New animal vaccine labels on the horizon

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.

Indication statement

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.

6 thoughts on “New animal vaccine labels on the horizon

  1. The insert that currently accompanies the vaccines states “only vaccinate healthy animals”. What bothers me is that I see many animals in my practice with severe chronic diseases (heart disease, diabetes, hyperthyroid, liver and kidney disease and cancer to name a few) who continue to get yearly vaccines by their regular veterinarians. It amazes me to think that these vets believe these animals fall into the “healthy” category and need to be re-vaccinated yearly for DA2PP, FVRCP, etc. Titers would seem a much better solution to show these animals have immunity.
    The Rabies vaccine is required by law. However in many cases a blood test to obtain a Rabies titer can be collected and if the titer is adequate, an exemption letter can be written on behalf of these chronically ill animals. I think we as veterinarians, who have sworn an oath to “do no harm,” should be more aware of what we are doing. Vaccines are not harmless. Let’s show some compassion for our animal patients and their owners.

  2. I agree with Dr Pegg re: the misuse of ALL OTC biologics including injectable antibiotics, powder antibiotics, vaccines etc. by the public (it’s not the public’s fault it is available to them). I think the AVMA should direct all it’s efforts in to getting these off the shelves PERIOD! Rabies vaccines are administered by license Veterinarians only, Leptospirosis, a zoonotic disease, is easily preventable with a quality biologic that is handled correctly per the manufacturers directions, yet is not regulated by the state? It seems the AVMA should work on putting the work of educating the public back into the hands of the animal professionals…the Veterinarian.

  3. Dear Dr. Pegg,

    I wanted to take a moment to thank you for your feedback. We are preparing to share feedback with the USDA, and you bring up a great point about clients who have inadvertently administered vaccines incorrectly (or perhaps administered the wrong vaccines), and/or stored them incorrectly. It underscores the value of consulting with a licensed veterinarian, to help ensure usage of the product matches the specific need of the patient (recognizing that many vaccines are legally available for purchase/use by non-veterinarians). Of course, some vaccines are, and should be, available for use only by or under a veterinarian’s direct supervision. Like you indicated, clients might falsely believe their animals are adequately protected when they might not be, if they are using vaccines incorrectly. Thanks again for your time and sharing your helpful input.

    Lynne White-Shim

  4. There should be more regulation as to who can use vaccines. Vaccines should only be obtainable by licensed veterinarians. There are so many people out there administering vaccines that cannot even interpret the vaccine label correctly

  5. Pingback: NewStat | USDA looking to simplify animal vaccine labels with new proposed rule