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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/494487/2011

EMEA/V/C/002005

EPAR summary for the public

Proteq West Nile

West Nile recombinant canarypox virus (vCP2017 virus)

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal's medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Proteq West Nile?

Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus). It is available as a suspension for injection.

What is Proteq West Nile used for?

Proteq West Nile is used to protect horses from 5 months of age against West Nile disease. West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord).The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.

The vaccine is given to young horses as two injections into the neck muscles. The first injection is given from five months of age and the second injection is given four to six weeks later. Protection starts four weeks after the first injection and lasts for a year. The horses should be revaccinated every year.

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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

How does Proteq West Nile work?

Proteq West Nile is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. The vaccine strain vCP2017 in Proteq West Nile is a 'carrier' canarypox virus that has been given a gene that makes it able to produce part of the West Nile virus, the proteins PreM and E. The canarypox viruses do not spread or multiply in the vaccinated horses.

When a horse is given the vaccine, the immune system recognises the West Nile proteins PreM and E as 'foreign' and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to West Nile virus, and this helps to protect against mortality due to West Nile disease.

The vaccine also contains an 'adjuvant' to enhance the immune response.

How has Proteq West Nile been studied?

The vaccine was tested in nine laboratory studies in horses from five months of age. The main measure of effectiveness was based on the number of horses who had viraemia or clinical signs of West Nile disease. In all studies the vaccinated horses were compared with horses that were not vaccinated.

What benefit has Proteq West Nile shown during the studies?

The studies showed that the vaccine prevents viraemia in horses and reduces clinical signs in horses infected with West Nile virus.

What is the risk associated with Proteq West Nile?

Horses vaccinated with Proteq West Nile may have a slightly raised body temperature (up to 1.5°C) lasting up to two days. They may also have a temporary swelling at the injection site which usually disappears within four days. For a full list of the side-effects reported with Proteq West Nile, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

If someone accidentally injects themselves with the medicine, the person should seek medical advice immediately and show the package leaflet or label to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption. The withdrawal period is zero days.

Why has Proteq West Nile been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) considered that Proteq West Nile is generally well tolerated and useful in reducing clinical outbreaks of West Nile disease. The CVMP therefore concluded that the benefits of Proteq West Nile exceed the risks for the vaccination of horses from 5 months of age against West Nile disease and recommended that Proteq West Nile be given a

Proteq West Nile

marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Proteq West Nile:

The European Commission granted a marketing authorisation valid throughout the European Union, for Proteq West Nile to MERIAL on 05/08/2011. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 05/08/2011.

Proteq West Nile

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