RABIES, ANIMAL - USA (FL)
*************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


Date: 12 Aug 03
From: "Banks, A-Lan"
Source: Boca Raton News (edited)



As the rabies alert continues throughout Palm Beach County, another rabid
animal was found in Boca Raton. A gray fox captured on Friday near Glades
Road and Federal Highway was confirmed on Monday to be the 22nd wild animal
in the county to test positive for rabies, a viral disease that attacks the
nerve and brain tissue.

The disease, which can be transferred through a bite, scratch or saliva,
can be [is always. - Mod.SH] deadly if not treated. The fox is the 7th
animal in South County to test positive for the virus and the 6th sick
animal found in Boca.

Most of the rabid animals discovered in the county have been raccoons.
Three of the cases have been foxes and one bat was discovered to have the
disease.

The high number of rabies cases, which are nearing last year's record of 27
in the county, prompted the Palm Beach County Health Department to put out
a countywide rabies alert on July 18. The 60 day alert, the most
far-reaching in the county's history, will probably be extended, health
officials have said.

A total of 12 people have come in contact with rabid animals and have been
treated with a series of rabies shots. The health department has warned
people to keep their distance from any wild animals in the area. In
addition, the department has recommended that residents cover their outdoor
garbage cans so wild animals won't be enticed to come around homes.

--
ProMED-mail


[The health department is to be commended for establishing a warning. But
people should also have their animals, including horses, vaccinated against
rabies. ­ Mod.TG]


- posted by Art @ 5:38 PM

 
Subj: vaccine changes

Denver, Colorado

American Veterinary Medical Association


Sunday, July 20, 2003

Vaccine labels: Are there changes in the future?

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 yesterday.

Guiding tenets
The COBTA's report on cat and dog vaccines, published in the November 15, 2002 JAVMA, recommended that veterinarians tailor their vaccine recommendations to their clients' dogs and cats, because variations in lifestyles and related disease risks and among individual vaccine products make a one-size-fits-all protocol inappropriate.

In order to do this well, COBTA believes label and adverse event information need to be improved. To address this issue, COBTA, the Department of Agriculture's Center for Veterinary Biologics, the Canadian VMA, and the vaccine industry have held several meetings, trying to hash out a new labeling initiative.

In their efforts, 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, communication of information needs improvement. "There is actually a lot of information that (the manufacturers) are kind of sitting on that the veterinarians who are using the product don't get access to," said Dr. Curry-Galvin. And finally, labels should communicate appropriate expectations of product performance.

"At the end of the day if the information there is scientifically sound, there is more of it to guide you, and 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.

In talking about label information, COBTA means not only the label on the bottle, but any inserts or any information on the package. The COBTA also believes the electronic freedom of information system has a role. This is a system within the government whereby information that is recorded during the licensure of a product can be shared with the public. In the future perhaps, you would be able to access this information on a Web site.

Room for improvement
The Council believes there is room for improvement in a number of standardization issues including true name, directions for use, efficacy, and safety.

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

In terms of directions for use, the COBTA believes that conclusions or recommendations should be kept off labels. For example, what if a label just said, "the administration of a single dose at an age of 9 and 12 weeks in dogs was demonstrated to be effective. Safety was demonstrated in dogs as young as 5 weeks of age."

"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, a label should not include an annual revaccination recommendation, unless studies have demonstrated this.

In terms of efficacy information, COBTA believes providing the details is key. For example, labels should 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.

Label 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 in a study and unvaccinated animals, there would be a difference in clinical scores, and if you looked at that difference, it would be statistically significant," Dr. Curry-Galvin explained. But 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 would be provided with pivotal efficacy data, data that the manufacturer provided to the government to prove the product was efficacious.

In terms of safety information, the COBTA also recommends a common safety warning, pivotal safety summary, and greater details including, for example, the minimum and maximum ages and numbers of animals in the safety studies, and any clinical relevant outcomes that were identified during the safety evaluation as well as in the field. The label should also include contact information for reporting possible adverse effects.

So when, if ever, can we expect these changes? According to Dr. Curry-Galvin, a proposed regulation is soon expected. The government will then allow a period for comment, and a final regulation is expected in 2004. Of course, there could always be holdups, and the regulation would need to be phased in over a period of years, most likely 2007. But if the changes do go through, they will not only affect vaccines for companion animals—they may affect vaccines for all animals.










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- posted by Art @ 12:44 PM