The USDA’s Center for Veterinary Biologics has issued a full license to Colorado Serum
Company for the manufacture and distribution of Brucella Abortus Vaccine, Strain RB-51, Live Culture. For the past seven years, the vaccine (under conditional license) has served as a significant factor in the government’s 50-plus year effort to eradicate brucellosis from the United States.
Brucellosis is a bacterial disease that primarily affects cattle and bison and causes abortions and lowered milk production. As part of the cooperative State-Federal Brucellosis Eradication Program, many states currently require each bovine heifer calf (4-12 months old) to be vaccinated with RB-51.
Brucella Abortus, Strain RB-51 was originally developed by Dr. Gerhardt Schurig of Virginia Tech, replacing the older Strain 19 vaccine. The advantage of RB-51 is that it produces immunity while not inducing antibodies which react in standard serological diagnostic tests (eliminating false-positives in diagnosis of infected cattle), nor does it produce an objectionable local reaction at the injection site. The organism is cleared from the blood stream within 3 days, is not present in nasal secretions, saliva, or urine, and does not spread from vaccinated to non-vaccinated cattle.
The issuance of full licensing by USDA confirms satisfactory conclusion of safety, efficacy, and potency studies that, in the case of RB-51, were completed some years ago. Cooperative evaluations were successfully completed by the FDA’s Centers for Disease Control and USDA regarding required environmental assessments.
Brucella Abortus Vaccine, Strain RB-51 has been distributed under a conditional license by Professional Biological Company (a marketing subsidiary of Colorado Serum Company) since 1996. Distribution of this product in the United States shall be for use by or under the supervision of a licensed veterinarian and the distribution in each state shall be limited to authorized recipients designated by proper state officials under such additional conditions as these authorities may require.
For further information about brucellosis: www.aphis.usda.gov/vs