APHIS issues conditional license for canine influenza virus vaccine
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced in late June that it has issued a conditional license to Intervet/Schering-Plough Animal Health for a canine influenza virus (CIV) vaccine.
The vaccine, made from killed virus, is intended to aid in the control of disease associated with canine influenza virus infection, type A, subtype H3N8. Canine influenza was first identified as a disease in U.S. dogs in 2004, after an outbreak of respiratory disease in racing greyhounds in Florida. Since then, it has continued to spread and has now been detected in dogs in 30 states and the District of Columbia.
APHIS, through its Center for Veterinary Biologics (CVB), granted the conditional license following the acceptance of data supporting product purity, safety and a reasonable expectation of efficacy. The safety data included the results of studies that evaluated the product under normal conditions, including field safety trials of the size and scope required for full licensure.
Studies indicate that the vaccine can reduce the incidence and severity of lung lesions, as well as the duration of coughing and viral shedding. The product is administered by by subcutaneous injection in two doses, two to four weeks apart, Intervet Schering/Plough explains. The new vaccine is recommended for use in healthy dogs at 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.
Under the conditional license, the product may be distributed as authorized in each state, and used by, or under the supervision of, veterinarians. During the one-year conditional license period, the CVB will continue to monitor the product’s performance and will evaluate the company’s progress toward full licensure.
APHIS issues conditional licenses in the event of an emergency situation, limited market or other special circumstance. In this case, the special circumstance was the emergence of a new virus for which there were no existing licensed veterinary vaccines.