What FMDV serotypes must be in the vaccine?
The vaccine must contain FMDV serotypes O, A, SAT 1, and SAT 2.
How was the composition of the vaccine decided?
The vaccine composition was decided by the AgResults Technical Committee following epidemiological surveillance information from the FAO/OIE FMD Reference Laboratory Network. The AgResults Technical Committee comprises experts with industry, technical and policy backgrounds. Membership of the Technical Committee is confidential.
What is the Eastern African FMDV Reference Antigen Panel?
The Eastern African FMDV Reference Antigen Panel is a collection of viruses that represent contemporary lineages circulating in Eastern Africa, selected by performing phylogenetic analysis of all VP1 sequences available from WRLFMD, the OIE/FAO FMD Laboratory Network, and GenBank. Further information about the genetic diversity and circulation of these specific viruses can be found on the WRLFMD website.
Which antigens are in the Eastern African FMDV Reference Antigen Panel?
The antigen panel comprises sixteen FMDV isolates tailored to cover the genetic diversity within the FMDV lineages that circulate in Eastern African countries (namely: Burundi, Democratic Republic of Congo, Eritrea, Ethiopia, Kenya, Rwanda, Somalia, South Sudan, Tanzania, and Uganda) that can be used to evaluate serological responses of FMDV vaccines in the context of their suitability for use in Eastern African countries (https://www.wrlfmd.org/node/2096/). Further information about the genetic diversity and circulation of these specific viruses can be found on the WRLFMD website.
Where can I find the Competition Rules?
The Competition Rules can be found on the GALVmed website: https://www.galvmed.org/wp-content/uploads/2020/09/FMD-Vaccine-Challenge-Project-RFA-FINAL-rev1-010920.pdf
What countries does the Competition cover?
The Competition covers Burundi, Ethiopia, Kenya, Rwanda, Tanzania, and Uganda. Vaccine manufacturers must achieve full registration for their vaccine in at least two of these countries to be eligible for the Competition.
When was the start date of the Competition?
The Competition officially started on February 7, 2020 with the launch of the Development Phase.
When is the closing date for the Competition?
The Competition will end four and a half years after the start of the Cost-Share Phase. The Cost-Share Phase will commence start after the first vaccine has been approved by the AgResults Judging Panel and the Competitor has received order(s) of at least 150,000 doses for such vaccine. Companies can continue to register FMD vaccines and submit applications to AgResults until one year before the end of the Cost-Share Phase.
We are currently in the Development Phase of the Competition. Key Development Phase milestone: at least one Competitor must submit an FMD vaccine dossier (that they believe meets all of the elements of the AgResults Target Product Profile) to the regulatory authorities in at least two target countries by August 7, 2023 (3.5 years after the launch of the Competition). If no dossiers are submitted by this date, AgResults reserves the right to terminate the Competition.
Can one company submit two applications for two different vaccines?
Yes! A company may submit applications for more than one vaccine, but they must submit them separately and provide an individual application and all other required documentation for each vaccine.
If a Competitor enters the Competition after the Cost-Share Phase has started, what proportion of the cost-share value does the Competitor receive?
Competitors who enter the Cost-Share Phase after it has begun will receive the benefit at the corresponding stage of the Cost-Share Phase at their time of entry. For example, if a second vaccine is approved six months into the Year 1 sales period, that Competitor will still be able to access the 75% cost-share award for the remainder of year 1. Both Competitors will then enter Year 2 together and at the same cost-share rates.
What does the AgResults Judging Panel do?
The AgResults Judging Panel will review applications quarterly (as needed) to determine whether manufacturers’ FMD vaccine(s) meet the criteria to become eligible for the Competition’s Cost-Share Phase.
Who is on the AgResults Judging Panel?
The AgResults Judging Panel consists of FMD, industry, and regulatory experts. Membership of the Judging Panel is confidential.
Does the AgResults Judging Panel decide the price?
No! The price is decided by the manufacturer.