23 June 2009
Vaccine Against Canine Flu Granted Conditional License by USDA
ROSELAND, N.J., June 23, 2009 – Intervet/Schering-Plough Animal Health, the global leader in veterinary biologicals, today announced the availability of the first vaccine against canine influenza virus (CIV), which was granted a conditional product license by the U.S. Department of Agriculture (USDA) on May 27, 2009, for use by veterinarians in the United States. (http://www.aphis.usda.gov/newsroom/content/2009/06/caninevacc.shtml)
“Canine influenza is a highly contagious respiratory infection that has a significant impact on dogs housed in shelters, kennels and communal facilities,” said Cynda Crawford, D.V.M., Ph.D., University of Florida, Clinical Assistant Professor of Shelter Medicine. “The availability of a vaccine can help prevent the medical, financial and emotional costs associated with this new virus.”
Canine influenza was first identified in the United States in 2004. Since then, CIV has continued to spread and has now been detected in dogs in 30 states and the District of Columbia, according to Dr. Crawford and Edward J. Dubovi, Ph.D., Professor of Virology, Cornell University College of Veterinary Medicine, two of the nation’s leading experts on Canine H3N8 who have been tracking the disease since 2004.
Most dogs have no immunity to canine influenza because it is a novel pathogen and, therefore, the infection can spread quickly through animal shelters, adoption groups, pet stores, boarding kennels, veterinary clinics and any location where dogs congregate. According to the U.S. Centers for Disease Control and Prevention (CDC), there is no evidence of transmission of the virus from dogs to people.
According to Terri Wasmoen, Ph.D., an immunologist and senior director of Biological Research for Intervet/Schering-Plough Animal Health, dog owners might not realize their pets are sick enough to need medical care until the dogs begin coughing, which occurs several days or more after the dog contracts CIV. The onset of coughing is a sign that the dog is vulnerable to pneumonia. “Preventing a viral infection that can make dogs susceptible to a complex of canine respiratory pathogens, commonly known as kennel cough syndrome, further strengthens the case for vaccination,” she said.
In 2006, the American Veterinary Medical Association (AVMA) called for the development of a vaccine against the spread of the disease, stating “there is urgent need for an effective canine influenza vaccine to improve the health and welfare of animals and reduce the financial impacts of canine influenza.”
Christopher Pappas, Jr., D.V.M., Director, Companion Animal Technical Services, Intervet/Schering-Plough Animal Health, said, “We developed the vaccine in response to the growing problem of the disease. We are pleased that our expertise in respiratory disease and vaccines can help prevent costly outbreaks and keep dogs healthier.”
Canine Influenza Vaccine, H3N8 has been demonstrated to reduce the incidence and severity of lung lesions, as well as the duration of coughing and viral shedding. The vaccine, made from inactivated virus, is intended as an aid in the control of disease associated with canine influenza virus infection, a type A, subtype H3N8. It is administered by subcutaneous injection in two doses, two to four weeks apart. It may be given to dogs six weeks of age or older and can be given annually as a component of existing respiratory disease vaccine protocols to ensure more comprehensive protection.
On May 27, 2009, the vaccine was granted a conditional license by the USDA’s Animal and Plant Health Inspection Service, which, through its Center for Veterinary Biologics (CVB), evaluates data supporting product purity, product safety under normal conditions of use in field safety trials and demonstration that the product has a reasonable expectation of efficacy. During the conditional license period, Intervet/Schering-Plough Animal Health will continue to submit data obtained in support of the product’s performance, which will be evaluated by government regulators to determine whether a regular product license may be issued.
About Intervet/Schering-Plough Animal Health
Intervet/Schering-Plough Animal Health is a leader in research and dedicated to the development, production and marketing of innovative, high-quality animal-health products for all major farm and companion animal species. For more information about Intervet/Schering-Plough Animal Health visit: www.intervet.com and 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, New Jersey, USA, and its website is www.schering-plough.com.”
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the private Securities Litigation Reform Act of 1995, including statements related to expectations or forecasts of future events.
Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A “Risk Factors” in the Company’s first quarter 2009 10-Q, filed May 1, 2009.