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   APHIS Rabies Vaccine Issue


It is sometimes heard that the rabies vaccine is ineffective in wolves and wolf/dog crosses. Such claims are usually made by those who disapprove of wolfdogs as companion animals, or local government overreaching attempts to make private ownership illegal. While the canine rabies vaccine is not officially 'approved' for wolves and wolfdogs, it is widely recognized to be effective in both wolves and wolf/dog crosses.

In 1993, taxonomists reclassified domestic dogs. Formerly known as Canis familiaris, domestic dogs are now recognized as a subspecies of wolf, Canis lupus. The reclassification is documented in 'Mammal Species of the World, A Taxonomic and Geographic Reference', the standard for mammalian taxonomy.

Based upon the reclassification, the US Animal and Plant Health Inspection Service (APHIS), which regulates vaccine protocol in all animals, was petitioned to recognize the rabies vaccine approved for dogs as being effective for both wolves and wolfdog crosses. A proposed rule to amend the Virus-Serum-Toxin Act regulation by adding a definition of the term 'dog' to include all members of the species Canis familiaris, Canis lupus, or any dog-wolf cross was attempted in September 1999. The following observations and conclusions regarding the efficacy of the rabies vaccine in wolfdogs were published by APHIS and documented in the proposed rule change, and can be read in the Federal Register Volume 64, Number 187, Page 52247-52248, September 28, 1999. Highlights from the proposed rule change follow:

"The fact that wolves and dog-wolf crosses share the same environment with dogs and have similar exposure to disease agents with ample evidence of protection against those diseases for which the animals were vaccinated provide strong evidence that wolves and dog-wolf crosses respond to canine vaccines in a manner similar to dogs."

"the lack of reported adverse reactions after vaccination provides strong epidemiological evidence that wolves and dog-wolf crosses respond to canine vaccines in a manner similar to dogs. In addition, manufacturers of canine vaccines acknowledge that their products have been used extensively in wolves and dog-wolf crosses with no reported adverse reactions."

"APHIS believes that dogs, wolves, and any dog-wolf cross can be safely and effectively vaccinated with canine vaccines. Therefore, we are proposing to add a definition of dog to 9 CFR part 101 to include all members of the species Canis familiaris, Canis lupus, or any dog-wolf cross. This would allow canine vaccines recommended for use in dogs to be recommended for use in wolves and any dog-wolf cross."

The following excerpt was provided by Faye E. Sorhage, the New Jersey State Public Health Veterinarian overseeing the New Jersey Rabies Control Program at the time. In correspondence dated October 2009, with regard to local officials concerned about wolfdogs being kept by a resident in Hunterdon County, New Jersey, Dr. Sorhage replied:

"it is my professional evaluation that rabies vaccines licensed for use in dogs are highly likely to be efficacious in wolf dog hybrids, and I am in support of vaccinating them with such vaccines to protect both the animal in question, as well as the public health"

While it is widely acknowledged the current canine rabies vaccine is effective for dogs, wolves and wolfdogs, the outdated APHIS definition of the term "dog" does not include wolves or wolf-dog crosses. Consequently wolfdogs in many areas of the country are outlawed or euthanized due to the mistaken belief they cannot be effectively vaccinated for rabies (ignoring the fact veterinarians, zoos and wildlife sanctuaries have been vaccinating these animals for decades, with no incidence of rabies).

The following documents were provided by APHIS to Howling Woods Farm upon making a request under the "'Freedom of Information Act" in 2002. These testimonials and decision documents are from APHIS, State veterinarians in New Jersey, Alabama & Oregon, 15 local veterinarians, academic scientists, attorneys, wolf rescue organizations, individuals, and a vaccine manufacturer, all of whom advocate the effectiveness of the canine rabies vaccine for wolves and wolfdogs. APHIS itself has acknowledged that while not approved 'on-label', the rabies vaccine is effective for wolves and wolfdogs.

These documents may prove useful to anyone who owns wolfdog and is challenged by their veterinarian or local animal control regarding the effectiveness of the rabies vaccine. Also see additional information provided regarding APHIS vaccine development protocols and the APHIS rulemaking processes.

Faye E. Sorhage, New Jersey State Public Health Veterinarian Oct 5, 2009

Donna M. Gatewood, DVM, MS, Section Leader, Virology, USDA/APHIS/VS/CVB

United States Wolf Refuge, ArizonaAmerican Animal Hospital Association, Colorado

Andrew Clark, State Veterinarian, Oregon

William Johnson, State Veterinarian, Alabama

Fort Dodge Animal Health, Iowa

N.E. Federoff, Wildlife Biologist, Virginia

Diane Delbridge, DVM, Oklahoma

William Ridenour, DVM, West Virginia

Lorri Stewart, DVM, Michigan

Jan Yerk, DVM, Indiana

K. Patrick Rains, DVM, California

Jim Cole, DVM, Elise Elliot, DVM, New Mexico

Dorothy Prendergast, Wildlife Education and Research Foundation, New Mexico

Dr. Stephanie Porter, University of Colorado Health Sciences Center, Colorado

I. Lehr Brisbin, Senior Ecologist, University of Georgia, Savannah River Ecology Laboratory, Georgia

Debbie Thurman-Beznal, Texas

Martha Eaton, DMV, California

Ronald T. West, Attorney, Alaska

Jan Noda, New Mexico

Michael Siegle, Ph.D., New Mexico

Lynn D. Andrade, MedCon LLC, Arizona

Ken Podkonjak, DVM, New Mexico

The Humane Society of the United States, Washington, DC

David LaFever, DVM, Kentucky


Additional Information regarding APHIS rule making procedures and vaccine development protocols

The Proposed Rule (Federal Register: September 28, 1999 (Volume 64, Number 187)] Page 52247-52248)

The Proposed Rule Withdrawal (Federal Register: April 18, 2001 (Volume 66, Number 75)] Page 19899-19990)l

Rule Withdrawal Office Copy with Handwritten Notes

Rule Withdrawal Worksheet

Rulemaking in APHIS an Overview

Rule Development and Clearance Process

Virus-Serum-Toxin Act

General Licensing Considerations Efficacy Studies

Functions Assigned to Regulatory Analysis and Development

113.209 Rabies Vaccine

Rabies Vaccine Immunogenicity Test Protocols

Production Outline for Vaccines, Bacterins, Antigens & Toxoids

Supplemental Assay Method for Potency Testing

Alternative Safety Testing - Oral Antibody Products


From: Donna.M.Gatewood@aphis.usda.gov
Sent: Thursday, June 10, 2010 10:02 AM
To: Xss@xxxxxxxxxx.com
Subject: Fw: Question from Ask the Expert-- Veterinary - 1275422414050

This query was forwarded to me for response in my capacity as the Section Leader for Virology at the USDA's Center for Veterinary Biologics (CVB).  The CVB is the regulatory authority for licensing and labeling of veterinary vaccines, diagnostic kits, and other biological products.  

The USDA approves label claims based on scientific data submitted by the regulated industry.  Our regulations require that rabies products be shown to be effective in each species for which there is a label claim.  No rabies vaccine manufacturers to date have conducted studies to support the use of rabies products in wolves or wolf-dog hybrids.  

In those states which have specific legislation declaring wolf-dog hybrids to be the same species as domestic dogs, the use of rabies vaccines in wolf-dog hybrids would be considered to be in accordance with the label claims if the product is licensed for use in dogs.  However, some states consider dogs and wolves to be distinct species, and consider the use of rabies vaccines in wolves and wolf-dog hybrids to be "off-label" use.  Depending upon state and local statutes, such animals may be considered to be unvaccinated in the event that the animal bites 1) bites a human or 2) is exposed to a rabid or suspected-rabid animal.  The USDA does not have jurisdiction over such matters.

Part of the reason behind state differences is the fact that there is general disagreement among taxonomists with regard to the taxonomic classification of wolves and dogs.  Some taxonomy experts consider domestic dogs to be a subspecies of wolves, while others consider them to be distinct species within the same genus.  Again, the USDA does not have jurisdiction over such matters.  

Please feel free to contact me if you have further questions.  


Donna M. Gatewood, DVM, MS
Section Leader, Virology
Policy, Evaluation, and Licensing
1920 Dayton Avenue
Ames, IA  50010
(515) 337-6150
Mail Stop: 2N005


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