Rana A. Hajjeh, M.D.

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• Rana A. Hajjeh, M.D.
• Project Director

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Hib Disease A Serious Problem in Children lt 5
yrs old

• Meningitis
• Hib a leading cause of bacterial meningitis
• Mortality 5 -30
• Permanent long term sequelae 15 - 35
• Pneumonia
• In several studies, Hib accounted for over 20 of
  severe pneumonia
• Mortality 2-20
• Resistance to first line antibiotics increasing
  worldwide

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Hib Disease The Global Burden ( WHO Estimates
- Children lt 5 years old)

• 3 million children with
• serious illness/ yr
• gt 400,000 deaths/yr, orgt1,000 preventable deaths
  each day
• On par with measles (395,000) and HIV/AIDS
  (321,000)

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Hib Disease is Preventable

• Hib conjugate vaccines
• Excellent safety record
• High efficacy ( over 90)
• Compatible with EPI schedules
• Additional advantage Herd immunity

Routine use has led to virtual elimination of
disease in many parts of the world
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The Gambia Hib Vaccine Experience
Incidence of Hib Meningitis/ 100,000 (children lt5
years) in the Western Region of the Gambia
Hib trial
National Immunization with Hib
Adapted from Adegbola R et al. Lancet, 2005
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Hib Vaccine A Missed Opportunity? Countries
with Hib vaccine in EPI - 2005
Hib in EPI
Source WHO/IVB database Data as of August 2005
Yes
No
GAVI/VF Support
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Hib Vaccine in GAVI Eligible Countries a long
way to go.
?
Using Benin, Burkina Faso, Burundi, the
Gambia, Ghana, Guyana, Kenya, Malawi, Mali,
Mongolia, Rwanda, Senegal, Uganda, Yemen, Zambia,
Angola and Ethiopia countries introduced prior
to GAVIBolivia, Cuba, Honduras, Nicaragua
Source WHO Country database
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Despite availability of an effective and safe
vaccine for over 15 years, and availability of
GAVI support for 5 years,

• 75 of the worlds children still dont have
  access to Hib vaccine

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Why are developing countries not adopting the Hib
vaccine?
?
?
?
?
?
?
?
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Barriers for Introduction of Hib Vaccine in
Developing Countries

• Under-recognition of disease burden
• Good surveillance data/ systematic studies rarely
  available
• Limited data from Asia and Eastern Europe
• Disease burden difficult to measure accurately

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Hib - A difficult organism to study

• Organism factors Fastidious, sensitive to
  environment
• Laboratory challenges lack of adequate
  infrastructure
• Lack of good clinical microbiology laboratories,
  adequate supplies
• Specimen handling/ transport
• Access to health care
• Antibiotics before presentation
• Healthcare utilization patterns
• Diagnostic testing
• Meningitis CSF often not obtained
• Pneumonia no sensitive tests

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Barriers for Introduction of Hib Vaccine in
Developing Countries

• Under-recognition of disease burden
• Financial considerations
• High cost 2.50 (monovalent)- 3.65
  (DTP-HepB-Hib)
• Pentavalent vaccine - Single manufacturerno
  reduction in price in 4 yrs
• Concerns about sustainability

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Obstacles for Introduction of Hib Vaccine in
Developing Countries

• Under-recognition of disease burden
• Financial considerations
• Lack of awareness, communication and focus
• Competing health priorities
• Disease burden/ vaccine impact often not
  communicated to or poorly understood by decision
  makers

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GAVI Response

• To expedite and sustain evidence-informed
  decisions at the global, regional and country
  levels regarding the use of Hib vaccination to
  prevent childhood meningitis and pneumonia

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The Hib Inititiative A Consortium of Academic
and Public Health Institutions

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Country Categories GAVI Eligible

• Countries that have introduced Hib vaccine
• - Support evidence-based decisions about the
  continuation of routine Hib vaccination
• Countries that have not introduced Hib vaccine
• - Countries with established disease burden
• - Countries with uncertain disease burden

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Strategy Filling the Gaps
Strategic Communication

• Increase awareness
• Make information reachable
• Share experiences
• Create sense of urgency

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Strategy Filling the Gaps
Strategic Communication

• Increase awareness
• Make information reachable
• Share experiences
• Create sense of urgency

Strategic Research

• Studies to clarify disease burden
• Support surveillance networks
• Support C-E studies if needed

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Strategy Filling the Gaps
Strategic Communication

• Increase awareness
• Make information reachable
• Share experiences
• Create sense of urgency

Strategic Coordination

• Consensus among partners
• Creative solutions to barriers
• Engagement with industry, financial planning,
  supply activities

Strategic Research

• Studies to clarify disease burden
• Support surveillance networks
• Support C-E studies if needed

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A Changing Environment for Hib Vaccine

• WHO SAGE recommendation (preliminary) SAGE
  recommends global implementation of Hib
  vaccination unless robust epidemiological
  evidence exists of low disease burden, lack of
  benefit, or overwhelming impediments to
  implementation
• GAVI Phase II and IFFim provide considerable
  financial resources to countries to purchase Hib
  vaccines for up to a 10-year period
• New vaccines, including some from developing
  country manufacturers, in the pipeline, will
  increase supply and influence price

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New manufacturers expected to ease supply of
pentavalent in coming years

• DTP-Hep B- Hib Manufacturers Stage of
  Development

7 additional manufacturers have products in
development or plan to develop
Sales and Marketing
Licensing/ Regulatory
Clinical Trials
Production
Ph II/III
Ph I

• 1 liquid-lyo

• 1 two-vial liquid

• 3 liquid-lyo
• 1 all liquid

• 1 liquid-lyo
• 1 ??

Up to 5 suppliers of combination vaccines in
production by 2007
Source GAVI Commissioned Boston Consulting
Group Study 2005
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Process Not Business as Usual-Strategic
Focus and Coordination for Hib Vaccine

• Country driven
• Focus on informed decision making
• Consider health system implications
• Maintains active dialogue and builds on existing
  efforts

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Hib Activities

• Visits to five WHO Regional Offices to assess
  needs and priorities
• Consultations in 4 countries in Africa and
  Eastern Europe
• India Burden of Disease Study
• Production of BBC Kill or Cure Hib Documentary
• Regional forums planned

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A Call for Action www.HibAction.org