Frequently Asked Questions about Autogenous Vaccines

Autogenous vaccines are typically considered when:

• A commercially licensed vaccine is not available
• Circulating field strains differ from those covered by licensed products
• Herd‑ or flock‑specific disease challenges persist despite standard controls

They offer a customized option to support herd health programs under veterinary oversight

Licensed commercial vaccines are approved for general interstate distribution and supported by large‑scale efficacy and safety data. 

Autogenous vaccines are custom‑made, not licensed, and are custom made for use in a specific herd or flock, as permitted by the USDA Center for Veterinary Biologics (CVB).

They are not substitutes for licensed products, but rather tools for specific, unmet needs.

Yes. In the United States, autogenous vaccines are regulated by USDA‑APHIS‑CVB under:

• Title 9 Code of Federal Regulations (9 CFR)
• CVB policy guidance for autogenous biologics

Manufacture, distribution, and use are subject to defined regulatory controls, including veterinary involvement and recordkeeping.

Autogenous vaccines:

• Are requested and prescribed by a licensed veterinarian
• Are manufactured by a CVB‑authorized facility, like our facility in Lenexa

This ensures responsible use within a clearly defined regulatory framework.

The typical process includes:

1. Collection of diagnostic samples from affected animals
2. Isolation and identification of the pathogen
3. Vaccine production using approved methods (e.g., inactivation)
4. Quality control testing and documentation
5. Release for veterinary‑directed use

Each step follows established CVB expectations for autogenous biologics.

Timelines vary depending on the organism, testing needs, and manufacturing complexity. 

In many cases, production can be completed within weeks once a pathogen has been isolated and purified, allowing timely support of herd health decisions.

Autogenous vaccines are inactivated products designed first and foremost with safety in mind. Although they are not supported by large-scale controlled efficacy trials before initial use, veterinarians evaluate their relevance based on the match to field strains and their performance in the target production setting. Their use is guided by:

• Antigenic relevance to the field strain
• Veterinary clinical judgment
• Observation of health trends and production outcomes

They are used with appropriate expectations and ongoing veterinary monitoring.

• Yes, in many cases. Autogenous vaccines may be incorporated into broader disease management strategies, provided that:
  • Use is directed by a veterinarian
  • Timing and product interactions are considered
  • Regulatory requirements are met

They may be considered as part of an overall health management plan and can complement licensed vaccines when those products are available and appropriate

Successful programs are built on:

• Open collaboration between our technical service and the veterinarian
• Strong veterinarian–producer collaboration
• Accurate diagnostics and sample collection
• Clear definition of the target population
• Consistent administration and recordkeeping
• Integration with biosecurity and management practices

Autogenous vaccines are most effective when used as part of a holistic health management approach.