Fort Dodge Animal Health, a division of Wyeth (NYSE:WYE), today announced the National Agency of Veterinary Medicine (France) has given temporary approval for Poulvac® FluFendTM i H5N3 RG, an inactivated virus reverse genetics avian vaccine to aid in the prevention of avian influenza (AI) caused by the H5N1 virus.

In collaboration with St. Jude Children's Research Hospital and the University of Wisconsin, Fort Dodge developed the vaccine as part of a control and eradication program in response to the growing concern about global avian influenza and the need to protect poultry from the disease.

Reverse genetics, a cutting-edge technology being utilized in the development of human vaccines, has enabled Fort Dodge to take components from three different influenza viruses and bring them together in a single product. This technology, licensed from the Wisconsin Alumni Research Foundation, not only results in a product that offers safe and effective protection against the most prevalent strain of AI currently threatening France, but also allows for differentiation between a field strain and the vaccine, using diagnostic tests that Differentiate Infected from Vaccinated Animals-the so-called DIVA system. DIVA is often used as part of a monitoring program to demonstrate the flock is not infected with the field virus.

The reverse genetics technology used for the preparation of the Fort Dodge H5 influenza vaccine was developed by Erich Hoffmann, Ph.D., Division of Virology, St. Jude Children's Research Hospital. This process, known as the eight plasmid reverse genetics system, is a significant advantage for future poultry vaccines because it allows the antigen content to be standardized, according to Robert Webster, Ph.D., holder of the Rose Marie Thomas Chair, Department of Infectious Diseases, at St. Jude. "The standardization of antigen content is similar to human influenza vaccines, and more recently for equine influenza vaccines," Webster said. "Thus, this new vaccine is a major advance for preventing infection of poultry with H5N1."

The French Ministry of Agriculture and Fisheries has requested an initial supply of 7 million doses of this vaccine for use in ducks as part of an avian influenza control program. Approval was based on the efficacy of the vaccine, which demonstrated the ability to reduce mortality, virus re-isolation and shedding after challenge with highly pathogenic AI viruses. The French Ministry recently started vaccinating outdoor ducks in parts of France, as authorities consider these areas at high risk for the transmission of AI virus by migrating birds.

As part of AI control programs, various Fort Dodge conventional vaccines have been registered or used in other parts of the world to provide safe and efficacious protection against Avian Influenza. In several different countries, Fort Dodge's products have been supplied as vaccine banks for use in the event of an outbreak. In addition to H5N3 RG, Fort Dodge has approvals for vaccines including H5N9, H5N2, H7N1, H7N2 and H7N3 strains.

Fort Dodge Animal Health

Fort Dodge Animal Health is a leading manufacturer and distributor of prescription and over-the-counter animal health care products for the livestock, companion animal, equine, swine and poultry industries in North America and international markets. Key poultry products include Bursine® -2, Bursine® Plus and Poulvac Aero®. The company is headquartered in Overland Park, Kan.

St. Jude Children's Research Hospital

St. Jude Children's Research Hospital is internationally recognized for its pioneering work in finding cures and saving children with cancer and other catastrophic diseases. Founded by late entertainer Danny Thomas and based in Memphis, Tenn., St. Jude freely shares its discoveries with scientific and medical communities around the world. No family ever pays for treatments not covered by insurance, and families without insurance are never asked to pay. St. Jude is financially supported by ALSAC, its fund-raising organization. For more information, please visit stjude.

Wisconsin Alumni Research Foundation

Wisconsin Alumni Research Foundation supports world-class research at the University of Wisconsin-Madison by protecting the intellectual property of University faculty, staff and students, and by licensing inventions resulting from their work. Through the licensing efforts, university ideas benefit the public by bringing resources back to the University to continue the cycle of investment, research and invention. Established in 1925, WARF was the first university technology transfer office in the United States.


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