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2002/11/20

EPM Vaccine License Reissued For Full Year The United States Department of Agriculture has reissued the conditional license to Fort Dodge Animal Health for their Equine Protozoal Myeloencephalitis (EPM) vaccine for one full year based on the demonstrated safety of the vaccine and the continued research to establish efficacy. The EPM vaccine originally received conditional license approval in December 2000 for a six-month period. It was renewed in June 2001 for a full year as a result of the USDA's review of information supplied by Fort Dodge Animal Health describing progress toward fulfilling the requirements for full licensure. Fort Dodge is actively conducting studies to further the understanding of the vaccine and to alleviate questions and concerns that veterinarians and horse owners may have about it. One study has already been completed and two additional studies are currently underway. EPM Vaccine Update: CMI Response to Vaccination. The CMI (Cell Mediated Immunity) Data Study was conducted in cooperation with the University of Missouri, Columbia. CMI is important because this part of the immune system is critical for resistance to parasites and intracellular organisms. The results of this study were presented during the 2002 meeting of the American Association of Veterinary Parasitologists. Dr. Antoinette Marsh, the principal investigator concluded, "vaccinated horses were successfully primed for CMI response to the S. neurona antigen following vaccination.. Case Control Study. As in human medicine, often times a challenge model is not available to test the efficacy of a vaccine. This is currently the case with the EPM vaccine. In such instances, a field performance study is initiated to demonstrate the field, or real world, performance of a vaccine. A Case Control Study is being conducted by Dr. Noah Cohen of Texas A&M University and Dr. Robert MacKay of the University of Florida with the assistance of eight veterinary teaching hospitals and three private practice centers. The results of this study should be available within a few years. Challenge Model Development Study. Since the beginning of the field efficacy, or Case Control Study, new information has become available that may enable Fort Dodge Animal Health to test the EPM vaccine in a controlled challenge model. The Challenge Model Development Study will be conducted in cooperation with The Ohio State University with Dr. William Saville as the principal investigator. "I am very encouraged by the progress we are making," said Dr. Steve Connell, Director of Professional Services for Fort Dodge Animal Health. "We have strong data that the vaccine works in the laboratory and we are making strides toward proving the vaccine is efficacious under controlled challenge situations. Given the potentially devastating effects of EPM, the difficulty in diagnosis and the expense of treatment, we feel that vaccination as an aid in the prevention of this disease is a valuable tool." For the latest information about the EPM vaccine, go to the Fort Dodge websitewww.epmvaccme.com.

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