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Introduction of New vaccines. Hib as an Example St. Petersburg 25-27 Jun 2001. Vaccines use in the world. For the past two decades, in most developing countries, vaccination restricted only to the initial EPI vaccines
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Introduction of New vaccines Hib as an Example St. Petersburg 25-27 Jun 2001
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
Number of Childhood Vaccines Routinely Used in Developing and Established Market Countries Acell pertussis Pneumococcal * meningoccoal C* Varicella Haemophilus Influenzae Hepatitis B Measles Mumps Rubella DPT Poliomyelitis Hepatitis B** Measles DPT Poliomyelitis BCG *Estimated future use **Used in ~ 50% of global birth cohort
Countries using Hib vaccine in their national immunization system, 2000
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
Why this difference? • Relatively higher prices of new vaccines; and • Lack of technical advice and guidance on introduction of new vaccines
Proportion of Countries introducing Hep B and Hib, by per capita GNP
Causes of death in children less than 5 years old 20% 20% 19% 13% The Global Burden of Disease Murray and Lopez, editors Total - 12.8 million
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)
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)
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
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’)
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
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
Hib vaccine efficacy in the Gambia: Protection against pneumonia and invasive disease 21% efficacy 95% efficacy Source: Mulholland et al. Lancet 1996
Impact of Hib vaccineon Hib meningitis in Uruguay Routine Hib vaccination started - with ‘catch up’ No. Cases Year Source: PAHO
Other conjugate vaccines already in use • Meningococcus • routine infant immunization in UK, Spain, Ireland • Pneumococcus • routine infant immunization in USA
WHO European Region 70 60 Mean annual incidence of Hib meningitis per 100 000 in children <5 years of age 50 40 30 28 30 27 27 22 20 19 20 17 15 14 13 12 11 9 8 8 8 8 10 7 7 6 6 1 1 0 UK Italy Poland Israel Malta Spain France Latvia Austria Finland Greece Bulgaria Sweden Hungary Slovakia Slovenia Denmark Germany Switzerland Netherlands Regional mean Czech Republic Russian Federation Republic of Ireland
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
Where do we go? • Surveillance for Hib disease • Further studies • Hib immunisation needs for special situations- day care centres, special paediatric units
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