The Vaccine Label
Labels for veterinary vaccines are in the process of substantial change. The U.S. Department of Agriculture Center for Veterinary Biologics (CVB) recently finalized regulations that will require significant changes to the labeling of almost all veterinary biological products.1,2 Beginning in the fall of 2016, these changes will be implemented over a 4 to 6 yr period. During this timeframe, veterinarians will likely see both the current and new label formats in the marketplace. Two of the most significant changes are identified here.
Efficacy Indication Statements
The approach to conveying information through efficacy indication statements on vaccine labeling will change. The historic approach has utilized a tiered system intended to convey information about differing levels of effectiveness for licensed vaccines. The most common tiers utilized have shown that a product “aids in the prevention” or “aids in the control” of disease or clinical signs caused by a specific organism. The stratification of efficacy indication statements was intended to convey differing levels of effectiveness, and products were categorized into one of the tiers based upon the review of the efficacy data submitted by the manufacturer.
More recently, it became clear this stratification system did not provide clinically relevant information to end users of vaccines. Under the new labeling format, CVB will no longer utilize these tiers. Rather, the vaccines will carry a simplified statement that the product has been shown to be effective for the vaccination of healthy animals of a specified age or older against a specific disease. This will be coupled with summaries of the efficacy and safety data utilized by the CVB to support licensure of the product, which will be available on the CVB website. This will not necessarily be all of the data available for the product.
The summaries of efficacy and safety studies are intended to present the information used by CVB to license a product in a succinct, non-confusing manner. The data will NOT be useful for making efficacy or safety comparisons between vaccines due to differences in study design and animal variation. The CVB website will carry a cautionary statement for the public informing them to consult with a licensed veterinarian for interpretation of data. There will also be some products (products approved many years ago) for which the efficacy and study data is no longer available to the CVB, and the summary for such products will indicate the data is not available. This should not be misconstrued to mean these products are inferior or not effective and safe vaccines.
The new labels will no longer carry a routine, default recommendation for annual revaccination. Revaccination statements on the new labels will be based upon data. Where there is not data indicating a specific revaccination interval, the label will carry a statement to indicate that a revaccination interval has not been established and a veterinarian should be consulted.
1 Single Label Claims for Veterinary Biologic Products, 80 Fed. Reg. 39669 (2015)
2 Packaging and Labeling, 81 Fed. Reg. 59427 (2016)