Brucellosis, Foot and Mouth Disease (FMD), and Transforming Animal-Health Solutions and Services for Low-and middle-income countries (TAHSSL).

Brucellosis

Past activities and Achievements

GALVmed has conducted a limited programme of work on Brucella abortus in the past which related to antimicrobial therapy. The programme was unsuccessful.

 

Overview and Objectives

Launched in 2016, the Brucellosis Vaccine Prize competition is a 12-year vaccine development initiative adopting an entirely new funding approach by providing monetary prizes on a pay-for-results basis as incentives for product development. This US $30 million competition is funded by AgResults, a collaboration between the Australian, Canadian, and UK governments, and the Gates Foundation, and is implemented by GALVmed. It is the first competition of its kind in animal health research and will reward organisations which develop and register a vaccine for Brucella melitensis that is safe and effective for use in sheep or goats and suitable for use by the small-scale livestock sector in limited-income and middle-income countries.

 

Programme Activities

The competition is running in 3 phases with prize awards available at the end of each phase to reward organisations which meet the milestone requirements of each phase.

  1. Phase 1 (application): Almost 40 organisations applied to the competition, of which 20 of the proposed development programmes were accepted into Phase 2, with each of the 10 best proposals receiving a US $100,000 Milestone 1 prize.
  2. Phase 2 (establishing proof of principle): During this phase, organisations must establish proof of principle of the safety and efficacy of their vaccine candidate in target animals. In addition, they must demonstrate a scalable process for commercial production. Each of the first four organisations to meet all the defined criteria will be eligible for a US $1 million prize.
  3. Phase 3 (registration): Final development work will be required to ensure that an organisation’s vaccine meets the minimum viable product profile set out in the competition rules. The first organisation to register a vaccine meeting all these requirements in the EU, US, Japan, Australia, Canada or UK will be awarded the grand prize of US $20 million.

Currently, more than half of the organisations which met the requirements of Phase 1 and entitled to progress into Phase 2, in 2017, continue with their development programmes towards achievement of Milestone 2.

The competition is still open to new applications.

More details can be found on the Brucellosis Vaccine Prize website.

Foot and Mouth Disease (FMD)

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$17.34 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 Australia, Canada, the United Kingdom, and the Gates Foundation.

Using a pay-for-results mechanism, the Project aims to meet 3 objectives:

  1. Develop and register high-quality FMD vaccines tailored to the needs of Eastern Africa
  2. Create greater market stability and affordability by 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.

 

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 encourages animal health pharmaceutical companies around the world to research, develop, register and commercialise 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 one of the target countries and demonstrates compliance with all 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 started in October 2024 following the first-ever development and registration of a quadrivalent FMD vaccine tailored for East Africa. The vaccine was registered in Rwanda by Biopharma, a vaccine manufacturer based in Morocco. During this phase, competitors will only be eligible to access the cost-share awards in countries where their vaccine has been granted full product registration. 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.

TAHSSL

Overview and Objectives

The focus of TAHSSL – Transforming Animal-Health Solutions and Services for Low-and middle-income countries – is to address the burdens of diseases in low- and middle-income countries (LMIC) by developing veterinary medicines and diagnostic solutions and providing services to help fill the product development pipeline.

TAHSSL will build a one-stop shop, located at the ILRI campus, Nairobi, Kenya to conduct research activities on animal health product technologies, assess technologies and technology platforms, and establish robust animal disease models. By this means, we will generate robust proof-of-concept data to de-risk potential private sector entry into product development, registration and use. This platform will thus provide services to the public and private sector to accelerate animal health product development and facilitate market development and entry. The objectives are:

  • To provide high quality technologies and services to facilitate laboratory and clinical research for development of safe and effective animal health products for small-scale livestock producers (SSPs)
  • To be a “one-stop-shop” that facilitates animal health companies to establish viable markets for animal health products in LMICs.

 

Further information

TAHSSL is a joint initiative between the International Livestock Research Institute (ILRI)Clinglobal, and GALVmed. Core funding for establishing TAHSSL has been provided by the Gates Foundation.