June 23, 2010
Intervet/Schering-Plough Animal Health receives positive opinion in Europe for simultaneous use of PORCILISÂ® PRRS and PORCILISÂ® M HYO vaccines in piglets
Intervet/Schering-Plough Animal Health has announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) concluded the referral procedure for PORCILISÂ® PRRS and for PORCILISÂ® M Hyo on simultaneous administration of these products in piglets.
Based on this opinion, it will be possible to dissolve the freeze-dried fraction of PORCILIS PRRS in PORCILIS M Hyo and administer the mixed vaccines as one single injection within one hour after reconstitution.
The efficacy and safety of this simultaneous administration is supported by the results from vaccine challenge studies. One of these controlled laboratory studies was recently published in Veterinary Record. In laboratory trials as well as field trials there were no differences between the different vaccinated (either single or simultaneous injection) groups with respect to lung lesion scores or viremia. The recommended vaccination scheme for finishing pigs with the mixed products is that the first administration of PORCILIS M Hyo is to be given from one week of age followed by the administration of PORCILIS PRRS reconstituted in PORCILIS M Hyo from four weeks of age.
''The development and subsequent approval of a vaccination strategy using a live porcine reproductive and respiratory syndrome (PRRS) vaccine and an inactivated Mycoplasma hyopneumoniae (M Hyo) vaccine in one injection without compromising efficacy or safety of either vaccine represents an innovation in the field of swine vaccines'', said Alex Eggen, DVM and Technical Lead for swine at Intervet/Schering-Plough Animal Health. ''Simultaneous use of these vaccines is expected to significantly improve convenience for swine veterinarians, resulting in more efficient animal husbandry. As a consequence, simultaneous use of these vaccines is also expected to result in lower costs for the farmer. Moreover, the reduction of the number of animal interventions and injections is also expected to reduce stress and therefore may lead to an overall improvement in animal welfare,' he added.
Infection of pigs with PRRS virus and M hyo is a concern in the pig industry as these infections cause significant morbidity and mortality. PRRS virus infection is characterised by reproductive failure in breeding pigs, pre-weaning mortality, and respiratory disease in younger pigs. Infection with M hyo leads to pathologic lung lesions. Mixed infections occur frequently and interact with each other in a complicated way, resulting in potentiation of symptoms and further growth reduction. The economic losses of PRRS virus and M hyo infections for the pig industry are estimated to be in excess of more than EUR1 billion (US$1.2 billion) per year.