Canadian Veterinary Medical Association and The Canadian Veterinary Journal.

Over the past year, numerous articles have been published on the current debate on vaccination guidelines in companion animals. While a significant number of veterinary schools in the United States have adopted revaccination guidelines for dogs and cats, whereby certain vaccines are given less frequently than annually, many practitioners across North America and at the veterinary schools in Canada remain cautious and continue to revaccinate according to label recommendations, which, for the most part, means annually.

To address this ongoing issue of concern, the American Veterinary Medical Association (AVMA) has embarked on a 2-year process of review and consultation, with the eventual goal of developing new guidelines. The CVMA is fortunate to be included in this process, through representation at the various stages in the process. Vaccination guidelines are a concern on both sides of the border, and sharing a common process and, hopefully, developing similar guidelines will help to provide a consistent approach across the continent. Furthermore, the CVMA is provided with access to the resources and network afforded the larger association.

Developing vaccination guidelines is not new for the AVMA. Periodically, the AVMA will publish recommendations in the Journal of the American Veterinary Medical Association for different species; the last review of canine and feline vaccines was in 1989. The AVMA’s Council on Biologic and Therapeutic Agents (COBTA) has embraced a larger review at this time, inviting feedback on vaccination usage for all species.

The review process began in August 1999 with a meeting of experts on vaccines. The day-and-a-half meeting reviewed current information on canine and feline vaccines, including efficacy of vaccines, duration of immunity, adverse reactions, information on the diseases themselves, reporting adverse reactions, use of serology, etc. Likewise, at a 2^nd meeting in October, held in conjunction with a meeting of the AVMA with the Center for Veterinary Biologics (CVB) of the United States Department of Agriculture, the Council heard summary presentations from representatives for other species groups, who provided feedback on current usage of vaccines in each species. The CVB reviewed the licensing process for vaccines, including initial prelicensing testing, licensing requirements, ongoing serial batch testing, and monitoring for adverse events. Legal concerns were also heard on the use of vaccines with regard to liability issues.

In February 2000, the Council expects to meet with other experts on vaccines and hear more presentations. A practitioner workshop is slated for July 2000 at the Annual Meeting of the AVMA in Salt Lake City, whereby veterinarians in practice can hear from the AVMA and provide input to the process. Following this exhaustive review, the Council will provide a recommendation to the AVMA for new guidelines to be considered by 2001.

The intent is that the CVMA and the AVMA will provide similar useful directions and guidelines for vaccine use, simultaneously, and thereby provide a common approach to this issue. The CVMA and AVMA will not be releasing summary information from the meetings until all consultation has concluded, in order to avoid any premature recommendations.

The COBTA has asked the CVB to remove the label recommendation for annual revaccination for vaccines while the consultations are ongoing, unless the scientific basis of the recommendation has been established. Most vaccines are challenge studied within weeks of the vaccination, not a year later.

The CVMA is interested in putting forward a similar request to the Veterinary Biologics and Biotechnology Section (VBBS) of the Canadian Food Inspection Agency (CFIA). The CFIA has acknowledged that the annual revaccination recommendation carries no legal weight, that it is only a recommendation. As with vaccines in the United States, it is an arbitrary extent of time for vaccination usage. By removing the label recommendation, practitioners will still be able to vaccinate annually, if they so desire; annual revaccination is still an acceptable guideline for most vaccines. The decision is fully in the hands of the veterinarian. Should vaccines prove to have longer or shorter durations of immunity, the practitioner will be able to adopt a guideline that reflects the current knowledge. For example, it is widely thought that many canine vaccines do not provide a year’s duration of immunity against bordetellosis, despite the recommendation for annual revaccination. Practitioners may want to vaccinate more frequently, when indicated, without the imposition of the label recommendation.

Removal of the label recommendation also allows for more general vaccination guidelines to be developed by the profession, not by government. In human medicine, for example, vaccines do not carry revaccination recommendations; these are developed by the profession. Arguably, for those practitioners who feel, for whatever reasons, that annual revaccination will continue to be necessary for most vaccines, the removal of the label recommendation for revaccination can be seen as the "thin edge of the wedge" for changing guidelines.

The 2^nd issue that the CVMA is investigating is the reporting of adverse reactions. It has been widely acknowledged that our ability to monitor adverse reactions to vaccines is limited by the reporting process available. Unlike in the United States, in Canada, any manufacturer is obligated to provide any and all reports of adverse reactions to the regulatory body. While manufacturers will usually reply to veterinarians who have made adverse reaction submissions, there is no mechanism in Canada for the profession to routinely access adverse reaction reports as a whole. In the United States, the AVMA has endorsed and promotes reporting of adverse reactions to a third party, nonprofit organization, namely, the US Pharmocopeia (USP). Founded in 1820, the USP’s primary function is to set standards for drugs and related technologies; it is funded primarily through the sale of reference standards and standards publications. Although most of the USP’s activities are in the human field, since 1994, the organization has developed a Veterinary Practitioners’ Reporting (VPR) Program, in cooperation with the AVMA.

The advantage of the VPR Program is that one needs to submit only one standardized form for any adverse reaction to drugs or biologics. The USP will alert the regulatory agency, the manufacturer, and the AVMA, and the information is captured on the VPR database for future queries and is accessible by the profession. Where trends or significant occurrences are noticed from collected reports, the VPR program will notify both the regulatory body and the AVMA.

In Canada, the regulatory body cannot provide similar information to the CVMA for a number of reasons. Therefore, as a profession, we are limited in our knowledge of types and incidence of adverse reactions attributed to the vaccines we use. As reporting adverse reactions has been identified as a key component of any vaccination guidelines or program, the CVMA National Issues Committee is exploring the benefits of using a program in Canada, similar to the VPR program. Under this program, reports received from Canadian veterinarians would be forwarded to the regulatory agency, the VBBS, and the appropriate Canadian biologic companies. As with the AVMA, the CVMA could also receive individual reports or reports of trends and significant occurrences. The VBBS, for its part, is also interested in this arrangement.

The National Issues Committee would like to hear from practitioners on these 2 issues, in particular, or on vaccination guidelines, in general. A survey questionnaire has been developed to assess practitioners’ support for vaccine label changes, but comments, questions and letters to the Journal on any aspect of this report are welcomed.

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