The FMD Vaccine Challenge Project launched on January 22, 2020. This marks the official announcement of the prize competition. The requirements for participation are set out in the Competition Rules, which were published on this website on February 7, 2020. This date marks the official start of the Development Phase of the Project.
During the Development Phase, animal health pharmaceutical companies with experience and/or capability in the development of FMD vaccines are encouraged to engage with the FMD Vaccine Challenge Project Manager to discuss Project requirements. The Project target countries are Burundi, Ethiopia, Kenya, Rwanda, Tanzania and Uganda.
The Request For Applications was published on this website on July 1, 2020 and contains the most up-to-date Competition Rules. Interested companies should review these rules, as well as the additional information provided on the Competitor Resources page, and can contact the Project Manager with any questions (FMDchallenge@galvmed.org).
All interested companies should provide informal and formal notifications directly to the Project Manager.
A company can provide an informal notification of its intention to participate in the Competition at any time by signing up to the Project’s mailing list at the bottom of this page. This mailing list will keep interested companies informed about important project developments and milestones.
The first formal notification required for participation in the Competition is for a company to advise the Project Manager that it has submitted an FMD vaccine dossier for Marketing Authorisation in at least two of the target countries.
If a company wants their vaccine to be considered for eligibility for an award in the Project’s Cost-Share Phase, a formal application (via the online application portal) must be made.
Once a company’s vaccine meets all of the eligibility criteria set out in the Competition Rules (which requires a Marketing Authorisation in at least two of the Project’s target countries AND demonstration that the vaccine meets all of the requirements of the Target Product Profile), then the company should submit an application to the Project Manager via the online application portal.
Companies can begin submitting applications starting on February 7, 2021 for consideration of eligibility by the Project’s Judging Panel. However, as the Competition Rules state, the Cost-Share Phase of the Project will not start until February 7, 2022 at the earliest.
The Project Manager will review each received application to determine its completeness and notify the application of this determination within thirty (30) days of submission. If an application passes this initial review, it will then proceed to the Judging Panel, who will conduct the final review. This final review could take up to ninety (90) days from the date of submission.
Companies whose applications are accepted will enter to the Cost-Share Phase and will subsequently be referred to as “Competitors.”
The full requirements for application and the Competition Rules are set out in the Request For Applications.
Note: AgResults reserves the right to terminate the Competition (a) at any time after August 7, 2023 if at that time no Qualified FMD Vaccine has been approved by the Judging Panel and GALVmed has not received written notice from any company that an FMD vaccine application has been filed with the applicable regulatory authorities in two or more target countries; (b) at any time after March 1, 2024, if at that time the Cost-Share Phase has not commenced.
As soon as the first vaccine that meets the eligibility requirements (vaccine registration and the Target Product Profile) has been approved by the Project’s Judging Panel, the Cost-Share Phase of the Project will commence. This will be announced via this website, press releases and directly to those organisations that have signed up to the Project’s mailing list – see signup at the bottom of this page.
Please note that companies can submit applications for consideration by the Project’s Judging Panel up to three years after the Cost-Share Phase start date, subject to the Competition Rules.
During the Cost-Share Phase, the Project Manager will keep Competitors updated on the total number of doses available within the cost-share mechanism, together with the status of the Country Reserve and Regional Pool dose allocations.