Contributions of GAVI and The Vaccine Fund toward global control of Hepatitis B

1. 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

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

3. Cancer rates, Gambian males 1986-96 incidence per 100,000 140 120 100 80 all cancer liver cancer 60 40 20 0 0-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65+ (GHIS Reports) age

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

5. 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

7. Hepatitis B carrier prevalence before and after immunization

8. Hepatitis B carrier prevalence before and after immunization

9. World Health Assembly, 1992:Hepatitis B vaccine should be integrated into national immunization programmes in all countries by 1997 • WHO 9th 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

10. 1999 HB vaccine: Universal Immunization Policy National program

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

12. 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

13. The GAVI Network World Bank WHO UNICEF National Immunization Services Foundations NGOs Academia Bilaterals Technical Organizations Industry

14. 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

15. 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

16. 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!

17. Global status of countries using hepatitis B vaccine in their national childhood immunization schedule, 2003 Routine HepB 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 DTP3>50% (N=15) No, not eligible for funding (N=26) August 2002

18. 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

19. 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

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

21. 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!

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

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

25. Detail of routine HB immunization and GAVI / Vaccine Fund eligibility 2003 Routine HB use Eligible when DTP3 > 50% (N=15) Eligible for funding (N=7) No use, not eligible for VF