The Hib Initiative

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					Hib disease and prevention in Africa




    www.HibAction.org
   Hib Disease – The Global Burden
        ( WHO estimates - Children < 5 years old)

• 3 million cases of severe illness
• Approximately 400,000 deaths/year
• The leading endemic cause of bacterial
  meningitis, where Hib vaccine not routinely used
• Important cause of bacterial pneumonia
   – Up to 20% of life-threatening pneumonia
• Resistance to first line antibiotics increasing
  worldwide



        www.HibAction.org
                Hib disease in Africa
• Currently estimated 160,000 annual deaths in children aged less
  than 5 years

• Meningitis
    – Hib: a leading cause of bacterial meningitis (40%-50% of all <5
      cases)
    – Mortality: 20-60% of hospitalized patients
    – 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



         www.HibAction.org
                                           Burden of disease
The African continent has the highest documented
     70       burden of Hib disease
                          60                 Incidence of Hib meningitis in children < 5 yrs of age,
                                             worldwide (pre-vaccine era)
                          50
Cases per 100,000




                          40

                          30

                          20

                          10

                            0
                                o a      r al a        it r a E             a il a le a          .       d d l n
                              as mbi Nige egAfric
                             F a        n           uwaQat arabi UA    n tinBraz nad Chi Cub U. S nlanel anIsrae de
                                                                                                                e
                                                                               a                   Fi Ic
                           a
                        i nhe G       Seuth       K
                                                        di
                                                           A
                                                                  A rgeNE C                                  Sw
                      rk             So             Sa
                                                      u
                    Bu T



                                                                            Source: WHO, literature review, 2002
                                www.HibAction.org
Hib meningitis incidence rates/ 100,000
     Population based studies pre-vaccine, children < 5 yrs of age




Senegal
39
                                                                      Kenya 66
Gambia 58

    Burkina Faso
    34-62
                   Niger
                   60
                                                           South Africa 32




          www.HibAction.org           Source: Hib meningitis in the pre-vaccine era (WHO
                                      2002); Kenya: Cowgill et al, JAMA 8/06.
Pneumonia causes almost a million child
     deaths in Africa every year
   Cause of death in African children under 5 years of age
                        5%
                              6%
                       2%
                                      16%                 HIV/AIDs
                                                          Diarrheal Diseases
                 27%
                                                          Measles
                                        5%                Malaria
 Hib causes up                                            Pneumonia
 to 20% of                                                Neonatal
 severe                              18%                  Injuries
 pneumonia             21%                                Other




                                   Source: WHO 2005 World Health Report
          www.HibAction.org
     Hib - a difficult organism to study

• Organism factors
   – fastidious, sensitive to environment

• Laboratory challenges
   – lack of adequate infrastructure
   – Lack of reagents
   – Lack of expertise


• Clinical issues
   – Readiness to perform lumbar
     puncture
   – Specimen transport delays



           www.HibAction.org
Surveillance underestimates the
    burden of Hib disease

                                Can be identified by
                                surveillance for
                 Culture        invasive disease
                 Positive
               Hib disease

            Culture Negative       Additional cases
             meningitis and
            pneumonia; other       preventable with
           undetected disease        vaccination



  www.HibAction.org
        Hib conjugate vaccines
• Excellent safety record
• Over 95% efficacious for invasive
  disease
• Compatible with EPI schedules
• Significant herd immunity effects due to
  reduction in carriage
          Routine use has led to virtual
          elimination of disease


     www.HibAction.org
Gambia: Incidence of Hib meningitis in
  GAMBIA: Incidence of Hib meningitis in children under 5 yrs of
                age, cases per 100,000 per yrs
     children under 5 year of age
                             100                                                                                                         National Immunization
cases per 100,000 per year




                                                                               Hib Trial                                                       Program
                              90
                              80
                              70
                              60
                              50
                              40
                              30
                              20
                              10
                               0
                                   Jan 1990


                                              Jan 1991


                                                         Jan 1992


                                                                    Jan 1993


                                                                                  Jan 1994


                                                                                             Jan 1995


                                                                                                        Jan 1996


                                                                                                                   Jan 1997


                                                                                                                              Jan 1998


                                                                                                                                          Jan 1999


                                                                                                                                                     Jan 2000


                                                                                                                                                                Jan 2001


                                                                                                                                                                           Jan 2002
                                                                                                                                  Source: Adegbola et al.,
                                        www.HibAction.org                                                                         Lancet 2005; 366:144-150
Hib vaccine has proven impact in Africa and
   developing countries around the world




                                Bahrain
                                Qatar
                                Kuwait
                                UAE             Bangladesh
           Dominican Republic
           Chile
                                 Kenya                Indonesia
           Uruguay
           Argentina             Uganda
                                 South Africa                     Fiji
                                 The Gambia
                                 Malawi
                                 Ghana
                                 Rwanda




      www.HibAction.org
                               November 24, 2006

WHO Position Paper on Haemophilus
Influenzae type B Conjugate Vaccines
In view of their demonstrated safety and efficacy, Hib
conjugate vaccines should be included in all routine
infant immunization programmes.

Lack of local surveillance data should not delay the
introduction of the vaccines, especially in countries
where regional evidence indicates a high disease
burden.



       www.HibAction.org
Timeline of Hib vaccine introductions
            GAVI-eligible countries




    www.HibAction.org
Routine Hib immunization programs 2008
Over 130 countries, including 66 GAVI countries, have introduced
     Hib vaccine or are expected to introduce by 2009-2010




                                72 GAVI countries:
                                   Introduced/plan to introduce (66)
            Non-GAVI country
            introductions           No GAVI application made (6)


                                                        Source: WHO/Hib Initiative database

                                                         February 2009
        www.HibAction.org
Progress of introduction of Hib vaccine
   36 GAVI-eligible countries in AFRO region



 AFRO region

    Introduced
    Planning to introduce in 2008-2009 *
    Hib vaccine in Multi-year Plan


    Not eligible for GAVI support
    Countries in EMRO region




                                      * Approved to introduce with GAVI support
                                             (WHO and Hib Initiative data as of January 2009)
          www.HibAction.org
The Value of Vaccinating Against Hib

 •   End preventable child mortality
 •   Important for reaching MDG #4
 •   Highly cost effective
 •   Health improves wealth
     – Education, Productivity, Investment




       www.HibAction.org
Cost-effectiveness of Hib vaccine
• Studies from multiple regions have shown Hib vaccine
  to be cost- effective

• In Kenya, $38/DALY and $1197/death averted (Akumu
  et al. Bull WHO 2007) = highly cost effective

• In Bangladesh, $250/death averted (2005) = highly
  cost effective

• In Lombok, Indonesia, Hib vaccine shown to be highly
  cost effective (submitted for publication)



        www.HibAction.org
          Hib vaccine formulations
• Monovalent (Hib) – 3 pre-qualified products available*
• Tetravalent (DTP-Hib) – 3 pre-qualified products available
• Pentavalent (DTP-HepB-Hib)
   – 5 pre-qualified products available
   – Preferred formulation in the majority of countries
   – Expecting additional pre-qualifications in 2009
• Other DTaP based combinations available

 Formulations fit into current EPI schedules
 Combinations have the potential to reduce wastage and increase
  coverage of Hepatitis B
     *5 pre-qualified, 3 procured by UNICEF



                                                          Jan-2009
       www.HibAction.org
  Currently pre-qualified Hib vaccines:
                     pentavalent (DTP-HepB/Hib)
                                        As of Jan 2009
Manufacturer                          Formulation                Vial size         UNICEF 2009
                                      (DTP-HepB/Hib)                               price /dose*
GSK (2 formulations)                  Liquid/Lyo**               2 dose            $3.50
Crucell (Berna)/ Novartis,
Shantha Biotech,                      Liquid                     1 dose            $3.41
Panacea Biotech
Shantha Biotech                       Liquid                     10 dose           N/A***


    * Weighted average price
    **Liquid DTP/Hep B is mixed with lyophilized (freeze dried) Hib prior to use
    *** No established demand




                                                                                            Jan-2009
              www.HibAction.org
   Currently pre-qualified Hib vaccines:
                             monovalent and tetravalent
                                 As of Jan 2009
Manufacturer (s)                 Formulation                                 Vial size      UNICEF 2009
                                                                                            Price/dose*
Sanofi Aventis, (GSK,            Hib                   Lyophilized**         1 dose         $3.40
Serum Institute***)

Novartis , Merck                 Hib                   Liquid                1 dose         N/A***
Novartis                         DTP-Hib               Liquid                10 dose        $3.40
Panacea Biotech                  DTP-Hib               Liquid                1 dose         N/A***
Sanofi Aventis                   DTP+Hib               Liquid/Lyo****        10 dose        $3.20


             * Weighted average
             **Hib is supplied with a liquid diluent for reconstitution prior to use
             ***No awards given ****Liquid DTP is mixed with lyophilized Hib prior to use



                                                                                             Jan-2009
                  www.HibAction.org
             Vaccine Landscape Analysis
                           Hib containing vaccine pipeline by 2015
                     GAVI-ELIGIBLE COUNTRY RELEVANT VACCINES*



                           Monovalent                     Tetravalent                     Pentavalent
                                                                                                             Total Vaccines
                                 Hib                       DTwP-Hib                 DTwP-HepB-Hib
                          Lyo          Liquid        Liq/Lyo          Liquid       Liq/Lyo         Liquid   Liq/Lyo     Liquid
  Total                     5              4              1              2                5          9        11         15
Expecting
WHO PQ                             9                              3                           14                   26




*Subset   of the total 58 products; includes all products (licensed and in development)


                                                                                                              As of Jan-2009
                       www.HibAction.org
             Pentavalent DTP-HepB/Hib
             Product Timeline Summary
                                                  WHO Pre-Qualified Approval
                                                  NRA Licensure Not Pre-Qualified

                                                                                   9 liquid products
Liquid                                                                             could be pre-
                                                                                   qualified by 2015




                                                                                   5 liquid/lyo
Liquid                                                                             products could be
/lyo                                                                               pre-qualified by
                                                                                   2012


         2005 2006   2007 2008 2009   2010 2011   2012   2013   2014 2015   2016    2017 2018   2019   2020




                                                                                      As of Jan-2009
           www.HibAction.org
GAVI helps make vaccine purchases
            affordable
            New & Under-used Vaccines Support
             Minimum co-financing/dose (US$)

                                             COUNTRY GROUPINGS

        Vaccines              Poorest      Intermediate       Least Poor       Fragile States

                                                                  .30
        First Vaccine           .20             .30          (+15% annual            .10
                                                               increment)

                                                                  .15
     Additional Vaccines        .15             .15          (+15% annual            .15
                                                               increment)




                           Products available for financing include:
  DTP-Hepatitis B(HepB), DTP-Hib, DTP-HepB/Hib, pneumococcal vaccine,
     rotavirus vaccine, yellow fever and second-dose measles vaccine




                                          Co-finance payments are fixed through 2010 except for least poor
                                          countries whose co-payment increases annually. Funding is available for
     www.HibAction.org                    the duration of the country’s planning and budget cycle, up to 2015
        Affordable supply is achievable
                                                  2007: 2
1. Demand in                                     pentavalent
   developing countries
                                                suppliers pre-
   is increasing                 Increased        qualified
                                  demand



3. Prices expected to
                                                        2. Additional
   begin declining in                        Expanded      developing
   2-3 years as                               supply
   demand increases       Lower                            country
                                                           manufacturers
   and supply             prices                           have submitted/
   increases
                                                           will submit for
                                                           pre-qualification



             www.HibAction.org
   Addressing programmatic concerns
• Pentavalent (DTP-HepB-
  Hib) vaccines are a
  preferred formulation in
  many developing countries
  –   Convenience
  –   No changes in schedule
  –   Improvements in coverage
  –   Reduced wastage, fewer
      needles used



           www.HibAction.org
    Supporting country efforts to take
evidence-informed decisions regarding the
            use of Hib vaccine




      www.HibAction.org
                     Mission
‘To expedite sustainable evidence-informed decisions
 at the global, regional, and country levels regarding
   the use of Hib vaccination to prevent childhood
              meningitis and pneumonia’


• Country driven
• Focus on decision making
• Considers health system implications



      www.HibAction.org
    Strategic Approach
               Communication




                     Evidence-
                     informed
                     decisions
       Research
          and                    Coordination
      Surveillance




www.HibAction.org
               Summary (1)
• Hib is a leading cause of bacterial
  meningitis in African children in countries
  not yet using vaccine
• Pneumonia is the leading cause of
  infectious death in African children under
  5 years old
• Hib accounts for a substantial proportion
  of pneumonia in children


     www.HibAction.org
               Summary (2)
• Hib vaccine: safe, effective and
  recommended for all routine infant
  immunization programs
• Pentavalent vaccine supply is increasing and
  prices are expected to decline
• GAVI funding provided through 2015 with
  country co-payment




     www.HibAction.org
Help reduce childhood meningitis and pneumonia today




                  www.HibAction.org



        www.HibAction.org

				
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