Session IV One of the most infectious livestock diseases in the world, Foot and Mouth Disease (FMD) presents a constant global threat to animal trade and country economies. To assist control measures, the global clustering of FMD viruses has been divided into 7 virus pools, where multiple serotypes occur but within which are topotypes that remain mostly confined to that pool. This clustering of viruses suggests that if vaccination is to be a major tool for control, each pool could benefit from the use of tailored/more specific vaccine formulations relevant to the topotypes present in that pool.

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EuFMD Open Session 2022
The AgResults Foot and Mouth Disease
Vaccine Challenge Project as an Example of
Innovative Vaccination Strategy
October 2022
Dr Jef M Hammond, FMD Industry Expert

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The Challenge: FMD in Eastern Africa
Currently no suitable vaccine addresses all Eastern African regional risks.
• FMD is a complex disease with high within-serotype variation which increases the
difficulty of developing an appropriate vaccine for the region.
• Vaccines currently available in Eastern Africa are not effective against all local strains.
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Even with a suitable vaccine developed, the private sector is unlikely to
distribute in the region due to current market conditions.
• In most countries in the region, governments consider vaccination to be a public good
and control FMD vaccine purchases.
• No multivalent FMD vaccine has been formally registered in the region as they are
procured through specialized processes or tenders.
• Government purchases are often reactive to outbreaks, leading to an unreliable
market demand.

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Overview: AgResults FMD Vaccine Challenge Project
The project aims to achieve 3 objectives:
1. Development and registration of high-quality FMD
vaccines, tailored for the needs of Eastern Africa
2. Increased vaccine production and regional purchases to
create greater market stability and reduce price
3. Development of private sector model for buying and
distributing FMD vaccines to complement public efforts
To achieve these objectives, we
propose the development of a
comprehensive mechanism:
 A Cost-Share, designed to
include public and private
sector buyers
An eight-year, US$17.68 million prize competition that launched in January 2020.
Supports the development and uptake of high-quality FMD vaccines tailored to meet
the needs of Eastern Africa in six target countries.

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Phase One: Vaccine Development
To be eligible for entry into Phase 2 the vaccine must meet the following conditions.

Vaccine Development to Target Product Profile (TPP) Standards:
• Quadrivalent Vaccine at least 6PD50 containing serotypes A, O, SAT1 and SAT2 that
match circulating Eastern African Foot and Mouth Disease Viruses
• 12-month shelf life
• 6-month duration of immunity
• Differentiating Infected from Vaccinated Animals (DIVA) capability
• Vial size to be appropriate for use by smallholder farmers in the region

Vaccine Registration: must achieve full registration in at least 1 target country
• Target countries: Burundi, Ethiopia, Kenya, Rwanda, Tanzania, and Uganda
• First vaccine was submitted for registration in Q4 2022

Vaccine Approval: must be approved by AgResults Judging Panel
• Judging Panel is composed of FMD, industry and regulatory experts.
• Judging Panel will review FMD vaccine applications and grant approvals to those that
meet the eligibility criteria above.

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Regional Virus Pools: FMDV
Pool 4
O, A, SAT 1,2,3

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Pool 4: Eastern Africa FMDV Status
Most countries in this region are endemic for serotypes A, O, SAT1, and SAT2.
= AgResults Project target country
Country
PCP
Stage
Serotype Reported
O A SAT1 SAT2 SAT3
Burundi (no samples since 2003) 0-1
Ethiopia 1
Kenya 1-2
Rwanda 2-3
Tanzania 2
Uganda 2
The Comoros 1 to 4?
Democratic Republic of Congo 1
Djibouti (never reported) 0-1 ? ? ? ? ?
Republic of Eritrea 1
Somalia 1
South Sudan 1
Republic of Sudan 2

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? Burundi –
(no reports since 2003)
10 Ethiopia - O- A- SAT1 -SAT2
5 Kenya - O -A -SAT1- SAT2
1 Rwanda - SAT2
(no reports since 2004)
3 Tanzania - O- A- SAT1
7 Uganda - O- A- SAT 1- SAT2-SAT3
(SAT3 in buffalo only)
• 5 serotypes – O, A, SATs 1,2 & 3
• At least 15 different strains/topotypes
FMD Reports from Competition Countries (last 5 years approx.)

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Vaccine Valency: Demonstrating Regional Relevance
• The World Reference Laboratory for FMD, Pirbright, UK (WRLFMD) has assembled a panel of
regional circulating FMDV strains. https://www.wrlfmd.org/node/2096/
• This Eastern African FMDV Reference Antigen Panel comprises 16 FMDV strains clustered into
4 serotype sets that are representative of the viruses currently circulating in Eastern Africa.
• For each vaccine submitted to the competition, cattle sera generated by vaccination will be
tested for relevance to the Eastern African region by Virus Neutralization Test (VNT) against
this panel.
• Must achieve a pre-defined titre for pass.
• One or two dose sera can be submitted for testing.
• Minimum 70% pass rate is required for each serotype set.
- 4x Serotype O
- 4x Serotype A
- 4x Serotype SAT1
- 4x Serotype SAT2
First time this novel approach has been applied to assess vaccines before use

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Project Progress: Achievements
• Added more than 400 contacts to our database for regular updates including: FMD vaccine
manufacturers (31), NGOs, Reference Labs, Research Organizations, Regulators and Governments.
• Development and adoption of the TPP as a standard for FMD vaccine quality and efficacy
• Engagement with Global FMD vaccine manufacturers
• Engagement with National FMD vaccine regulatory authorities/assessors
• Collaboration with UK Veterinary Medicines Directorate for harmonizing the evaluation of FMD
vaccine dossiers
• Collaboration with WRLFMD and adoption of the EA FMDV Reference Antigen Panel as a standard
to test vaccines for relevance to the region’s circulating FMD strains
• Development of Public-Private Partnership Framework to address challenges in the vaccine value
chain
• Introduction of cost-share mechanism - financial incentive for public and private sector buyers to
make proactive vaccine purchases in line with their country’s FMD control strategy
• Publication of Project Review article (Viruses Journal) and GALVmed Blog articles
“Hot off the press”
Q4 2022 submission of FMD vaccine registration dossiers
o completed in 1 target country
o expected in 3 additional target countries

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An Example of Innovative Vaccination Strategy
The AgResults solution combines:
High-Quality Vaccine(s) Improved Distribution
Summary:
• Manufacturers willing to adopt pre-determined specific requirements for vaccine to be
accepted into the Competition
• First time vaccines have been tested for expected efficacy before use in the region
• First time multi-valent FMD vaccines have been submitted for full registration in the region
• Gives purchasers more confidence in vaccine (both public and private sector)
• Expected to lead to increased uptake and improved FMD control
• Vaccine dossiers expected to be submitted for registration in 3 countries by year end and
more expected next year
For more information and resources, visit the AgResults or GALVmed websites:
https://agresults.org/projects/fmd-vaccine
www.galvmed.org/foot-and-mouth-project