On 4 November 2021, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product CircoMax, emulsion for injection, intended for pigs for fattening. The applicant for this veterinary medicinal product is Zoetis Belgium SA.
CircoMax is an immunological medicinal product containing recombinant chimeric porcine circovirus 1 containing the porcine circovirus 2b open reading frame 2 protein, inactivated, recombinant chimeric porcine circovirus 1 containing the porcine circovirus 2a open reading frame 2 protein, inactivated (ATCvet code: QI09AA07) as active substance, for active immunisation.
The benefits of CircoMax are its capacity to induce active immunisation of pigs against PCV2 subtypes 2a and 2b and reduce viral load in blood and lymphoid tissues and faecal shedding caused by infection with PCV2. Cross-protection against PCV 2d was demonstrated. The product was shown to have an onset of immunity at 3 weeks after vaccination with duration of immunity of 23 weeks after vaccination against PCV2.
CircoMax has a safety profile with mainly local tissue reactions and transient temperature increases as possible adverse reactions. A transient increase in body temperature, not exceeding 2.1°C, is very common during the first 24 hours after vaccination. In a laboratory study, a post-mortem examination of the injection site, performed 2 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild lymphocytic-granulomatous inflammatory response, as evidenced by the absence of tissue necrosis and absence of fibrosis. Local tissue reactions in the form of swelling at the injection site, below 2 cm in diameter, are common and may last for up to 10 days. Erythema may be uncommonly observed during the first 24 hours after vaccination. Hypersensitivity reactions, vomiting, incoordination, lethargy, and laboured breathing were uncommonly observed in field studies. The animals mostly recover within 24 hours.
The vaccine is safe in minimum age piglets when administered by the recommended route and regimens.
The full indication is: active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, faecal shedding and the lesions in lymphoid tissues associated with PCV2 infection. Protection was demonstrated against porcine circovirus types 2a, 2b and 2d.
Onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.
Duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for CircoMax and therefore recommends the granting of the marketing authorisation.
1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
|Agency product number||
|International non-proprietary name (INN) or common name||
Pigs (for fattening)
|Date opinion adopted||
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 202108/11/2021