Past activities & Achievements    

Since inception of the programme in 2011, GALVmed has collaborated with more than 20 research partners comprising a global mix of private pharmaceutical companies, universities, and public research institutes to develop a better product for reducing the impact of this major African cattle disease. Early collaborations included the search for an effective vaccine. Focus has subsequently changed to discovery and development of a new class of trypanocides, a pen-side diagnostic test, improved integrated control methods and better quality control for drugs sold in Africa. A pen-side diagnostic test is marketed by a commercial animal health company and the trypanocide is in full development with a private sector partner.  

Overview and Objectives   

The focus of the AAT programme is to de-risk the development of a target molecule to generate information allowing a commercial partner to prepare a registration package and subsequently commercialise the product.  

Over the lifetime of the project approximately 12,000 compounds have been assessed resulting in the selection of a target molecule which fulfils the target product profile (TPP) for safety, efficacy and cost. The target molecule is now in final development with the objective of achieving the first marketing approvals in 2028.  

Programme Activities    

Current activities include chemical process optimisation, upscaling of the manufacturing process for the drug substance and chosen formulation, environmental safety assessment, human food safety studies, animal dose confirmation and target animal safety studies, and field safety and efficacy studies.  

Past activities & Achievements

There are existing vaccines available in Africa against CBPP, but there is great scope to develop a more effective, accessible system of integrated disease control. Our first work towards this was to test the BEN-1 cattle vaccine, used to eradicate CBPP in China, in an African context. From 2014 to 2017, we coordinated a consortium led by the Harbin Veterinary Research Institute, which originally developed the vaccine in the 1960s. Three batches of BEN-1 vaccine were produced and trialled in Africa, and found to be effective, but no more effective than the existing vaccine. Work is now proceeding to improve the performance and production processes of the existing vaccine. Additionally, data on the use of two modern antibiotics for the treatment of clinical cases of CBPP will be incorporated into an integrated control programme model.

Overview and Objectives

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.  This product is in the late stages of full development with final efficacy and production studies remaining, leading to dossier submission in 2023. 

Past activities & Achievements

The only immunological intervention that protects cattle against ECF is the ECF-ITM (Infection and treatment method) vaccine (the largest example is the Muguga Cocktail), which is relatively complicated to manufacture and administer, yet highly effective. ECF-ITM involves injecting a preparation of live sporozoites of the Theileria parva parasite at the same time as a long-acting antibiotic. GALVmed supported work to improve the production process – reducing the vaccine production time by three months and cattle usage by 80% – while transferring the technology from the International Livestock Research Institute (ILRI) in Nairobi, where it was originally produced, to larger-scale production at the African Union Centre for Ticks and Tick-borne Diseases (CTTBD) in Malawi. This vaccine is registered in Malawi and is in the process of registration in three other East African countries. Development work has also been conducted to produce 10-dose vials of the ECF-ITM vaccine, which would be preferable for the small-scale livestock keeper rather than the current 40-dose vials. A novel diluent, which will significantly reduce the production, distribution and storage costs of the ECF-ITM vaccine, has been identified and is ready to be field-tested before commercial implementation.

Between 2010 and 2022, 2.39 million doses of the vaccine were sold, averting approximately $119 million of cattle mortalities. Sales are ongoing in East and Central Africa through the African Union Centre for Ticks and Tick-borne Diseases (CTTBD).

Overview and Objectives

The current support for the extended use of the Muguga Cocktail version of ECF-ITM is to publish field epidemiological data on T parva strain prevalence and efficacy data from field exposure studies. A small project conducted in collaboration with Sciensano, Brussels, Belgium aims to simplify the formulation and potency release assays of the Muguga Cocktail ECT-ITM.

Past activities & Achievements

Historically Foot and Mouth Disease has not had a funded programme in GALVmed.

Overview and Objectives 

In 2019 GALVmed was awarded the contract to be Project Manager of the AgResults FMD Vaccine Challenge Project.  Launched in January 2020, the Project is an eight-year, US$17.68 million prize competition that supports the development, registration 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 competition is funded by AgResults, a collaborative initiative between the governments of Australian, Canadian, the United Kingdom and the United States governments and the Bill & Melinda Gates Foundation.

Through a pay-for-results mechanism, the Project aims to achieve 3 objectives:

1. Develop and register high-quality FMD vaccines tailored to the needs of Eastern Africa
2. Create greater market stability and affordability through increased production and purchase of regionally relevant vaccines
3. Build a private sector model for FMD vaccine purchase and distribution to complement public sector efforts

To achieve this, the Project will utilise a cost-share mechanism that reduces the cost-per-dose for FMD vaccine buyers, enabling public and private sector actors to better combat FMD through more consistent purchases of the new vaccines. In this way, the project encourages the widespread The competition will conclude in July 2028.

Programme Activities 

The Project is being implemented as a two-phased competition:

• 1. Development Phase: During this phase, which began in February 2020, the Project will encourage animal health pharmaceutical companies around the world to research, develop, register and commercialize FMD vaccines for Eastern Africa. The Target Product Profile (TPP), set out in the Competition Rules, defines the characteristics which a vaccine must meet including standards related to safety, efficacy and utility in the small-scale livestock producer setting. The Competition requires vaccines to be registered in the Project’s target countries; either through the East African Community Mutual Recognition Procedure (EAC MRP) or individual country registration procedures.  A vaccine which is granted full product registration in at least 1 of the target countries and demonstrates compliance with all the requirements of the TPP, as assessed by the Project’s Judging Panel, will then be approved as eligible for the next phase of the Competition.

• 2. Cost-Share Phase: The Cost-Share Phase is expected to begin three to four years after the start date of the Development Phase and will end in July 2028.  The commencement of this phase will be announced via the Project’s website, press releases and directly to those organizations that have signed up to the Project’s mailing list.  Competitors will only be eligible to access the cost-share awards in countries where their vaccine has been granted full product registration.  During this Phase, the Project Manager (GALVmed) will work with public and private sector vaccine buyers in Eastern Africa to facilitate the purchase of registered and qualified FMD vaccines developed by “Competitor” companies. The Project will contribute to the cost-per-dose paid to the competing manufacturers, thereby encouraging government and private sector actors to better combat FMD by consistently purchasing high-quality vaccines. To build a stable market around FMD control, the Project will promote the development of a private sector model for buying and distributing vaccines, while enhancing existing public sector control efforts.

More details can be found on the AgResults FMD Vaccine Challenge Project webpages.

Past activities & Achievements

A limited project was undertaken with the OIE Reference Laboratory for LSD at Sciensano, Belgium to determine the comparative merits of different commercially available and prototype LSD vaccines, both live attenuated and killed. It was clear that the duration of immunity was longer for the live attenuated vaccines used in the study.

Overview & Objectives

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.  This product is in the late stages of full development with final efficacy and production studies remaining, leading to dossier submission in 2023. 

Past activities & Achievements

Together with a commercial partner GALVmed has focused on a cattle vaccine to protect against RVF infection using the strain known as Clone 13. This vaccine strain was known to be effective but did not have a long shelf life. Stability improvements have extended its shelf life beyond 12 months, opening up the possibility of establishing a strategic reserve of the vaccine that can be quickly deployed across Southern Africa to prevent epidemics. Parallel work developing a rapid pen-side diagnostic test to track the disease in the field easily was completed. The technology is being transferred to a partner for manufacturing and distribution. Clone 13 has the potential for use in combination vaccines for other cattle, sheep and goat diseases.

Overview and Objectives

The deployment and provision of RVF vaccination is being addressed through policy debate, including regional and supranational stakeholders.

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.  This product is in the late stages of full development with final efficacy and production studies remaining, leading to dossier submission in 2023.