From Dairy Vaccines
Preventative herd health has become a key focus of livestock management and vaccination is a cornerstone of most herd health programs. However, if a ranch is using a vaccine that does not perform to satisfaction, or if a vaccine is simply unavailable for a specific disease, what should the producer try next? Unfortunately, due to the high costs of research and development, many vaccines are mass produced using decades-old bacterial and viral strains. Rarely are strain variations taken into account. Consequently, a producer in Arizona may find himself using a bacterin made from an organism isolated ten years ago in Wisconsin. However, a more precise alternative is available. Manufactured from pathogens specifically isolated for an individual ranch, autogenous vaccines target only the problem organisms. In this way, a producer does not pay for unnecessary vaccine strains, as he may with standard multi-way vaccines.
Under federal regulation, an autogenous vaccine is manufactured from bacterial or viral strains which are isolated in conjunction with animal disease. The product developed from these strain(s) may only be sold back to the veterinarian or farm from which they were isolated. Farms in the same region which share common veterinarians may be able to obtain the same autogenous vaccine under regulations which permit adjacent or at-rick premises to use product developed for the initial farm.
Hygieia Biological Laboratories' autogenous vaccines are manufactured under a USDA license with the same stringent quality control processes that are applied to its over-the-counter vaccines. A key focus in the production of any Hygieia vaccine is reduction of free endotoxin. Endotoxin is released during the manufacture of any gram-negative vaccine. Simultaneous administration of multiple gram-negative vaccines creates the risk of endotoxic shock or more subtle problems such as early embryonic loss, decreased production, and immunosuppression. During the development of its over-the-counter J5 E. coli bacterin, Hygieia perfected manufacturing techniques designed to reduce the levels of free endotoxin in the vaccine. These same techniques are employed in the assembly of autogenous vaccines.
Since autogenous products are made for individual herds, Hygieia staff work closely with the veterinarian and producer to develop the product best suited for each herd. Production of an autogenous vaccine typically proceeds along the following lines:
- The veterinarian and the producer recognize an infectious disorder in the herd.
- The veterinarian contacts Hygieia Biological Laboratories to discuss the possibility of an autogenous vaccine with the staff veterinarians.
- Appropriate samples are taken from infected animals by the herd veterinarian .
- The samples are sent to the local or state diagnostic laboratory for culture and isolation unless specific arrangements have been made.
- If using a diagnostic laboratory for culture and isolation, the diagnostic laboratory sends the appropriate cultures to Hygieia in an overnight shipment.
- Hygieia begins antigen production and vaccine manufacture. The vaccine is manufactured with either an aluminum hydroxide or oil-based (Freund's incomplete) adjuvant, determined in consultation with the attending veterinarian.
- The vaccine undergoes rigid safety testing and quality control before is it shipped to the veterinarian for use in the herd.
- The first vaccine lot is typically ready for shipment three to four weeks after reception of the pure culture.
Examples of autogenous vaccines produced by Hygieia Biological Laboratories include: Corynebacterium pseudotuberculosisbacterin-toxoids, Salmonella bacterins, Staphylococcus bacterin-toxoids, Pasteurella bacterins, avian bronchitis and paramyxovirusvaccines and Mycoplasma bacterins. The minimum order for an autogenous bacterin is one 250 cc bottle; depending on the dose size, this may be 50, 125, or 250 doses. The cost of the vaccine varies with the difficulty of bacterial propagation and the number of strains involved. For instance, E. coli, Salmonella, and Staphylococcus bacterins are typically cheaper than Hemophilus, andMycoplasma strains. Typically, a preliminary estimate is discussed with the veterinarian before the initial culture is performed. Final cost and delivery estimates are provided after determining what is involved in propagating the strain for manufacture. All billing is done through the attending veterinarian. Since Hygieia Biological Laboratories is primarily a research and manufacturing facility, field samples should be sent first to a diagnostic laboratory for isolation and culture, unless specific arrangements have been made.
The government mandates the following disclaimer: 'Potency and efficacy of autogenous products have not been determined.' Specifically, each serial of autogenous vaccine is not tested for its ability to induce a measurable titer rise in animals ('potency'), nor has the ability of a particular serial to treat or prevent disease ('efficacy') been measured. However, the amount of bacteria formulated into each dose (antigenic mass) is known. In short, while Hygieia cannot guarantee positive results to any autogenous vaccine, every scientifically rational step is taken to ensure safety and adequate antigenic mass in every vaccine produced.