M. hyo. M. hyo. M. hyo. Single injection. Double protection. Ready-to-use protection against both PCV2 and M. hyo. It s easy. It works.

Transcription

1 M. hyo P C V 2 P C V 2 M. hyo M. hyo P C V 2 Single injection. Double protection. Single injection. Double protection. Ready-to-use protection against both PCV2 and M. hyo. PCV M Hyo It s easy. It works.

2 Co-infection with PCV2 and M. hyo Vaccinating against both pathogens at the same time is recommended to protect pigs against damage from infection. Porcine circovirus type 2 (PCV2) and Mycoplasma hyopneumoniae (M. hyo) are the two most prevalent pathogens within swine production systems worldwide. Around for decades, they have a costly impact on pig performance, as weight gain and feed conversion suffers during the vital grow/finish phase and treatment is needed for sick animals. This in turn results in increased days to market, which disrupts pig flow, causing economic losses and higher animal treatment costs. Found in several multi-factorial diseases, these two pathogens require interventions, such as vaccination, along with proper environmental and management strategies to control them. PCV2 a silent threat PCV2 is such a ubiquitous virus in swine production systems that up to 100% of pigs are seropositive for PCV2 at slaughter. It is associated with Porcine Circovirus Diseases (PCVD) and is a significant contributor to the Porcine Respiratory Disease Complex (PRDC). Often present as subclinical infections during the growing phase, PCV2 silently threatens with poor growth performance in apparently healthy pigs, which may then intermittently shed the virus, keeping it circulating within the herd. PCV2 is present in pigs regardless of PCVD severity in the farm and there are always more subclinical pigs than clinical pigs. 1 PCV2 infection impacts the immune system, resulting in: 2 M. hyo intensifies respiratory disease M. hyo is the primary initiator of enzootic pneumonia a widespread and chronic disease in swine herds. M. hyo is also a common agent implicated in the development of PRDC. Because M. hyo damages the cilia in the lower respiratory tract, secondary viral and bacterial pathogens can more easily invade and infect the pig. For example, it increases the likelihood of disease caused by viral infections, such as PCV2. The synergistic impact of immunosuppression and co-infection results in not only disease, but also a significant reduction in average daily weight gain (ADWG) in growing pigs. Together, they are stronger Concurrent infection with PCV2 and M. hyo causes severe respiratory disease and lesions consistent with PRDC. Impacting your bottom line PCV2 and M. hyo are costly infections that negatively impact performance through: Increased mortality and culls Reduced ADWG Concurrent infec,on infection M. hyo PCV2 Severe respiratory disease and lesions Poor feed conversion Increased days to market Increased medication cost Clinical Disease 70-80% Mortality In England, PCVD costs the pig industry 71 million per year. 1 Even a low average lung lesion score of 5 caused by enzootic pneumonia can cost 1.27 per pig, which increases as the lung lesion score rises. 3 High Viremia Low Viremia Subclinical Disease ADG Feed Conversion Rate Uniformity Intervention needed To minimize the economic impact and effectively manage the health and well-being of growing pigs, swine veterinarians and pork producers routinely administer PCV2 and M. hyo vaccines. While this helps reduce shedding and disease, vaccination does not eliminate these resilient pathogens, so they remain persistent in the environment. In the case of dual infection, it has been demonstrated that vaccination against either PCV2 or M. hyo alone does not reduce the severity of the other pathogen, nor does it protect against the other pathogen. 4 Making matters worse, PCV2 potentiates the severity of M. hyo lesions, and M. hyo potentiates the severity of PCV2 viremia. 5 Vaccination against one of the two pathogens alone is not sufficient to protect animals from disease, highlighting the need and the benefit of a combined PCV2 and M. hyo vaccine. 2

3 Why Porcilis PCV M Hyo Porcilis PCV M Hyo is a new ready-to-use (RTU), one-dose combination vaccine that protects your pigs from both PCV2 and M. hyo throughout the critical grow/finish period. A single 2-mL intramuscular dose starting at 3 weeks of age is all the protection your pigs need. The convenient formulation, which does not require mixing, saves labor and reduces the number of injections given to piglets. As the first RTU combination PCV2 and M. hyo vaccine approved in Europe, it provides dual protection with less work. Dependable safety profile Porcilis PCV M Hyo with the proprietary adjuvant Emunade has minimal to no adverse reactions. In < 1% of animals, transient local injection site reactions were restricted to minor swellings (< 2 cm in diameter) that disappeared within one day. This also means low tissue reaction and no growth setbacks in the nursery. Plus, the vaccine has excellent syringeability, making vaccination easy. Indications for use Porcilis PCV M Hyo reduces: Viremia Virus load in lungs and lymph tissues Virus shedding caused by PCV2 infection Lung lesions caused by M. hyo infection Loss of daily weight gain during the finishing period following infection with M. hyo and/or PCV2 (as observed in field studies) Protects against PCV2 and M. hyo throughout the grow/finish period Following vaccination, Porcilis PCV M Hyo elicits long-lasting protection with a PCV2 duration of immunity (DOI) of 22 weeks and an M. hyo DOI of 21 weeks. Works in the presence of high MDA Timing of vaccination with Porcilis PCV M Hyo is not impacted by the level of maternally derived antibodies (MDA), as the vaccine is efficacious even in the presence of high MDA at 3 weeks of age. 6 % protected animals n = Vaccine Control low (<4 log2) medium (_>4 log2-<10 log2) high (_>10 log2) * Protected animals are defined as pigs that stayed negative for PCV2 on all blood sampling time points. Presentation sizes Choose the size that best suits your needs. 50 ml / 25 doses 100 ml / 50 doses 200 ml / 100 doses % protected animals with low, medium and high MDA against PCV2 at 3 weeks of age* Duration of Immunity (DOI) Vaccination Porcilis PCV M Hyo PCV2 M. hyo 21 weeks DOI 22 weeks DOI Weeks of Age 3

4 7,8,9 Proof from the field The efficacy and safety of Porcilis PCV M Hyo was studied under a range of field conditions, with one trial conducted in a commercial swine herd in France and two in Greece. For each trial, piglets were randomly sorted into equal-sized groups, including a placebo-vaccinated control group and a Porcilis PCV M Hyo-vaccinated group. The vaccine was given as a single 2-mL dose to 3-week-old piglets according to the product label. Field trial key results 7,8,9 The field trials support that Porcilis PCV M Hyo is safe and effective in field conditions in herds with M. hyo and/or PCV2 infections. This new RTU combination vaccine: Produced minimal local or systemic reactions Figure 1: Safety results % Pigs Vaccine Control Vaccine Control Local reactions Systemic reactions French Trial (Figure 1): Systemic and local reactions were found in only a low percentage of vaccinated pigs, and the local reactions were small and transient. Greek Trial I: No local or systemic reactions were observed. Greek Trial II: No local or systemic reactions were observed. Had no negative effect on growth during the nursery phase Reduced M. hyo lung lesion severity at slaughter Figure 2: ADWG in nursery (3-10 weeks of age)* Figure 2: ADWG in nursery (3-10 weeks of age)* Figure 3: M. hyo lung lesion results at slaughter ADWG (g) ± ± ± ± ± ± 12 Vaccine Control Vaccine Control Vaccine Control p = p = p = * Mean ADWG adjusted for sow, sex, batch and weight at admission ± standard error of the mean. % animals with lung lesions Vaccine Control Vaccine Control Vaccine Control p < KEY (lesion score) > 10 > 5-10 > > 10 > 5-10 >

5 Significantly improved finishing ADWG in pigs infected with M. hyo and/or PCV2 Significantly reduced PCV2 viral load, shedding and viremia Figure 4: ADWG during the finishing period (g/day)* ADWG (g) ± ± ± ± 5 Vaccine Control Vaccine Control Vaccine Control p < p < p < * Mean ADWG adjusted for sow, sex, batch and weight at admission ± standard error of the mean. 816 ± ± 16 Figure 3.55: PCV2 viremia results Weeks post-vaccination Weeks post-vaccination Weeks post-vaccination log 10 copies per µl DNA extract 100 Vaccine AUC** 3.1* ± 6.1 Control AUC** 14.6 ± 9.5 *p < 0.05 **Area under the curve Vaccinates Control Vaccine AUC** 1.47* ± 0.0 Control AUC** 5.42 ± 5.36 *p < **Area under the curve Peace of mind With this ready-to-use, single-dose formulation, it s never been easier to provide strong protection against both PCV2 and M. hyo. PCV2 and M. hyo are ever-present dual infections that negatively impact performance. Concurrent infections induce severe respiratory disease and lesions, costing you money. Vaccination against one of the two pathogens alone is not sufficient to protect animals from disease with both pathogens, highlighting the need for and the benefit of a combined PCV2 and M. hyo vaccine. Porcilis PCV M Hyo provides you peace of mind because it does not require mixing and it protects against both PCV2 and M. hyo all the way through the vital grow/finish period. Ready-to-use, one-shot Porcilis PCV M Hyo is: Easy - Convenient for the user, saving labor and time - Minimizes pig handling and stress because fewer injections are needed Safe - Minimal to no adverse events - Low tissue reaction and no growth setbacks in the nursery Effective - Fast-acting and long-lasting protection - Field trials support that Porcilis PCV M Hyo keeps pigs healthy and growing throughout the critical finishing period in the face of M. hyo and/or PCV2 infections - Following vaccination, PCV2 DOI lasts for 22 weeks and M. hyo DOI lasts for 21 weeks 5

6 International summary of product information Indications for use: For active immunization of clinically healthy pigs to reduce viremia, virus load in organs and lymphoid tissues, virus shedding caused by PCV2 infection, and severity of lung lesions caused by M. hyo infection. To reduce average daily weight gain loss during the finishing period in face of infections with M. hyo and/or PCV2 (as observed in field studies). PCV2: Onset of immunity: 2 weeks after vaccination. Duration of immunity: 22 weeks after vaccination. M. hyo: Onset of immunity: 4 weeks after vaccination. Duration of immunity: 21 weeks after vaccination. Administration: Vaccinate pigs by the intramuscular route in the neck. A single dose of 2 ml in pigs starting at 3 weeks of age. Before using the vaccine, allow it to reach room temperature and shake well before use. Avoid introduction of contamination. Precautions: Vaccinate only healthy piglets. Do not mix Porcilis PCV M Hyo with any other veterinary medicinal product. Shelf life after first opening the immediate packaging is 8 hours. Store Porcilis PCV M Hyo in a refrigerator (2 C 8 C). Do not freeze. Protect the vaccine from direct sunlight. Composition: Each dose of 2 ml (intramuscular application) contains: Active substances PCV2 ORF2 subunit antigen: 2828 AU 1 M. hyo J strain inactivated: 2.69 RPU 2 Adjuvant (Emunade) Light mineral oil: ml Aluminium (as hydroxide): 2.0 mg 1 Antigenic units as determined in the in vitro potency test (ELISA). 2 Relative potency units defined against a reference vaccine. PCV M Hyo REFERENCES 1. Alarcon P., Rushton J. and Wieland B. Cost of PMWS and PCV2 subclinical infection in England: an economic model. Preventive Veterinary Medicine (2), pp Opriessnig T., Meng X. J. and Halbur P. G. Porcine circovirus type 2 associated disease: Update on current terminology, clinical manifestations, pathogenesis, diagnosis, and intervention strategies. Journal of Veterinary Diagnostic Investigation Nov. 19 (6) Burch D. Cost of disease Enzootic pneumonia. Pig World Seo H., Park S., Park C. and Chae C. Interaction of porcine circovirus type 2 and Mycoplasma hyopneumoniae vaccines on dually infected pigs. Vaccine ;32(21): Opriessnig T., Thacker E. L., Yu S., Fenaux M., Meng X. J. and Halbur P. G. Experimental Reproduction of Postweaning Multisystemic Wasting Syndrome in Pigs by Dual Infection with Mycoplasma hyopneumoniae and Porcine Circovirus Type 2. Vet Pathol : Data on file. 7. Witvliet M., Holtslag H., Nell T., Segers R. and Fachinger V. Efficacy and safety of a combined Porcine Circovirus and Mycoplasma hyopneumoniae vaccine in finishing pigs. PUBLICATION TBD PUBLICATION TBD. 9. PUBLICATION TBD. GL/PMH/1114/ Intervet International B.V., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved.