The FIRST intradermal M Hyo vaccine

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1 The FIRST intradermal M Hyo vaccine Effective, safe and animal friendly in a single dose Porcilis M Hyo ID Once Take the leap forward with easy-to-use needle free vaccinations

2 Porcilis M Hyo ID Once One intradermal administration is all it takes MSD Animal Health is proud to offer Porcilis M Hyo ID Once, the first single-dose vaccine against Mycoplasma hyopneumoniae (M Hyo) using IDAL (IntraDermal Application of Liquids). Thanks to this innovative, superior approach, it s no longer necessary to use needles to vaccinate against M Hyo. This new administration method means there is much less stress and pain for the piglets, plus there is no accidental transmission of pathogens caused by reusing needles. Other benefits include ease of use, increased food quality and less risk of self-injection.

3 Product Profile Trade Name Indications Antigen Adjuvant Dose Number of doses Vaccination scheme Administration Presentations Onset of immunity Duration of immunity Shelf life Withdrawal period Preparation Storage Porcilis M Hyo ID Once For active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by Mycoplasma hyopneumoniae Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11 X-Solve 0.2 ml One dose Vaccinate once from an age of 2 weeks onward Intradermal administration of 0.2 ml per animal, preferably at the side of the neck or along the muscles of the back using an intradermal device 50 doses (10ml vial) 100 doses (20 ml vial) 3 weeks after vaccination 22 weeks after vaccination 2 years as packaged for sale 3 hours after first opening the immediate pack Zero days Allow vaccine to reach room temperature (15-25ºC) and shake well before use Store in refrigerator (2ºC 8ºC) Administration device Intradermal device (we recommend only IDAL )

4 Porcilis M Hyo ID Once Production Benefits of Needle-free Vaccination for Piglets Animal friendly: Much less pain and stress to pigs being vaccinated Better hygiene / health: Important for disease control as there s no accidental transmission of pathogens like PRRSV caused by needle reuse Meat quality: No introduction of foreign bodies (abscesses), broken needles and avoidance of muscles lesions Ease of use for producers / veterinarians: The IDAL determines the correct volume and pressure for vaccine administration in a more relaxed environment Greater handler and environmental safety (no needles) Bristles Epidermis Antigen Dermis Dermis Hypodermis Dendritic Cells Production Benefits of Intradermal Vaccination for Piglets Animal friendly: Much less pain and stress to pigs being vaccinated with just 0.2 ml volume Powerful antigen-presenting cells in the epidermis cause an induction of a broad range of immune responses Potential to overcome pre-existing immunity because (maternal) antibodies are not located in the skin Less systemic adverse events because of minimal invasiveness into the piglet s body Higher food safety: The injected volume is just 10-20% of the total volume of a onedose intramuscular vaccine and the distribution of the vaccine is limited to the skin With the increase in available intradermal vaccines, this innovative and superior approach to vaccine administration will grow into the standard for vaccine administration Animal welfare: Public interest and image of pork producing sector

5 Production Benefits of using IDAL for Piglets When it comes to needle-free, intradermal vaccinations for piglets, IDAL is scientifically proven to be effective and safe. This revolutionary technology can be used with registered vaccines for intradermal administrations that have been tested with the IDAL. That means: Better hygiene and less spread of diseases Fixed, low volume (0.2 ml) Less risk of self-injection IDAL compared to other intradermal devices Easy handling, cleaning, and less maintenance One compact device - no tubes, extensions, or heavy gas bottles Safe power supply with rechargeable batteries Function reliably at a low cost Unique patented mechanism for converting electric spring action into a needle-free injection

6 Porcilis M Hyo ID Once MSD Animal Health Intradermal Vaccine Line Vaccines Intradermal Administration Intramuscular Administration Porcilis M Hyo ID Once Porcilis PRRS Porcilis Begonia IDAL Porcilis Begonia Porcilis M Hyo ID Once: For the active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused Mycoplasma hyopneumoniae. Porcilis PRRS: A live vaccine for the immunisation of pigs against Porcine Reproductive and Respiratory Syndrome. Porcilis Begonia & Porcilis Begonia IDAL: A live, attenuated vaccine for the immunisation of pigs against Aujeszky s disease virus infections (Pseudorabies).

7 Efficacy Trial The herd 900-sow, farrow-to-finish farm in Greece Positive for Mycoplasma hyopneumoniae by presence of typical lung lesions in 95% of 30 slaughtered pigs examined before trial Groups 700 suckling pigs randomly assigned to two groups for 28 days (± 3 days) Intradermal: 346 piglets vaccinated ID with 0.2 ml of Porcilis M Hyo ID Once (MSD AH) Controls: 354 piglets injected with a placebo (adjuvant only) Parameters measured from 4 weeks to market Performance parameters: ADG Health parameters: lung lesion scores Average daily gain (g/day): Porcilis M Hyo ID Once (n=346) Control (n=354) Difference Nursery period 472 ± ± Finishing period 666 ± 35 b 640 ± 37ª 26 b Total period 623 ± 33 b 600 ± 33ª 23 b Average body weight (kg): At vaccination 6.4 ± ± End of nursery 22.8 ± ± At slaughter ± 5.4 b 99.5 ± 5.3ª 3.7 b a,b Values with different superscripts in the same row differ significantly (p<0.05) Production Phase Indication Porcilis M Hyo ID Once (n=346) Control (n=354) Difference Finishing Respiratory Other Total 17 / 335 (5.1%) b 52 / 335 (15.5%) a 35 / 671 (10.4%) b a,b Values with different superscripts in the same row differ significantly (p<0.05)

8 GL/POI/1213/ , Intervet International B.V. a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. References: Veterinary Records, Clinical evaluation of intradermal vaccination against porcine enzootic pneumonia (Mycoplasma hyopneumoniae), P. D. Tassis, V. G. Papatsiros, T. Nell, D. Maes, C. Alexopoulos, S. C. Kyriakis, E. D. Tzika, 19-January-2012 Intervet International bv P.O. Box 31, 5830 AA Boxmeer The Netherlands Phone +31 (0) Fax +31 (0) info@merck.com