Download Proven IHN prevention

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