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Commercial Success of ECLAIR Programme
AGRE-0009: Development of a delivery system for the oral administration of vaccines for the prevention of diseases in fish in aquaculture |
AGRE-0009: Development of a delivery system for the oral administration of vaccines for the prevention of diseases in fish in aquaculture
Science Background
Prior to this project, fish vaccines had to be administered by injection or the fish had to be immersed. A delivery system for oral vaccination of fish would be easier and less expensive to administer.
Objectives
Development of a new delivery vehicle for the oral administration of vaccines to fish in the feed to prevent disease including the bacterial diseases enteric redmouth – ERM (Yersinia ruckeri), vibriosis (Vibrio anguillarum) and furunculosis (Aeromonas salmonicida).
Significant changes and results since end of ECLAIR
During the project, a license was obtained for injectable forms of a new vaccine for furunculosis. A system for large-scale production of a novel antigen protection vehicle was developed. This was suitable for use with all the antigens studied and could be incorporated into normal fish feed. The coordinators were the SME Aquaculture Vaccines Ltd (AVL). They launched the first products based on this technology in 1993/94 and are the biggest supplier in Europe and the only company manufacturing oral vaccines for fish. Development of effective oral vaccines was one of the major goals for fish pathologists for many years but proved particularly difficult due to the antigens being degraded in the fish stomach. This problem has been overcome by the development of a reliable antigen protection vehicle (APV) which protects the antigens through the acidic environment of the fish stomach and delivers them intact to the hind gut where an immune response is stimulated. Products based on this technology have been extensively field tested under different farming conditions and AVL are still the only company producing oral vaccines. AVL currently produce 3000 litres per year (3 million fish doses), most of which is for two products, sold mainly into Europe but also South America. The APV system has been patented and a number of new products have been developed. These have been, or are in the process of being, licensed.
Results
At end of this ECLAIR project
Existing production technology and strains for ERM and vibriosis gave vaccines that offered good protection and were suitable for encapsulation, thus it was not necessary to develop new strains. New IROMP (iron regulated outer membrane protein) furunculosis vaccines were developed, as well as production technology and quality control methodology for oral vaccines. This met the exacting standards of the Veterinary Licensing Authorities for vaccine production. Licenses were granted for injectable forms of the furunculosis vaccine. A delivery system was identified that was capable of encapsulating the antigens in a form that retains immunogenicity. It was palatable to fish, safe for use and able to withstand the physical environment in which it is used. An antigen protection vehicle (APV) suitable for encapsulation of all the antigens studied was identified. This can be incorporated into normal fish feed. A production protocol was developed for a large-scale production system for the APV.
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The products developed by this project are marketed by AVL under their AquaVacTM trademark |
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Current position
Using in-house funds, AVL developed the technology and vaccines from this project to produce the first effective oral vaccines. They also produce a range of immersion-applied vaccines and cost-effective injectable vaccines. They currently produce 3000 litres per year (3 million fish doses), sold mainly into Europe but also South America. The majority of this is for two products for sea bass and bream. Oral vaccines include those for pasteurellosis, caused by the gram-negative photobacterium Pasteurella damsella subsp. piscicida (AquaVacTM Pasteurella Oral), vibriosis mainly caused by Vibrio anguillarum (Serotype I) and Vibrio anguillarum (Serotype II - V. ordalii) (AquaVacTM Vibrio Oral), furunculosis, caused by the gram-negative bacterium Aeromonas salmonicida (AquaVacTM Furovac Oral) and ERM, caused by the gram-negative bacterium Yersinia ruckeria (AquaVacTM ERM Oral). AVL also produce injectable and immersion vaccines for including vaccines for furunculosis, which was licensed during this project.
Impact
Commercial
AVL considers itself to be a world leader in fish health. In 1972, they were the first company to introduce trout vaccines on a commercial scale. They supply vaccines to 25 countries worldwide, covering all the major farmed fish species. Their main market consists of two products for sea bass and bream sold into Europe and, to a lesser extent, South America. In Europe, the market is far from saturated, with only twenty percent of the fish produced currently being inoculated. They have two main competitors, multinationals from Norway and Canada, however AVL is the biggest player in Europe, supplying 70% (3,000 litres or 3 million fish doses) of the vaccines and it is still the only company marketing oral vaccines for fish. Development continues and a new oral vaccine for pasteurellosis was commercialized in 1998. The biggest barrier to commercialization is the complex licensing system. New regulations were introduced in 1995 with compliance mandatory in 1997. The licensing system is not yet operating at its optimal level; the process is quoted as taking up to 200 days, however in practice can take considerably longer. Patents
Associated
As an SME, AVL found the funding extremely useful to bring the technology forward rapidly. The biggest barrier to commercialization was licensing. This was a small focussed project involving only one other partner, University College Galway, Ireland. AVL considered obtaining further funds from VALUE, but was put off by the bureaucracy.
Contacts
Aquaculture Vaccines Ltd
Author
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Updated
by CPL Press:
03/07/2007
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