Regulations for vaccines against emerging infections and agrobioterrorism in the United States of America

Summary The Virus-Serum-Toxin Act of 1913, as amended in 1985, provides the legal basis for the regulation of veterinary vaccines and related biological products in the United States of America (USA). The regulatory authority for the issuance of licences and permits that allow the shipment or importation of pure, safe, potent, and effective veterinary biological products lies with the Center for Veterinary Biologics (CVB), an agency of the United States Department of Agriculture (USDA). Under the standard licensing or permitting process, a manufacturer must develop and completely characterise and evaluate a product prior to licensure, and the CVB must review and evaluate the submitted information, audit and inspect the manufacturing facilities and methods of production and testing, and confirm key product test results through independent testing of product. This complete and comprehensive evaluation may not be possible in emergency situations, so processes and mechanisms are in place that allow for the more rapid availability of veterinary vaccines. Next generation vaccine development against foreign animal diseases such as foot and mouth disease is actively in progress in the USA and the authorities must ensure that there is an adequate supply of these vaccines in the National Veterinary Stockpile.