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Single-Shot Schedule for Porcilis PCV Approved

26 January 2010

MSD Animal Health - Pigs

NETHERLANDS - Intervet/Schering-Plough Animal Health today announces that it has received marketing authorisation from the European Commission on 12 January 2010 for a single-shot vaccination schedule of its Porcilis® PCV vaccine against porcine circovirus type 2 (PCV2) infections.

The new approval allows to vaccinate with one dose of 2 mL in pigs from an age of three weeks onwards (known as the '1 – 2 – 3' approach) in case of low- to medium-levels of maternal antibodies against PCV2 and also to include reduction of mortality as additional indication. This new single-shot application for Porcilis PCV will add flexibility in use to the currently available dosage scheme of this vaccine that has been available in Europe since April 2009.

Based on the original and complementary data presented, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion after it had concluded that the quality, safety and efficacy of Porcilis PCV for the addition of a single shot administration and the inclusion of the indication for reduction of mortality were considered to be in accordance with the requirements of Council Directive 2001/82/EC, as amended, and that the benefit-risk balance was favourable.

Major characteristics of Porcilis PCV are: (1) it contains the Cap-2 sub-unit antigen coded by ORF2 and therefore induces strong immunity against PCV2 infection; (2) it is combined with XSolve, an adjuvant offering immunity until the end of the finishing period; and (3) is able to break through of all levels of maternally derived antibodies in piglets depending on the vaccination schedule used.

It has been demonstrated that one single dose of Porcilis PCV induced both humoral and cell-mediated responses against PCV2, despite the presence of low- to medium- levels of maternal antibodies. According to a recent study published in the journal, Vaccine, the immunity induced by a single dose of the vaccine resulted in reductions of viraemia, viral shedding and viral load in tissues in vaccinated pigs as compared to controls. Moreover, field trials have demonstrated that vaccination of pigs at three weeks of age or older reduces the presence of virus load in the blood and reduces weight loss associated with PCV2 infection during the fattening period.

Infection with PCV2 is known to cause a variety of syndromes in pigs, together known as Porcine Circo Virus Disease (PCVD). Symptoms may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, pale skin and jaundice.

For full prescribing information please consult the Summary of Product Characteristics.

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