure 3) expediting introduction of new vaccines

The Vaccine Fund Application Criteria • GNP of US $1, 000 per capita or The Vaccine Fund Application Criteria • GNP of US $1, 000 per capita or less (74 countries) • NIS assessment during last 3 years • multi-year, sustainable immunization plan • functioning ICC • willingness to do transparent, district level immunization coverage reporting • India, China, and Indonesia require special considerations

Cost effectiveness • In the last century politicians have killed about 100 million people, Cost effectiveness • In the last century politicians have killed about 100 million people, a fraction of those killed by vaccine preventable diseases, and they have spent a lot of money doing it. • If we could immunize our children against politicians for a few dollars each what a bargain that would be!

Global status of countries using hepatitis B vaccine in their national childhood immunization schedule, Global status of countries using hepatitis B vaccine in their national childhood immunization schedule, 2003 Routine Hep. B immunization Yes (N=168) Includes countries with funding from The Vaccine Fund and plans to introduce 2003 No, eligible for funding (N=7) No, eligible when DTP 3>50% (N=15) No, not eligible for funding (N=26) August 2002

GAVI and The Vaccine Fund in China, India, and Indonesia • One third of GAVI and The Vaccine Fund in China, India, and Indonesia • One third of the world’s newborns! • China: $75 Million project (~50% Chinese Govt. and 50% Vaccine Fund) • Free Chinese hepatitis B vaccine and safe injection equipment to 1/3 of Chinese infants in 12 Western provinces and “poverty counties” (7 million children/yr) • All infants in China to get free HB vaccine • AD syringe industry is developing in China

GAVI and The Vaccine Fund in China, India, and Indonesia • India: 45 hepatitis GAVI and The Vaccine Fund in China, India, and Indonesia • India: 45 hepatitis B vaccine and safe injection introduction projects • Plan to integrate hepatitis B Vaccine into Indian EPI in next 5 year plan • Indonesia: First dose of HB in Uniject for all children; Indonesia to provide doses 2 & 3 • First major attempt to offer birth dose where most babies born at home • Local production of HB vaccine in Uniject

Injection Safety • ~16 billion injections/year • ~33% unsafe in developing countries • ~20 Injection Safety • ~16 billion injections/year • ~33% unsafe in developing countries • ~20 million HBV infections/yr + ~2 million HCV and ~260, 000 HIV infections • Little change until GAVI and SIGN • Fund eligible countries get auto-disable syringes for 3 years. 200 million already distributed • Countries responsible for national plan, training, waste management • Major GAVI gift to wider HC community

Summary • GAVI’s first milestone is met! • HB vaccine approved in 44 countries Summary • GAVI’s first milestone is met! • HB vaccine approved in 44 countries (72 million newborns, including Big Three) • 10 million additional children in 33 countries will get GAVI-supplied HB vaccine in 2002 preventing > 1 million new carriers and ~100, 000 deaths • GAVI stimulating local production of DTP-HB vaccine and AD syringes • Major steps toward a new global standard for injection safety • Sustainability is up to you!

Poster for first African trial of HB Vaccine Senegal, early 1980’s Poster for first African trial of HB Vaccine Senegal, early 1980’s

Hepatitis B Deaths per Birth Cohort in Fund Eligible Countries by Coverage Hep B Hepatitis B Deaths per Birth Cohort in Fund Eligible Countries by Coverage Hep B Coverage (%)

Detail of routine HB immunization and GAVI / Vaccine Fund eligibility 2003 Routine HB Detail of routine HB immunization and GAVI / Vaccine Fund eligibility 2003 Routine HB use Eligible when DTP 3 > 50% (N=15) Eligible for funding (N=7) No use, not eligible for VF