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Proven IHN prevention Allison MacKinnon Head Technical Services Aqua NA Today’s Agenda Innovation in Aqua APEX-IHN® and Novartis NAV Technology Video Summary 2 Campbell River, British Columbia October 9, 2012 The Current Situation 2012 IHN Outbreaks British Columbia IHN confirmed on two farm sites in Tofino North and one farm in Sechelt 1.9 million fish eradicated at first affected farm in Tofino Financial consequence Lost revenue totaling millions Eradication, disposal, and clean up costs Disruption to future harvest plans Industry consequences Adds more fuel to environmental debate Undermines confidence throughout the value chain Source: Canadian Food Inspection Agency Campbell River, British Columbia October 9, 2012 The Disease Infectious hematopoietic necrosis (IHN) Caused by a rhabdovirus that targets salmonids Likely introduced to Atlantic salmon farms by returning Pacific salmon IHN is endemic amongst more-resistant Pacific salmon Highly infectious among farmed Atlantic salmon Current outbreak shows it is very difficult to model and predict Source: World Organization for Animal Health. An OIE Collaborating Center, Iowa State University College of Veterinary Medicine. Campbell River, British Columbia October 9, 2012 The Disease TYPICAL MORTALITY CURVE for IHN in Atlantic salmon Source: IHNV White Paper, 2003. Karreman and Stephen, eds. Campbell River, British Columbia October 9, 2012 The IHN virus spreads quickly – and without warning So what’s the best way to control a lethal disease? Campbell River, British Columbia October 9, 2012 Stop it before it starts. Campbell River, British Columbia October 9, 2012 Innovation in Aqua In 2001, Novartis began work on a technology that would safely and effectively protect fish against IHN. The result was a new generation of vaccines known as NAV vaccines or plasmid DNA vaccines. Campbell River, British Columbia October 9, 2012 Innovation in Aqua What is a NAV vaccine, exactly? Rather than using whole viruses, Nucleic Acid Vaccines are constructed using only the relevant genetic components of the virus that trigger antigen development. These components are inserted into a circular piece of nucleic acid called a plasmid. Campbell River, British Columbia October 9, 2012 Innovation in Aqua What is a NAV vaccine, exactly? The plasmid can be injected directly into the muscle, without causing side effects, and carries the information directly to cells around the injection point. Campbell River, British Columbia October 9, 2012 Innovation in Aqua What is a NAV vaccine, exactly? The plasmid then instructs cells to produce antigens, which initiate an immune response mimicking the natural infection of the virus. The following video provides further explanation. NAV Video: Apex-IHN Campbell River, British Columbia October 9, 2012 Innovation in Aqua Benefits of a NAV vaccine A more powerful and targeted immune response without the need of an oil adjuvant Reduced risk of side effects No possibility of inducing the disease Greater stability of the vaccine itself Campbell River, British Columbia October 9, 2012 ® APEX-IHN and Novartis Why APEX-IHN is the best way to ensure your farm is protected against IHN. ® Easy to administer Safe for humans, the environment, and fish Proven highly protective in salmon Campbell River, British Columbia October 9, 2012 ® APEX-IHN and Novartis Ease of use: dosing and admin Dose rate: 0.05 mL (50 microlitres) injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle Composition: Plasmid in saline solution Adjuvant: None Packaging: Ready-to-use flexible intravenous bag Pack size: 250 mL (5000 doses) Application: Standard injection guns 0.5 mm X 3 mm stainless needles Campbell River, British Columbia October 9, 2012 ® APEX-IHN and Novartis Safety assessment Human safety Self-injection by operator – no synthetic adjuvant hence very low risk of inflammatory complications Dosage – Fish vaccine dose relatively low (10 μg) as compared to the human dose in clinical trials (100 – 300+ μg) where no adverse effects were reported Declared safe for humans by Health Canada; poses no risk in food Environmental safety Plasmids are not organisms and are not self-replicating Plasmids are non-infectious Expression of the antigen already occurs in the natural environment Vaccinated fish do not shed vaccine Campbell River, British Columbia October 9, 2012 ® APEX-IHN and Novartis Safety assessment (cont) Animal safety Average mortality in Atlantic Salmon for three batches 1.5 % less than 6 % as per requirements No significant histopathological observations at the injection site (2x dose) No lethargy, darkening, normal return to feed Source: IVVDC 2006, N.C. Simard. Data on file. Campbell River, British Columbia October 9, 2012 ® APEX-IHN and Novartis Proven efficacy In an in-vivo vaccination challenge performed under controlled conditions, APEX-IHN® proved to be well tolerated and highly effective at protecting Atlantic salmon against IHN. Challenge study – 4 months post – vaccination Percentage mortality of treatment groups Campbell River, British Columbia October 9, 2012 Field Performance More than 60 million vaccinated since 2005 No reported adverse events of lack of efficacy claims since APEX-IHN® was licensed in 2005 No reported side effects or downgrades at harvest for the life of the product No reported cases of IHN in vaccinated fish Campbell River, British Columbia October 9, 2012 Summary IHN virus continues to be a threat to the industry in BC Increased surveillance of wild populations of Pacific salmon species Better understanding of the risk factors associated with clinical disease Increased research on the dynamics of shed / spread from wild populations Proven Protection for plasmid DNA vaccine No known treatment for IHN Prevention needs to be part of Health Management Plan Campbell River, British Columbia October 9, 2012 Thank you! NAAQ2012-001 Campbell River, British Columbia October 9, 2012