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Proven IHN prevention Allison MacKinnon

Head Technical Services Aqua NA

Today’s Agenda

NAV Technology Video

Summary

2 Campbell River, British Columbia October 9, 2012

Innovation in Aqua

APEX-IHN® and Novartis

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

Campbell River, British Columbia October 9, 2012

Source: Canadian Food Inspection Agency

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.

The Disease


Source: IHNV White Paper, 2003. Karreman and Stephen, eds.

TYPICAL MORTALITY CURVE for IHN in Atlantic salmon

The IHN virus spreads quickly –

and without warning

So what’s the best way to

control a lethal disease?


Stop it before it starts.


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.


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.


Innovation in Aqua


The plasmid can be injected directly into the muscle, without causing side effects,

and carries the information directly to cells around the injection point.


Innovation in Aqua


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

E:/IHN Workshop 2012/Clynav_Technology_1080_WMV_110920.wmv



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



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



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



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



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.

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

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


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


Thank you!


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