Regulatory Brief

 Changing Bovine Viral Diarrhea Virus vaccine labels


Formal title: USDA Center for Veterinary Biologics (CVB) Notice No. Draft-007: Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea Virus(es)


Brief Description:

The USDA Center for Veterinary Biologics proposes that Bovine Viral Diarrhea Virus (BVDV) vaccine labels include the vaccine BVDV type(s) in the indications statement and the type of the BVDV challenge virus for which efficacy has been demonstrated as part of the product claim.

AVMA Response:

In principle, the AVMA is very pleased with the CVB's attempt to provide additional science-based information on biologic labels to help veterinarians have a clearer expectation of product performance. However, we believe the diversity of BVDV and the accompanying variability in biologic protection poses significant challenges. As proposed, the CVB draft may cause more problems for veterinarians who recommend and/or administer vaccines than it may solve because it oversimplifies the dynamics of BVDV protection.

To resolve our concerns, the AVMA recommends that the vaccine virus type and challenge type be identified only if accompanied by a statement on the label of all BVDV products that explains that because of the diversity of BVDV, protection between and among virus types is variable.

Background Documents:

View AVMA response to USDA (PDF)

View document on USDA Web site (PDF)

Status:

The USDA concluded that BVDV Type(s) included in a biologic should be disclosed on the label as part of the indications statement. In addition, the label should indicate, as part of the product claim, the Type of BVD challenge virus for which efficacy has been demonstrated.