1. Introduction of New vaccines Hib as an Example St. Petersburg 25-27 Jun 2001

2. Vaccines use in the world For the past two decades, in most developing countries, vaccination restricted only to the initial EPI vaccines Where-as in most developed countries, several new vaccines such as HepB, Hib, meningococcal, pneumococcal, were gradually added to the initial EPI vaccines, Thus widening the gap in protection against infectious diseases between the rich and the poor

3. Number of Childhood Vaccines Routinely Used in Developing and Established Market Countries Varicella Acell pertussis Pneumococcal * meningoccoal C* Measles DPT Poliomyelitis BCG Hepatitis B** Measles Mumps Rubella DPT Poliomyelitis Haemophilus Influenzae Hepatitis B *Estimated future use **Used in ~ 50% of global birth cohort

5. Countries using Hib vaccine in their national immunization system, 2000

6. Why this difference? Failure to demonstrate efficacy in developing country settings early in the course of vaccine development; Lack of disease burden data, or awareness of disease burden in developing countries Failure to account for production for the developing world

7. Why this difference? Relatively higher prices of new vaccines; and Lack of technical advice and guidance on introduction of new vaccines

8. Proportion of Countries introducing Hep B and Hib, by per capita GNP

10. Causes of death in children less than 5 years old 19% 20% 13% The Global Burden of Disease Murray and Lopez, editors Total - 12.8 million

11. Bacterial Meningitis Haemophilus influenzae type b (Hib) –30% -50% of bacterial meningitis Pneumococcus –25- 35% of bacterial meningitis Meningococcus –25 - 35% of bacterial meningitis (except during epidemics)

12. Pneumonia Haemophilus influenzae type b (Hib) –20-25% of all severe bacterial pneumonia –Gambia, Chile, other studies pending Pneumococcus –? 50-60% of severe bacterial pneumonia –South Africa, Gambia, Philippines, etc Others (RSV, adenovirus, etc)

13. Hib in the world Global burden of disease –Most common cause of bacterial meningitis in children –Second most common cause of serious bacterial pneumonia in children less than five years of age –Total - estimated 400,000-500,000 deaths/year in children less than five

14. Hib vaccines: Safety and Effectiveness Hib vaccines are safe and easily administered within existing regimens Hib vaccines have high efficacy against: –Meningitis –Pneumonia –Bloodstream infections –Carriage Hib vaccines have prevented disease in unimmunized persons (‘herd immunity’)

15. Hib vaccine efficacy studies: Protection against invasive disease Hib vaccines have proven their effectiveness in careful studies in Africa, South America, No. America and Europe Hib vaccines provide 90-100% protection against invasive Hib disease

16. Hib Conjugate vaccines Eliminate bacterial meningitis as a public health problem Reduce largest single remaining cause of infant mortality (pneumonia) by over 80% Safe, immunogenic and highly effective Widely used in industrialized countries

17. Hib vaccine efficacy in the Gambia: Protection against pneumonia and invasive disease 95% efficacy 21% efficacy Source: Mulholland et al. Lancet 1996

18. Impact of Hib vaccine on Hib meningitis in Uruguay Year No. Cases Source: PAHO Routine Hib vaccination started - with ‘catch up’

19. Other conjugate vaccines already in use Meningococcus –routine infant immunization in UK, Spain, Ireland Pneumococcus –routine infant immunization in USA

20. WHO European Region Mean annual incidence of Hib meningitis per 100 000 in children <5 years of age 30 28 27 22 20 19 17 15 13 12 11 9 8888 77 66 11 14 0 10 20 30 40 50 60 70 Sweden Switzerland Denmark Finland Netherlands UK Israel Slovakia France Austria Republic of Ireland Slovenia Malta Germany Spain Italy Greece Russian Federation Czech Republic Poland Bulgaria Hungary Latvia Regional mean

21. The situation in CEE, NIS From available data, Hib does not appear to be a major public health problem This could be real or fictitious If fictitious, the reasons could be –problem in the collection of csf –lack of lumbar puncture for suspected cases –problem with laboratory technique

22. Where do we go? Surveillance for Hib disease Further studies Hib immunisation needs for special situations- day care centres, special paediatric units

23. The available tools Generic protocol for Pop based Hib studies HibRAT for quick assessment of the Hib burden based on retrospective analysis of laboratory data Management guidelines for those countries that are already using the vaccine