Dear Editor,
In Canada, veterinary biologics, which include veterinary vaccines, diagnostic kits, and antibody products for therapeutic use, are regulated by the Canadian Food Inspection Agency’s (CFIA) Canadian Centre for Veterinary Biologics (CCVB). The CCVB approves and licenses only those veterinary vaccines that meet the criteria established under the authority of the Health of Animals Act and Regulations.
The use of autogenous vaccines is permitted only during emergency situations when licensed commercial vaccines against a disease are either not available or not effective against a new strain(s) of the organism. An autogenous vaccine is prepared from the microorganism(s) or strain(s) of microorganism isolated from a specific farm, animal, or herd. This type of vaccine is used to vaccinate the animals at the same farm or related farm(s) from which the original microorganism or strain was isolated and cannot be used on unrelated farms.
The potency and efficacy of autogenous vaccines have not been established because these vaccines are manufactured directly from the field strains, or isolates, instead of from approved master seeds and therefore make it difficult to maintain batch to batch consistency. The prescribing veterinarian must sign a declaration stating that the veterinarian and the client are fully aware of the fact that the potency and efficacy of autogenous vaccines are not known.
Recently, an article titled “Field studies evaluating the direct, indirect, total, and overall efficacy of Streptococcus suis autogenous vaccine in nursery pigs” was published in the Can Vet J (2019;60:386–390). The CFIA-CCVB would like to caution readers that the overall efficacy of an autogenous vaccine cannot be determined based on the use of one particular batch of the vaccine prepared from a field strain because the production method and the effectiveness of the vaccine may vary from batch to batch and from strain to strain.
For these reasons, autogenous vaccines must only be used to vaccinate animals at the farm of origin or related farm(s) under the direct supervision of the prescribing veterinarian. Any conclusions drawn from one study cannot be extrapolated to establish efficacy claims for other batches or types of autogenous vaccines.
Detailed information on the regulation of autogenous vaccines in Canada is available in “Veterinary Biologics Guideline 3.13E — Guideline for Autogenous Veterinary Biologics” accessible on the CFIA’s website at the following URL: http://www.inspection.gc.ca/animals/veterinary-biologics/guidelines-forms/3-13e/eng/1328594554673/1328594626360
For additional information on autogenous vaccines, Canadian veterinarians and producers are encouraged to visit the above website or contact CFIA-CCVB.