USDA Approves Full License for West Nile Virus Vaccine
OVERLAND PARK, Kan (February 6, 2003) - The United States Department of Agriculture (USDA) has issued a full license to Fort Dodge Animal Health for the West Nile Virus (WNV) vaccine. The name of the vaccine is West Nile - InnovatorTM
The original conditional license for the vaccine was issued in August 2001 under expedited review, while efficacy studies were ongoing, due to the potential threat of West Nile disease in horses.
One of the keys to conversion from conditional to full-license status was satisfying USDA requirements for proof of efficacy. The efficacy study results submitted to the USDA demonstrated that Fort Dodge Animal Health's inactivated WNV vaccine is immunogenic and efficacious. According to the study summary, 95% of the horses vaccinated with two doses of West Nile - InnovatorTM and challenged with the live virus 12 months later, were free from viremia. Eighty-two percent of the non-vaccinated horses developed active WNV infection, as evidenced by recovery of the virus from blood samples.
"Horse owners and veterinarians can be confident this is a safe and effective vaccine to aid in the prevention of this potentially deadly disease," explains Lynn Bixler, Equine Product Manager for Fort Dodge Animal Health. "Ninety five percent efficacy is a great result."
"Overall, the safety demonstrated by West Nile - InnovatorTM in the field has been excellent," explains John Tuttle, D.V.M., Manager of Professional Services with Fort Dodge. "Calls received by Fort Dodge Animal Health Professional Services regarding potential vaccine reactions have involved fewer than 0.0 1% of the estimated doses used. These reports have varied little from the types of calls we get on other routinely used equine biologicals."
West Nile virus is one of the fastest growing health threats to U.S. horses today. Since its discovery in New York in 1999, the West Nile virus has spread quickly throughout the United States and recently has been confirmed as far west as Washington. In 2001, 738 cases of clinical West Nile virus infection were reported in horses. As of December 31, 2002, the total number of equine cases involving WNV infection confirmed by the USDA's National Veterinary Services Laboratories (NVSL) or reported by state officials was 14,717, representing an increase of over 13,000 cases in just one year. West Nile virus is a devastating threat to horses coast-to-coast.
"Fort Dodge has taken a proactive approach to educate horse owners and veterinarians about the threat of the disease as well as the availability of the vaccine," explains Bixler. "Up to 40% of horses who have been diagnosed with WNV have died or been euthanized. Vaccination prior to exposure is the single most important tool in protecting the health of these animals. Prevention is the best approach toward this deadly disease."
Contact your veterinarian to discuss appropriate immunization strategies for your immediate area. Previously vaccinated horses will need to be boostered according to your veterinarian's recommendation. The initial vaccination consists of two injections given three to six weeks apart.
West Nile-InnovatorTM is available from licensed veterinarians only and is to be used where a legitimate Doctor-Client-Patient relationship exists. This method of distribution has been established to ensure proper vaccine administration, storage and vaccination protocols based on geographical risk. For additional information on the disease, visit www.equinewestnile.com.
Fort Dodge Animal Health is a world leader in the equine animal health industry with over 30 years of innovative product development to better horse health. Key equine products include QUEST® Gel, PinnacleTM I.N., vaccines for EPM and West Nile virus, and the FLUVAC® Innovator line of vaccines.
Fort Dodge Animal Health, a division of Wyeth (NYSE:WYE), 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 products include CYDECTIN® Pour-On, QUEST® Gel, EtoGesic® Tablets and ProHeart® Injection. The company is headquartered in Overland Park, Kansas.
Germinder & Associates, Inc.
Lea-Ann Germinder, APR