The FMD Vaccine Challenge Project

The AgResults Foot and Mouth Disease (FMD) Vaccine Challenge Project is an eight-year, US$17.68 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 also increase the market potential for vaccines in the region. GALVmed serves as the Project Manager for this competition.

About Foot and Mouth Disease

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$2.3bn 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 the OIE. 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 Foot and Mouth Disease 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.

What Will Make a Vaccine Eligible for the Cost-Share?

To meet the needs in Eastern Africa, AgResults is looking for 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 will be eligible to participate in this cost-share initiative. This will provide 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.

Vaccine Adoption

To support the adoption of high-quality, regionally-relevant vaccines, AgResults has established a cost-share mechanism which will reduce the cost-per-dose for both public and private sector buyers. Each year, AgResults commits to funding a portion of the purchase price of the vaccine for a specified volume of vaccine doses. AgResults provides funding directly to vaccine manufacturers, on behalf of the buyers. The Cost-Share Phase is expected to begin three to four years after the start date of the Development Phase (February 7, 2020) and will end on July 31, 2028. The total value of cost-share support available through the Competition is $15.8M.

During the Cost-Share Phase, the level of cost-share support will start at 75% and gradually decrease in each sales period to help buyers prepare for price adjustments that will occur after the Project has closed. The Project will fund a portion (e.g., 75% in Sales Period 1) of the price of the vaccine up to a selling price of USD$2.00 per dose. If the vaccine has a selling price above USD$2.00, the buyer will pay the difference. The volume of doses eligible for the cost-share benefit will gradually increase over the Cost-Share Phase, up to five million in the final sales period.

The start date of the Cost-Share Phase, along with the timing and duration of the sales periods will be announced on this webpage and by email to the project mailing list (sign up at the bottom of this webpage). The announcement will include the following information for each sales period: percentage of cost-share support (e.g., portion of sales price reimbursed through the Project) and volume of doses eligible for cost-share support.

 Dose Allocation

Each sales period, AgResults will allocate a portion of the total available vaccine doses for individual target countries to use (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.

 

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

The majority of the Regional Pool will be 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 will be set aside for private sector purchase only, as described more fully in the Competition Rules.