Veterinary biologics (veterinary vaccines, antiserums, immune modulators) includes all viruses, serums, toxins, or analogous products of natural or synthetic origin which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. Such products include but are not limited to vaccines, bacterins, allergens, antibodies, diagnostics, antitoxins, toxoids, immunostimulants, antigenic or immunizing components of microorganisms intended for use in the prevention, diagnosis, management or cure of disease in animals.

Mechanism of Action and Inteded Use: The veterinary product’s mechanism of action and intended use underpin which regulatory agency will have oversight and purview.  Immune stimulation, supplementation, enhancement or modulation is what largely distinguishes veterinary biologics (veterinary immuno-biologics) from veterinary medical drugs or veterinary devices.

Woods Consulting, LLC’s veterinary consultants have worked on a number of veterinary projects involving veterinary cancer vaccines, veterinary immune modulators, therapeutic vaccines, veterinary diagnostics, antivenoms and a number of other products regulated by the USDA-CVB.  Consultant Profiles.

Developing Veterinary Vaccines and Biologics

Technical Sections

In the United States, vaccines and biologics for veterinary medicine are regulated by the United States Department of Agriculture – Center for Veterinary Biologics (USDA-CVB).  The USDA-CVB regulates the shipment, evaluation, approval and enforcement per the Virus-Serum-Toxin Act, or VSTA.  In order to satisfy a Veterinary Product License, the following aspects must be completed by the Sponsor or license holder.

• Safety in target species
• Efficacy in target species
• Potency of the final product
• Purity of the final product

Regulatory Links

Additional Information Concerning Veterinary Vaccines and Veterinary Biologics

Manufacturing and Shipment of Veterinary Vaccines and Biologics

Manufacturing of Veterinary Antiserums, Antibodies, Vaccines and Veterinary Diagnostic Kits:  The manufacture and distribution of veterinary immune modulators, biologics, and certain diagnostics are regulated by the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS).  These products should be manufactured according to an Outline of Production, which should be conducted according to Good Manufacturing Practices.

Shipment of Experimental Vaccines and Biologics:  Before shipping experimental vaccines or biologics for clinical evaluation, the Sponsor should obtain USDA’s authorization to transport (ship), which may include providing the USDA a list of recipients (study sites and investigators).  Approval for veterinary immuno-biologics is conducted under the guidance of the USDA-Center for Veterinary Biologics (USDA-CVB).

Conditional Licenses