The FMD Vaccine Challenge Project launched on January 22, 2020. 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 has been updated as needed to reflect 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 one 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 one 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.
The Project Manager will review each received application to determine its completeness and notify the application of this determination within 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 90 days from the date of submission.
Companies whose applications are accepted will enter 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) 3.5 years after the Launch (August 7, 2023), or any time thereafter, if at that time GALVmed has not received written notice from a Competitor that such Competitor has submitted an application for Product Registration with the applicable regulatory authorities in one (1) or more countries in the Region for an FMD vaccine that, if approved, would satisfy the Target Product Profile, (b) at any time after the 4th anniversary of Launch, if at that time no Qualified FMD Vaccine has been (or continues to be) approved by the Judging Panel or (c) if at any time during the Cost-Share Phase, fewer than 150,000 doses have been the subject of Awards during the prior 12 months.
The Cost-Share Phase will commence when the first vaccine that meets the eligibility requirements has been approved by the Project’s Judging Panel, and the Competitor Agreement between the applicable Competitor and GALVmed has been executed. This will be announced via this website, press releases, and emails directly to those individuals 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 until July 31, 2027.
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.
For more details on the Cost-Share Phase, visit About The Project.