The European Commission has granted Zoetis marketing authorisation for CircoMax Myco for the active immunisation of pigs against porcine circovirus type 2 (PCV2) and Mycoplasma hyopneumoniae (M Hyo).
The company said that, in a one-shot injection, the vaccine offers the longest lasting combined protection against PCV2 and M. hyopneumoniae pathogens.
This reduces the PCV2 viral load in blood and lymphoid tissues, PCV2 fecal shedding, lymphoid tissue lesions associated with PCV2 infection, and lung lesions associated with M. hyopneumoniae infections.
After vaccination in fattening pigs for both PCV2 and M. hyopneumoniae, protection was demonstrated against porcine circovirus genotypes 2a, 2b and 2d, lasting for at least 23 weeks.
“Porcine circovirus type 2 has demonstrated high mutation and recombination rates and is known to be rapidly evolving in Europe and worldwide,” said Monica Balasch,Zoetis’ director of global biologicals development.
“Commercial PCV2 vaccines have been efficacious in controlling the clinical disease, but there is a growing genetic gap between field viruses and vaccines. So far, all vaccines in Europe have been based on one single genotype, PCV2a, while today the most prevalent viruses found belong to other genotypes: PCV2b and especially PCV2d.
“We believe that there is a need for new vaccines, like CircoMax Myco, which includes two PCV2 genotypes for a broader coverage. We found excellent results showing reduction of body weight gain losses in field trials in the EU.
“This innovative one-dose vaccine is a new tool for veterinarians and producers that may improve their PCV2 and M. hyopneumoniae control programs, especially in the face of multi-genotype PCV2 infections.”
Alvaro Aldaz, the company’s director for global commercial development, swine, said Zoetis was excited to bring the product to Europe.
“For many years, intensive vaccination has contributed to selective pressure and emergence of new PCV2 genotypes. European pig farms are often infected with more than one genotype and subclinical disease is frequent.
“Commercial vaccines are all based on PCV2a genotype, while CircoMax Myco is the first vaccine that includes two PCV2 genotypes (a & b), and the inventive M. hyopneumoniae purified fraction.”
It is formulated with MetaStim for active immunisation, resulting in 23 weeks of protection against these threats, he added.
Zoetis said the efficacy and safety the vaccine are supported by a comprehensive program of clinical studies reviewed by the European Medicines Agency and included in the regulatory procedure approved by the European Commission.
PCV2 is one of the main pathogens in the global pig industry, which has brought significant economic losses to the pig industry.
It is the causal agent of Porcine Circovirus Systemic Disease (PCV-SD), previously called post-weaning multisystemic wasting syndrome (PMWS) and may result in secondary infections, particularly respiratory & reproductive diseases, diarrhoea, porcine dermatitis and nephropathy syndrome (PDNS) in infected pigs.
Mycoplasma hyopneumoniae (M Hyo) causes economically very costly respiratory disease and is a core pathogen in the porcine respiratory disease complex (PRDC) that involves viruses, and enzootic pneumonia (EP) when associated to secondary bacteria.