CircoMax Myco

The vaccine is given to pigs from three weeks of age as a single 2 ml intramuscular injection in the neck behind the ear. The vaccine can be also given to pigs from three days of age as a split dose vaccination consisting of two 1 ml-injections, given approximately 3 weeks apart.

Protection starts three weeks after the last injection for both vaccination schedules (either single or split) and lasts for 23 weeks.

The medicine can only be obtained with a prescription. For further information, see the package leaflet or contact your veterinarian or pharmacist.

CircoMax Myco is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When CircoMax Myco is given to pigs, the animals’ immune system recognises the virus and bacteria in the vaccine as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly. This will help protect the pigs against porcine circovirus and M. hyopneumoniae infections.

Laboratory studies in pigs showed that the vaccine had its full effect three weeks after the last vaccination for both vaccination schedules (either single or split), and that protection lasted 23 weeks after vaccination.

To test whether maternally derived antibodies (MDA), which are passed to the piglets via the colostrum (first milk), could influence the response of the piglets to the vaccine, three studies were performed in MDA-positive piglets to assess the efficacy of the PCV2a component of CircoMax Myco, an additional three studies for the PCV2b component, and two studies for the M. hyopneumoniae component. These studies showed that the split dose vaccination scheme provides notably better protection against PCV2 infection than the single dose scheme in the presence of MDAs. No detrimental effect of MDAs on the efficacy of the M. hyopneumoniae component of CircoMax Myco were observed in relevant studies.

In order to assess the efficacy of CircoMax Myco in field conditions, six studies were conducted in two different EU countries involving 3-day-old pigs (split dose: 3 studies) and 3-week-old pigs (single dose: 3 studies). The field studies generally supported the claims of protection against PCV2a and PCV2b, and partly supported the claim for protection against M. hyopneumoniae. Cross-protection against PCV2d was demonstrated in three studies conducted in the United States. The field studies provided evidence on reduction of the disease-induced losses of body weight.

The most common side effects with CircoMax Myco (which may affect more than 1 in 10 animals) are a transient increase in body temperature, not exceeding 2.1°C that resolves spontaneously within 24 hours without treatment and mild inflammation at the site of injection.

For the full list of side effects of CircoMax Myco, see the package leaflet.

Safety information has been included in the summary of product characteristics and the package leaflet for CircoMax Myco, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. 

The withdrawal period for meat from pigs vaccinated with CircoMax Myco is ‘zero’ days, which means there is no mandatory waiting time.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that CircoMax Myco’s benefits are greater than its risks and recommended that it be approved for use in the EU.

CircoMax Myco received a marketing authorisation valid throughout the EU on 09/12/2020.