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

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.

Regulatory considerations for emergency use of non-USDA licensed vaccines in the United States.

The Virus-Serum-Toxin Act of 1913 (21 US Code 151-159) provides the legal basis for the regulation of veterinary biologicals in the United States; the United States Department of Agriculture's Center for Veterinary Biologicals (CVB) has the regulatory authority for the issue of licences and permits for such products. The law was intended to establish standards and control the importation of products into the United States and the distribution of products interstate assuring the purity, safety, potency, and efficacy of veterinary biological products. Administrative regulations and standards appear in the Title 9, Code of Federal Regulations, Parts 101-118, with additional programme guidance found in CVB Notices, Veterinary Services Memoranda, General Licensing Considerations, and other guidance documents. Pre-licensing data evaluation procedures are designed to assess the purity, safety, potency, and effectiveness of each product and support all product label claims. To fulfil these criteria, data from all phases of product development are evaluated against these key elements. Under the standard licensing process, this spectrum of evaluation includes complete characterization and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This comprehensive evaluation may not be possible during the emergence of a new animal disease. While there are no specific regulations addressing the licensing standards of products for an emerging animal disease, there are mechanisms that allow for the availability of products in an emergency animal health situation. These mechanisms include autogenous biologicals, conditional licences, experimental and emergency use authorizations, and the importation of products in use elsewhere in the world. Pre-approved vaccine banks provide an additional mechanism.

Avian thymic hormone (ATH) is a parvalbumin.

Amino acid sequence analysis of a protein from chicken thymus tissue which promotes immunological maturity in chicken bone marrow cells in culture has established sequences of a 45-residue fragment, a 24-residue fragment and a 9-residue and an 8-residue peptide. Independent comparison of the 45- and 24-residue fragments with known amino acid sequences by computer search has unequivocally identified avian thymic hormone as a parvalbumin. This is the first demonstration that a protein previously identified by a biological function is a parvalbumin.