September 15, 2003


 The changing face of vaccine labels

Posted Sept. 1, 2003


Government expected to propose new regulation

Do you feel like you need more vaccine information to treat the dogs and cats in your practice? If you do, you are not alone. Many veterinarians feel this way, and the AVMA Council on Biologic and Therapeutic Agents agrees.

"We are in a place that we need more information. It's very hard to customize recommendations if you don't have accurate information," said Dr. Elizabeth Curry-Galvin, assistant director of the AVMA Scientific Activities Division, who addressed veterinarians on July 19 at the AVMA Annual Convention.

Guiding tenets
The COBTA report on cat and dog vaccines, published in the Nov. 15, 2002, JAVMA, recommends that veterinarians tailor their vaccine recommendations to their clients' pets. Variations in lifestyles and related disease risks, and among individual vaccine products, make a one-size-fits-all protocol inappropriate.

For practitioners to do a good job, however, labels and adverse event information need improvement. Label information is defined as any information that is on the bottle label, package, or insert. Veterinarians and their clients should also be able to educate themselves via the electronic freedom-of-information system. This system allows the public to access information recorded during a product's licensure. In the future, clients and veterinarians may be able to access this via a Web site.

To address the issue, representatives of the COBTA, Department of Agriculture's Center for Veterinary Biologics, Canadian VMA, and the vaccine industry have held several meetings, trying to hash out a new labeling initiative.

The COBTA has been guiding themselves by a few basic tenets. First, only scientifically supportable statements and facts, not conclusions or recommendations, should appear on product labels. "You don't want someone making the decision for you. You want to be able to use the information to customize your recommendation," said Dr. Curry-Galvin, who is also staff consultant to the COBTA. Next, manufacturers need to be more forthcoming with information. "There is actually a lot of information that manufacturers are kind of sitting on that the veterinarians who are using the product don't get access to," she commented. And finally, labels should communicate appropriate expectations of product performance.

"At the end of the day, if the information there is scientifically sound, if there is more of it to guide you, and if you are not bound by some recommendation, then you can have a better expectation of product performance, and you can pass that along to your client," Dr. Curry-Galvin said.

Room for improvement
The council has several ideas of how to improve the system with regard to a number of standardization issues, including true name, directions for use, and efficacy and safety information.

A true name is a categorization of biologic components. "Currently, this does not accurately describe what is in the product," Dr. Curry-Galvin said. For example, you can't tell what fraction of a vaccine is modified-live versus killed. The council recommends developing meaningful standardized nomenclature and abbreviations for labels.

Second, instead of conclusions or recommendations, a label should state facts. For example a label could read: "The administration of a single dose at an age of 9 and 12 weeks in dogs was demonstrated to be effective, and safety was demonstrated in dogs as young as 5 weeks of age." Those are the facts, and veterinarians can use them to make their own decisions.

"You are a little less hamstrung, and yet, you have good information from which to make your professional recommendation," Dr. Curry-Galvin said.

In keeping with this, the COBTA also argues against including annual revaccination recommendations. Labels should state the interval following vaccination at which studies demonstrate immunity, but companies and regulators should not use this minimum duration-of-immunity interval to make label revaccination recommendations. They should state that a specific revaccination schedule hasn't been established.

In terms of efficacy information, the COBTA believes that providing details is key. For example, this could include a description of the challenge model and scoring system, the percentage of animals protected from signs, and the vaccine's impact on the animal's performance.

Efficacy claims can also be improved. Currently, the most common claim on a label is that a vaccine aids in disease prevention. "This means if you looked at vaccinated animals and unvaccinated animals in a study, there would be a difference in clinical scores, and if you looked at that difference, it would be statistically significant," Dr. Curry-Galvin explained. The problem is that veterinarians don't know the clinical relevance of that difference.

To improve the situation, the council recommends a common efficacy claim such as "the product stimulates immunity." Then, through the electronic freedom of information system, veterinarians could be provided with pivotal efficacy data, data that the manufacturer provided to the government to prove the product was efficacious, Dr. Curry-Galvin said.

The council also recommends including a common safety warning, pivotal safety summary, and greater details, for example, the minimum and maximum ages and numbers of animals in the safety studies, and any clinically relevant outcomes identified during the safety evaluation or in the field. Contact information, for reporting possible adverse effects, is also a must.

So when, if ever, can we expect these changes? According to Dr. Curry-Galvin, a proposed regulation is in the works, and the government will then allow a period for comment. She says a final regulation may be issued by 2004, and this would then be phased in over a period of years, most likely 2007. While this timeline may change, if the regulation does finally make it through, the label changes may affect vaccines not only for companion animals—they may affect vaccines for all animals.