Professional Documents
Culture Documents
2006 AAHA
Canine Vaccine Guidelines, Revised
In 2005, AAHAs Canine Vaccine Task Force met to re-examine and revise guidelines on the use of
vaccines in dogs. The results of the Task Forces work are summarized and tabulated in this article and
are published in their entirety on the AAHA website (www.aahanet.org). The 2006 AAHA Canine Vac-
cine Guidelines contain information on new technological developments in vaccines, an introduction
to conditionally licensed vaccines, and detailed recommendations on the use of available vaccines.
Perhaps the most noteworthy addition to the guidelines is a separate set of recommendations created
for shelter facilities. Vaccines are classified as core (universally recommended), noncore (optional), or
not recommended. The Task Force recognizes that vaccination decisions must always be made on an
individual basis, based on risk and lifestyle factors.
Report of the American
Animal Hospital Association (AAHA)
Canine Vaccine Task Force:
Michael A. Paul, DVM
Chairperson
Leland E. Carmichael, DVM, PhD
Diplomate ACVM
Henry Childers, DVM
Diplomate ABVP
Susan Cotter, DVM
Diplomate ACVIM
Autumn Davidson, DVM
Diplomate ACVIM
Richard Ford, DVM
Diplomate ACVIM
Kate F. Hurley, DVM, MPVM
James A. Roth, DVM, PhD
Diplomate ACVM
Ronald D. Schultz, PhD
Diplomate ACVM
Eileen Thacker, DVM
Diplomate ACVM
Link Welborn, DVM
Diplomate ABVP
Executive Summary
Since the publication of the AAHA Canine Vaccine Guidelines in 2003,
the profession and the biologics industry have moved in the direction
advocated in that document by the Canine Vaccine Task Force. The pro-
fession has witnessed no negative medical ramifications to the recom-
mendations issued by the Task Force, several well-documented studies
have demonstrated the extended duration of immunity (DOI) and sup-
ported the extended vaccine intervals advocated by the guidelines, and
the industry has responded in the main by supporting the use of products
with extended DOI protocols. While a number of rabies vaccines have
long been available as licensed for 3 years by the US Department of
Agriculture (USDA), vaccines against other infectious diseases of dogs
have generally been licensed as 1-year vaccines. At least one manufac-
turer has been successful in obtaining a 3-year license from the USDA
Center for Veterinary Biologics (USDA/CVB).
This document was developed by the American Animal Hospital Association
through a collaborative effort among Task Force members to aid practi-
tioners in making decisions about appropriate care of their canine patients
with respect to currently available vaccines. The Task Force included experts
in immunology, infectious diseases, internal medicine, and medicine and
clinical practice.
The guidelines are supported by professional, scientific and clinical evi-
dence, as well as published and unpublished documentation.
These guidelines and recommendations should not be construed as dictat-
ing an exclusive protocol, course of treatment, or procedure. Variations in
practice may be warranted based on the needs of the individual patient,
resources, and limitations unique to each individual practice setting. The
guidelines are not intended to be an AAHA standard of care.
The guidelines were revised February 2007 to update new information about
parvovirus and distemper vaccination.
2 2006 AAHA Canine Vaccine Guidelines, Revised
In early 2005, the Canine Vaccine Guidelines Task Force
was reconvened with the charge of updating the guidelines
and developing a plan to simplify the revision process and
make it more responsive to the emergence of new vaccines
and developments. To that end, the guidelines will be pub-
lished in their entirety electronically on the AAHA web site
(www.aahanet.org), where they can be readily accessed by
the profession.
The Task Force recognizes that individual readers will
find some sections of immediate interest and others of back-
ground interest. However, practitioners are urged to read the
entire document for reference, with special attention to cer-
tain key sections that have been revised and new sections
that have been added.
Revised sections include those addressing the vaccine
licensing process and the medical and legal implications of
vaccine medicine. Because serologic interpretation in con-
junction with or in lieu of vaccination is of major interest to
the profession, the section addressing serologic testing has
been expanded. The question is not the validity of serology
but the application and indication for serologic testing.
A key section of the 2003 guidelines focused on vaccine
adverse events and emphasized the importance of reporting
adverse events to the appropriate agency. A vaccine adverse
event is any undesirable or unintended outcome (including
failure to achieve the desired result) that occurs in conjunc-
tion with vaccine administration. The section on vaccine
adverse events has been updated to reflect recent develop-
ments in reporting procedures. The Task Force reiterates its
recommendation that practitioners take the time to docu-
ment and report all adverse events. As changes in protocols
are adopted and innovative vaccines and vaccine technolo-
gies gain ground, such vigilance is even more essential.
Included in the 2006 guidelines is a section highlighting
the science of vaccine development, specifically such tech-
nologies as live vectored, subunit, gene-deleted, and deoxy-
ribonucleic acid vaccines. In adding this material, the Task
Forces intent is to introduce its audience to new concepts
and future technologies and to stimulate awareness of where
the science of vaccine development is headed.
The Task Force has also introduced the subject of con-
ditionally licensed vaccines in one of the several tables
included in this update. These vaccines have demonstrated
safety and purity and in preliminary studies have demon-
strated a reasonable expectation of efficacy. Though only
granted conditional licenses by the USDA/CVB, these prod-
ucts may have definite indications in individual animals and
bear consideration in selected animals.
Another notable addition to these updated guidelines is a
section devoted to shelter medicine. The impetus for separate
shelter vaccination guidelines was the Task Forces recogni-
tion that this rapidly developing area of veterinary practice
faces unique challenges. What best serves a clinical com-
panion animal practice may not be ideal in an environment
housing an ever-changing population. This section discusses
some of the special considerations and issues confronting
shelter medicine and provides tables listing vaccines that
are recommended, optional, and not recommended for the
shelter environment.
For many readers, a highlight of the 2006 guidelines will
be the recommendations for selecting appropriate vaccines to
be administered to the individual patient. The vaccine type,
optimal time of administration for puppies and adult dogs,
and general comments are compiled in an easy-to-use table
within the main guidelines. Vaccines are now categorized as
core, noncore (or optional), and not recommended. Core vac-
cines are those that all dogs should receive in one form or
other. Optional vaccines should be administered selectively,
based on the animals geographic and lifestyle exposure and
an assessment of risk/benefit ratios. The table does not men-
tion specific products or manufacturers; it is the position of
the Task Force that all major manufacturers produce quality
canine vaccines and that these decisions are best left to the
clinician.
Even in their revised and updated form, the 2006 guide-
lines reflect the same underlying principles that imbued the
2003 edition:
Vaccination is a medical decision and a medical proce-
dure that should be individualized based on the risk and
lifestyle of the individual animal.
An extended vaccine interval is reasonable, safe, and
effective in preventing most infectious diseases.
Veterinary medicine must remain vigilant of emerging
diseases, changes in incidence of known diseases, and
adverse events associated with vaccine administration.
It is incumbent on veterinarians to proactively report
adverse events.
Decisions surrounding vaccination of client-owned pets
should include a discussion with clients and always be
fully documented in the medical record.
Introduction
In 2003, the AAHA Canine Vaccine Task Force released
its first set of guidelines specifically addressing canine
vaccination.
1
The 2003 guidelines advocated a number of
changes in the then generally accepted vaccine protocols of
most practices. The guidelines undertook to increase aware-
ness of the complexities involved in the development and
licensing of a biologic product and emphasized the need for
vigilance and the reporting of adverse events to appropriate
agencies or the manufacturer.
Immunization was categorized as a medical procedure
with definite benefits and risks, and one that should be
undertaken only with individualization of vaccine choices
and after input from the client. The guidelines specifically
recommended that some vaccines be given to all dogs, some
be given to a more select population, and some generally not
be used because of a lack of demonstrated efficacy or indi-
cation of unacceptable risk of side effects. Additionally, the
guidelines advocated for an extended interval between adult
revaccination and stated that under typical conditions, pro-
tective revaccination intervals for the major viral diseases of
normal adult dogs could safely be extended to 3 years.
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10 2006 AAHA Canine Vaccine Guidelines, Revised
modified live (attenuated) bacteria or viruses. Advances in
immunology, molecular biology, genetics, microbiology,
and the understanding of disease pathogenesis have resulted
in innovative approaches to developing vaccines. Examples
include live vectored vaccines and subunit vaccines, which are
currently on the market. Other new approaches are also being
investigated, including gene-deleted vaccines and vaccines
that consist of only nucleic acid.
6
In addition, new adjuvants
are being developed and tested. Adjuvants are chemicals,
microbial components, or mammalian proteins that enhance
the immune response to vaccine antigens.
7
New-generation
adjuvants may be used to induce specific types of immunity or
reduce vaccine-related adverse effects. The goal of these new
vaccine technologies is to produce safer and more efficacious
vaccines against both diseases for which vaccines are already
available and diseases for which the conventional approach to
developing vaccines has not been successful.
Live Vectored Vaccines
Live vectored vaccines are based on known protective
antigens of an organism. The genes associated with those
antigens are inserted into another organismtypically a
virusthat then expresses the antigenic proteins upon infec-
tion of the host. The expressed proteins are then capable of
inducing an immune response. Currently there is a live vec-
tored canine distemper vaccine, in which the hemagglutinin
and fusion genes have been inserted into a canarypox virus.
8
When injected into a dog, the canarypox virus infects canine
cells and expresses the hemagglutinin and fusion proteins
intracellularly but does not replicate. Thus, humoral and T-
cell-mediated immune responses similar to those induced by
a modified live vaccine should occur. Another advantage to
this type of vaccine is there is no opportunity for the virus to
revert to virulence or to be virulent in an immunosuppressed
animal because the vaccine consists only of genes from
canine distemper, not the entire virus genome.
A potential advantage of live vectored vaccines is their
ability to overcome inactivation by maternal antibodies.
Maternal antibodies may prevent effective humoral and/or T-
cell-mediated immune responses from occurring in response
to conventional vaccines. The live vector carrying the genes
may be able to induce protective immunity prior to the loss of
maternal antibody protection. Potentially, diagnostic assays
can be developed against inserted marker genes or antigens
not found in the live vectored vaccine, allowing differentia-
tion between natural infection and vaccine-induced immune
responses.
Subunit Vaccines
Subunit vaccines contain a portion of the organism. As with
vectored vaccines, subunit vaccines require information on
the protective antigens of the infectious agents. Currently
there is a subunit vaccine to an outer surface membrane pro-
tein, OspA, of Borrelia burgdorferi. Use of only the por-
tion of the organism needed to induce a protective immune
response precludes the necessity of using the entire organ-
ism. A study of dogs in a Lyme disease-endemic area found
reduced infection rates in dogs vaccinated with OspA, com-
pared with dogs not vaccinated with the protein.
9
In order
to produce efficacious subunit vaccines, the protective anti-
gens must be identified and purified or, similar to a vectored
vaccine, the genes for the antigens can be inserted into an
expression system and the proteins produced in the labora-
tory for injection into the host.
An important advantage of subunit vaccines is the reduced
levels of antigen required for immune stimulation due to the
elimination of irrelevant antigens. Furthermore, large amounts
of purified proteins can be produced for use in subunit vac-
cines, which can make the vaccines cost-efficient. However,
for many diseases, more than one protein is required for pro-
tection against disease and the proteins are very specific;
therefore, subunit vaccines often dont provide the necessary
cross-protection because they induce an immune response
to only the proteins contained in the vaccine. In addition,
since the vaccine consists of a purified protein, no replication
occurs within the host; thus, minimal T-cell activation occurs
unless potent adjuvants are used.
Gene-Deleted Vaccines
Gene-deleted vaccines are produced from organisms that
have been altered to either delete or inactivate a gene.
10
The
gene selected for deletion cant be responsible for proteins
required for immune protection against disease. Gene-
deleted vaccines can be generated for either live or killed
vaccines. Gene deletion can be a mechanism by which
organisms are attenuated and may occur naturally over time
under laboratory conditions. Gene-deleted vaccines have
been used successfully as marker vaccines in some (but not
all) eradication programs. Some vaccinated animals can be
differentiated from naturally infected animals by the pres-
ence of antibodies to the protein expressed from the deleted
gene. Currently no gene-deleted vaccines are available for
use in dogs.
Deoxyribonucleic Acid Vaccines
Deoxyribonucleic acid (DNA) vaccines are strands of DNA
coding for the genes for protective antigens.
11
The genes are
inserted into bacterial plasmids (circular pieces of DNA)
and placed in their bacterial hosts where they replicate. The
plasmid DNA is purified from the bacteria and can then
be directly administered into hosts. A number of different
mechanisms for administering the vaccines have been used
including gene guns with DNA on gold microbeads, needle
injection into the muscle with or without liposomes, and
transdermally with needle-free bioinjectors. To be effective,
the DNA must enter into the host cells, be transcribed into
messenger ribonucleic acid, and then transcribed into pro-
teins that can be presented to the immune system.
Potential advantages of naked DNA vaccines include
vaccine stability, affordability, potential of overcoming
maternal antibody interference, intracellular synthesis of
protein antigens for presentation to cytotoxic T cells, and
duration of immunity. The first DNA vaccine for use in ani-
mals was recently licensed for protecting horses from West
2006 AAHA Canine Vaccine Guidelines, Revised 11
Nile virus.
12
As of this writing, no DNA-based vaccines have
been approved for use in dogs, but experimental canine DNA
vaccines have been developed for CPV-2 and CDV.
The vaccines described here touch on only a few of the
potential technologies that can and will be used to create bet-
ter and more effective vaccines. The cutting-edge technolo-
gies used to develop vaccines typically have higher research
and development costs. The ability to use these technologies
requires detailed knowledge of the pathogen and the immune
response required for control of infection and/or disease by
each pathogen, further increasing the research costs for the
development of these vaccines. For many organisms, these
factors remain unknown or are poorly understood. The avail-
ability of effective conventional vaccines typically reduces
the incentive to develop improved vaccines unless it can be
shown that these technologies increase the safety of conven-
tional vaccines without loss of efficacy.
Licensing of Vaccine Products
How Are Vaccines Licensed?
i
In order to market a veterinary biological product, a firm
must acquire both a product license and an establishment
license from the USDA Center for Veterinary Biologics
(CVB). To obtain the establishment license, the firm must
establish the appropriateness of the facility for the product
in question as well as the appropriateness of the qualifica-
tions of the personnel involved in developing and producing
the product; in addition, the facility must be inspected by the
CVB. To obtain the product license, a firm must complete
the following steps:
Submit an application that includes an Outline of Pro-
duction, which is a detailed analysis of the proposed
production. Once the Outline of Production has been
approved, the firm cannot deviate from it without CVB
permission.
Identify the labeling to be used with the product,
which must be reviewed against data submitted to and
approved by the CVB.
Provide supporting data, including data from field stud-
ies and studies to support efficacy and safety. Prior to the
initiation of the studies, the CVB reviews and approves
protocols to ensure quality of design and acceptability
of the data generated. The applicant firm must demon-
strate to the satisfaction of the CVB that the proposed
product is pure, safe, potent, and efficacious.
Provide three or more consecutive prelicensure serials
for testing by the CVB. A serial is an identifiable, homo-
geneous quantity of the completed commercial product
(i.e., it may be a blend of several production batches
and/or antigen components). Each of these prelicen-
sure serials must be produced according to the Outline
of Production from separate batches of medium, cells,
production serum, and other applicable production
components. The purpose is to demonstrate commercial
consistency of production.
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3.
4.
Once the product and establishment are licensed, samples
from each serial must be sent to the CVB, along with results
of the firms testing of it. The serial cannot be released for
commercial sale until the firm is notified by the CVB.
What Is Required of a Vaccine Prior to Licensure?
Purity: Purity is the quality of a biological product (in
its final form) that assures the product is free of extrane-
ous microorganisms and extraneous material (organic or
inorganic) that can adversely affect safety, potency, or effi-
cacy.
13
All product components and ingredients must meet
standards of purity and quality. Master seed, master cell
stock, primary cells, ingredients of animal origin, and final
products must be tested and shown to be free of extraneous
microorganisms. If eggs are used in production of biological
products, they must be acquired from flocks free of specific
pathogens. Purity and identification of master seed and mas-
ter cell stocks are confirmed by testing at the CVB Labora-
tory in Ames, Iowa.
In addition to testing of the first serials (batches of com-
pleted product) prepared under license, a random sample of
serials is subjected to prerelease purity testing at the CVB
Laboratory to verify the manufacturers quality assurance/
quality control on the final product. This testing assures
to a reasonable level of confidence that all components of
biological products are correctly identified and free of con-
taminating agents (pathogenic or not). The exact specifica-
tions of the testing performed depend to a great extent on the
nature of the antigen or microorganism.
Safety: Safety in a vaccine is defined as freedom from
properties causing undue local or systemic reactions when
the vaccine is used as recommended or suggested by the
manufacturer.
14
As with purity, safety testing begins with
evaluation of the master seed and concludes with testing
of each serial prior to release. All master seeds and master
cell stocks must be fully identified and characterized. Pro-
duction passage levels (limits) beyond the master seed/cell
stocks are established.
For modified live products, the master seed is evaluated
to ensure that it does not revert to a virulent state. This is
accomplished by administration and recovery of the vac-
cine strain in susceptible dogs through several passages
and observation of characteristic clinical signs. This test is
designed to detect the potential for reversion to virulence of
an attenuated product. The ability of a modified live product
to be shed and spread among animals is also evaluated.
Field safety studies are performed in which the final
product (at the titer, dose, and route of administration for
the commercially released product) is administered to a
minimum of 600 animals, of which at least one third must
be at the minimum age indicated for administration. The
field safety studies are designed to detect relatively frequent
safety issues. Relatively rare safety issues will be detected
by postmarketing surveillance.
Additionally, each serial of product released to the mar-
ket is tested for safety. For modified live products, the tests
involve laboratory animal testing as well as the administration
12 2006 AAHA Canine Vaccine Guidelines, Revised
of a 10 dose to two animals of the target species followed by
observation for 14 days. For inactivated products, laboratory
safety tests are performed to confirm inactivation.
Potency: Potency is the relative strength of a biological
product as determined by test methods or procedures estab-
lished by the CVB or in the approved Outline of Production
for a product.
15
The purpose of potency testing is to assure
that each serial of vaccine produced is equal to or more
potent than a reference serial (equal to or more antigen than
a reference) or the minimum antigenic content as specified
through licensure. Potency tests correlated to host animal
vaccination and designed to measure the relative strength
of each serial must be developed prior to licensure. In addi-
tion, each serial is formulated and tested prior to market-
ing to ensure effectiveness and reproducibility of activity
(potency) according to standards set at the time of licens-
ing. Generally, this is accomplished through established
laboratory animal or in vitro minimum potency levels using
microbiological counts or virus titrations. However, the type
of potency assay used can be both product (antigen)-specific
and firm-specific. Standard potency assay requirements for
some established canine antigens can be found in the Code
of Federal Regulations.
16
As standard assays are developed
for emerging antigens, the procedures should become avail-
able from the CVB.
Because of the heterogeneity of antigens required to pro-
tect the health of canine patients, a multitude of potency assay
formats exist. These include laboratory animal-based in vivo
tests, target animal-based in vivo tests, and in vitro tests.
Regardless of the format, all potency assays must be approved
by the CVB and correlated to efficacy. Making the reference
vaccine a serial that was used to demonstrate efficacy gener-
ally allows a firm to make this correlation. This system of
potency testing assures that each serial produced contains
a minimum amount of antigen; however, no upper limits to
antigen content currently exist. This oversight should be given
further consideration because an excessive amount of antigen
could result in both safety and efficacy concerns.
Efficacy: The efficacy of a biological product is the spe-
cific ability or capacity of the product to effect the result for
which it is offered when the product is used under the condi-
tions recommended by the manufacturer.
17
In other words,
efficacy is generally thought of as the ability of the product
to stimulate the immune response required to provide pro-
tection from challenge (i.e., protective immunity). In con-
trast, immunogenicity is the ability of a product to elicit an
immune response whether or not the response is correlated
to protection.
All products must be shown to be effective according to
the indication on the label. Efficacy and product immuno-
genicity are almost always demonstrated by statistically
valid host animal vaccination-challenge studies. In some cir-
cumstances, where serology is well correlated to protection,
serology may be used to demonstrate efficacy. However, in
todays regulatory climate, it is difficult to license a prod-
uct using serology alone to establish efficacy. The following
general considerations are applied to efficacy studies:
Immunogenicity studies must be conducted using mini-
mum levels of antigen at the highest passage level from
the master seed that is permitted for production.
The product must be prepared in production facilities
on a scale representative of normal production.
Although challenge methods and criteria for evaluating
protection will vary with the immunizing agent, tests
are generally conducted under controlled conditions
using seronegative animals of the youngest age recom-
mended on the label.
Duration of immunity data demonstrate efcacy to a
specied date after vaccination, which could be 1 year,
3 years, or another time interval. The DOI data are re-
quired for only one existing productthe rabies vaccine.
In the future, however, the minimum DOI must be dem-
onstrated for all newly licensed antigens.
Data are required for each species for which the product
is recommended and for each route, dose, and regimen
of administration.
For products with two or more fractions (components),
data are required demonstrating that there is no interfer-
ence among antigens in eliciting a protective response.
Stability studies are required to set the expiration date
on the label.
Relevance: The clinical relevance of products is con-
sidered in the licensure process. The CVB will not issue
licenses for products it believes are not warranted or clini-
cally relevant. However, the CVB determination may or may
not meet with general agreement within the profession or
among experts. The decision to bring a vaccine to market is
made by the manufacturer on the basis of perceived need,
market, and relevance of the agent involved. Determining
which products, among all of those approved, are appropri-
ate for any individual patient should be based on careful
consideration of the risk of infection, the severity of disease,
and the efficacy of the products available. As with all medi-
cal care decisions, the client/owner should be included in
these determinations.
How to Evaluate and Interpret a Vaccine Label
Labeling and Claims: Labeling is defined as the totality of
the written, printed, or graphic material accompanying the
final product container as it is sold in the marketplace. The
labeling conveys important information about the product.
The labeling and all the information conveyed therein must
be approved by the CVB before use by a manufacturer.
What is considered a label claim is sometimes a source
of confusion. This is understandable because the term is not
an administrative term that has been defined by the CVB,
and different people use it to convey various meanings. How-
ever, the CVB considers anything contained in the product
labeling to be a claim for the product. Therefore, regardless
of whether the information pertains to an indication, storage
requirements, or duration of immunity, if it is contained in
the labeling, it is a claim.
Proposed Labeling Policy Revision: The CVB has indi-
cated it is developing sweeping changes in the content and
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*
M
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.
24 2006 AAHA Canine Vaccine Guidelines, Revised
Vaccines NOT Recommended
for the Shelter Environment
In the opinion of the Task Force, several vaccines licensed for
use in the United States are not indicated for dogs residing in
an animal shelter. In addition to representing an unnecessary
expense, the vaccines listed in this category are for diseases
that do not represent a significant threat to the population of
dogs residing in shelters, have limited efficacy against clini-
cal disease, and/or may represent potential harm or injury to
the individual dog. The vaccines not recommended for shel-
ter use are listed in Table 5.
Vaccination Recommendations for Specific Cases
in the Shelter Environment
Dogs With a Documented Vaccination History
at Time of Admission
There is no compelling reason to administer vaccines to an
individual dog at the time of admission to a shelter if clear
documentation of vaccination is provided. The following is
the minimum information acceptable as documenting proof
that a valid vaccination has been administered:
proprietary name of product,
manufacturer name,
serial/lot number,
date vaccine was administered (at least month and
year),
expiration date of vaccine administered, and
signature of a licensed veterinarian.
This information should be associated with a medical
record that clearly describes the dog in question. If any of
this information is not available at the time of admission or
cannot be associated with a formal record for the dog, then
immediate vaccination is indicated.
Dogs Held Long Term in Shelters
Historically, shelters have been thought of as short-term hold-
ing facilities for animals. However, as the number of dogs
entering shelters has decreased in recent years, many shelters
are holding some dogs for extended periods. Whether a dog is
undergoing behavioral or physical rehabilitation, being held
for legal reasons, awaiting adoption, or being held in per-
manent sanctuary, special considerations apply when deter-
mining a vaccination program for these animals. Unique
infection control challenges exist because of the extended
time individual dogs reside in the facility and the increased
opportunity for exposure to infectious pathogens.
Implementing an effective vaccination program for dogs
held on a long-term basis poses significant additional chal-
lenges, both economical and immunological. At this time,
the Task Force recommends that all dogs entering a long-
term care facility (or any dog entering a shelter for which
a long-term stay is anticipated) be inoculated with all rec-
ommended vaccines, plus rabies vaccine, at the time of
admission to the facility. If a dog is routinely exposed to the
outdoors, then optional vaccines should be considered (as
for pet animals), depending on the dogs risk profile.