Vaccine delivery and demand workshop

Introduction to vaccine security and an
overview of EuFMD/FAO initiatives.
European Commission for the Control of Foot-and-Mouth Disease (EuFMD)
M. Ilott,
D. Mackay, F. Rosso, B. Ahmadi, P. Compston
Vaccine delivery and demand workshop, 26-27 June 2023
Vaccine value chain and demand workshop – June 2023

What is vaccine security and why is it important?
M. Ilott
● Vaccine Security …..people, at all times have physical, social and economic access to sufficient, safe and effective (‘quality’)
vaccines to meet their needs and of the livestock in their care……
● In the case of FMD, vaccine is needed:
○ By FMD free countries as part of contingency planning for incursions of disease;
○ By endemic countries seeking freedom from FMD for progress along the FMD Progressive Control Pathway.
● Vaccine security is needed in both situations but the factors that constrain the availability of vaccine differ depending
on the needs and situation of the country concerned (government policy, manufacturers, market size, etc.).
● If we consider Foot-and-mouth disease vaccines in non-free countries
○ Total Large ruminant population approx. 1.8 billion (excluding China), with 1 billion in non-free FMD countries
○ Therefore approx. 1.8 billion doses needed annually if vaccinated every 6 months
○ FMD vaccine coverage only approx. 13% and much less in some regions e.g. Sub-Saharan Africa

Work by EuFMD 2019–2023
Vaccine security – elements in the 2019-2023 work plan
Pillar I: Improve preparedness for FMD and similar Transboundary Animal Diseases (FAST)
● Create a system for prequalification of FMD vaccines to provide independent assurance of quality and properties
of FMD vaccines (qualification assurance).
● establish a Multi-stakeholder Platform (MSP) for FAST disease vaccination with the aim of identifying pathways or
actions to improve the availability of vaccines suitable for use in disease emergencies recognizing that vaccine
security requires public private partnerships and cooperation
Pillar III: Sustained Progress
● Support the MSP platform aim to increase understanding and promote practical solutions to improve the access of
FMD endemic countries, particularly in PCP Stage 1 to 3, to quality FMD vaccines on vaccine security.
● Develop the VADEMOS model to estimate vaccine demand to assist governments and the private sector by
improving predictability and thereby reducing risk of investment for FMD vaccine manufacture.
● Further develop the PRAGMATIST model to assist risk managers in prioritizing strains for inclusion in vaccine
banks.
3

4
Proposed EuFMD
contribution in the
area of Vaccine
Security in the next
work plan 2023-27
PULL
PUSH
& demand

Multistakeholder platform (MSP)
Composition and activities
● MSP brings together:
○ International organizations (EuFMD, FAO, WOAH, and others as required such as WHO);
○ Manufacturers and industry associations (large and small manufacturers with global coverage);
○ Regulatory authorities (global coverage);
○ Reference laboratories;
○ Research institutes and academic community;
○ Non-governmental organizations (e.g., Bill and Melinda Gates Foundation, GALVmed);
○ Other experts as required (e.g., legal, IT).
● Recognizes that solutions to vaccine security require a multisector approach involving private and public sector.
● It is envisaged that MSP will be actively engaged on topics related to vaccine security throughout the next work
programme.
5

Workshops – three on vaccine security
● Explore Options to improve security of
vaccine supply, 2020.
● Improving FAST Vaccine security
through stakeholder engagement, 2022.
● The Impact of the Nagoya Protocol on
Vaccine Security for Foot-And-Mouth
Disease Research and Development:
Options for a solution, 2023.
6

Nagoya Protocol
● The overarching conclusion was that the Nagoya Protocol is severely
constraining the exchange of FMD viruses, and therefore, having an
impact on vaccine security. This has the potential for negative
consequences for animal health in both FMD-free countries and in
countries where the disease is endemic through the impact on disease
surveillance and research and development of new vaccine strains.
7

Vaccine Security
Business models that promote vaccine security
● Long established business models for investing in FAST vaccines are coming under increasing pressure:
○ Competition within companies for limited investment funding;
○ The high cost of setting up and maintaining independent vaccine banks to modern regulatory standards.
● Looking for models that:
○ Share risk between manufacturers and customers;
○ Provide certainty in supply arrangements and price in the event of an outbreak;
○ Pay manufacturers for the costs of mitigating risks by holding stocks of antigens even if no sales of vaccines
takes place;
○ Increase the attraction for investing in FAST vaccines.
○ Examples include Long-term Supply Arrangements (LTA) and Assured Emergency Supply Options (AESOP)
8

Prequalification
Progressive implementation of PQv system
● Phased, step-wide implementation of a system for prequalification of FAST vaccines (FMD in the first instance).
● Independent, transparent and consistent evaluation of FAST vaccines against minimum international standards of
the WOAH by teams of experts and endorsed by the Standing Committee for Prequalification of Vaccine.
● International scope - companies from any country and of any size can apply as WOAH standards are applied by all
WOAH member countries (as a minimum).
● PQv list can be used by any organization that wishes to assure the quality of the FMD vaccine it procures.
● Particularly useful for long-term supply arrangements by assuring that a company can consistently produce
vaccines that comply with at least minimum international standards.
● Aim to build a ‘global community of best practice’ in FAST vaccine evaluation as has arisen through the WHO
prequalification scheme for human vaccines.
9

VADEMOS - Vaccine Demand Estimation Model - FMD
Estimation of vaccine demand
● Estimating current and future vaccine dose demand is required at both national and regional levels to support
decision-making in both public and private sectors.
● VADEMOS is a tool developed by EuFMD that aims to bridge the gap between FMD vaccine demand and vaccine
production/supply.
● It is a stochastic quantitative model which uses predictors of vaccine dose demand such as livestock population
forecast, disease control policy (related to how disease is controlled, i.e., projected FMD Progressive Control
Pathway (PCP-FMD) stage), vaccination schedule and outbreak forecasting.
● Once the size of demand has been determined, strategies for meeting this demand through current supply options
in the country/region, alongside the estimated cost of supplying the number of doses estimated, can be identified.
● VADEMOS could also inform any investment decisions by the private and public sector in producing the needed
vaccine doses.
10

Vaccine Value Chain & demand
Scope of work
● Effective vaccination strategies must consider vaccine delivery and demand alongside vaccine efficacy to result in
effective vaccination.
● Vaccine delivery must be cost-effective, timely and well-managed for disease control to be achieved.
● There are a range of common policy and technical constraints that exist for FMD vaccination, especially in
endemic settings.
● Addressing these as part EuFMD’s vaccine security work is important to ensure that resources invested into
ensuring that high quality vaccine is manufactured in sufficient volumes are optimized.
● Interventions that aim to strengthen vaccine delivery and demand will encompass:
○ Animal health systems;
○ Economic analysis;
○ Social and behavioural studies.
● Analysing and understanding these factors will help countries to implement FMD vaccination campaigns as part of
progress along the FMD Progressive Control Pathway.
11

Conclusions
Vaccine security
● Vaccine security is an essential consideration for countries of all FAST disease status.
● Improving vaccine security requires a multistakeholder approach recognizing the need to engage both public and
private stakeholders at a global level in designing and implementing solutions.
● EuFMD will support a range of activities which collectively aim to improve vaccine security:
○ through measures to assure access to high quality vaccines in case of need, and
○ by assisting countries to progress along the FMD Progressive Control Pathway by assuring the sustained
supply and effective delivery of vaccine as part of control and eradication campaigns.
12

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An introduction to vaccine value chains
Vaccine delivery and demand workshop, online, 26th – 27th June 2023
Polly Compston
European Commission for the Control of Foot-and-Mouth Disease

Veterinary vaccine value chains
Presentation title
Meeting name
● Value chain = “the full range of activities required to bring a product or service from
conception, through the different phases of production …and delivery to final consumers”
(Kaplinsky et al, 2000)
- Activities and actors
- Relationships, networks and power
- Governance and market structure
- Final value is represented by use of the product or service by the final consumer
● Veterinary vaccine value chains include both private and public actors, and can result in
significant private goods, public goods and externalities
2

Presentation title
Meeting name
3
Product
What kind of
vaccine
should be
used?
Production
How many
doses are
produced
and when?
Allocation
Which
animals are
vaccinated?
Distribution
How are
vaccines
distributed?
Cross-cutting factors
Stakeholder
engagement
Epidemiology
Logistics

Surveillance
Vaccine value
chain
Resourcing
Coordination
and
communication
Effective
implementation
Enabling
environment
Monitoring
Epidemiology
Farming
systems
Cross-cutting
factors
Inclusion and
equity
Vaccine choice
Stakeholder
engagement
Demand
Capability
Opportunity
Motivation
Logistics

6
• Adequate and aligned to strategy
• Public and private support
Resourcing
• Formal and informal communication networks
• Coordination across borders (decentralisation)
• Common understandings and definitions
Coordination and
communication
• Cold chain facilities
• Process and logistics
• Animal welfare
Effective
implementation
• Private-public relationships and partnerships
• Matching demand and manufacture.
• Synergy with animal health system strengthening initiatives
Enabling
environment
• Aligned record keeping
• Prescription
• Traceability
Monitoring
vaccination
programmes
Logistics

Epidemiology
7
• Surveillance linked to disease control
• Common understandings and definitions
• Consistent passive surveillance
• Seasonality
Surveillance
• Heterogenous farming systems
• Multiple government actors are involved in vaccination
regulation
• Traceability
Farming systems

Stakeholder participation in vaccination campaigns
8
• Relevant technical knowledge about vaccination and disease
control
Capability
(Physical / Psychological)
• Accessible, affordable, acceptable, available
• Cultural norms and stereotypes need to be identified and
acknowledged, and where needed mitigated
Opportunity
(Physical / Social)
• Relationships and trust
• Appropriate articulation and understanding of vaccine side
effects and vaccine breakdown
Motivation
(Reflective / Automatic)
• Complex interplay of volume required, supply of product
available, price-point and opportunity cost
• Willingness-to-pay
• Communication between government and manufacturers
Demand

Stakeholder participation in vaccination campaigns
9
Michie et al (2011):
The behaviour change wheel

Cross-cutting factors
10
• Post vaccination monitoring guidelines
• The purpose of a vaccination programme (e.g. disease
mitigation or control)
• Vaccine matching and standards
Vaccine choice
• All activities must consider equity across social groups and
farming systems
• Often specific gendered barriers to participation in vaccination
programme, including financial access, social barriers,
socioeconomic status
Inclusion
and equity

Veterinary vaccine value chain analysis
● Human health sector: vaccine value chain analysis has often focuses on supply chain logistics
11
Frameworks derived
from food systems
Map stakeholders, processes and relationships
involved from vaccine manufacture to administration
South Africa (Chiumbu et al, 2018)
Senegal (McKune et al, 2021)
Outcome mapping
(Jones et al, 2009)
“Set of tools and guidelines that steer project or
programme teams through an iterative process to
identify their desired change and to work
collaboratively to bring it about”
Newcastle disease and Rift Valley fever
vaccination in Rwanda (Gannaway et al,
2022)
Contagious caprine pleuropneumonia
vaccination in Kenya (Kyotos et al, 2022)
Network mapping
(Schiffer et al, 2008)
Focus on relationships of power and influence Peste des petits ruminants vaccination in
Mali (Dione et al, 2019)
FMD, contagious bovine pleuropneumonia
and East Coast fever in Zambia (Lubungu
et al, 2018)
Vaccine adoption Vaccine availability, access and demand One Health programme implemented in
five African and two South Asian
countries, targeting East Coast fever and
Newcastle disease (Donadeu et al, 2013)

Describing the vaccine value chain:
● Assists the calculation of costs associated with vaccine delivery
● Helps to understand the qualitative aspects of demand for vaccination,
enabling
- market assessment
- economic efficiency
● Supports disarticulation of private and public interests to support
successful partnerships across sectors
12

How can we support vaccine value chain strengthening?
● Structured support and capacity development
● Sharing experiences and successes
● Assured delivery systems
● Developing an evidence base
● Integration with synergistic animal health system strengthening
● …….
13

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References
● Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-
5908-6-42. PMID: 21513547; PMCID: PMC3096582.
● Chiumbu, S., Maziya, M. & Gumede, N.A. (2018) An assessment of the policy framework and value chain analysis for livestock vaccines in South Africa . (Commissioned by the International Development
Research Centre (IDRC)). http://hdl.handle.net/20.500.11910/13751
● McKune S, Serra R, Touré A. Gender and intersectional analysis of livestock vaccine value chains in Kaffrine, Senegal. PLoS One [Internet]. 2021 Jul 1 [cited 2022 Oct 7];16(7):e0252045. Available from:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252045
● Jones H, Hearn S. Outcome Mapping: a realistic alternative for planning, monitoring and evaluation Background Note Background Note. 2009 [cited 2022 Oct 8]; Available from: www.odi.org.uk
● Gannaway T, Majyambere D, Kabarungi M, Mukamana L, Niyitanga F, Schurer J, et al. Using Outcome Mapping to Mobilize Critical Stakeholders for a Gender Responsive Rift Valley Fever and Newcastle
Disease Vaccine Value Chain in Rwanda. Front Glob Women’s Heal. 2022;3(April):1–15.
● Kyotos KB, Oduma J, Wahome RG, Kaluwa C, Abdirahman FA, Opondoh A, et al. Gendered Barriers and Opportunities for Women Smallholder Farmers in the Contagious Caprine Pleuropneumonia
Vaccine Value Chain in Kenya. Anim 2022, Vol 12, Page 1026 [Internet]. 2022 Apr 14 [cited 2022 Oct 7];12(8):1026. Available from: https://www.mdpi.com/2076-2615/12/8/1026/htm
● Schiffer E, Waale D. Tracing power and influence in networks:Net-Map as a tool for research and strategic network planning [Internet]. 2008 [cited 2022 Dec 26]. Available from:
https://www.ifpri.org/publication/tracing-power-and-influence-networks
● Dione MM, Traoré I, Kassambara H, Sow AN, Touré CO, Sidibé CAK, et al. Integrated Approach to Facilitate Stakeholder Participation in the Control of Endemic Diseases of Livestock: The Case of Peste
Des Petits Ruminants in Mali. Front Vet Sci. 2019;6(November):67–73.
● Lubungu M, Birner R. Using process net-map to analyse governance challenges: A case study of livestock vaccination campaigns in Zambia. Prev Vet Med [Internet]. 2018;156:91–101. Available from:
http://www.sciencedirect.com/science/article/pii/S0167587717305767
● Donadeu M, Dungu B. Market Development & Adoption: Lessons learned and observations during Phase 1 of Protecting Livestock, Saving Human Life (PLSHL-1) programme [Internet]. 2013 [cited 2022
Dec 26]. Available from: http://galvdox.galvmed.org/docs/20_GALVmed_MDA_Lessons_Learned_PLSLHL_1__2013_EXTERNAL.pdf
Presentation title
Meeting name

Progressive Management Pathway for
Terrestrial Animal Biosecurity (PMP-TAB)
Towards a sustainable and resilient livestock sector
Melissa McLaws
and the PMP-TAB team, Emergency Prevention System for Animal Health, NSA, FAO

Outline
1. Introduce the Progressive Management Pathway for Terrestrial Animal Biosecurity (PMP-TAB)
2. Consider its application for FMD vaccination and vaccine security

PMP-TAB: Progressive Management Pathway for Terrestrial Animal Biosecurity
FAO defines biosecurity as a strategic and integrated approach that encompasses the policy and regulatory frameworks
for analysing and managing relevant risks to human, animal and plant life and health, and associated risks to the
environment
https://www.fao.org/documents/card/en/c/cc5771en

PMP-TAB:
• Builds on and brings together
existing tools and approaches
• Not disease specific
• Process, not scoring
• Framework to make
sustainable improvements
➢ At value chain level
(practices)
AND
➢ At public sector/national
level (policies,
capacities)
PMP-TAB is an Umbrella framework
Oh no…not
another pathway!

Getting Started with the PMP-TAB
1. Situation assessment and Stakeholder consultation:
a. Identify priority sector(s) for biosecurity pilot
b. Map stakeholders, compile information and results from
past/current activities
c. Assess the policy environment: what are policy goals? How
can legislation and/or compliance be strengthened to achieve
the goals?
d. Set up PMP-TAB taskforce with public and private
stakeholders
e. Draft of minimum biosecurity standards
2. Co-create and implement Pilot project
• Private sector improve agreed practices
• Public sector audit compliance
a. Monitor, evaluate
3. Expand based on lessons learned

Core components: consider at every step of improving
biosecurity
Principles guide PMP-TAB approaches and
actions
Collaborative, inclusive
Stakeholder led
Consensus building approach
Sustainable
One Health and PPP approaches
Business and economic incentives at each step
Facilitate replicability/uptake
Understanding of the risk situation
Knowledge and information
The broader context within which individuals and
organizations function (governance, policies, etc)
Enabling Environment
Human, physical and financial resources
Infrastructure and capacity
Actions and activities that influence and impact biological
risks
Practices

•The program has been implemented since
2012 in all provinces of Viet Nam through 5
projects supported by USAID and WPF
•110 biosecurity model poultry farms,
hatcheries, pig farms enrolled
•Profit markup of model farms was higher than
control :
• Poultry: 3.9%- 48.7%;
• Pig farms by 15.4%;
•Vet. medicine costs reduced by 20-50% in
model poultry farms
•Improved farm prestige and market access
•Model farm practices recognized and applied
by neighboring farmers
Case Study: Biosecurity management along the value chain- Viet Nam
Read More: https://www.fao.org/3/ca5516en/CA5516EN.pdf

• Co-create and share knowledge about terrestrial animal biosecurity
• Promote collaboration amongst members and experts
• Membership inclusive, everyone welcome (public/private sectors,
academia)
• Hosted on FAO’s Virtual Learning Center (VLC) Platform
• Include monthly webinars, knowledge repository/toolkit, member-
driven activities and outputs
• Subgroups foreseen for in-depth discussion of topics of interest
• Monitoring biosecurity; Behaviour change; Benefit-cost of biosecurity
• Looking for co-leaders for Subgroups from Community
Community of Practice (CoP) for Terrestrial Animal Biosecurity
Join us!
Visit https://virtual-learning-center.fao.org/mod/page/view.php?id=8724&forceview=1
or contact us at PMP-TAB@fao.org

Vaccination is part of biosecurity
• Vaccination alone will not prevent FMD
• Short duration of immunity
• High level of contagiousness – low infectious dose,
multiple species
• Variable protection (matching circulating strains)
• Non-sterile immunity
• Need biosecurity measures as well
• Only move healthy (vaccinated) animals
• Thorough cleaning of clothing/footwear/equipment
between farms – including vaccinators and their
syringes!
• Quarantine (vaccinate) new introductions
PMP-TAB and Vaccination

Vaccination is part of biosecurity
• Knowledge and evidence
• Circulating strains
• Target population
• (Cost) Effectiveness of vaccination
• Enabling environment
• Supportive policy and legislation
• licensing effective vaccines and monitoring use
• Fits with stakeholder priorities
• Infrastructure and capacity
• Vaccine doses
• Vaccinators, equipment, transport
• Capacity For FMD surveillance and PVM
• Practices
• Vaccination strategy and schedule
• Ensure vaccination does not lead to disease spread
Biosecurity
Knowledge
and evidence
Enabling
environment
Infrastructure
and capacity
Practices

Application of PMP-TAB approach to FMD vaccination
• Thorough understanding of stakeholders and their
priorities
• If FMD is not a priority, can vaccination be combined
with other herd health support and biosecurity
improvements?
• Review of policy and legislation to ensure
compatibility with objectives
• Feasible with capacity and resources available
• Public sector auditing (PVM)
• Private sector business models
• Value of starting with pilot project and scaling up
• Sector, zone

Protecting people, animals, and the environment every day
Drawings: FAO/Chiara Caproni
Acknowledgements
Vietnam Case study: Minh Nguyen Thi Tuyet, Pawin Padungtod and FAO Vietnam ECTAD
Indonesia case study: Alfred Kompudu and FAO Indonesia ECTAD
PMP-TAB team: Madhur Dhingra, Aashima Auplish, Martin Heilmann, Shija Jacob, Koen Mintiens, Yushan Li, Nina
Militzer, Andriy Rozstalnyy, Mirzet Sabirovic, Ismaila Seck, Daniel Toro, Melissa McLaws & FAO PMP-TAB taskforce

Better lives through livestock
Livestock Vaccine Value chains
Dr Theo Knight-Jones, Principal Scientist
International Livestock Research Institute (ILRI)

Vaccine value chains
• Large burdens of livestock disease
• Often existing medicines for addressing these diseases
• But due to system failures animal disease is not controlled
• Investment in improved vaccines – who will pay? Is there a market?

GBADs Ethiopia - Cattle Animal Health loss %
86%
13.5%
0.3%
Production loss
mortality
AH expenditure

4
Burden of animal diseases
0
1
2
3
4
5
6
7
8
Endoparasites
PPR
CBPP
Ectoparasites
CCPP
FMD
Tryps
Shoat
pox
Newcastle
Brucellosis
Bovine
TB
LSD
RVF
ECF
BVD
Billion
$
lost
yearly
South Asia
Africa
Young Adult
Cattle 22% 6%
Shoat 28% 11%
Poultry 70% 30%
Source: Otte & Chilonda; IAEA
Annual mortality of African livestock
Estimates from BMGF

Production Distribution
- Quality
- Cost/efficiency
- Quantity/
- Sustainable/funded/
demand driven
Markets
- Import
- Private/public
distribution
- Cold chain
- Import
- Private/public
distribution
- Cold chain
Consumers
- Money
- Knowledge
- Access
Vaccine value chains - Issues
Policy – Enabling environment

6
Access to veterinary inputs - LMICs
• Most of the livestock keepers have small
scale enterprises
• These people are poor and, in many
situations, have poor access to veterinary
services and veterinary technologies
• The inadequate distribution of animal
health systems is a market failure which
needs societal intervention

• Public sector dependant animal health service
• Look at Public-Private delivery
• User-pays
• Private sector working for government (Sanitary mandate)
• Consumers are willing to pay for better livestock health care
• But value chains are set up for the public sector for many vaccines
Health of Ethiopian Animals for Rural
Development (HEARD)

8
Behavioral challenges to vaccination (cont.)
Trust between parties
“Veterinarians have lost credibility and their
service is no more respected by the farmers; the
vets have no authority nowadays, compared to
before privatization of the veterinary profession”
(Farmer in Mopti, Mali)

9
Behavioral challenges to vaccination
Awareness and knowledge
▪ Willingness to vaccinate (WTV) study in Mali (304 cattle and
small ruminant farmers interviewed)
✓Positive factors
• Information on the campaign calendar (faster if from places
of worship)
• Awareness of the benefits of vaccination
• A recognition of the vital importance of vaccines
• Able to recognize a vaccine of good quality

• At the farm level who manages the livestock?
• Who makes the decisions and who has the funds for vaccines?
• Womens Empowerment (WE)
Gender and vaccines
Omondi, I.; Galiè, A.; Teufel, N.; Loriba, A.; Kariuki, E.; Baltenweck, I. Women’s Empowerment and Livestock Vaccination:
Evidence from Peste des Petits Ruminants Vaccination Interventions in Northern Ghana. Animals 2022, 12, 717.
https://doi.org/10.3390/ani12060717

• At the farm level who manages the livestock?
• Who makes the decisions and who has the funds for vaccines?
Women's access to PPR vaccination in Ghana
Omondi, I.; Galiè, A.; Teufel, N.; Loriba, A.; Kariuki, E.; Baltenweck, I. Women’s Empowerment and Livestock Vaccination:
Evidence from Peste des Petits Ruminants Vaccination Interventions in Northern Ghana. Animals 2022, 12, 717.
https://doi.org/10.3390/ani12060717
“access to vaccines” is strongly associated with
“knowledge of animal health and vaccines”,
and the latter is strongly associated with WE.

• Countries want to produce their own vaccines rather than spend hard
currency on imports
• FMD about 30 vaccine producers? [OIE/FAO ref lab]
• But producing quality vaccines is challenging, especially with variable
infrastructure
• Import restrictions mean even those keen to pay for vaccines cannot
access the vaccines they need
Import Vs domestic production of vaccines

Production Distribution Markets Consumers
Vaccine value chains - Issues
Policy – Enabling environment

14
Final thoughts
Product
profile
Social
participation
(incentive)
Policy
Innovation
Private sector
Increase
vaccine
adoption
Much to be done

This presentation is licensed for use under the Creative Commons Attribution 4.0 International Licence.
better lives through livestock
ilri.org

Vaccine Value Chains - Eastern Africa
EuFMD workshop on vaccine demand and delivery, 26-27 June 2023
Badi Maulidi

- 3 -
Client
Confidential
Project Overview
We are in the 4th year of an 8-year, USD$17.68M prize competition that supports development,
registration, and uptake of high-quality FMD vaccines tailored to match the currently circulating
strains in six Eastern Africa countries: Burundi, Ethiopia, Kenya, Rwanda, Tanzania, and Uganda.
Develop and register high-quality
FMD vaccines tailored to the needs
of Eastern Africa
Create greater market stability and
affordability through increased
production and purchase of FMD
vaccines that are regionally
relevant
Build a private sector model for
FMD vaccine purchase and
distribution to complement public
sector efforts
Incentivize manufacturers to support
long-term efforts to control FMD in
the Eastern African market with
regionally appropriate vaccines
Increase access to and uptake of
effective FMD vaccines
Reduce FMD-driven production
losses for small-scale farmers in the
region (estimated USD$2.3 billion
per year across sub-Saharan Africa)
Project Objectives Anticipated Impact

- 4 -
Client
Confidential
Project Timeline
Eight-year time commitment over two phases: Development and Cost-Share
Year 4
Year 4
Year 3
Year 2
Year 1 Year 1 Year 2 Year 3
Competition
Launch
Jan 2020
Cost-Share Phase
Development Phase
High-Level Overview of Timeline
• Development Phase: The first vaccine is estimated to be approved by the AgResults Judging
Panel within the first four years. This phase can extend to July 2027 for subsequent vaccines
seeking approval.
• Cost-Share Phase: This phase begins after the first vaccine is registered in at least one target
country and approved. Additional manufacturers with a qualified FMD vaccine are encouraged to
join after the start of the Cost-Share Phase. This phase will end in July, 2028.
Competition
End
Jul 2028

- 5 -
Client
Confidential
Fostering Development of Regionally Relevant and High-Quality
FMD Vaccines
To be eligible for the AgResults competition, the vaccine must meet the following conditions.
✓
Vaccine Development to Target Product Profile (TPP) Standards, which includes:
• Quadrivalent Vaccine at least 6PD50 containing serotypes A, O, SAT1, and SAT2 that
match circulating Eastern African FMDV strains, demonstrated through serological
testing against WRLFMD’s Eastern African FMDV Reference Antigen Panel
✓
Vaccine Registration: must achieve full registration in at least 1 target country
• Registration can be achieved either through the Mutual Recognition Procedure (MRP)
or through individual country registrations (Ethiopia must be individual).
✓
Vaccine Approval:
• The AgResults Judging Panel will approve vaccines that meet the TPP and are
registered in at least one target country for competition entry.
Buyers of approved vaccines will benefit from the AgResults cost-share the project will
fund a portion of the sales price of the vaccines purchased by government and private
sector buyers, for a target volume of vaccines.
$

- 6 -
Client
Confidential
FMD Vaccine Value Chain (VVC) – Eastern Africa
•Target Product Profile
•Eastern African FMDV Panel
Vaccine Development
•Evaluation of multivalent vaccines
•Enabling environment
Vaccine Registration
•Local Technical Representative
Importation /
Distribution
•Cost-Share Mechanism
•Budget allocation
Vaccine Procurement
Retailer
Vaccination
Post-Vaccination
Monitoring
The AgResults FMD Vaccine Challenge Project addresses the upstream challenges in the VVC.
Support for downstream challenges is still needed.
AgResults
FMD
Vaccine
Challenge
Project

- 7 -
Client
Confidential
Lessons Learned: FMD Vaccine Value Chain – Eastern Africa
Vaccine Development/Manufacturing
• Project requires demonstrated serological testing
against WRLFMD’s Eastern African FMDV Reference
Antigen Panel.
• AgResults Judging Panel will approve vaccines that
meet the Target Product Profile.
• Lack of capacity for local/regional manufacturers to
upgrade their facilities.
• Difficulty for some global manufacturers to access
and work with SAT1 and SAT2 strains.
Registration/Market Authorization
Importation/Distribution
• Local Technical Representative (LTR) needed for
product registration.
• Limited number of available LTRs with capacity to
handle FMD vaccine business.
• Limited availability of cold-chain facilities to
preserve the vaccines.
Vaccine Procurement
• Project requires that vaccine must achieve full
registration in at least 1 target country.
• The Project has worked with EAC MRP and
UKVMD to build capacity of regulatory
authorities to evaluate multi-valent FMD
vaccine.
• Resistance by some countries to register
‘foreign’ FMD vaccines.
• Through Cost-Share mechanism, the project will
fund a portion of the sales price of the vaccines
purchased by public and private sector buyers.
• Key challenges with the three different points of
vaccine procurement:
1. Government tender:
Irregularity of tender purchases
2. Distributors/private clinics:
Lack of cold chain and frequent stock-outs
3. Vaccinators:
Require training and supervision
from registered veterinarians

Thank you!
For more information and resources, visit the AgResults or GALVmed
website:
https://agresults.org/projects/fmd-vaccine
www.galvmed.org/foot-and-mouth-project

Importance of vaccine dose
demand estimation for countries
and regions
Vaccine Delivery and Demand
Workshop
26-27 June 2023
Melissa McLaws
GF-TADs FMD WG:
Melissa McLaws, Madhur Dhingra, Muhammad Arshed (FAO)
Neo Mapitse, Bolortuya Purevsuren, Mohamad Sirdar (WOAH)
Fabrizio Rosso (EuFMD)

26-27 June 2023
Vaccine delivery and demand workshop
• Established in 2011, initially FAO & WOAH; EuFMD
joined in 2018;
• Guided by its Terms of Reference and the GF-TADs
Management Committee;
• Activities at Global, Regional and National level;
• Meetings:
• Operations every 2 weeks;
• Strategic every month
GF-TADs FMD Working Group
State of play of the Global Strategy implementation

26-27 June 2023
FMD Roadmap meetings and PCP progression
PCP-FMD progression mapped at Regional Roadmaps.
NB. Pools 1 (E. Asia) and 7 (S. America) do not have roadmaps but these countries
collaborate in other regional initiatives, ie SEACFMD and COSALFA
In the last 2 years:
• 5 countries advanced from PCP-FMD Stage 0 to 1;
• 3 countries advanced from PCP-FMD Stage 1 to 2
• 1 country advanced from PCP-FMD Stage 2 to 3
WOAH Official recognition procedures (2022-23)
• 1 country and 3 zones for free with vaccination status
• 1 zone free without vaccination, and
• 1 country official control programme (PCP-FMD Stage 4)

26-27 June 2023
The evolution of Global FMD PCP and WOAH
official status 2012 and 2023
28
31
9
3 3
0
5
10
15
20
25
30
35
stage 0 stage 1 stage 2 stage 3 stage 4
2012
14
32
26
6
3
0
5
10
15
20
25
30
35
stage 0 stage 1 stage 2 stage 3 stage 4
2023
2023
+4

26-27 June 2023
A. FMD is continuing to spread, e.g.;
• Incursion into Botswana free zone and recovery with
containment zone; Kazakhstan zones
and Indonesia (previously free since 1986) and suspensions
of official free status; Mongolia withdrawal of endorsed
programme.
• Serotype O in Southern Africa, as well as outbreaks of SAT2
and SAT3 in S. Africa
• SAT2 in West Eurasia and Middle East
B. Control is hampered by:
• Lack of financial resources and competing priorities
• Gaps in surveillance (needed to understand epidemiology
and how to break transmission chains)
• Challenges to procure effective and affordable vaccine,
appropriate for the circulating strains
Main challenges and gaps identified for the effective prevention and control

26-27 June 2023
Countries completed vaccine questionnaire as part of
preparation and information sharing during recent roadmap
meetings:
• Southern Africa (SADC) 2020
• Middle East 2021
• Central Africa 2022
• E. Africa 2022
• S. Asia 2023
• W. Eurasia 2023
Information from Roadmap vaccine and vaccination surveys
0
5
10
countries
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0 1 2 3 4
PCP-FMD stage
PCP Stages at the time of Roadmap meetings

26-27 June 2023
Any FMD vaccination
• No countries in C. Africa vaccinated
• More than half of countries in W. Africa, E. Africa and S.
Africa did some
• All countries in Middle East, S. Asia and W. Eurasia
reported some FMD vaccination
Number of doses
• Middle East and W. Eurasia reported using more doses
than cattle population
• S. Asia (India) is increasing vaccine use tremendously,
approaching doses for entire population
• Cattle population in Africa vastly exceeds doses used.
0
100000000
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Large ruminant doses Cattle population

26-27 June 2023
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owner VPP
private vet local public vet
national vet
Vaccination strategy
• “Emergency vaccination” done most countries and all roadmaps
(except C. Africa)
• Vaccine available upon owner request highly variable
• most countries in Middle East. S. Asia and W. Eurasia
• less common in African countries
• “Mass vaccination” most common in Middle East and W. Eurasia
• Difficult to categorise and terms not consistently understood
Who Vaccinates?
• Usually the VPPs and local public veterinarian
• Owners permitted to vaccinate in few countries
• Private veterinarians involvement variable.
0
2
4
6
8
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mass vaccination emergency vaccination
owner request
Vaccination Strategy
Who gives the vaccine?

26-27 June 2023
Post vaccination monitoring
- Many countries report not doing PVM
Who pays?
- No owner contribution in the majority of
countries
- National budget considered insufficient in
most countries (except in W. Eurasia)
- 10 countries reported using donor funds for
FMD vaccine: covering from 1-100% of vaccine
costs
0
5
10
15
E
.
A
f
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owner pays something national budget sufficient
number of countries
0
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PVM vaccinated last year

26-27 June 2023
Conclusion
• There has been progress on FMD control in some areas and setbacks in
others
• Vaccination critical tool for FMD control (in combination with other
measures)
• At global level, access to vaccine clearly insufficient and highly variable
• Also need supply for ‘emergencies’ (free and endemic countries)
• Different strategies, payment and delivery models – which is ‘best’ in
different situations?
• Other critical factors include quality (potency) and match to circulating
serotypes/strains – [which can suddenly change!... serotype O in Southern Africa,
SAT2 in W. Eurasia and Middle East]
• Why aren’t countries doing PVM??
• How to optimize the way forward?
• to advocate for and secure ongoing budgetary support, availability and
demand for effective vaccines, compliance with best practices etc etc

Factors influencing investment and
production schedules in quality vaccine.
production & supply for FAST diseases.
European Commission for the Control of Foot-and-Mouth Disease (EuFMD)
M. Ilott
Vaccine delivery and demand workshop, 26-27 June 2023

● $6 billion annual vaccine market in Animal Health, 6.5% predicted year on year growth to 2028
● Livestock vaccine development is costly and time-consuming, and has low margins compared to
companion animal products
2

Veterinary vaccine development in EU takes on average 5 to 7 years
3
Research & development
costs approx. $30-$50 M

Quality, safety and efficacy data to support EU registration
4
EU Registration file 1990s before
EU Directive 20001/82/EC
EU Marketing Authorisation application after
Implementation of EU Directive

FMD vaccine specific challenges
● Constant competition between regular, predictable demand and sudden surges due to:
○ Outbreaks in free or endemic countries
○ Unexpected funding availability
● There is no spare manufacturing capacity ready to serve an increase in demand. Lead times can be
12-18 months for new orders as production schedules are usually FULL
● Sales forecasts are often unreliable in a market mostly based on tenders & orders with often
unrealistic delivery expectations
● FMD antigen banks are usually the only available solution for rapid access to emergency vaccines
from a supply perspective but are relativly expensive:
○ Small volumes ordered infrequently (every 5 years typically)
○ High storage and testing costs of antigen
○ Niche strains often subject to destruction at the end of contract
● FMD vaccine production must meet not only standards of Good Manufacturing Practice (GMP) &
Biosecurity/Biosafety (BSL-3)
5

FMD vaccine specific challenges
● FMD vaccine production needs to take account of
○ Six/Seven serotypes O, A, C, Asia 1, SAT 1, SAT 2 and SAT 3
○ seven global endemic pools
○ Many subtypes within serotypes that require specific vaccine strains
○ Multi-valent FMD vaccines required in most endemic regions
○ Companies may need to maintain a large pool of Master Seed Viruses (MSVs)
○ Production schedules complicated to meet global supply & sensitive to any disruption
● Research & development challenges for new FMD vaccine strains to match emerging field strains
● Regulatory challenges to meet data requirements for national and regional National Competent
Authorities
6

7
Approx 3-4 months to manufacture
& Quality Control FMD antigens for
conventional inactivated FMD vaccines
(vaccine seed grown on BHK cells)
Approx 1 – 2 weeks to formulate emergency vaccine
if FMD antigens pre-tested in trial blend according to
WOAH guidelines (FMD Antigen Banks)
Approx 60 - 90 days to release formulated FMD vaccines
under standard process (Routine release)

Market environment for FMD vaccines can disincentivise investment
Vaccination programmes are based on Public Good rather than Private Good mostly
● Policies need to be enabling to vaccine manufacturers: local vs international
market access
● Advocacy needs to be in place to encourage cooperation
■ Markets are disaggregated and episodic
■ Supply chains are longer and harder to maintain for endemic regions (LMICs)
● Veterinary Services may be under resourced
Impact: commercial companies are disinclined to develop new FMD vaccines due to
unpredictable markets
8

Market Failure for FMD vaccines with the emergence of new field strains
○ Rapid response is difficult with conventional inactivated vaccines:
■ Cost for manufacturers to switch to FMD vaccine production and/or new strain;
■ Completely novel vaccine strain may take >18 months to develop and is costly
compared to tender value;
■ Registration can take >18 months, less in ‘emergencies’, but regulatory pathway is
unpredictable;
■ Regulatory Authority capacity in endemic countries is variable;
■ ‘Emergency use’ vaccines need higher potency for rapid onset compared to ‘routine use’
vaccines that increases cost and reduces number of available doses;
■ Public sector facilities may struggle to maintain capacity for FMD vaccine development.
Impact: appropriately matched FMD vaccines of high quality in high volumes may not be
available.
9

Market Failure for FMD vaccines due to vaccine delivery challenges
● Distribution – delivery from manufacturing site to animal-side is complex:
○ Infrastructure may not be available post-airport/port delivery;
○ Accountability and cold chain maintenance/security can be compromised;
○ Post-marketing surveillance/pharmacovigilance is more difficult;
○ Inadequate capacity for trained vaccinators to deliver remotely;
○ The cost of vaccination 2-3 x cost of vaccine production itself needs to budgeted.
Impact: last mile delivery issues reduce the efficacy of a vaccination programme.
10

Conclusions: incentivisation for FMD vaccine investment
● FMD manufacturers need INFORMATION
○ About FMD
■ information about FMD at national, regional and global level
■ timely information on disease monitoring/surveillance lacking
● requires significant national investment
■ rapid access to emerging FMD strains for new vaccine development
○ FMD policy developments
■ clear public policy goals
■ clarity about disease control strategies in countries
11

Conclusions: incentivisation for FMD vaccine investment
● FMD manufacturers need PREDICTABILTY & ACCESS
■ Stable markets
■ Long-term agreements (LTAs) and/or Assured Emergency Supply Options (AESOP) to
promote investment in new production capacity & supply
■ clarity on regulatory pathways for FMD vaccines to access markets
● manufacturing standards
● registration requirements
● import & distribution requirements
■ harmonizing application of global and regional standards –WOAH, Ph.Eur, 9CFR, EMA
GLs etc
12

Conclusions: return on investment for FMD vaccines
● Return on investment
● Pharmaceutical companies will consider their expected ROI using the indicators
● Information, Predictability, Accessibility
● AND
● market size, diseases focus, product portfolio, future projections, etc.
● AND
● competing demands for their investment € $
13

Classical vaccine value chain in Animal Health
18
Research & Development: Public/private partnership
Commercial Development: Working with private
sector partners
Enabling Environment: Advocacy groups, regulators, the animal health industry and government bodies to ease
barriers in the regulatory and market environment
Monitoring & Evaluation: Delivering data which quantifies impact and informs strategy and operational plans
Favorable Policy
1
2
4
1 2
3
4
Data & Monitoring
Trained Frontline
Vets
3 Robust Markets
Vets & Paravets
Classical vaccine value chain in Animal Health
General Session EuFMD

The generic case for vaccination: a cost-benefit decision (2/2)
● Vaccine purchase is driven by situational decisions:
○ Long term: ‘Perceived Risk’ by policy makers for emergency situations;
○ Short term: ‘Perceived Benefit’ by owners or policy makers facing productivity losses, market access
closure.
● Commercial companies develop vaccines for shareholder profit:
○ $12 billion annual vaccine market in Animal Health, 6.5% predicted year on year growth to 2028;
○ Open competition should drive up quality, choice and availability;
○ Open access to global markets can suppress local competition;
○ Local and public vaccine producers may fail to attract adequate investment and technology;
○ Livestock vaccine development is costly and time-consuming, and has low margins compared to
companion animal products;
○ Companies do not like unpredictability in Markets;
○ ‘Vaccination’ requires a lot more than just a vaccine – appropriate, quality, delivery, administration.
19
Vaccine Security

Vaccine Security
What is vaccine security and why is it important for EuFMD?
● Vaccine security relates to ensuring the availability of sufficient amounts of a suitable vaccine when needed.
● In the case of FMD, vaccine is needed:
○ By FMD free countries as part of contingency planning for incursions of disease;
○ By endemic countries seeking freedom from FMD for progress along the FMD Progressive Control
Pathway.
● Vaccine security is needed in both situations but the factors that constrain the availability of vaccine differ
depending on the needs and situation of the country concerned (government policy, manufacturers, market size,
etc.).
● Many of the same challenges exist for other FAST diseases such as sheep and goat pox, lumpy skin disease and
Peste des Petites Ruminants.
20
Vaccine Security

The generic case for vaccination: a cost-benefit decision (1/2)
● Vaccination since the last century has shown clear benefits in
infectious disease control:
○ Eradication: smallpox and rinderpest;
○ Control: Covid-19, rabies, polio, anthrax, BVD, CSF.
● Successful vaccination programmes depend upon ‘enabling
factors’:
○ Adequate production, quality products, distribution
networks, willingness to pay, adequate demand.
● Market forces determine supply and demand:
○ Human health: primarily B2B ‘Public Good’ through
private profit motives supported by government/NGOs.
○ Veterinary medicine: primarily a B2C Private Good market,
with some incentives from government and NGOs.
21
Vaccine Security

The case for FAST vaccines
● Enabling factors:
○ Cost-benefit analyses are often positive;
○ Individual choice positive;
○ Movement through the PCPs.
● Disincentives:
○ Cost of vaccination;
○ Quality assurance;
○ Response times;
○ FMD strain variation.
22
Average value
of goat:
$54
Average value of goat:
$54
Cost of PPR vaccine:
US 2 cents
*Lyons NA, and all Prev Vet Med. 2019 Feb 1;163:37-43. doi: 10.1016/j.prevetmed.2018.12.007. Epub 2018 Dec 15.
Component Mean cost (ETB) per dose (%)*
Pastoral
Mixed Crop
Livestock
Vaccine 0.53 (20.2) 0.53 (10.3)
Vaccine transport 0.031 (1.0) 0.022 (0.36)
Vaccine storage 0.00025 (0.0081) 0.00022 (0.0036)
Field delivery 2.0 (64.8) 1.1 (17.3)
Farmer’s time 0.22 (7.2) 4.0 (65.0)
Co-ordination 0.17 (5.6) 0.29 (4.7)
Publicity 0.041 (1.3) 0.14 (2.4)
The case for FAST vaccines

Market Failure for FMD/TBD vaccines limits Vaccine Security (1a)
● Supply and Demand:
○ In the ‘50’s and ‘60’s quality vaccine markets operated in Europe, mass vaccination aided eradication of FMD;
○ In 2023 FMD exists in LMICs where supply and demand are fractured:
■ Reduced market overall: fewer vaccinating endemic countries and limited size vaccine banks for ‘free
countries’;
■ Ability to pay in LMICs is lower;
■ Access to appropriate strains is limited:
● Field sampling limited;
● Diagnostics limited;
● Nagoya Protocol impedes access to novel strains.
23
“The 2001 FMD outbreak in the UK was one of the most costly
livestock disease outbreaks reported, generating economic
losses of over £8 billion , 6 million animals were slaughtered
either due to infection or to limit the spread of the disease.”
- UK NAO, 2002
Market Failure for FMD/TBD vaccines limits Vaccine Security

Market Failure for FMD/TBD vaccines limits Vaccine Security (2b)
● Distribution – delivery from manufacturing site to animal-side is complex:
○ Infrastructure may not be available post-airport/port delivery;
○ Accountability and cold chain maintenance/security can be compromised;
○ Post-marketing surveillance/pharmacovigilance is more difficult;
○ Inadequate capacity for trained vaccinators to deliver remotely;
○ The cost of vaccination 2-3 x cost of vaccine production itself needs to budgeted.
Impact: last mile delivery issues reduce the efficacy of a vaccination programme.
24
Market Failure for FMD/TBD vaccines limits Vaccine Security

Example Market Support Solutions in Vaccine Security for TBDs
25
● Vaccine development:
○ FMD Reference laboratory network (FAO/WOAH/EU);
○ AgResults FMD Vaccine Prize – Advance Market Commitment E Africa (GALVmed);
○ EAC MRP (GALVmed); SMART initiative (VMD);
○ Platform vaccine technology development and Regulatory acceptance.
● Vaccine Manufacturing:
○ CVIM at The Pirbright Institute, England;
○ Quality control: AU PANVAC.
● Vaccine distribution and demand:
○ WOAH training programmes for Community Animal Health workers;
○ EuFMD work programmes:
■ Sustainable Business through Training for Veterinary Paraprofessionals (VPP) EuFMD;
■ EuFMDiS European Commission for the Control of Foot-and-Mouth Disease Spread model;
■ VADEMOS Vaccine Demand Estimation Model – FMD.
Example Market Support Solutions in Vaccine Security for TBDs

EuFMD contribution to vaccine security

Work by EuFMD 2019–2023
Vaccine security – elements in the 2019-2023 work plan
Pillar I: Improve preparedness
● Create a system for prequalification of FMD vaccines to provide independent assurance of quality and properties
of FMD vaccines (qualification assurance).
Pillar III: Sustained Progress
● Establish a multi stakeholder platform on vaccine security recognizing that vaccine security requires public private
partnerships and cooperation.
● Develop the VADEMOS model to estimate vaccine demand to assist governments and the private sector by
improving predictability and thereby reducing risk of investment.
● Further developing the PRAGMATIST model to assist risk managers in prioritizing strains for inclusion in vaccine
banks.
27
Work by EuFMD in 2019–2023

28
Proposed EuFMD
contribution in
the area of
Vaccine Security
2023-27
Proposed EuFMD contribution in the area of Vaccine Security 2023-
27

Composition and activities
● MSP brings together:
○ International organizations (EuFMD, FAO, WOAH, and others as required such as WHO);
○ Manufacturers and industry associations (large and small manufacturers with global coverage);
○ Regulatory authorities (global coverage);
○ Reference laboratories;
○ Research institutes and academic community;
○ Non-governmental organizations (e.g., Bill and Melinda Gates Foundation, GALVmed);
○ Other experts as required (e.g., legal, IT).
● Recognizes that solutions to vaccine security require a multisector approach involving private and public sector.
● It is envisaged that MSP will be actively engaged on topics related to vaccine security throughout the next work programme.
29

Workshops
● Options to improve vaccine security.
● Vaccine security through stakeholder
engagement.
● The Impact of the Nagoya Protocol on
Vaccine Security for Foot-And-Mouth
Disease Research and Development:
Options for a solution.
30

Nagoya Protocol
● Concern expressed at MSP about the impact of the current implementation of the
Nagoya Protocol (NP) on access to veterinary pathogens, particularly FMD.
● EuFMD convened a meeting of experts, including from FAO/WOAH FMD Reference
Laboratory Network, to define the problem and identify potential approaches to
resolve the issues arising.
● Reference Laboratory Network will publish an article to raise awareness.
● EuFMD will publish a ‘Report on the animal health implications of implementation of
the Nagoya Protocol with respect to Foot-and-Mouth Disease.’
The overarching conclusion was that the Nagoya Protocol is severely constraining the
exchange of FMD viruses, and therefore, having an impact on vaccine security. This has
the potential for negative consequences for animal health in both FMD-free countries and
in countries where the disease is endemic through the impact on disease surveillance and
research and development of new vaccine strains.
31

Vaccine Security
Business models that promote vaccine security
● Long established business models for investing in FAST vaccines are coming under increasing pressure:
○ Competition within companies for limited investment funding;
○ The high cost of setting up and maintaining independent vaccine banks to modern regulatory standards.
● Looking for models that:
○ Share risk between manufacturers and customers;
○ Provide certainty in supply arrangements and price in the event of an outbreak;
○ Pay manufacturers for the costs of mitigating risks by holding stocks of antigens even if no sales of
vaccines takes place;
○ Increase the attraction for investing in FAST vaccines.
32
Vaccine Security

Prequalification
Progressive implementation of PQv system
● Phased, step-wide implementation of a system for prequalification of FAST vaccines (FMD in the first instance).
● Independent, transparent and consistent evaluation of FAST vaccines against minimum international standards of
the WOAH by teams of experts and endorsed by the Standing Committee for Prequalification of Vaccine.
● International scope - companies from any country and of any size can apply as WOAH standards are applied by
all WOAH member countries (as a minimum).
● PQv list can be used by any organization that wishes to assure the quality of the FMD vaccine it procures.
● Particularly useful for long-term supply arrangements by assuring that a company can consistently produce
vaccines that comply with at least minimum international standards.
● Aim to build a ‘global community of best practice’ in FAST vaccine evaluation as has arisen through the WHO
prequalification scheme for human vaccines.
33
Prequalification

VADEMOS
Estimation of vaccine demand
● Estimating current and future vaccine dose demand is required at both national and regional levels to support
decision-making in both public and private sectors.
● VADEMOS is a tool developed by EuFMD that aims to bridge the gap between FAST diseases vaccine demand
and vaccine production/supply. It is a stochastic quantitative model which uses predictors of vaccine dose
demand such as livestock population forecast, disease control policy (related to how disease is controlled, i.e.,
projected FMD Progressive Control Pathway (PCP-FMD) stage), vaccination schedule and outbreak forecasting.
● Once the size of demand has been determined, strategies for meeting this demand through current supply
options in the country/region, alongside the estimated cost of supplying the number of doses estimated, can be
identified.
● VADEMOS could also inform any investment decisions by the private and public sector in producing the needed
vaccine doses.
34
VADEMOS

Vaccine Value Chain
Scope of work
● Effective vaccination strategies must consider vaccine delivery and demand alongside vaccine efficacy to result in
effective vaccination.
● Vaccine delivery must be cost-effective, appropriate, timely and well-managed for disease control to be achieved.
● There are a range of common policy and technical constraints that exist for FMD vaccination, especially in
endemic settings.
● Addressing these as part EuFMD’s vaccine security work is important to ensure that resources invested into
ensuring that high quality vaccine is manufactured in sufficient volumes are optimized.
● Interventions that aim to strengthen vaccine value chains will encompass:
○ Animal health systems;
○ Economic analysis;
○ Social and behavioural studies.
● Analysing and understanding these factors will help countries to implement FMD vaccination campaigns as part of
progress along the FMD Progressive Control Pathway.
35
Vaccine Value Chain

Conclusions
Vaccine security
● Vaccine security is an essential consideration for countries of all FAST disease status.
● Improving vaccine security requires a multistakeholder approach recognizing the need to engage both public and
private stakeholders at a global level in designing and implementing solutions.
● EuFMD proposes to look for options to support a range of activities which collectively aim to improve vaccine
security both:
○ directly for Member Nations of EuFMD through measures to assure access to high quality vaccines in case
of need, and
○ indirectly by assisting countries to progress along the FMD Progressive Control Pathway by assuring the
sustained supply and effective delivery of vaccine as part of eradication campaigns.
36
Conclusion

GBADs Stakeholder Workshop
ILRI Campus, Azage Hall
11th May 2023
https://animalhealthmetrics.org
Global Burden of Animal Diseases (GBADs)
Jonathan Rushton
Director GBADs
jrushton@liverpool.ac.uk

Animal Disease Decision Making
0
10
20
30
40
50
60
70
80
Unfair Guesstimates Opaque Not user
friendly
Inadequate
metrics
%
Agreeing
Courtesy of Delia Grace

Background
• Imagine a situation:
• Where the scale of investments on animal health are based on gut feelings at
best, guesses at worst...
• We rely on perceptions to allocate the resources to diseases and animal health
problems to achieve our goals...
• And when the animal health investment and allocations have been made there
are no systematic ways to capture data and information to evaluate our
successes or failures.
• This is reality for animal health - the Global Burden of Animal Diseases programme
aims to fill this void of data and information for animal health and One Health

1. GBADs Ethiopia case study
• Ethiopia selected as one of the first GBADs
case study
• Large and diverse livestock population
• Prominent role of livestock in livelihood and
economy
• Led by ILRI and Implemented since January
2021
• Major activities
• Livestock disease burden related analytics
• Stakeholder engagement and capacity
building in animal health economics

How much
are we
losing
How much
are we
spending
Absolute burden
due to each
disease
Relative burden
compared to total
burden
Who across
society is
affected
Attribution by disease,
health problem and accidents
Impact across
the economy
Livestock
populations
& production systems
Their
biomass
Value of the
animals and their
output
Animal Health
Loss Envelope
2. GBADs analytical structure and Ethiopia case study progress
adapted from Rushton et al, 2021

3. Animal health loss envelope (AHLE)- Farm level disease burden
Parameters from
existing data from
central statistical
agency and meta-
analysis of
literature data
Current Gross margin
Ideal Gross margin
Mortality = 0
Reproduction
Offtake
Growth rate
Yield
------
Feed
Labour (- % on
health)
Healthcare = 0
Mortality
Reproduction
Offtake
Growth
Yield
------
feed
Labour
Healthcare
Difference
Ideal parameters
are derived form
expert elicitation
workshop using
Cooke’s method AHLE
-

Cattle AHLE (year 2021)
755 billion
Birr

AHLE Ethiopia 2021
• Initial animal health loss envelope has been estimated for Ethiopia
• for cattle (US$17billion/yr)
• small ruminants (US$2.8billion/yr)
• and poultry (US$2.5billion/yr)
• with production and population estimates made for working equids and
camelids.
• Overall, this loss equates to 20% of Ethiopian GDP (all 2021 figures).
• This represents all production losses arising from suboptimal animal health
• In reality these losses cannot be eliminated in their entirety, but they give a
measure of the full scale of livestock disease burden.
• For reference, livestock currently contribute nearly 20% of Ethiopian GDP.

Cattle AHLE components
86.261%
13.466%
0.273%
Production loss
mortality
AH expenditure

Cost-Effectiveness of vaccines
• GBADs estimates could be linked with other sources (VADEMOS)
• Estimate reduction in disease burden for set investment in vaccination
• Consider
o Also investments in research, education, diagnostic laboratory capacity and
the coordination of the vaccination campaigns

Thank you for listening

VADEMOS:
VAccine Demand Estimation Model for FMD
EuFMD. European Commission for the Control of Foot-and-Mouth Disease

Background
• Vaccination is an essential
component of any foot-and-mouth
disease control programme in endemic
contexts
• A gap exists between the amount
of vaccine required for these
control programmes and the
amount manufactured
• Organisations that produce
vaccine need to understand the size of
this gap at national and regional levels in
order to be able to justify manufacture
of increased doses
0% 20% 40% 60% 80% 100%
Cattle (Africa)
Cattle (Asia)
Small ruminants (Africa)
Small ruminants (Asia)
Pigs (Africa)
Pigs (Asia)
Vaccine doses Total population
FMD vaccine dose numbers were aggregated from
WOAH WAHIS, population values taken from FAOSTAT
for 2020

Aims
• To bridge the gap between FMD vaccine
demand and vaccine production/supply in
endemic countries.
• To assess the vaccine requirements for
different strategies
Image by <a href="https://www.freepik.com/free-photo/long-shot-cows-walking-old-
metal-bridge_5078697.htm">Freepik</a>

VADEMOS
Vaccine Demand Estimation Model for FMD
VADEMOS is a decision-support tool intended to be used to estimate current and future
vaccine dose demand for Foot-and-Mouth disease (FMD) at a national and regional level.
It is a stochastic quantitative model which uses predictors of vaccine dose demand such as
livestock population forecast, disease control policy related to projected FMD Progressive
Control Pathway (PCP) stage, vaccination schedule and outbreak forecasting.
The WOAH WAHIS and FAOSTAT databases, as well as country-specific data
on current FMD outbreaks, livestock population and density were used along with
experts’ opinion sought to determine the extent of vaccine coverage, as well as the
reduction in number of outbreaks for each PCP stage.

A web-based format with
an interactive interface allows
the user to modify parameters
and therefore run simulations for
“ad-hoc” scenarios.

Results
What outputs does VADEMOS provide?
Expected number of doses for FMD by:
•Geographic area: Country, Subregion and Continent level
•Type of vaccination: prophylactic, emergency, total vaccination
•Species: Large Ruminants, Small Ruminants, Pigs
•Year: 10-year period predictions
•Sector: dairy/beef/smallholders

Reality vs Prediction
Accuracy of present version of VADEMOS?
A comparison is currently difficult due to data quality regarding the
real use of vaccines in the countries
• Scarce availability of official data
• Missing or inaccurate data from Authorities
• Vaccination scheme/strategy not clear
Some VADEMOS parameters are responsible of relevant uncertainty:
• Animal population prediction and density has to be improved
• % coverage of animal populations by year
• Outbreaks data are scarce
- Most Probable (MP) predictions
are often overestimated and
Credible Intervals are still large
+ Good prediction for some some countries
and numbers are always within the calculated
credible intervals

Future developments
What are the next steps?
• Validation & Reduction of Uncertainty
• Addition of a further geographical level (i.e.
provinces)
• Improvement of accuracy of livestock population
density and vaccination coverage
• Extension of the model to other FAST diseases (i.e.
PPR, LSD)
<a href="https://www.freepik.com/free-vector/business-concept-vector-illustration-businessman-who-running-
with-increase-graphic-chart-see-imagination-
future_13399716.htm#query=future&position=1&from_view=search&track=sph">Image by jcomp</a> on
Freepik

The EuFMD / European Commission for the Control of Foot-and-Mouth Disease.
HOLD-FAST strategy. Foot-and-mouth And Similar Transboundary animal diseases.
www.fao.eufmd.org www.linktr.ee/eufmd..
Sustainable development goals, UN-SDGs. EuFMD’s programme has a main focus on

VADEMOS breakout session
Vaccine delivery and demand workshop, online, 26th – 27th June 2023
European Commission for the Control of Foot-and-Mouth Disease

2
Expected number of doses for FMD by:
▪ Geographic area: Country, subregion and continent level
▪ Type of vaccination: Prophylactic, emergency and total
▪ Species: Large ruminants, small ruminants, pigs
▪ Time horizon: 10-year period predictions
▪ Sector: Dairy, beef, smallholders
Year Area PCP Prophylactic Emergency Total CI low CI up
2022 Middle East 2 43,755,985 213,634 44,074,113 44,014,585 44,130,406
2022 South Asia 2 549,555,931 1,807,895 551,547,521 550,838,825 552,656,713
2022 West Eurasia 2 274,498,319 1554,904 276,389,094 274,997,221 277,428,840
2022 Central Africa 1 44,297,249 86,754 44,444,800 44,351,321 44,539,739
2022 East Africa 1 176,513,207 605,099 177,241,880 176,567,161 177,868,294
2022 South Africa 2 96,482,909 558,086 97,193,652 97,074,796 97,419,900
2022 West Africa 1 101,902,402 30,032 101,942,254 1,011,917,420 101,967,004
TOTAL 1,287,006,002 4,856,404 1,292,833,314 1,289,761,329 1,296,010,89
6

Results (doses estimated)
3
0 20 40 60 80
Turkey (Thrace)
Turkey (Anatolia)
Kenya
Uganda
United Republic of Tanzania
Ethiopia
Millions
Area PCP Prophylactic Emergency Total CI_low CI_high
Türkiye
(Thrace)
4 1,460,349 0 1,460,349 1,405,739 1,506,628
Türkiye
(Anatolia)
1 7,676,659 150,104 7,920,989 7,569,288 8,322,331
Kenya 1 24,482,612 107,604 24,617,215 22,486,071 26,495,069
Uganda 2 34,225,437 0 34,225,437 33,113,039 35,115,018
Tanzania 2 51,570,624 0 51,570,624 49,493,788 53,536,864
Ethiopia 1 60,587,930 0 60,587,930 57,133,358 64,908,738

Discussion points
● Do you think the VADEMOS tool could help you with your FMD control plan?
● What do you expect from the VADEMOS team? What do you want to see to be
covered in the tool?
● How the VADEMOS tool performs fir your country/region? Is there a big gap between
actual vaccine doses used and what is predicted by the model?
● Would you be interested to work closely with the VADEOS team to conduct a case
study for your country/company?
● Further development of the model
● Other diseases to be covered; data and technical aspects
4

Recommendations on VADEMOS
1. To ensure continued use by end users at national and regional levels (e.g. RMMs) with feedback
2. To create an advisory group to guide the progress/usage of the tool consists of experts (FAO,
WOAH and the multistakeholder vaccine security platform).
3. To include an economic module to the model that covers the costs of manufacturing to vaccine
delivery.
4. To conduct economic analysis based on the results for advocacy and resource mobilization
purposes. e.g., costs throughout value chain by integrating that work and by liking to GBADs
framework and conduct CBA or CEA. Conducting case studies are suggested.
5. To analyse market failure gap between supply and demand identified in vaccine value chain
6. To link the outputs/results of the model with business model development e.g. AESOP, LTSA, PPPs
7. Gathering/using data on actual vaccine usage (prophylactic and emergency) by working with the
FMD WG.
5

Summary
● Accuracy of estimation, input data
● Inclusion of serotypes → PRAGMATIST tool
● Increasing resolution; adding weights for certain sectors such as dairy
● Vaccination regime: Cost vs effectiveness
● Importance of using the tool for advocacy and recourse mobilization
● Case studies
6

Vaccine delivery and demand workshop

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