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USDA Approves Transdermal Administration Claims for Modified Live Virus Antigens and Avirulent Live Cultures for Beef and Dairy Cattle
DE SOTO, Kan. (Oct. 10, 2008) – The Center for Veterinary Biologics (CVB) with the U.S. Department of Agriculture (USDA) has granted Intervet/Schering-Plough Animal Health safety and efficacy claim approvals for the transdermal administration of three vaccines, which include modified-live virus (MLV) strains of Bovine Virus Diarrhea (BVD) Type 1 and Type 2, Infectious Bovine Rhinotracheitis (IBR) and the avirulent-live culture strains of Pasteurella multocida and Mannheimia haemolytica. This means beef and dairy producers soon will have one more needle-free option for effectively administering these important respiratory antigens.
Dr. Scott Nordstrom, Manager, Veterinary Technical Services for Intervet/Schering-Plough Animal Health, says these approvals are another example of the company bringing to the marketplace innovative new vaccine technologies that deliver improved immune response while reducing stress on the animal.
"Vaccine administration has evolved into a strategic tool," Nordstrom says. "Improvements in vaccines and their delivery systems to increase vaccine efficacy, safety, Beef Quality Assurance compliance and to minimize animal stress are essential in the beef and dairy industries. Transdermal administration, like intranasal administration, offers a highly efficacious and safe, needle-free option for vaccine delivery. The uniting factors of these two forms of vaccine administration are that both are noninvasive and provide a proven immunologic advantage."
Research indicates vaccine delivery via a transdermal (TD) or intranasal (IN) administration route, may provide a more rapid immunological response than vaccines administered subcutaneously or intramuscularly because the vaccine antigens go directly to the major sites of immune response — rather than taking a systemic route. In addition, immunization by either a TD or IN route may be an effective strategy to avoid interference by maternal antibodies.
"Research also shows mucosal specific immunization provides systemic immunologic memory to future infection; hence, priming the immune system," Nordstrom says.
Nordstrom adds: "Perhaps more than anything, it is amazing to visually witness the difference in stress when the use of a needle is eliminated. As a veterinarian, there are few things more gratifying than helping to reduce stress on an animal."
In the case of these transdermal safety and efficacy claims, TD administration means the vaccine is delivered through the skin using a high-pressure, needleless-delivery system. Using mechanical compression to force vaccine fluid through a small orifice, these devices produce a high-pressure stream that is smaller in diameter than a 21-gauge needle. Subsequently, the stream can penetrate skin and subcutaneous tissue, delivering a broad dispersion of vaccine antigens directly to the mucosal surface just below the animal's skin.
In addition, needle-free vaccine delivery carries the added benefit of reducing the risk of disease transmission of bovine leukosis (leukemia), anaplasmosis and BVD persistent infections (PI) through blood transfer.
Similarly, the intranasal route of vaccine administration provides the important advantage of vaccine delivery directly to mucosal surfaces, via the nasal passageway. Nordstrom says this is significant because nearly all infectious diseases of cattle initiate at the mucosal surface, such as in the nose.
"With the recent launch of Onset™ 5 IN, we've applied this understanding of mucosal immune response to calves as young as 3 days of age, further advancing alternative vaccine administration strategies to incorporate with very young and high-risk cattle."
Intranasal and transdermal routes of administration also offer many safety advantages, including the elimination of injection site issues, the potential to reduce immunosuppression associated with subcutaneous and/or intramuscular vaccination and safe administration of gram negative antigens, such as Pasteurella multocida, to newborn calves and high-stress cattle.
Raising the Bar "Intervet/Schering-Plough continues to invest heavily in the development of industry-leading vaccine technologies that help maximize the return on investment for producers, while minimizing the stress of handling on cattle," Nordstrom says. "This was exemplified with the launch of Vista® and continues today with the recent introduction of Onset 5 IN. These transdermal claims provide another example of the advancements available to veterinarians and producers to help fight the costly effects of infectious diseases while improving animal welfare."
For more information about Vista, Onset 5 IN, and the full line of Intervet/Schering-Plough Animal Health cattle products, contact customer service at 1-800-441-8272 or visit www.intervetusa.com.
Schering-Plough is an innovation-driven, science-centered global health-care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal-health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
Intervet is a leader in research and dedicated to the development, production and marketing of innovative, high-quality animal-health products, such as Vista, Vision®, Once PMH®, NeoGuard® and Onset IN vaccines; Fertagyl® hormone preparations; Chorulon® gonadotrophin; Revalor® implants; Zilmax® feed additive; and Safe-Guard® dewormer.
Vista, Vision, Once PMH, NeoGuard, Fertagyl, Chorulon, Revalor, Zilmax, Safe-Guard and BluShadow are registered trademarks and Onset is a trademark of Intervet Inc. or an affiliate. © 2008 Intervet Inc. All rights reserved
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For more information, contact:
Susan Conroy, 816-410-5158, or