AgResults launches bid to stimulate FMD vaccine R&D with 'pay-for-results' competition
An AgResults competition is aiming to support the uptake of high-quality foot-and-mouth disease (FMD) vaccines in eastern Africa.
The AgResults FMD Vaccine Challenge Project is an eight-year initiative that intends to bring specifically-tailored FMD vaccines to Burundi, Ethiopia, Kenya, Rwanda, Tanzania and Uganda. GALVmed will manage the project for AgResults – the organization already manages another AgResults competition focused on brucellosis vaccines.
The $15.8 million FMD prize differs from the brucellosis competition, as it features a cost-share mechanism designed to reduce the cost-per-dose for buyers. The buyer of the vaccine will pay a portion of its price, while AgResults will cover the rest of the cost.
This method should enable public and private sector actors to combat FMD through more consistent purchases of the new vaccines.
The project has three overarching objectives:
Development of high-quality FMD vaccines, tailored for the Eastern African strains;
Increased vaccine production and regional purchases to create greater market stability and a reduction in price; and
Development of a private sector model for buying and distributing FMD vaccines to complement public sector efforts.
The competition is open to any animal health companies with experience in the development and commercialization of FMD vaccines. The vaccines developed and registered as part of the project will need to be safe, efficacious and viable for use against the current strains of the four serotypes of FMD in the region's cattle.
The competition rules state: "Vaccines registered in at least two 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."
Poor market availability
The competition was recently launched at the FAO headquarters in Rome.
At this event, GALVmed's Nina Henning stated: "There is currently no suitable vaccine that addresses all the risks in eastern Africa. It's a complex disease and there are a lot of variations in the strains. The point of this competition is to encourage the vaccine manufacturers to tailor their vaccines to match the current strains that exist in eastern Africa.
"Even if we had a suitable vaccine that covered all the risks, there are market conditions that discourage the private sector from getting involved."
In many countries in eastern Africa, purchases of FMD vaccines are reactionary after outbreaks. This means there is unreliable availability in many areas.
Ms Henning also pointed out there is a lack of registered products in region, with no approved multivalent FMD vaccine available. The AgResults competition hopes to support a more structured environment for approval and uptake of vaccines.
The first stage of the competition is the development phase, which should last 2-4 years. Manufacturers interested in participating in the competition will aim to meet the target product profile during this phase.
To be eligible for inclusion in the competition, any vaccine must meet valency and efficacy testing requirements. Ms Henning said a viable vaccine must have a shelf life of 12 months and a minimum duration of immunity of six months, as well as a vial size accessible to smallholder farmers (one vial must have a maximum of 40 doses).
Companies need to achieve full registration in at least two of the competition's target countries. This approval can be achieved either through the mutual recognition procedure or via individual country registrations (although Ethiopia must be authorized individually).
Before entering the prize's cost-share phase, vaccines need to gain approval by the AgResults Judging Panel, which will be composed of FMD, industry, regulatory and regional experts. Testing to demonstrate vaccine eligibility must be done at a laboratory that has been approved by the project's Technical Committee.
Firms should apply once their vaccine meets all of the eligibility criteria. The application window opens February 7, 2021. The Judging Panel will meet every three months to review applications and determine if any meet the eligibility criteria.
The next part of the project will see AgResults aid the uptake of FMD vaccines by sharing a portion of the purchase price with the buyer (governments or private sector players).
The organization explained: "The AgResults-funded portion of the vaccine cost will not exceed a vaccine price of $2.00. Anything above $2.00 will be paid for by the buyer. AgResults provides funding directly to manufacturers."
The competition will cover 75% of the vaccine cost in year one, 65% in year two, 55% in year three and 45% in year four. This gradual decrease will help buyers prepare for price adjustments that could occur after the project has closed.
Other countries outside the focus of the competition will be able to purchase the FMD vaccines directly from manufacturers. However, the cost-share mechanism will not apply to these purchases.
AgResults – a collaborative initiative established in 2010 by the governments of Australia, Canada, the UK and the US, as well as the Bill & Melinda Gates Foundation – has set regional purchase volume targets that will gradually increase, rising from two million doses in the first year to five million doses in year four.
The cost-share phase of the project will not start until February 7, 2022, at the earliest. This segment of the competition will last four-and-a-half years and begins after the first eligible vaccine is approved by the Judging Panel.
The complete rules of the competition are available here.