The AgResults Foot and Mouth Disease (FMD) Vaccine Challenge Project is an eight-year, US$17.34 million prize competition that supports the development and uptake of high-quality FMD vaccines tailored to meet the needs of Eastern Africa, targeting in particular: Burundi, Ethiopia, Kenya, Rwanda, Tanzania, and Uganda.  The prize is structured as a cost-share that reduces the cost-per-dose for buyers, enabling public and private sector actors to better combat FMD through more consistent purchases of the new vaccines.  This will help to increase the market potential for vaccines in the region. GALVmed serves as the Project Manager for this competition.

FMD is a viral disease of livestock that affects cattle, swine, sheep, goats and other cloven-hoofed ruminants. The FMD virus is highly contagious, and outbreaks of the disease can have severe economic consequences due to decreased livestock productivity and disruption of regional and international trade of animals and animal products. Africa loses about US$2.3B annually due to FMD, with most of the economic burden falling on sub-Saharan Africa. FMD is estimated to circulate in 77% of the global livestock population, according to WOAH. Morbidity levels are very high, reaching 100% in susceptible populations, while mortality is generally low in adult animals. In Eastern Africa, where FMD is endemic, outbreaks typically strike as waves of infection one to two years apart with outbreaks exacerbated when multiple serotypes or strains circulate concurrently.

The following video explores the impact of FMD in Eastern Africa, from the perspective of both the small-scale livestock producers whose livestock and livelihoods are affected, as well as those who seek to control the disease on the ground and through policy development.

To meet the needs in Eastern Africa, AgResults encourages animal health companies with experience in the development and commercialisation of FMD vaccines to develop and register vaccines that are safe, efficacious, and viable for use against the currently circulating strains of the four serotypes of FMD in the region’s cattle. Vaccines registered in at least one of the AgResults target countries that meet all the requirements set out in the Target Product Profile are eligible to participate in this cost-share initiative. This provides an incentive to both public and private sector buyers in the region to purchase vaccines as part of a disease control strategy.

Full details of the Target Product Profile requirements can be found in the Competition Rules section (Annex 1) of the Request For Applications.

On September 24, 2024, AgResults formally announced that the first quadrivalent FMD vaccine tailored for Eastern Africa had been successfully registered in August. By registering in one of the six project Target Countries and meeting the Project’s Target Product Profile, Biopharma (BIOPHARMA – Société de Productions Biologiques et Pharmaceutiques), a Morocco-based vaccine manufacturer, qualified to become the project’s first “Competitor”. Following this announcement, the AgResults FMD Vaccine Challenge Project officially launched the Vaccine Distribution Cost-Share Phase on October 1, 2024.

In the Vaccine Distribution Cost-Share Phase, a $15.8 million cost-share mechanism helps to increase the distribution and adoption of high-quality FMD vaccines by funding a portion of the selling price of vaccine(s) that meet all of the AgResults eligibility criteria. AgResults provides the cost-share funding to manufacturers on behalf of public and private sector buyers who purchase directly from the manufacturers, including the manufacturers’ Local Technical Representative(s). Each sales period, the cost-share covers a percentage of the vaccine price for a fixed number of vaccine doses, as illustrated in the table below, totalling 12.5 million doses over the entirety of the Cost-Share Phase. The cost-share vaccine doses are allocated to the country(ies) where the approved vaccine(s) are registered.

The cost-share support is structured in three sales periods that run from October 2024 – July 2028:

Each sales period, AgResults allocates a portion of the total available vaccine doses to individual target countries (Country Reserves) based on:

1. countries which have or will have achieved Product Registration for the new vaccine(s),
2. the individual country’s share of the Region’s cattle population, and
3. discussions with each country’s government.

Countries also have access to a Regional Pool open to buyers with the registered vaccine(s), that provides access to additional cost-share doses beyond the Country Reserves. Forty percent (40%) of the total cost-share doses available in each sales period are allocated to the Regional Pool and sixty percent (60%) are allocated to the Country Reserves.

The majority of the doses in the Regional Pool are available for use by any buyer; however, to encourage governments to create a regulatory environment that supports private sector involvement in vaccine distribution, thirty-five percent (35%) of the Regional Pool doses will be set aside for private sector purchase only, as fully described in the Competition Rules.

Any buyer interested in purchasing the AgResults-approved FMD vaccine(s) may contact the Project team (FMDchallenge@galvmed.org) to request contact information for the vaccine manufacturer directly and/or the manufacturer’s in-country Local Technical Representative. Please note that the cost-share benefit is available only to buyers who are eligible to purchase directly from the vaccine manufacturer.