Veterinary Vaccines and Biologics

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.

Important: The veterinary product’s mechanism of action is central to how the veterinary product will be regulated.  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 immune modulators, including small peptide immune modulators, immune stimulating glycoproteins, and T-cell receptor peptide therapeutic vaccines.  Consultant Profiles.

• Antiserums, antivenoms and antitoxins
• Antibody products and allergen extracts
• Bacterins and toxoids
• Diagnostic kits
• Immune stimulants and modulators
• Prophylactic and therapeutic vaccines

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

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