1. Scale and reach of commercial development initiatives
During the first phase of GALVmed, the commercial development projects were reaching 10,000 to 20,000 smallholder households. By the end of 2017, this figure had risen to well over 2.5 million households benefiting during the past decade. This is a significant increase in scope and scale over a relatively short period. Furthermore, it points towards the viability and sustainability of these business initiatives that provide valued farming inputs actively sought after by the majority of smallholders who are willing to pay the market price for these products.
2. Engaging the animal health industry in product and commercial development initiatives
During the early years of GALVmed’s existence, there was little appetite from the animal health industry in specifically targeting the smallholder sector. A decade later, we are either directly partnering with, or planning activities with, a wide representation of the animal health industry, covering both product and commercial development activities. This emerging engagement reflects, in large part, our sustained focus and effort in highlighting the opportunities in the smallholder sector.
3. An expanded and innovative product development pipeline
When GALVmed was created, it was, in part, based on the assessment that, while a lot of good research into livestock diseases impacting on smallholder farmers had been undertaken, few products had been taken through to development and registration. By the end of the decade, 25 product development projects were completed or are currently underway. This expansion reflects a judicious and dynamic portfolio approach whereby development projects with little likelihood of success are stopped early and the funding channelled into new opportunities with good potential for impact.
4. Mutual recognition of vaccine registration
Over the past eight years, substantial effort has been devoted to facilitating the standardisation of registration requirements across six countries in the East African Community (EAC) leading to mutual recognition of veterinary vaccine registration. The highest level of political and legal endorsement was obtained in 2016 when the EAC Council of Ministers issued a directive to EAC partner states to implement the Mutual Recognition Procedure (MRP) developed with GALVmed support. MRP will make the system of registration of veterinary products more efficient through simultaneous granting of marketing authorisations by participating countries. The first product, submitted by a multinational company, has been registered and two more products are in the process of registration.
5. Leveraging organisational capability for other development projects
The significant scope and scale of the two main PLSHL programmes necessitated a good degree of organisational support and effectiveness. This support infrastructure has enabled us to support a range of other animal health development programmes. These include a programme to develop a novel trypanocide (the Tryps programme), the Brucellosis Vaccine Prize (focusing on development of improved vaccines to control brucellosis in small ruminants) and a number of smaller projects. Over the course of the past five years, GALVmed has refined its support functions so that these form a lean and effective foundation for the delivery of product and commercial development projects.
6. Products delivered
In addition to substantially expanding the pipeline of new products in development, the original target to develop three to five and five to seven new products during the PLSHL 1 and PLSHL 2 programmes, respectively, was achieved. Ten products have been delivered in the past decade.
The following are developments and achievements in addressing smallholder needs in each disease area
East Coast Fever (ECF)
The only immunological approach that protects cattle against ECF is the ECF-ITM (or Muguga Cocktail) vaccine, which is relatively complicated to manufacture, yet highly effective. ECF-ITM involves injecting a preparation of live Theileria parva parasite, which takes more than a year to produce, at the same time as a long-acting antibiotic. We supported work to improve the production process – reducing the vaccine production time by three months – while transferring the technology from the International Livestock Research Institute, where it was originally developed, to larger-scale production at the African Union Centre for Ticks and Tick-borne Diseases (CTTBD) in Malawi. This vaccine is now registered in Malawi and Rwanda and is in the process of registration in three other countries. Development work has also been conducted to produce 10-dose vials of the ECF-ITM vaccine, which would be preferable for the smallholder dairy sector than the current 40-dose vials. A novel diluent, which will significantly reduce the production and storage costs of the ECF-ITM vaccine, has been identified and is ready to be field-tested before commercial implementation. Despite the complex process of producing and administering this vaccine, an unprecedented 1.7 million cattle have been vaccinated so far.
A growing flock
Silanti Linda, a mother of one in the Indian state of Jharkhand, used to keep three or four backyard chickens at a time. In a region of falling land productivity, deforestation and rising living costs, every household like Linda’s is on the lookout for new income opportunities – but she could not treat her little flock as an opportunity when it was regularly wiped out by Newcastle Disease.
The LaSota vaccine has helped change this. A year after learning about the vaccine, Linda owns 40 to 45 chickens, selling birds to bring in extra money and supplement her husband’s income. This helps meet increasing food costs, take care of medical expenses and support her child’s education. “As we can get some income from chicken sales now, we can even save some money,” she says.
Newcastle Disease (ND)
Two thermotolerant ND vaccines, which are easy to transport and administer to poultry, were among the most successful product development outputs funded during the first years of GALVmed. A LaSota strain vaccine, manufactured in India, and an I-2 strain vaccine, made in Morocco for the African market, are already in widespread use in both regions. The relative thermotolerance of these vaccines means that they are suitable for the rural environment, where maintaining a cold chain is particularly challenging; their delivery as ocular drops means that they can easily be administered by village-based vaccinators or farmers themselves. Through our partners, about 170 million doses have been sold. We have also funded the development of a fast-dissolving tablet form of the vaccine, and are facilitating transfer of the technology to commercial partners, which could make this much-needed vaccine even easier to deliver to smallholder farmers in remote areas.
Insight
Our field projects demonstrate that significant increases in livestock productivity can occur when diseases are controlled through effective vaccines. Within 16 months in a project site in India, the average household flock size increased by 123% when farmers used the ND vaccine. In Tanzania, an increase of 95% was observed over a period of 24 months.
Average flock size before and after introduction of ND vaccine
Animal African Trypanosomosis (AAT)
Since 2011, we have successfully collaborated with a large group of partners to develop a better product for reducing the impact of this major African cattle disease. More than 20 such research partnerships have comprised a global mix of private pharmaceutical companies, universities and public research institutes. The collaborations originally included a search for an effective vaccine but the focus changed to discovery and development of a new class of trypanocides, a pen-side diagnostic test, improved integrated control methods and better quality control of the various drugs sold across Africa. The pen-side diagnostic test is now marketed by a commercial animal health company while the trypanocide is close to moving into full development with a private sector partner.
The power of diagnosis
In 2012, Aboubakary Hamadou, a cattle farmer in northern Cameroon, lost more than 50 of his animals to AAT. In 2015, he lost another 26. The reason for these economically catastrophic deaths was ineffective treatment based on misdiagnosis.
In 2016, a rapid diagnostic test developed by GALVmed’s partners in the Tryps project came on the market in Cameroon. With just a drop of blood, the test reveals the presence of one of two different strains of the Trypanosoma parasite, informing farmers to begin the right course of treatment. Across Cameroon, rapid diagnosis has led to correct treatment of cattle leading to increased productivity. “This innovation has given farmers a plus, it is like health security for our cattle,” says Hamadou. Since he has started administering treatment based on the test, he has not lost a single animal.
Rift Valley Fever (RVF)
Together with our partners, we have focused on a cattle vaccine for RVF known as Clone 13. This vaccine 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 pen-side diagnostic test to track the disease in the field easily was completed. The technology is being transferred to a partner. Clone 13 has the potential for use in combination vaccines for other cattle, sheep and goat diseases.
Contagious bovine and caprine pleuropneumonia (CBPP and CCPP)
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. The product development effort for CCPP has focused on a novel live vaccine approach, which could eventually be included in a combination vaccine for other goat diseases.
Capacity building at national labs
Many African countries have national laboratories for producing veterinary vaccines. In 2009 and 2010, through VACNADA, a special capacity building programme, GALVmed supported improvement of the technical capabilities of laboratories in Botswana, Cameroon, DRC, Ethiopia, Ghana, Kenya, Mali and Senegal. In Ethiopia, the establishment of a new Process Development Laboratory at the African Union Pan-African Veterinary Vaccine Centre (AU-PANVAC) led to this facility becoming a key partner in later product development activities.
Porcine cysticercosis (PC)
We have supported the testing and commercial development of a dual approach to break the zoonotic cycle of this parasite between pigs and humans. A new vaccine, based on technology from the University of Melbourne, became the first licensed cysticercosis vaccine for pigs. It was launched in India through our manufacturing and distributing partner Indian Immunologicals Ltd. Another partner based in Morocco, MCI Santé Animale, has developed a therapeutic drug to eliminate parasite larvae. As a combined therapeutic-prevention approach, these products were successfully field tested in Nepal, Tanzania, Uganda and Zambia from 2016 to 2017. They are now in various stages of the registration process in African countries.
Brucellosis
Launched in 2016, the Brucellosis Vaccine Prize competition is an entirely new approach providing monetary prizes as incentives for product development. The USD 30 million competition is funded by AgResults, a collaboration between the Australian, Canadian, UK and US governments, as well as BMGF and is implemented by GALVmed. It is the first competition of its kind in animal health research and will reward researchers who can develop and register a vaccine for Brucella melitensis that is safe and effective for use in sheep or goats across the developing world. Milestone 1 of the 10-year vaccine development competition resulted in a total of USD 1 million being awarded to 10 organisations across four continents.
Brucellosis vaccine prize journey
Peste des petits ruminants (PPR) and sheep and goat pox (SGP)
The multivalent vaccine for PPR and SGP in sheep and goats, developed by our commercial partner MCI Santé Animale in Morocco, is a convincing example of the advantages of combining protection. The two diseases affect many of the same animals in the same regions, and are not, in fact, easy to distinguish. Many farmers vaccinate against the more frequently occurring SGP, but not against the less common, but more deadly, PPR. By organising market priming and acceptability trials in three African countries, we have been able to show that smallholders are willing to purchase a combination vaccine that is cheaper than vaccinating against each disease separately. Commercial sales of the multivalent vaccine during these licensed trials – which were almost 7 million doses – are a promising step towards the long-sought control and eradication of both diseases. Our work with a British biotechnology company, Arecor – which specialises in vaccine diluent technologies to enhance vaccine thermostability – has identified a novel diluent that will significantly reduce the production and storage costs of the ECF-ITM vaccine. This approach is being used to prepare a potentially thermotolerant PPR vaccine, currently in long-term stability studies, with possible extension for use in other vaccine targets. This development is timely given the expected global eradication scheme for PPR where thermotolerance will have real benefit