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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/286116/2007

EMEA/V/C/000114

EPAR summary for the public

Circovac

Porcine circovirus type 2

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 Circovac?

Circovac is a vaccine for use in pigs. It contains an inactivated (killed) porcine circovirus type 2 (PCV2) strain.

What is Circovac used for?

Circovac is used to reduce the changes in and damage to lymphoid tissues (cells and tissues that make up the lymphatic system, such as lymph nodes) associated with PCV2 infection in piglets and to help reduce the risk of dying from this infection. The vaccine is given to female pigs before and/or during pregnancy. Their piglets then become immunised (protected against PCV2) when they drink the colostrum (first milk) from their vaccinated mothers. This is called 'passive immunisation'. In this case, the effect of the vaccine lasts for up to 5 weeks.

Circovac can also be given directly to piglets from three weeks of age (active immunisation). In this case, the effect of the vaccine lasts for at least 14 weeks.Circovac is given by injection into a muscle. For the initial vaccination the number of injections needed and the dose varies according to the type of female pig being treated: gilts (female pigs that have not yet had piglets) should receive one 2 ml injection three times; sows (female pigs that have had piglets before) should receive one 2 ml injection twice. The timing of the injection is adjusted according to the dates of mating and farrowing (giving birth). In all cases the last dose is given at least two weeks before the expected date of farrowing.

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Sows should be revaccinated at each pregnancy with one injection two to four weeks before farrowing. Piglets should be vaccinated with one 0.5 ml injection once.

How does Circovac work?

Porcine circovirus type 2 (PCV2), is known to infect, and cause a wide variety of clinical signs and syndromes in pigs. The infection of piglets occurs mostly during the first 6 weeks of life, when the immune system of piglets is still maturing. Symptoms include weight loss (or failure to grow), enlarged lymph nodes, difficulties in breathing, and, less commonly, diarrhoea, pale skin and jaundice (yellowing of the skin).

Circovac is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Circovac contains PCV2 strain that has been inactivated so it cannot cause the disease. When it is given to piglets (or their mothers), the immune system recognises the virus as 'foreign' and makes antibodies against it. When given to the mother, these antibodies are transferred from the mother to the piglets through the colostrum. In the future, if the animals are exposed to PCV2, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease.

Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with an emulsion. The resulting 'emulsion' is then injected. The emulsion contains an 'adjuvant' (a compound containing oil) to enhance the immune response.

How has Circovac been studied?

Laboratory and field studies have been conducted with Circovac in pregnant pigs of various breeds.

Both sows and gilts (and their piglets) were investigated in these studies. The effectiveness of the product was demonstrated by measuring the amount of antibodies to PCV2 in the blood of the vaccinated sows (or gilts) and also in the blood of their piglets (after they have had the colostrum).

The effectiveness of the product was further investigated in piglets which were directly exposed to the virus, by observing them for the development of circovirus-related symptoms. Parameters such as body weight, and the amounts of PCV2 found in some specific lymph nodes and in blood and faeces, were taken into account. Additionally, the overall number of deaths occurring in field conditions amongst piglets born to vaccinated sows and gilts was investigated and compared with those born to unvaccinated mothers.

The length of time that Circovac is effective in the piglets has also been studied. The main measure of the immune response was the level of antibodies against PCV2 in the piglets' blood.

Additional laboratory and field studies were conducted with Circovac in piglets. The purpose of the laboratory studies was to establish in piglets vaccinated at three weeks of age how long it took for piglets to be fully protected and the time protection lasts against PCV2 infection.

What benefit has Circovac shown during the studies?

The studies showed that vaccination of the mothers with Circovac can reduce the incidence of lesions associated with PCV2 infection in the lymphoid tissues of their piglets. Although the outcome of some of the studies was partially compromised by the complex nature of PCV2 infections, the large number of pigs involved (from 63 farms) and the variety of experimental and clinical conditions did show a reduction in the overall death rates of piglets related to PCV2 infections of between 3.6% and 10%.

What is the risk associated with Circovac?

Circovac can cause a temporary redness or swelling at or around the injection site, which can last for up to four days after the injection. Following injection, pigs may have an increased rectal temperature of about 1.4 °C for up to two days, and in some pigs of up to 2.5 °C, but this should not last more than 24 hours after the injection. Other rarer side effects in the injected pigs are reduced activity and food intake, but these are also temporary. For a full list of all side effects reported with Circovac, see the package leaflet.

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

Circovac contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical advice immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

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.

The withdrawal period for Circovac is zero days.

Why has Circovac been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Circovac outweigh its risks for the approved indications and recommended that Circovac should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Circovac:

The European Commission granted a marketing authorisation valid throughout the European Union, for Cirovac on 21 June 2007. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in May 2013.

Circovac

EMA/286116/2007

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