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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/65820/2013

EMEA/V/C/002588

EPAR summary for the public

Ecoporc Shiga

Genetically modified recombinant Stx2e antigen

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 Ecoporc Shiga?

Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.

What is Ecoporc Shiga used for?

Ecoporc Shiga is used in pigs from the age of 4 days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut. Damage to the wall of small blood vessels in the brain results in characteristic nervous signs. It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli. Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.

The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear. Protection starts 21 days after vaccination and lasts for 105 days.

How does Ecoporc Shiga work?

Ecoporc Shiga is a vaccine containing the modified toxin Stx2e. When Ecoporc Shiga is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as 'foreign' and makes antibodies against it. In the future, if the animals are exposed to the bacteria producing the unmodified

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toxin, the immune system will be able to make antibodies against it more quickly. This will help protect against the disease.

Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.

The modified toxin in the vaccine is produced by a method known as 'recombinant DNA technology': it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.

How has Ecoporc Shiga been studied?

The effectiveness of the vaccine was first studied in a number of laboratory studies in piglets. The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.

Three field trials were also performed to assess the effect on mortality and clinical signs of oedema disease in a total of 518 piglets receiving Ecoporc Shiga compared with a similar number of piglets receiving placebo (a dummy injection).

What benefit has Ecoporc Shiga shown during the studies?

The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection; protection was not affected by antibodies transmitted from the mother. The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.

What is the risk associated with Ecoporc Shiga?

The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to 7 days, at the injection site and a slight rise in body temperature for up to two days after injection; both resolve without treatment.

For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.

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

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown 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 for Ecoporc Shiga is zero days.

Why has Ecoporc Shiga been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Ecoporc Shiga:

The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in February 2013.

Ecoporc Shiga

EMA/65820/2013

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