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Development and Licensure of Vaccines in the United States

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Development and Licensure of Vaccines in the United States DEVELOPMENT AND LICENSURE OF VACCINES IN THE UNITED STATES Ignacio Correas, DVM, PhD, Diplomate ACVM (Bacteriology/Mycology, Virology) Manager I, VMRD Global Regulatory Affairs Zoetis 333 Portage St Kalamazoo, MI 49007 In the United States, the Center for Veterinary Biologics (CVB), an agency of United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), regulates veterinary biologics to ensure that they are pure, safe, potent, and effective. Biological products can be defined as all viruses, serums, toxins, or analogous products which are intended for use in the treatment of animals and which act primarily through the immune system or immune response. This includes vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, among others. The law under which veterinary biologics are regulated is the Virus-Serum-Toxin Act of 1935, as amended 1985 (21 USC 151-159 et. seq.). The CVB implements the provisions of the Virus- Serum-Toxin Act to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are not worthless, dangerous, contaminated, or harmful. Other authorities under which the CVB operates includes Title 9, Parts 101–122 of the Code of Federal Regulations (i.e. 9 CFR), and guidance documents in the form of Veterinary Services Memoranda, Veterinary Biologics Notices, etc. There are two types of veterinary biologic licenses issued by the CVB: establishment license (i.e. manufacturer) and product license. Product licenses can be: regular (full), conditional, for export only, autogenous, or prescription, among others. Basic requirements for a veterinary biologic product license include an outline of production and key supporting data, including research data, laboratory test records, and field testing reports. Key licensing elements, such as the characterization of the master seed (bacteria/virus/etc.), master cell stock, host animal efficacy study(ies), potency assay(s), field safety study(ies), and stability study(ies) should reflect “good science” and “good sense”. Data review is done on a case-by-case basis, taking into consideration standard licensing requirements, and ensuring that the product is pure, safe, potent, and efficacious. Additional licensing elements required for live veterinary biologics include back-passage tests and shed and spread study(ies). Pure veterinary biologics must be free of extraneous viruses, bacteria, fungi, and mycoplasma. To demonstrate this, veterinary biologics manufacturers test their master seeds, master cell stocks, and other ingredients that are used in the manufacturing process. Inactivated products are further tested for completeness of inactivation, to confirm that all microorganisms are not viable. Finally, the finished product is must be tested for sterility (i.e. freedom of bacterial and/or fungal contamination). Veterinary biologics manufacturers must test, prior to licensure, product in laboratory and host animal studies in order to demonstrate safety. Environmental safety must be demonstrated, particularly in live, replicating products. Efficacy and potency data include immunogenicity host animal studies and duration of immunity studies, that have to support the product’s label claim (including the age of the host animal and route of administration). Manufacturers must file with the CVB an outline of production. An outline of production is a contract between the manufacturer and the USDA, which provides a description of the ingredients and processes to manufacture a veterinary biologic product. An outline of production ensures that the product is made consistently in the way it was made when efficacy (immunogenicity) was demonstrated. Any deviations must be approved by the CVB. Conditional licenses are authorized to meet an emergency condition, limited market, local situation, or other special situation. Conditionally licensed products must meet all the requirements for a fully licensed products; however, only a “reasonable expectation” of efficacy, as defined by the CVB, is needed. Additionally, a fully validated potency test may not be required. Unlike regular or conditionally licensed veterinary biologics, autogenous biologics consist of herd-specific antigens (e.g. bacterial or viral isolates). Autologous therapeutic biologics are derived from animal cells, where the individual animal is both the donor and recipient, and are often used in the treatment against cancer. The licensing process is an accumulation of data and information that provides the necessary support to justify a veterinary biologic product license. Whilst the manufacturers are accountable for developing and executing the studies, and keeping appropriate documentation, the CVB is responsible for ensuring that the regulatory requirements are met and appropriately applied. A veterinary biologic product, when licensed, must stand on the merit of the data provided to the CVB. .
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