Thanks to the work of our AVMA volunteers, the efficacy claims on vaccine labels we’ve all grown accustomed to in practice are going to become much simpler. The United States Department of Agriculture (USDA) has published a final rule that will require vaccine labels to contain simple label claims, with the public having the opportunity to view relevant safety and efficacy studies online. This important change will make the instruction on labels less difficult to understand and help veterinarians in their work to provide more effective care for patients. This results from an over a decade-long effort by our dedicated members on AVMA’s Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee, who found that there was a real need for these changes in vaccine labels and led the way by advocating for their member colleagues and meeting with USDA’s Center for Veterinary Biologics (CVB) and vaccine manufacturers.
So what can veterinarians expect to see? Instead of the “tiered” labels companies previously have used to emphasize differences between competing products (read more about tiers in a 2014 USDA memorandum [PDF]), vaccines will say: ‘‘This product has been shown to be effective for the vaccination of healthy <insert name of species> <insert number> weeks of age or older against <insert name of disease>.’’ Additionally, to help veterinarians make informed, science-based decisions about vaccine use, manufacturers will be required to summarize the efficacy and safety data used to license the product in a standardized, user-friendly format. The summaries will be checked by CVB and then posted online at productdata.aphis.usda.gov for access/review by veterinarians. The same breadth of data for licensure will be required by USDA, but the information will be presented in a more understandable, transparent format, which also creates more of a level playing field for manufacturers.
The USDA’s final rule will go into effect September 8, 2015. The vaccine industry will be required to comply by 2019, by which time the vast majority of labels will be revised. However, veterinarians could see limited numbers of the newly revised labels as early as February 2016. The implementation of these vaccine label changes will be no small task. The USDA reports that there are approximately 100 veterinary biological establishments that produce about 1,900 different products. In total, there are approximately 11,700 active approved labels for veterinary biologics, all of which will need label revisions.
As monumental as this final rule is for veterinary medicine, we still have more advocacy to do for our members. First, we anticipate simultaneous implementation of another USDA rule [PDF] on vaccine labeling which will help promote additional label transparency. We also look forward to advocating for a common adverse event warning to appear on all biologics, as well as a more robust, active adverse event reporting structure for USDA to be able to detect any safety and/or efficacy issues that could occur with vaccines.
View a clinical practitioner’s perspectives on the proposed changes in the video below.