Simpler. Uniform. Clear. These are some of the ways USDA has described future animal vaccine labels, if its proposed rule published on April 21 comes to fruition. The AVMA’s volunteers within our Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee have long advocated for vaccine labels to include clinically relevant information that provide more insight into product performance expectations. View a clinical practitioner’s perspectives on the proposed changes in the video below.
Currently, the animal vaccine licensure system is weighed down by a four-tiered label claim hierarchical system that is difficult to understand. Not only do the tiers necessitate substantial USDA and industry resources to position veterinary vaccines into the most appropriate label “tier”, the tiers do not provide enough clarity for veterinarians in the field. This new approach would allow the government and vaccine manufacturers to share pivotal safety and efficacy data that should be more useful. If the proposed rule is a success, this simpler, more efficient federal vaccine licensure process is expected to provide some needed relief for the USDA’s Center for Veterinary Biologics program and be a better all-around support for use of these products.
Here is a brief summary of key proposed changes, which USDA seeks comments on by June 20, 2014. You can view the entire proposal, including proposed timelines, economic impacts, and other information in the Federal Register. The AVMA anticipates submitting comments (as we did in 2011), and as always, we welcome AVMA member input.
Current process: Depending on the degree of safety and efficacy presented, a manufacturer’s vaccine can achieve one of four tiers, which can emphasize the differences between competing products.
“For the prevention of infection with…”
“For the prevention of disease due to…”
“As an aid in the prevention of…”
“As an aid in the control of…”
Proposed process: A single statement that says “This product has been shown to be effective for the vaccination of healthy animals ___ weeks of age or older.”
Safety and efficacy study summaries
Current process: A vaccine’s label and packaged information with safety and efficacy study data are approved by the USDA as part of the licensure process and incorporated into the labeling that comes in the box shipped to the end-user.
Proposed process: The same breadth of data for licensure would be required by USDA that is currently required. Instead of paper labeling that includes some of the study data, the label would instead refer the end-user to the USDA’s website where all of the data USDA utilized in the product’s licensure would be summarized and made available, including USDA-accepted post-marketing studies demonstrating additional product performance insights. Only studies applicable to the product’s licensure would be included (not promotional studies), with a goal of creating a level playing field for vaccine manufacturers and more disclosure to end-users. The site would encourage the public to consult their veterinarian for specific recommendations.