Merck Animal Health Announces European Union Approval for PORCILIS M Hyo ID ONCE Swine Vaccine
Merck Animal Health (known as MSD Animal Health outside the USA and Canada) today announced that it has received marketing authorization in the European Union for PORCILIS® M Hyo ID ONCE, the first single-shot vaccine against Mycoplasma hyopneumoniae (M Hyo) infection in pigs for intradermal administration. PORCILIS M Hyo ID ONCE is approved in the 25 member states of the European Union plus Iceland and Norway for the active immunization of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by M Hyo.
The new vaccine differs from the existing PORCILIS M Hyo in that: (1) the new vaccine comes as a single-shot (whereas the existing vaccine is available as a two-shot vaccine), and (2) the new vaccine is approved for use as an intradermal administration (whereas the existing vaccine is approved for use as an intramuscular administration). This new single-shot, intradermal application of the vaccine adds flexibility and convenience in use to the current dosage scheme that has been available in Europe since 2004. Market introduction in the individual countries will depend on the granting of national licenses that have been scheduled for the coming four to six months.
Merck Animal Health already has two other vaccines with a label claim for intradermal use (in addition to an intramuscular claim) – PORCILIS PRRS and PORCILIS Begonia. The company has a needle-free ‘Intra Dermal Application of Liquids’ (IDAL®) device which is used for the intradermal application of these vaccines. Before or in conjunction with the commercial launch of PORCILIS M Hyo ID ONCE the company will introduce an improved IDAL device for intradermal use with all three vaccines.
Infection with M Hyo is known to cause enzootic pneumonia, a chronic pneumonia which can be complicated by opportunistic bacterial infections (such as P. multocida, B. bronchoseptica, S. suis, H. parasuis and A. pyogenes). There is usually an incubation period of two to eight weeks before clinical signs of M Hyo infection are seen. Over the first six to eight weeks after it enters the population there may be severe acute pneumonia, dehydration, heavy breathing, coughing, respiratory distress and fever. This results in increased mortality, as well as a reduced rate of weight gain and lower feed efficiency. As a consequence, M Hyo infection in a pig herd often results in significant economic losses for the farmer.
For full prescribing information please consult the Summary of Product Characteristics.
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About PORCILIS M Hyo ID ONCE
PORCILIS M Hyo ID ONCE is an inactivated bacterial vaccine containing whole cell concentrate of Mycoplasma hyopneumoniae (M Hyo) strain 11. This antigen is incorporated in an adjuvant based on a combination of light liquid paraffin and dl-α-tocopheryl acetate in order to give a prolonged stimulation of immunity. The product stimulates the development of active immunity in finishing pigs against M Hyo infection, reducing both pulmonary lesions and the decrease in daily weight gain due to infection. It allows intradermal vaccination with 1 single dose of 0.2 mL in pigs at the sides of the neck or along the muscles of the back from an age of 2 weeks onwards.
About IDAL®
The IDAL is a needle-free device for the administration of a fixed vaccine dose of 0.2 ml into the dermis of the pig. The IDAL is strictly for Merck Animal Health vaccines that have the specific label claim for intradermal use: PORCILIS Begonia, PORCILIS PRRS and as of now also PORCILIS M Hyo ID ONCE. The device has advanced features, including automatic rinsing, automatic vaccine recognition, automatic vaccine dose release, a display with a counter and a battery allowing 500 vaccine doses per fully charged battery.
About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.
