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GAVI Vaccine Investment Strategy Rabies Analysis Final October 27, 2008 Rabies CONTENTS Disease Overview Vaccine Landscape Vaccination Policy & Strategies Vaccine Need & Adoption Forecast Vaccine Cost Analysis Implementation-Associated Cost Analysis Analysis Summary Key Resources

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gavi vaccine investment strategy

GAVI Vaccine Investment Strategy

Rabies Analysis

Final

October 27, 2008

rabies
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
disease overview
Disease Overview

DISEASE PATHOGEN, TRANSMISSION & TARGET POPULATION*

DISEASE PATHOGEN, TRANSMISSION & TARGET POPULATION1

  • Disease Pathogen
    • Rabies Virus (lyssavirus)
  • Transmission
    • Usually dog bites in developing countries; animal to person via saliva from a bite
    • Incubation periods have been as short as 5-6 days, in the majority of cases is 20-60 days
  • Geographic Distribution
    • Most human cases are in rural areas of Africa and Asia
  • Disease Target Population
    • All ages are susceptible, however, rabies is most common in ages 5-15 years old, the majority of whom are male
disease overview4
RabiesDisease Overview

DISEASE IMPACT2,3

  • Total Morbidity
    • >10 million suspected cases per year in developing countries
    • Rural poor and children are most at risk
  • Total Mortality
    • ~55,000 cases reported annually and thought to be grossly underreported with the majority of deaths occurring in Asia and Africa
    • Case fatality rate is 100% once clinical symptoms present (with exception of one known survivor to date)
  • Epidemic Potential
    • Human outbreaks can occur as a result of epidemics in the animal population and/or when a rabid animal bites multiple people
  • Disease Sequelae
    • Permanent neurological sequelae in the one survivor to date
disease overview5
RabiesDisease Overview

DISEASE BURDEN – GEOGRAPHIC DISTRIBUTION4

Note: “This figure is an unrealistic representation of the true epidemiological situation as a result of problems with reporting biases, e.g. dog rabies is endemic throughout Africa” - Partners for Rabies Prevention Informal Group (PRP)

disease overview6
RabiesDisease Overview

0

=

None Reported

Data Not Available

or Non-Endemic

=

DISEASE BURDEN IN GAVI-ELIGIBLE COUNTRIES – MORBIDITY5

4

disease overview7
RabiesDisease Overview

None Reported

Data Not Available

or Non-Endemic

0

=

=

DISEASE BURDEN IN GAVI-ELIGIBLE COUNTRIES – MORTALITY6,7

4

GAVI Vaccine Investment Strategy

Vaccine Landscape Analysis_Cholera_Apr08

disease overview8
RabiesDisease Overview

NON-VACCINE PREVENTION & TREATMENT INTERVENTIONS8

  • Non-Vaccine Preventions
    • Control and vaccination of domestic dogs and wild carnivores
  • Treatment Interventions
    • Post-exposure prophylaxis rabies vaccination and passive immunoglobulin administration around the wound (to neutralize the virus before it enters the CNS)
    • After symptoms ensue there is no recognized effective treatment
disease overview9
RabiesDisease Overview

INEQUITIES8

  • Inequity of Poor
    • Poor access to post-exposure prophylaxis and increased inability to control and vaccinate dogs exists in low socioeconomic areas
  • Gender Inequities
rabies10
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
vaccine landscape
RabiesVaccine Landscape

LICENSED VACCINES* (I)

*PEP dosing only

vaccine landscape12
RabiesVaccine Landscape

LICENSED VACCINES* (II)

*PEP dosing only

slide13
Rabies

First NRA Licensure

WHO Pre-Qual Approval

Vaccine Landscape

ESTIMATED VACCINE AVAILABILITY

RabAvert/Rabipur (Novartis)

Rabivac (Novartis/Chiron-Behring)

Imovax Rabies (Sanofi-Pasteur)

Verorab (Sanofi-Pasteur)

PDEV*(Zyddus Cadila)

Emerging Supplier (Bharat, SII)

BioRab (BioPort)

Rabies Vaccine (Vaccine China Biol)

(if motivated)

Prior to 2009

2009

2010

2011

2012

2013

vaccine landscape analysis
RABIESVaccine Landscape Analysis

COST EFFECTIVENESS LITERATURE SUMMARY

  • Post-exposure rabies prophylaxis is estimated to prevent 330,304 (90% CI: 141,844 - 563,515) deaths in Asia and Africa. Rabies is responsible for an estimated 1.74 million (90% CI: 0.25M – 4.57M)DALYs. Global expenditure for rabies prevention is over $1 billion.16
  • A 1996 study demonstrated that pre-exposure rabies prophylaxis for the international travelerwas worth$275,000 per case averted.17
  • Cost comparison of rabies pre-exposure vaccination to post-exposure vaccination in Thai childrenshowed that pre-exposure vaccination was cost-effective when the dog bite incidence is 2% to 30% of the population.18
rabies15
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
vaccination policy strategies17
Vaccination Policy & Strategies

VISP DECISION FRAMEWORK

GAVI VIS Rabies

Decision Framework

Support Strategies for

Financial Planning Purposes

PEP Only

Offer Vaccine Financing

to GAVI-Eligible Countries

  • Develop & implement pilot programs in 2-3 countries
  • Monitor & evaluate impact and develop recommendations

Pilot Regional Bite Center

& District Hospital Studies to Demonstrate Impact

of GAVI Support

  • Develop educational programs aligned with national rabies prevention control strategies
  • Implement pilot programs in 2-3 countries
  • Monitor & evaluate impact and develop recommendations

Pilot Rabies

Education Programs to Demonstrate Reduced Disease Burden Impact

Provide Alternative

Investment Support

Fund RIG Capacity

Building in GAVI Countries

To Eliminate Shortages and Reduce Treatment Costs

  • Accelerate tech transfer of RIG to emerging suppliers
  • Motivate supplier capacity development

Don’t Support

in 2009 - 2013

rabies18
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
vaccine need adoption forecast
Vaccine Need & Adoption Forecast

GAVI-ELIGIBLE COUNTRY VACCINE NEED

Vaccine Need: 49

VISP Scope: 49

  • The vast majority of deaths due to rabies occur in Asia and Africa (WHO position paper, Dec07); the current countries in scope represent countries with high rabies incidence or countries in need of rabies education and vaccination with safe rabies vaccines (F. Meslin, WHO & D. Briggs, Alliance for Rabies Control)
vaccine need adoption forecast20
Vaccine Need & Adoption Forecast

INTEGRATED ADOPTION FORECAST

Vaccine Need: 49

VISP Scope: 49

Armenia

Benin

CAR

Lao

Mali

Nepal

Pakistan

Rwanda

Tajikistan

Uzbekistan

Bangladesh

Bolivia

Djibouti

Georgia

Haiti

Honduras

Korea

Nicaragua

Uganda

Bolivia

Burkina Faso

Cameroon

Ethiopia

India

Tanzania

Togo

Sri Lanka

Viet Nam

Cambodia

Cameroon

Chad

Cote d’Ivoire

Kenya

Malawi

Senegal

Sudan

Zimbabwe

Angola

Indonesia

Mozambique

Zambia

Azerbaijan

Kyrgyzstan

Ukraine

Madagascar

Nigeria

DR Congo

Ghana

Afghanistan

vaccine need adoption forecast21
Vaccine Need & Adoption Forecast

RABIES DEMAND METHODOLOGY

Total Country Population

Rural Population

Urban Population

%

Rural

%

Urban

AFRO: 100%

AMRO: 50%

EMRO: 50%

EURO: 50%

SEARO: 100%

WPRO: 100%

AFRO: 75%

AMRO: 50%

EMRO: 50%

EURO: 50%

SEARO: 100%

WPRO: 100%

%

Rural at Risk

%

Urban at Risk

At Risk Rural Population

At Risk Urban Population

(Based on UN data)

Rural Suspect Bites

Urban Suspect Bites

Rural Suspect Bite Rate

Urban Suspect Bite Rate

% Rural Bites Presen-ting

% Urban Bites Presen-ting

90%

AFRO: 1000/M

AMRO: 500/M

EMRO: 500/M

EURO: 500/M

SEARO: 1000/M

WPRO: 1000/M

AFRO: 1000/M

AMRO: 500/M

EMRO: 500/M

EURO: 500/M

SEARO: 1200/M

WPRO: 1200/M

75%

Rural Bites Presenting

Urban Bites Presenting

Rural Bites Tx with ID

Urban Bites Tx with ID

30% ID

90% ID

10% IM

70% IM

Rural Bites Requiring RIG

Urban Bites Requiring RIG

% Rural Bites Req. RIG

% Urban Bites Req. RIG

Rural Bites Tx with IM

Urban Bites Tx with IM

66%

66%

vaccine need adoption forecast22
Vaccine Need & Adoption Forecast

CURRENT COUNTRY SUPPORT AS PERCENT OF TOTAL NEED

  • Rabies experts provided estimate of current country-by-county vaccine usage as percent of total need*
  • Approximately 35% of total GAVI-eligible country vaccine requirements are currently being supported by countries themselves

* F. Meslin, WHO & D. Briggs, Alliance for Rabies Control

vaccine need adoption forecast23
Vaccine Need & Adoption Forecast

GAVI VACCINE FINANCING POLICY

  • As a matter of policy, GAVI does not replace country funds already allocated to rabies vaccines
  • However, most countries are under resourcing rabies vaccination due to:
    • High cost of vaccine and rabies immunoglobulin
    • Vaccine and immunoglobulin supply shortages
  • Therefore, GAVI would only plan to financially support the difference between actual vaccine need and percent of need currently covered by country
  • This incremental need assessment will be complicated given a country’s level of funding in any given year is influenced by many factors and may differ year on year
  • This analysis is focused on GAVI-eligible countries’ total need
vaccine need adoption forecast24
Vaccine Need & Adoption Forecast

VACCINE DEMAND GIVEN INTEGRATED FORECAST

rabies25
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
vaccine cost analysis
Vaccine Cost Analysis

ANALYSIS INPUT SUMMARY – GENERAL

vaccine cost analysis27
Vaccine Cost Analysis

ANALYSIS INPUT SUMMARY – STRATEGY-SPECIFIC

rabies28
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
    • Post-Exposure Prophylaxis (PEP)
    • Additional Investment Alternatives
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
slide29
PEP

KEY OUTPUT SUMMARY Integrated Demand Forecast

2009-2020

slide30
PEP

ANNUAL ANALYSIS RESULTS Integrated Demand Forecast

2009-2020

rabies31
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
    • Post-Exposure Prophylaxis
    • Additional Investment Alternatives
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
additional investment opportunities
Additional Investment Opportunities

BACKGROUND OF UNDERSTANDING

  • Although rabies has the highest case fatality rate of any disease known to mankind, preventing human rabies in reality is not a complicated issue as it is one of the easiest diseases to prevent
  • There are three basic steps to preventing human rabies:
    • Increase educational awareness activities to reduce exposures, increase professional expertise and improve diagnoses and surveillance
    • Administer prompt and appropriate post-exposure prophylaxis (PEP) when exposures do occur
    • Conduct preventative immunization (PreP) to protect the relatively few numbers of the populace that are living in high-risk, remote geographic locations with no access to PEP
  • It has been proven in many countries that if and when these three steps are instituted the number of human rabies deaths quickly and dramatically decreases
additional investment opportunities33
Additional Investment Opportunities

OPTION A*

Pilot PEP in Select Countries

To Demonstrate GAVI Impact

  • Experience over two decades has proven that reduced dose regimens for PEP are both efficacious and cost-effective
    • Updated Thai Red Cross (TRC) intradermal (ID) regimen or “2-2-2-0-2” is most cost effective PEP regimen recommended by WHO
    • TRC has increased access to vaccines in poor countries and has reduced the PEP cost per patient from 40 to 80%
  • Awareness as to the utilization and benefit of reduced dose regimens is lacking in most poor countries where it could be of great value
  • By piloting ID PEP in 4 select countries (2 in Asia & 2 in Africa), GAVI can demonstrate the health impact and cost reduction potential of this approach
    • With pilot PEP data, GAVI can then decide whether to extend support to all relevant GAVI-eligible countries
  • Estimated Total 5-Year Budget: $6M ($300K/year/country)
    • Vaccine + RIG: $2 million
    • Service Delivery: $400,000 annually
    • Social Mobilization/Education: $400,000 annually

* Potentially eligible for GAVI Operations Research funding, if available

additional investment opportunities34
Additional Investment Opportunities

OPTION B

Support Rabies Education Programs to Reduce Disease Burden

  • Rabies is one of few diseases that can be dramatically reduced through increased education
  • Activities to improve educational awareness is inadequate in most poor developing countries
  • Educational initiatives specifically targeted for national governments, professional public health staff and the general public are clearly the least expensive of investments that would result in the highest return in lives saved within the shortest amount of time.
  • Education for professionals in poor developing countries would include:
    • Use of intradermal (ID) administration for PEP
    • Dissemination of latest WHO recommendations
    • Increased awareness of source of rabies
    • Training on modern diagnostic tools currently available for rabies confirmation
  • Estimated 5-Year Budget per Country: $1.2M
    • Education materials development: $200,000
    • Education and training: $200,000 annually
additional investment opportunities35
Additional Investment Opportunities

OPTION C

Fund RIG Capacity Building

To Eliminate Shortages

and Reduce costs

  • Rabies immunoglobulin (RIG) is the most expensive component of rabies treatment needed for approximately 66% of all suspect bites
  • Strengthening the production of equine RIG and supporting the development of alternative technologies to replace equine RIG is critical for ensuring adequate supplies and lowering the current price
  • Estimated 5-Year Budget: $4M
    • Equine RIG: $3M
    • Monoclonal antibody preclinical and clinical testing: $1M
rabies36
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
implementation associated cost analysis
Implementation Associated Cost Analysis

typical IMPLEMENTATION CHALLENGES

implementation associated cost analysis38
Implementation Associated Cost Analysis

UNIQUE IMPLEMENTATION CHALLENGES

implementation associated cost analysis39
Implementation Associated Cost Analysis

POTENTIAL IMPLEMENTATION SYNERGIES

Traditional = Routine EPI vaccines includes Baccillus Calmette-Guérin (BCG), Diphtheria-tetanus-pertussis (DTP) , measles containing vaccines (MCV), oral polio (OPV), Tetanus toxoid (TT)

  • Vaccine-Specific Synergies
  • No vaccine-specific synergies were identified
  • Other Synergies
  • No other synergies were identified
implementation associated cost analysis41
Implementation Associated Cost Analysis

Quantitative Cost Assessment – PEP

WHO GIVS Study: Wolfson LJ, Gasse F, et.al., WHO, Estimating the costs of achieving the WHO-UNICEF Global Immunization Vision and Strategy, 2006-2015, BLT (2008) 86(1)

rabies42
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
analysis summary
Analysis Summary

KEY METRIC SUMMARY

rabies44
Rabies

CONTENTS

  • Disease Overview
  • Vaccine Landscape
  • Vaccination Policy & Strategies
  • Vaccine Need & Adoption Forecast
  • Vaccine Cost Analysis
  • Implementation-Associated Cost Analysis
  • Analysis Summary
  • Key Resources
key resources
Key Resources

EXPERT CONSULTATION

  • Vaccine Experts
    • Francois Meslin, Head of Zoonotic Disease, WHO
    • Deborah Briggs, Board of Directors, Alliance for Rabies Control
    • Sarah Cleaveland, Board of Directors, Alliance for Rabies Control
    • Charles Rupprecht, Chief of the CDC Rabies Program, CDC
    • Herve Bourhy, Director of the WHO Collaborating Center for Rabies, Institute Pasteur
  • Suppliers
    • Michael Attlan, Marketing Director, Sanofi
    • Shawn Gilchrist, Sanofi
    • Ferdinando Borgese, Global Brand Manager, Novartis Vaccine
    • John-Kenneth Billingsley, Executive Director, Novartis
    • Olga Popova, Director Government Affairs, Crucell
appendix
RABIESAppendix

REFERENCES (I)

  • Plotkin et al, Vaccines, 5th Edition, Chap. 27, 2008.
  • Weekly Epi Record, No. 49/50, 2007, 82, 425-436, 7Dec07.
  • WHO, Disease Outbreak News, Rabies, www.who.int/csr/don/archive/disease/Rabies_disease/en/, Mar 2008.
  • WHO, Essential rabies maps, www.who.int/rabies/rabies_maps/en/index.html.
  • WHO, RabNet, “Human rabies, number of people bitten by suspected dogs per 100,000 population,” www.who.int/globalatlas/default.asp, Mar08 (data is incomplete or not reported).
  • WHO, RabNet, Human rabies deaths, www.who.int/globalatlas/default.asp, Mar08 [Mortality = Average of reported deaths between 2000-2007].
  • UN Population Division, World Population Prospects: The 2006 revision population database, esa.un.org/unpp/index.asp?panel=2 [Mortality Rate = Mortality/(Population) x 1,000,000].
  • Plotkin et al, Vaccines, 5th Edition, Chap. 27, 2008.
appendix47
RABIESAppendix

REFERENCES (II)

WHO Prequalified Vaccines, www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/index.html.

RabAvert Package Insert, www.novartis-vaccines.com/products/Rabavert_PI_0404.pdf; www.novartisvaccines.com/products/travel.shtml.

Imovax Product Insert, www.vaccineshoppe.com/image.cfm?doc_id=5983&image_type=product_pdf.

Travel Med Infect Dis. 2007 Nov;5(6):327-48. Epub 2007 Sep 17; www.ncbi.nlm.nih.gov/pubmed/17983973.

Berna Biotech recently transferred to Cadila Health Ltd, an Indian manufacturer; Zyddus Cadila is currently seeking WHO prequalification according to Partners for Rabies Prevention Informal Group; RIG = rabies immunoglobulin; TRC Verorab (Thai Red Cross)

Plotkin et al, Vaccines, 5th Edition, Chap. 27, 2008.

Correspondence with WHO and Partners for Rabies Prevention Informal Group (PRP), June-August 2008.

appendix48
RABIESAppendix

REFERENCES (III)

WHO, Weekly Epidemiology Record, No. 49/50, 2007, 82, 425-436, 7Dec07.

LeGuerrier P, et al, Pre-exposure rabies prophylaxis for the international traveler: a decision analysis; Vaccine, 14(2):167-176, 1996.

Chulasugandha P, et al, Cost comparison of rabies pre-exposure vaccination with post-exposure treatment in Thai children, Vaccine, 24(9): 1478-1482, 2006.

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