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Vaccines and diagnostics—The case for regional One
Health centres of excellence
One Health Colloquium: Sustainable livestock and disease control - exploring
the links to climate change, improving human nutrition and the refugee crisis,
London, 31 May – 1 June 2016
Delia Grace, Phil Toye, Shirley Tarawali and Vish Nene
Overview
• One health
– Definitions
– ILRI working in a OH paradigm
– OH addressing vaccine delivery and use
• Case studies
– East Coast Fever vaccine
– Newcastle disease vaccine
– Diagnostics for TBD
• Conclusions
Health is “a state of complete physical, mental, and social well-being
and not merely the absence of disease or infirmity”(World Health
Organisation).
One Health "the collaborative effort of multiple disciplines —
working locally, nationally, and globally — to attain optimal health
for people, animals and the environment” (One Health Commission).
Ecohealth “recognizes complex biophysical, social, cultural, political
and economic relationships between the ecosystem and human
health” (National Council for Science and the Environment).
Health and One Health
4
Human
health
Societies, cultures,
Economies, institutions
Policies
Agroecosystem
health
Animal
Health
Vet
Pub
Health
EcoHealth
One
medicine
ONE HEALTH
Wildlife
health
Plant health
International Livestock Research Institute
•a member of the CGIAR Consortium, ILRI conducts livestock, food and
environmental research
 to help alleviate poverty
 and improve food security, health & nutrition,
 while protecting the natural resource base.
CIMMYT
Mexico City
Mexico
IFPRI
Wash. DC
USA
CIP
Lima
Peru
CIAT
Cali
Colombia
Bioversity
International
Rome Italy
IITA
Ibadan
Nigeria
ILRI
Addis Ababa
and Nairobi
World
Agroforestry
Nairobi
ICARDA
Beirut
Lebanon ICRISAT
Patancheru
India
IWMI
Colombo
Sri Lanka
IRRI
Los Banos
Phillippines
World Fish
Penang
Malaysia
CIFOR
Bogor
Indonesia
International Livestock Research Institute
• Founded in 1974
• Budget: around US$80 million
• Staff: 750: Senior scientists from 39
countries: >half from developing
countries
• 34% of internationally recruited staff
are women --and 50% of the senior
leadership team
• Main campuses in Kenya and Ethiopia,
and offices in 16 other countries
around the world
ILRI experiences: Knowledge transfer, disease control and
innovation in vaccines and diagnostics
• East Coast fever vaccine: ILRI involved development,
manufactured and transferred vaccine use to northern
Tanzania and manufacturing to CTTBD in Malawi
• Newcastle disease vaccine for village poultry: ACIAR
led development, widely promoted, recently evaluated
by ILRI in Tanzania
• Tick borne disease diagnostics: ILRI developed and
runs diagnostics
East Coast fever (ECF)
 ECF present in 12 countries; it could spread to 8 more
 Caused by a tick-transmitted protozoan – Theileria parva
 ~28 million cattle at risk; ~1million deaths/year; losses > 300 $ million a year
 Small-holder farmers who would benefit from control: ~ 20 million
 Not zoonotic: affects food supply, livelihoods, and vulnerable groups
Infection and treat method
Control milestones
• 1911-14: 283,000 cattle vaccinated in S. Africa, low
success rate
• 1911-1940: “T” brand oxen Kenya- exposed & immune
• 1980: DANIDA projects in Malawi, Zambia, Zimbabwe,
Kenya
• 1983: Field use endorsed by FAO expert panel
• 1996: First commercial vaccine batch produced at
ILRAD
• 2012: Authorized for dairy cattle in Kenya
• 2014: CTTB Malawi launched
• 2016: vaccine used Malawi, Kenya, Tanzania, Uganda
Research contributions
• 1928: Tick homogenates produce immunity and can be stored (Theiler & du Toit)
• 1953: OTC prevent reactions after vaccination (Neitz in S Africa)
• 1954-57: Cocktail method developed in the Congo and Rwanda (Jezierski et al)
• 1973: Sporozoite stabilates (Cunningham in Kenya)
• 1975: Muguga cocktail
• 1993: 30% solution
Donor investments
• 1967: UNDP funded tick program at EAVRO develops ITM: continues at KARI and ILRAD
• 1980: DANIDA projects in Malawi, Zambia, Zimbabwe, Kenya
• 1996: First commercial vaccine batch produced at ILRAD
• 2004: GALVmed founded – ECF a disease of focus
• 2014: CTTB Malawi launched
• 2016: vaccine used Malawi, Kenya, Tanzania, Uganda
Challenges to availability of appropriate
new products
Discovery
Research
Development Registration Production
Commer-
cialisation
Sustained
delivery
Technical
challenges.
Lack of
appropriate
product profiles
Ill-designed
proofs-of-concept
Lack of funding for
development studies
- high risk,
high cost.
Poorly designed,
poorly controlled
field trials.
Unclear and varied
regulatory
requirements.
Lack of QA/QC.
Multiple regulatory
authorities.
Lack of market
pull-through
Poor estimates of
need or demand
Inappropriate
pack-sizes
Lack of knowledge
or education on
proper use
Inconsistent
supply
Counterfeit
products.
Lack of patent
protection.
Poor quality and
efficacy.
No commercial
interest
Expensive
processes
No process
development
A technical and market-based approach to
delivery
Success of ITM in Zambia and Tanzania
Since 1990s around 1.5 million cattle vaccinated – 1% of cattle at risk during that time
Most in Zambia and Tanzania
1982-2002 Belgian veterinary support project
• Local Katete strain
• Calf mortality reduced from 33% to 3%. Cost $10
• First year of charging: only 10% of farmers brought calves
2008-2014 IFAD project $15 million
• 300,000 vaccinated – around 20% of the at risk population
• Farmers pay 15% cost – revolving fund – unlikely to be sustainable
Success of ITM in Zambia and Tanzania
Since 1990s around 1.5 million cattle vaccinated – 1% of cattle at risk during that time
Most in Zambia and Tanzania
1995- 1998 ITTBD in Northern Tanzania
• 10-20,000 a year vaccinated
• Pastoral areas
2004-16 VetAgro private sector,
• Around 80,000 a year, up to 80% of calves
• full cost recovery ($10 a calf)
• 2006 FAO subsidy, 2012-13 GALVMed, 2014 USAID
Transfer, impact and challenges
• MC produced on commercial basis by CTTBD
• GALVmed targets 2 million doses a year
Technology
• Live vaccine
• Production demanding
• Breakthrough infections
• Liquid nitrogen cold chain
Delivery
• Relatively high cost $9-17
• Distribution has high financial risk
• Production and much delivery outside private sector
Newcastle disease
 Worldwide distribution; caused by virus; emergence potential
 Major poultry disease: 30-80% of village chickens die each year
 Minor zoonoses; impacts on livelihoods and food & nutrition security
 Strong gender dimension: most owned by women
 Epidemic disease and hence communal action important
History of Newcastle disease vaccination
• 1927 virus isolated from outbreak in Newcastle
• Spread rapidly in Asia and more slowly to rest of the world
• Second pandemic in late 1960s, devastated poultry industries
• Brought under control using live vaccines
• 1984 ACIAR started to fund research into ND in village poultry
• A new strain I-2 developed at the University of Queensland for village poultry
2003-2005 SANDCP project funded by Australia
• Mozambique, Malawi and Tanzania
• Participatory, gender-responsive, sustainable, approach
• Informed by one health thinking
• With support from production to end use and cost recovery
A one health approach to delivery
TRANS-DISCIPLINARITY
PARTICIPATION
EQUITY
Social
Political
Economic
Ecological
0
10
20
30
40
50
60
70
80
90
100
Is currently using
ND vaccine
Has ever used ND
vaccine
Knows how they
work
Has heard of ND
vaccine
Heard about
vaccine
Active
Inactive
Wyatt et al., 2012
Farmer knowledge and practice
EO: Farmers lie about diseased chicken to get
them vaccinated….
I train the vaccinators on handling, giving
injections, side affects
Vx: People complain about the
amount charged….
3 out of 10 don’t pay…..
I have received no training…
Some sell vaccine to rich households and
use water to vaccinate the birds of the poor
households to make money
FGD: We are willing to pay 100 TSH
(twice the price currently charged)
Wyatt et al., 2012
0 2 4 6 8 10 12 14 16 18
Lost from ND last year
Chickens currently owned
No project
After project
Best case: losses still high
Wyatt et al., 2012
P<0.001
56%
37%
0%
10%
20%
30%
40%
50%
60%
Unprotected Protected
Overall n=429
Proportion flock lost to ND
n.s
Tick-borne diseases diagnostics
• Ticks and tick-borne disease
• Important cattle disease; zoonotic potential
0
200
400
600
800
1000
1200
1400
1600
1800
2000
GITparasites
AAT
TicksandTBD
Heartwater
PPR
Newcastle
CBPP
BVD
Ectoparasites
FMD
LSD
Brucellosis
bTB
Gumboro
ASF
ECF
Shoatpox
Brucellosis
Coccidiosis
Dermatophilosis
CCPP
Footrot
Mastitis
Echinococcosis
Aflatoxicosis
Erysipelas
Cysticercosis
MillionUSD
ILRI diagnostics for ticks and tick-borne
disease
• ELISA for: Theileria parva, Theileria mutans, Babesia bigemina, B. bovis,
trypanosomes, Anaplasma marginale
• ELISA tests for 4 major TBDs – developed ~ 20 years ago
• Used mainly for resarch
• Anaplasma and Babesia tests offered commercially
• Point-of-care assays (lateral flow) for human trypanosomiasis (with FIND),
cysticercosis (ASARECA) and PPR (Pirbright)
• Development proof of concept
• Business plan developed for cysticercosis tests but not funded
Use of tick borne diagnostics
• Explored commercial production but not viable
2012-2014
12,503
7,524
In house
External
Vaccines: good efficacy but (so far) less impact,
Dx: high impact factors, hard to attribute impacts
Conclusions
• Impact that scales:
• Vaccines intuitively enormously attractive
• Adoption by smallholders and pastoralists
challenging
• Evidence that counts:
• Insights into disease require investments into
infrastructure
This presentation is licensed for use under the Creative Commons Attribution 4.0 International Licence.
better lives through livestock
ilri.org

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Vaccines and diagnostics—The case for regional One Health centres of excellence

  • 1. Vaccines and diagnostics—The case for regional One Health centres of excellence One Health Colloquium: Sustainable livestock and disease control - exploring the links to climate change, improving human nutrition and the refugee crisis, London, 31 May – 1 June 2016 Delia Grace, Phil Toye, Shirley Tarawali and Vish Nene
  • 2. Overview • One health – Definitions – ILRI working in a OH paradigm – OH addressing vaccine delivery and use • Case studies – East Coast Fever vaccine – Newcastle disease vaccine – Diagnostics for TBD • Conclusions
  • 3. Health is “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity”(World Health Organisation). One Health "the collaborative effort of multiple disciplines — working locally, nationally, and globally — to attain optimal health for people, animals and the environment” (One Health Commission). Ecohealth “recognizes complex biophysical, social, cultural, political and economic relationships between the ecosystem and human health” (National Council for Science and the Environment). Health and One Health
  • 5. International Livestock Research Institute •a member of the CGIAR Consortium, ILRI conducts livestock, food and environmental research  to help alleviate poverty  and improve food security, health & nutrition,  while protecting the natural resource base. CIMMYT Mexico City Mexico IFPRI Wash. DC USA CIP Lima Peru CIAT Cali Colombia Bioversity International Rome Italy IITA Ibadan Nigeria ILRI Addis Ababa and Nairobi World Agroforestry Nairobi ICARDA Beirut Lebanon ICRISAT Patancheru India IWMI Colombo Sri Lanka IRRI Los Banos Phillippines World Fish Penang Malaysia CIFOR Bogor Indonesia
  • 6. International Livestock Research Institute • Founded in 1974 • Budget: around US$80 million • Staff: 750: Senior scientists from 39 countries: >half from developing countries • 34% of internationally recruited staff are women --and 50% of the senior leadership team • Main campuses in Kenya and Ethiopia, and offices in 16 other countries around the world
  • 7. ILRI experiences: Knowledge transfer, disease control and innovation in vaccines and diagnostics • East Coast fever vaccine: ILRI involved development, manufactured and transferred vaccine use to northern Tanzania and manufacturing to CTTBD in Malawi • Newcastle disease vaccine for village poultry: ACIAR led development, widely promoted, recently evaluated by ILRI in Tanzania • Tick borne disease diagnostics: ILRI developed and runs diagnostics
  • 8. East Coast fever (ECF)  ECF present in 12 countries; it could spread to 8 more  Caused by a tick-transmitted protozoan – Theileria parva  ~28 million cattle at risk; ~1million deaths/year; losses > 300 $ million a year  Small-holder farmers who would benefit from control: ~ 20 million  Not zoonotic: affects food supply, livelihoods, and vulnerable groups
  • 10. Control milestones • 1911-14: 283,000 cattle vaccinated in S. Africa, low success rate • 1911-1940: “T” brand oxen Kenya- exposed & immune • 1980: DANIDA projects in Malawi, Zambia, Zimbabwe, Kenya • 1983: Field use endorsed by FAO expert panel • 1996: First commercial vaccine batch produced at ILRAD • 2012: Authorized for dairy cattle in Kenya • 2014: CTTB Malawi launched • 2016: vaccine used Malawi, Kenya, Tanzania, Uganda
  • 11. Research contributions • 1928: Tick homogenates produce immunity and can be stored (Theiler & du Toit) • 1953: OTC prevent reactions after vaccination (Neitz in S Africa) • 1954-57: Cocktail method developed in the Congo and Rwanda (Jezierski et al) • 1973: Sporozoite stabilates (Cunningham in Kenya) • 1975: Muguga cocktail • 1993: 30% solution Donor investments • 1967: UNDP funded tick program at EAVRO develops ITM: continues at KARI and ILRAD • 1980: DANIDA projects in Malawi, Zambia, Zimbabwe, Kenya • 1996: First commercial vaccine batch produced at ILRAD • 2004: GALVmed founded – ECF a disease of focus • 2014: CTTB Malawi launched • 2016: vaccine used Malawi, Kenya, Tanzania, Uganda
  • 12. Challenges to availability of appropriate new products Discovery Research Development Registration Production Commer- cialisation Sustained delivery Technical challenges. Lack of appropriate product profiles Ill-designed proofs-of-concept Lack of funding for development studies - high risk, high cost. Poorly designed, poorly controlled field trials. Unclear and varied regulatory requirements. Lack of QA/QC. Multiple regulatory authorities. Lack of market pull-through Poor estimates of need or demand Inappropriate pack-sizes Lack of knowledge or education on proper use Inconsistent supply Counterfeit products. Lack of patent protection. Poor quality and efficacy. No commercial interest Expensive processes No process development A technical and market-based approach to delivery
  • 13. Success of ITM in Zambia and Tanzania Since 1990s around 1.5 million cattle vaccinated – 1% of cattle at risk during that time Most in Zambia and Tanzania 1982-2002 Belgian veterinary support project • Local Katete strain • Calf mortality reduced from 33% to 3%. Cost $10 • First year of charging: only 10% of farmers brought calves 2008-2014 IFAD project $15 million • 300,000 vaccinated – around 20% of the at risk population • Farmers pay 15% cost – revolving fund – unlikely to be sustainable
  • 14. Success of ITM in Zambia and Tanzania Since 1990s around 1.5 million cattle vaccinated – 1% of cattle at risk during that time Most in Zambia and Tanzania 1995- 1998 ITTBD in Northern Tanzania • 10-20,000 a year vaccinated • Pastoral areas 2004-16 VetAgro private sector, • Around 80,000 a year, up to 80% of calves • full cost recovery ($10 a calf) • 2006 FAO subsidy, 2012-13 GALVMed, 2014 USAID
  • 15. Transfer, impact and challenges • MC produced on commercial basis by CTTBD • GALVmed targets 2 million doses a year Technology • Live vaccine • Production demanding • Breakthrough infections • Liquid nitrogen cold chain Delivery • Relatively high cost $9-17 • Distribution has high financial risk • Production and much delivery outside private sector
  • 16. Newcastle disease  Worldwide distribution; caused by virus; emergence potential  Major poultry disease: 30-80% of village chickens die each year  Minor zoonoses; impacts on livelihoods and food & nutrition security  Strong gender dimension: most owned by women  Epidemic disease and hence communal action important
  • 17. History of Newcastle disease vaccination • 1927 virus isolated from outbreak in Newcastle • Spread rapidly in Asia and more slowly to rest of the world • Second pandemic in late 1960s, devastated poultry industries • Brought under control using live vaccines • 1984 ACIAR started to fund research into ND in village poultry • A new strain I-2 developed at the University of Queensland for village poultry 2003-2005 SANDCP project funded by Australia • Mozambique, Malawi and Tanzania • Participatory, gender-responsive, sustainable, approach • Informed by one health thinking • With support from production to end use and cost recovery
  • 18. A one health approach to delivery TRANS-DISCIPLINARITY PARTICIPATION EQUITY Social Political Economic Ecological
  • 19. 0 10 20 30 40 50 60 70 80 90 100 Is currently using ND vaccine Has ever used ND vaccine Knows how they work Has heard of ND vaccine Heard about vaccine Active Inactive Wyatt et al., 2012 Farmer knowledge and practice
  • 20. EO: Farmers lie about diseased chicken to get them vaccinated…. I train the vaccinators on handling, giving injections, side affects Vx: People complain about the amount charged…. 3 out of 10 don’t pay….. I have received no training… Some sell vaccine to rich households and use water to vaccinate the birds of the poor households to make money FGD: We are willing to pay 100 TSH (twice the price currently charged) Wyatt et al., 2012
  • 21. 0 2 4 6 8 10 12 14 16 18 Lost from ND last year Chickens currently owned No project After project Best case: losses still high Wyatt et al., 2012 P<0.001 56% 37% 0% 10% 20% 30% 40% 50% 60% Unprotected Protected Overall n=429 Proportion flock lost to ND n.s
  • 22. Tick-borne diseases diagnostics • Ticks and tick-borne disease • Important cattle disease; zoonotic potential 0 200 400 600 800 1000 1200 1400 1600 1800 2000 GITparasites AAT TicksandTBD Heartwater PPR Newcastle CBPP BVD Ectoparasites FMD LSD Brucellosis bTB Gumboro ASF ECF Shoatpox Brucellosis Coccidiosis Dermatophilosis CCPP Footrot Mastitis Echinococcosis Aflatoxicosis Erysipelas Cysticercosis MillionUSD
  • 23. ILRI diagnostics for ticks and tick-borne disease • ELISA for: Theileria parva, Theileria mutans, Babesia bigemina, B. bovis, trypanosomes, Anaplasma marginale • ELISA tests for 4 major TBDs – developed ~ 20 years ago • Used mainly for resarch • Anaplasma and Babesia tests offered commercially • Point-of-care assays (lateral flow) for human trypanosomiasis (with FIND), cysticercosis (ASARECA) and PPR (Pirbright) • Development proof of concept • Business plan developed for cysticercosis tests but not funded
  • 24. Use of tick borne diagnostics • Explored commercial production but not viable 2012-2014 12,503 7,524 In house External
  • 25. Vaccines: good efficacy but (so far) less impact, Dx: high impact factors, hard to attribute impacts
  • 26. Conclusions • Impact that scales: • Vaccines intuitively enormously attractive • Adoption by smallholders and pastoralists challenging • Evidence that counts: • Insights into disease require investments into infrastructure
  • 27. This presentation is licensed for use under the Creative Commons Attribution 4.0 International Licence. better lives through livestock ilri.org