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In the Toronto Small Claims Court

Cour des petites creances Toronto ,


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Dr. Jean Dodd's Response to Defendant
Expert Opinion Report prepared by
Dr. Dana Gray Allen
11-126218
Nina Penteado
v
Rosedale Animal Hospital
Ontario Veterinary Group (2004) Inc.
Greater Toronto Veterinary Professional Corporation
Toronto Small Claims Court/Sheppard - Clerk: Please file with materials filed by
Plaintiff
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January 7, 2013
Mr. Frank Caruso
Kerzner, MacDermid, McKillop
200 University A venue, Suite 1000
Toronto, ON M5H 3C6
Fax:416-628-8118
Tel: 416-628-8100
VIA FAX and MAIL
Dear Mr. Caruso:
Re: Rosedale Animal Hospital, Ontario Veterinary Group (2004) Inc., Greater Toronto Veterinary
Professional Corporation (GTVPC)
Your file: 86792
Court File: 11-126218
I contacted your previous Bay Street address today at Tel: 416-628'-8100 to confirm your 'new' phone
and fax numbers. Bay Street office staff indicated that even though you have moved to 200 University
Avenue since December 19th/12, you have the same phone and fax nun.lbers. I have attempted to fax Dr.
Dodd's response to Dr. Allen's expert opinion report several times, and will continue to do so.
Dr. Jean Dodd's Rebuttal Report:
Attache<! fmd a copy of Dr. Jean Dodd's rebuttal report dated January 7th, 2013 to Dr. Dana Gray Allen's
report you mailed to me November 29th, 2012. This report was available since October 25th, 2012, yet it
appears you waited over a month to serve it on me.
I was out of the country until December 26th, 2012, and did not have the opportunity to prepare a response
prior to this date. It should be noted that Dr. Dodd's also resides in California, and reaching her to prepare
a response as you can time consuming.

I am therefore relying on Rule 3.02(1) and 2.02 of the Rules of Small Claims Court in order to serve the
attached documents on you via fax and mail, and Will file an affidavit of service accordingly.
'Plaintiff- Additional Documents' and 'Plaintiff Book of Authorities':
You were personally served with the following documents on December 28th, 2012 'Plaintiff- Additional
Documents' and 'Plaintiff Book of Authorities' at your new office address at 200 University Avenue
pursuant to Rule 18.02(1) and 8.03(5).
An affidavit of service was filed with Small Claims Court with a signature from staff at 365 Bay Street
confirming you moved office locations as of December 19th, 2012 to 200 University A venue, and that
Michelle Goodman (receptionist) would be able to accept service since you were away on holidays.
1
I also spoke with you on the 28th of December and you indicated Michelle Goodman would be able to
accept the documents in question. Finally, Michelle Goodman endorsed service of the materials at your
200 University A venue office address confirming receipt in writing.
It should be noted that you did not advise me or the courts of your address change as is required under
Rule 8.09(1) of the Rules of Small Claims Court. Your offices were well aware that I was going to be
away until December 26th, 2012.
The following documents have been previously filed and served on you, but I am serving them on you
again via fax today. These documents were attached to Dr. Jean Dodds expert opinion report dated May
5th, 2012 which was served on you April 17th, 2012
i) 'W. Jean Dodds'
ii) 'AAHA Vaccination Protocols for Dogs Predisposed to Vaccine Reactions'
You were also served with the AAHA 2011 Canine Vaccination Guidelines, which was served February
7th, 2012, and on April 17th, 2012. I am not faxing this document to you again. Please see Black Binder
Tab 12 and 'Expert Opinion Medical Report (Dr. Jean Dodds, DVM).
Documents and Reports received by you:
Finally, note that the following documents were served on me to date:
i)
. ii)
iii)
iv)
v)
vi)
vii)
Dec 7th/ll Statement of Defence with attached revised Rosedale Animal Hospital Patient
Chart dated December 6th/11 .
April13th/12 an Affidavit of Service and 9A defence form for the GTVPC (later deemed to
be an insufficient defence on an April 17th/12 Motion Hearing
April 17th/12 a revised Veterinary Emergency Clinic Patient History Report dated November
28th/11 never served previously or seen by Dr. Judy Au my subsequent veterinarian (you were
given an additional extension to file a defence for the GTVPC at the April 17th/11 Motion
Hearing).
May 14th/12 a letter stating you had no intentions of filing a defence for the GTVPC
May 16th/12 a letter stating the GTVPC operates under Rosedale, which is false
May 24th/12 a fresh as amended defence served on me at May 24th/12 at end of Motion
Hearing after you were once again ordered to file a defence for the GTVPC by May 31 st/12
The fresh as amended defence contained another set of changes to Rosedale's Patient Chart
November 29th/12 you mailed Dr. Dana Gray Allen's expert opinion report
You have not filed any other documents including any additional VEC documents, and therefore expect
you will be relying on documents which have been previously filed and served on me between December
7th/11 and November 29th/12.
I have ftled and served all VEC and Rosedale al pita! Charts inclu ther documents, which
have been made available to me- which includes set of 12 VEC X Ray images o my dog Colombo (on
CD disc).
Regards,
Nina Penteado
cc: Clerk/ Small Claims Court- Toronto
HEMOPET /HEMOLIFE
W. Jean Dodds, DVM
938 Stanford Street
Santa Monica, CA 90403
31 0-828-4804; Fax 310-453-5240
www.hemopet.org; hemopet@hotmail.com
Response from Dr. Jean Dodds by E-Mail to Ms. Nina Penteado, January 7, 2013
Dear Nina: I have read over the complete opinion response provided by Dr. Dana Allen
(Professor Emeritus from my alma mater, OVC ). I have excerpted some material to which I
provide a rebuttal:
To begin with, despite the fact that some colleagues believe me to be "anti-vaccine", that is not
the case as exemplified by the introduction to my current teaching handout on vaccine issues,
and other prior publications (copies attached). Modern vaccines have saved countless animals
from suffering diseases and dying. But, I object to the continuing trend within our profession to
over-vaccinate previously immunized animals, and to do so when the animal neither needs a
booster vaccine or is unhealthy at the time. There is plenty of scientific literature available today
to support a more appropriate protocol for vaccinating adult animals that received prior
vaccinations, thereby having been immunized against the prevalent serious infectious diseases
of the species.
In my opinion, the defining questions in this case are:
1) Was Columbo truly healthy at the time he received a DAPP combo booster vaccination with
bordetella plus a rabies booster ? What aging-related or other conditions did he have ?
2) Even if he was judged to be healthy at the time, were these boosters necessary (except for
rabies) at his advanced age, given that he had been consistently given booster vaccines
throughout his adult life? Were vaccine titers offered to the client as an alternative to these
boosters?
3} Was the client informed about the benefits and risks of giving him these vaccines, and did
she provide oral or written Informed Consent ?
4) It is my understanding that the client expressly wanted only a rabies booster as required by
law, and no other vaccines. In that case, there was no Informed Consent for the DAPP
combo booster and bordetla vaccines.
[the cited 2011 AAHA Canine Vaccination Guidelines address these issues.]
As stated by Dr. Allen:
An opinion letter drafted by Dr. Jean Dodds and dated March 5, 2012 states "Furthermore older
animals frequently have ongoing or sub-clinical disease states associated with aging that would
preclude giving booster vaccines, even for rabies.
In my professional opinion, vaccination was unnecessary (DAPP combo + bordetella) and
unwise (rabies) given his age and ill state at the time. Further, beyond a reasonable doubt, this
combination of vaccines likely contributed adversely to his health in that the adverse effects of
giving multiple vaccines to an aging dog with diarrhea and weight loss contributed to the
progression of illness that led to his death II.
Opinions of Dr. Jean Dodds and My Response [Or. Allen]
1) Older animals frequently have ongoing or subclinical disease states associated
with aging that would preclude giving booster vaccines, even for rabies.
RESPONSE from Dr. Allen [Rebuttal from Dr. Dodds, in RED]
"Compared to mice and relatively little is known about the ef;/ct of age on
the immune system of dogs. That is an irrelevant point. Dr. lan Tizard in his classical textbook
"Veterinary lmtnunology'', now in gth edition, Elsevier, and others have clearly defined the
immune system of dogs in detail, and the effect of aging on immune function. No difference in
the concentration of serum lgG was found between young and aged German shepherd dogs.
You wouldn't expect the total concentration of lgG to vary with aging beyond adulthood in
healthy animals, but individual components of specific lgG could certainly vary, depending upon
the immunological exposure history of thE? individual dog over time. BUT, this has no bearing
whatsoever on the higher risk of older animals with their increased likelihood of aging conditions
to react adversely to the mixture of antigens. tissue culture remnants. adjuvants and other
immune stimulating components contained within one let alone with several vaccines given
simultaneously. In dogs of various bre.eds, 32 young and 33 old dogs were vaccinated against
distemper, parvovirus and rabies.
No differences in. post-vaccination lite.rs against any of the viruses between old and
young dogs were noted. That's also off point - older animals, whether -given boosters or not,
likely encounter these native viruses in the environment. Titers reflect the combined effect of
vaccination boosters plus natural exposure. Again, the difference, if any, in titers does not
preclude or portend a potential vaccinal event in an older animal.
From: Greene CE, Schultz. lmmunoprophylaxis. In: Infectious Diseases of the Dog
and Cat. 3rd edition. Greene CE, ed, page 1087. Saunders Elsevier publishers
2) In my professional opinion vaccination was unnecessary (DHPP combo+
bordetella) and unwise (rabies) given his age and ill state at the time. Further,
beyond a reasonable doubt, this combination of vaccines likely contributed
adversely to his health.
RESPONSE from Dr. Allen [Rebuttal from Dr. Dodds, in RED]
.. Despite claims of many anti-vaccination advocates, epidemiologic analysis does not
show a correlation between vaccination within the last 3 months and ill health in
dogs". However, that is not the same thing as stating that dogs vaccinated regularly throughout
life, need more boosters when they become geriatric, or, that once geriatric, adverse events do
not occur in individual cases when a series of vaccines is given simultaneously.
From. Edwards OS, Henley WE, Ely ER, et al. 2004. Vaccination and ill-health in
dogs: a lack of temporal association and evidence of equivalence. Vaccine 22(25-
26):3270-3273.
3) After the vaccination Colombo's diarrhea continued and he progressed to being
lethargic, having excessive, thick gelatinous drool, fatigue, and decreased
mobility. About 5 weeks after receiving the booster vaccine combo + rabies he
became blind.
RESPONSE from Dr. Allen [Rebuttal from Dr. Dodds, in RED]
"Middle-aged and old dogs of any breed can be affected by sudden acute retinal
degeneration. This is true, although there clearly was a temporal relationship between the
multiple vaccines given to Columbo and the onset of these signs of illness and subsequent
blindness. The presenting complaint is loss of vision with complete blindness
occurring over a period of hours to weeks and often overnight. Many affected dogs
have concurrent polyuria, polydipsia, weight gain and lethargy. Biochemical findings
may be typical of hyperadrenocorticism. But, as stated from the physical examinations and
laboratory tests performed in the time frame of his vaccinations, there was no evidence of
serum chemistry findings or clinical signs suggestive of hyperadrenocorticism. No consistent
response to treatment has been reported. Blindness is permanent".
From: Taylor SM. In: Small Animal Veterinary Medicine 4th Ed. Nelson RW, Couto CG,
eds. Mosby Elsevier 2009 St. Louis. "SARDS is an idiopathic syndrome causing sudden
bilateral blindness".
VacCinations: What to expect after your pet's vaccination- AVMA
Rebuttal Comments from Dr. Dodds in RED
Pages 3-4. Adverse events diagnosed within three days of vaccine administration in dogs
JAm Vet Med Assoc. October 2005;227(7):1102-8. George E Moore
CONCLUSION: Young adult small-breed neutered dogs that received multiple vaccines
per office visit were at greatest risk of a vaccine-associated adverse events within 72
hours after vaccination. Correct, but this very large study did not go beyond the first 3
days post-vaccination, so no conclusions can be drawn about delayed adverse vaccinal
events. These factors should be considered in risk assessment and risk communication with
clients regarding vaccination. Correct; was Ms. Penteado so informed?
Vaccination of healthy subjects and autoantibodies: from mice through dogs to humans.
Lupus. November 2009; 18(13): 1186-91. N Toplak1; T Avcin
Abstract: It is well known that certain infections are involved in triggering the production
of autoantibodies, which could lead to autoimmune adverse reactions in genetically
predisposed subjects. Based on these findings it was assumed that vaccinations might
induce similar autoimmune reactions. At present there is no clear-cut evidence that
vaccinations are associated with overt autoimmune diseases but it has been
demonstrated that in genetical/ypredisposed persons vaccination can trigger the
production of autoantibodies and autoimmune adverse reactions. Correct; the
retrospective studies I and other have performed over the years among dog families at
increased risk for adverse vaccine reactions clearly support a genetic predisposition.
The first studies investigating the production of autoantibodies following vaccination were done
in dogs and mice. Several studies investigated the production of autoantibodies following
vaccination in patients with autoimmune diseases, but there are only limited data on the
autoimmune responses after vaccinations in apparently healthy humans.
Vaccine side effects: fact and fiction. Vet Microbial. October 2006;! 17(1):51-8.
M J Day Abstract: The debate over adverse reactions associated with companion animal
vaccination has considerably exercised the veterinary profession internationally over the
past decade. A range of suspected adverse reactions to vaccines is reported including
the onset of inflammatory, allergic, autoimmune or neoplastic diseases. Lack of
efficacy, interference with diagnostic testing and other occasional suspected product related
issues are also reported. Available data suggest that the overall prevalence of
true adverse reactions is exceedingly low and that vaccination does not significantly
contribute to ill-health in companion animals. With all due respect to my esteemed
colleague, who by the way has also studied dog.breed families at risk for autoimmune
diseases, while adverse vaccine reactions are rare in the general pet pqpulation, they
are not rare events among predisposed breeds and dog families (just ask
breeders/owners of Akitas, Weimaraners, American Eskimo Dogs, and Old English
Sheepdogs, to name a few) . Furthermore, like in human medicine, adverse vaccine-
associated events are under-reported in veterinary medicine. We must not lose sight of
the fact that vaccination is a safe procedure that has impacted significantly on infectious
disease control. Reduced population uptake of vaccination leads to re-emergence of disease in
both humans and animals. Nevertheless, there have recently been a series of practical
recommendations produced to ensure reduced 'vaccine load' on our companion animals and
vaccine manufacturers are moving towards developing non-adjuvanted products with an
extended duration of immunity. Correct. These measures will further reduce the very small
current risk of any adverse consequences to vaccination in our pet population.
Greene Infectious Diseases of the Dog and Cat. 3rd Edition p 1081. Serotesting pets each
year to determine whether boosters are needed rather than administering vaccines may be
impractical, expensive and inaccurate. Not true; a distemper+ parvo titer panel costs about
$45-75, and is readily available for in-house measurement, or at a reference lab with
rapid turnaround. Serum antibody titers do not represent an absolute measure of protection. It
can not be assumed that an animal with a low serum antibody liter is unprotected or that an
animal with a high antibody titer is protected. This is outdated - see 2011 AAHA Guidelines
on this issue (pp.17-19).
No differences in postvaccination titers against any of the viruses between old and young dogs
was noted. As stated above, that's irrelevant.
Colombo most likely succumbed to aspiration pneumonia, the cause of which was
undetermined. Agreed That said, there is no evidence linking vaccinations with this disease
Agreed, but the series of health concerns and overt illnesses he developed and
escalated until his demise began after he received the multiple vaccine boosters, all of
which, except for rabies , were unnecessary, and were specifically not authorized by the
client. ; see references listed under Schedule A; Additional References. Furthermore Colombo
developed pneumonia more than 3 months after having been vaccinated. The time frame
from when he was last seen at the Rosedale Animal Clinic to the time when he contracted
aspiration pneumonia is inconsistent with current peer literature i.e. there is no
connection between those vaccinations he received in March 2011 and his ultimate
demise Strongly disagree, for reasons stated above.
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Appendix:
Excepted from 2011 AAHA Canine Vaccination Guidelines
Page 13. Missed Dose-Adult Booster
The DOl conferred by infectious core vaccines is known to last for many years. Even if serum
antibody levels are determined to be below "protective" levels, immunologic memory (T-
and 8-lymphocytes) is likely to be sustained. Therefore, a single dose of infectious
vaccine administered to an adult dog is considered protective regardless of the time
since a previous vaccine was administered.
Page 13. Duration of Immunity and Booster Recommendations
In general, DOl to infectious viral and bacterial vaccines is longer than to noninfectious viral and
bacterial vaccines, and immunity conferred is generally much longer to viral vaccines than to
bacterial vaccines. DOl is often related to the immunologic mechanisms of killing or control of
the pathogens, and also to the complexity of the disease and the disease agent.
Infectious core vaccines are not only highly effective, they also provide the longest 001,
extending from 5 yr up to the life of the dog. A 3 yr interval is currently recommended for
revaccinating adult dogs with infectious viral core vaccines. In contrast, revaccination of dogs
with infectious bacterial vaccines (specifically IN Bb vaccine) is recommended annually. 3
yr recommendation for core vaccines is made on the basis of minimum DOl studies over the
past 30 yr for canine vaccines. These studies were done by all of the major vaccine companies,
as well as by independent researchers. The results of the studies conducted by the major
manufacturers for canine core vaccine demonstrated that a minimum DOl for their core
vaccines (CDV, CPV-2, CAV) 3 yr, based on challenge and/or serologic studies. Similar
DOl studies were conducted for the 3 yr rabies vaccines using challenge studies only.
V Page 19. Vaccine Adverse Events
Since the original canine vaccines were developed and licensed > 50 yr ago, there has been a
continuing effort to make canine vaccines safer and more efficacious. Today, it is generally
/\
agreed that canine vaccines have an excellent safety record. Although AE documentation in
veterinary medicine is limited, severe adverse reactions are considered uncommon.
I Vaccines are, however, biologic products and can cause unpredictable adverse effects in
\ some dogs after administration. -
Vaccines are biologic products and, as such, provoke a series of complex immune reactions
that may culminate in rapid-onset side effects lasting from a few hours to a few days. Rarely do
these self-limiting side effects escalate into serious AEs (SAEs). For this reason, veterinarians
are encouraged to inform clientele that their pet, regardless of breed or size, may manifest
transient side effects for up to 2, and possibly 3, days after administration of any vaccine or any
combination of vaccines. Side effects commonly observed include: reduced or loss of appetite
(lasting for one or two feedings), pain at the injection site, lethargy (lack of activity), reluctance
to walk and/or run, and mild fever. Treatment is usually not indicated; however, some
veterinarians have reported administering short-term symptomatic treatment (e.g., a
nonsteroidal anti-inflammatory drug [NSAIDs]).lt is recommended that clientele be advised
to contact the practice in the event any physical and/or behavioral manifestations
progressively worsen or continue beyond 2-3 days. Clientele shoulq be advised to contact
the practice at any time if signs of systemic illness, such as vomiting, diarrhea, seizures, facial
swelling, collapse, or difficulty breathing, develop.
Vaccine AEs are underreported in veterinary medicine. However, mechanisms are in place
for reporting such reactions; veterinarians are strongly encouraged to participate by reporting all
known or suspected AEs associated with vaccine administration.
Vaccination Protocols for Dogs
Predisposed to Vaccine Reactions
W. Jean Dodds, DVM
X
From Hemopet,
938 Stanford Street,
Santa Monica, California 90403.
JOURNAL of the American Animal Hospital Association
There is increasing evidence in veterinary medicine that vaccines can trig-
ger immune"mediated and other chronic disorders (i.e., vaccinosis), espe-
cially in certain apparently predisposed breeds.l-6 Accordingly, clinicians
need to be aware of this potential and offer alternative approaches for pre-
venting infectious diseases in these animals. Such alternatives to current
vaccine practices include: measuring semm antibody titers; avoidance of
unnecessary vaccines or overvaccinating; and using caution in vaccinating
ill, geriatric, debilitated, or febrile individuals, and animals from breeds or
families known to be at increased risk for immunological reactions.3.5-8
Fortunately, the most common effect of vaccine administration is the
stimulation of an immune response that conveys protection for that dis-
ease. This outcome has resulted in the widespread reduction in morbidity
and mortality from the many infectious diseases that have plagued both
animals and hun1ans. An excellent exan1ple of this benefit is the global
eradication of smallpox as the result of a comprehensive immunization
program. Despite these intended benefits, however, vaccination does carry
with it attendant risks.
Adverse Effects of Vaccines
As the most commonly recognized adverse effect of vaccination is an
immediate hypersensitivity or anaphylactic reaction, practitioners are less
familiar with the more rare but equally serious acute or chronic immune-
mediated syndromes that can occur. The veterinary profession and vac-
c.ine industry have traditionally emphasized the importance of giving a
series of vaccinations to young animals to prevent infectious diseases, to
the extent that this practice is considered routine and is generally safe for
the majority of animals. Few clinicians are prepared, therefore, for encoun-
tering an adverse event and may overlook or even deny the possibility.
Beyond the immediate hypersensitivity reactions, other acute events
tend to occur 24 to 72 hours afterward, or 7 to 45 days later in a delayed-
type immunological response_l,6,9,10 Even more delayed adverse effects
include mortality from high-titered measles vaccine in infants, canine dis-
temper antibodies in joint diseases of dogs, and feline injection-site
fibrosarcomas.3,11 The increasing antigenic load presented to the host
individual by modified-live vims (MLV) vaccines is presumed to be
responsible for the immunological challenge that can result in a delayed
hypersensitivity reaction.6,9
The clinical signs associated with nonanaphylactic vaccine reactions
typically include fever, stiffuess, sore joints and abdominal tenderness,
susceptibility to infections, neurological disorders and encephalitis,
autoimmune hemolytic anemia (AIHA) resulting in ictems, or immune-
mediated thrombocytopenia (ITP) resulting in petechiae and ecchymotic
211
212
JOURNAL of the American Animal Hospital Association
hemorrhage.1-4,9,10,12-15 Hepatic enzymes may be markedly
elevated, and liver or kidney failure may occur by itself or
accompany bone-marrow suppression) Furthermore, MLV
vaccination has been associated with the development of
transient seizures in puppies and adult dogs of breeds or
crossbreeds susceptible to immune-mediated diseases, espe-
cially those involving hematological or endoc1ine tissues
(e.g., AIHA, ITP, autoimmm1e thyroiditis).l-3 Postvaccinal
polyneuropathy is a recognized entity associated occasionally
with the use of distemper, parvovirus, rabies, and possibly
other vaccines.3,6,9 This can result in various clinical signs,
including muscular atrophy, inhibition or interruption of neu-
ronal control of tissue and organ function, incoordination, and
weakness. 3 Therefore, we have the responsibility to advise
companion animal breeders and caregivers of the potential for
genetically susceptible littem1ates and relatives that are at
increased risk for similar adverse vaccine reactions.l-5
Conunercial vaccines, on rare occasion, can also be con-
taminated with other adventitious viral agents,6,16 which can
produce significant untoward effects such as occurred when a
conunereial canine parvovirus vaccine was contaminated by
blue tongue virus. It produced abortion and death when given
to pregnant dogsl6 and was linked causally to the ill-advised
but all-too-conm1on practice of vaccinating pregnant animals.
The potential for side effects such as promotion of chronic
disease states in male and nonpregnant female dogs receiving
this lot of vaccine remains in question, although there have
been anecdotal reports of reduced stamina and renal dys-
function in performance sled dogs.3 Recently, a vaccine man-
ufucturer had to recall all biological products containing a
distemper component, because they were associated with a
higher-than-expected rate of central nervous system postvac-
cinal reactions 1 to 2 weeks following administration.3
If, as a profession, we conclude that we are overvaccinat-
ing, other issues come to bare, such as the needless client
dollars spent on vaccines, despite the well-intentioned solici-
tation of clients to encourage annual booster vaceinations so
that pets also can receive a wellness examination.5 Giving
annual boosters when they are not necessary has the client
paying for a service which is likely to be of little benefit to
the pet's existing level of protection against these infectious
diseases. It also increases the risk of adverse reactions from
the repeated exposure to foreign substances.
Polyvalent ML V vaccines, which multiply in the host,
elicit a stronger antigenic challenge to the animal and should
mount a more effective and sustained immune response.5,6,9
However, this can ovenvhelm the immunocompromised or
even healthy host that has ongoing exposure to other envi-
ronmental stimuli as well as a genetic predisposition that
promotes adverse response to viral challenge)-3,9,13 The
recently weaned young puppy or kitten being placed in a
new environment may be at particular risk. Furthem10re,
while the frequency of vaccinations is usually spaced 2 to 3
weeks apart, some veterinarians have advocated vaccination
once a week in stressful situations. This practice makes little
sense, scientifically or medically.5
May/June 2001, Vol. 37
An augmented inumme response to vaccination is seen in
dogs with preexisting inhalant allergies (i.e., atopy) to pol-
lens.3 Furthemwre, the increasing nment problems with
allergic and immunological diseases have been linked to the
introduction of MLV vaccines more than 20 years ago.6
While other environmental factors no doubt have a contribut-
ing role, the introduction of these vaccine antigens and their
environmental shedding may provide the final insult that
exceeds the immunological tolerance threshold of some indi-
viduals in the pet population.
Predisposed Breeds
Twenty years ago, this author began studying families of
dogs with an apparent increased frequency of immune-medi-
ated hematological disease (i.e., AIHA, ITP, or both).l,2
Among the more commonly recognized predisposed breeds
were the Akita, American cocker spaniel, Gem1an shepherd
dog, golden retriever, hish setter, Great Dane, Kerry blue ter-
rier, and all dachshund and poodle varieties; but predisposi-
tion was found especially in the standard poodle, long-haired
dachshund, Old English sheepdog, Scottish terrier, Shetland
sheepdog, shih tzu, vizsla, and Weimaraner, as well as breeds
of white or predominantly white coat color or with coat color
dilution (e.g., blue and fawn Dobe1man pinschers, the merle
collie, Australian shepherd, Shetland sheepdog, and harlequin
Great Dane).l-3 Recently, other investigators have noted the
relatively high frequency of AIHA, ITP, or both in American
cocker spaniels 10 and Old English sheepdogs.B
A significant proportion of these animals had been vacci-
nated with monovalent or polyvalent vaccines within the 30-
to 45-day period prior to the onset of their autoinmmne dis-
ease.I,2,10 Furthermore, the same breeds listed above appear
to be more susceptible to other adverse vaccine reactions,
particularly postvaccinal seizures, high fevers, and painful
episodes of hype1trophic osteodystrophy (HOD).3 For ani-
mals that have experienced an adverse vaccine reaction, the
recommendation is often to refrain from vaccinating these
animals until at least after puberty, and instead to. measure
serological antibody titers against the various diseases for
which vaccination has been given. This recommendation
raises an issue with the legal requirement for rabies vaccina-
tion. As rabies vaccines are strongly immunogenic and are
known to elicit adverse neurological reactions,3,5 it would be
advisable to postpone rabies vaccination for such cases. A
letter from the primmy care veterinarian stating the reason
for requesting a waiver of rabies vaccination for puppies or
adults with documented serious adverse vaccine reactions
should suffice.
As further examples, findings from the autllor's large,
accumulated database of three susceptible breeds are sum-
marized below.
Vaccine-Associated Disease in
Old English Sheepdogs
Old English sheepdogs appear to be predisposed to a variety
of autoimmune diseases.l-3,13 Of these, the most conm10nly
seen are AIHA, ITP, thyroiditis, and Addison's disease.2.17
May/June 2001, Vol. 37
Between 1980 and 1990, this author studied 162 cases of
immune-mediated hematological diseases in this breed. One-
hundred twenty-nine of these cases had AIHA, ITP, or both
as a feature of their disease. Vaccination within the previous
30 days was the only identified triggering event in seven
cases and was an apparent contributing factor in another 115
cases.2 Thyroid disease was as either a primary
or secondary problem in 71 cases, which is likely an under-
estimate of the true incidence, as thyroid function tests were
not run or were inconclusive in most of the other cases.
Experience with a particular Old English sheepdog family
supported a genetic predisposition to autoimmune thyroiditis,
Addison's disease, and AIHA or ITP or both-an example of
the polyglandular autoimmtme syndrome.2,17 Pedigrees were
available from 108 of the 162 Old English sheepdog cases of
autoimmune disease; a close relationship was fotmd among
all but seven of the affected dogs.
2
Two of three pedigrees
available from the studies of Day and Penhalel3 were also
related to this large North American study group.
Vaccine-Associated Disease in Young Akitas
Akitas also are subject to a variety of immune-mediated dis-
orders, including Vogt-Koyanagi-Harada syndrome (VKH),
pemphigus, and heritable juvenile-onset immune-mediated
polyarthritis (IMPA). 3,!
4
Juvenile-onset lMPA occurs in
Akitas less than 8 months of age. Of 11 closely related pup-
pies in the author's case series, the mean age of onset was 14
weeks. 3 Initial signs appeared 3 to 29 days following vacci-
nation with polyvalent MLV or killed virus or both, with a
mean reaction time of 14 days. All had profound joint pain
and cyclic febrile illness lasting 24 to 48 hours. Hemograms
revealed mild nonregenerative anemia, neutrophilic leukocy-
tosis, and occasional thrombocytopenia. Joint aspiration and
radiography indicated nonseptic, nonerosive arthritis.
Despite treatment for immune-mediated disease and pyrexia,
all eight dogs had relapsing illness and died or were eutha-
nized by 2 years of age from progressive systemic amyloido-
sis and renal failure. Necropsies were performed on three
dogs, two of which had glomerular amyloidosis and wide-
spread evidence of vasculitis. The history, signs, and close
association with immunization suggested that juvenile-onset
polyarthritis and subsequent amyloidosis in these Akitas may
have been an autoimmune response triggered by the viral
antigens or other components of vaccines. 3
The vaccine-related history was reviewed for 129 puppies
belonging to the family of Akitas discussed above. Polyva-
lent MLV vaccine was given to 104 of them, with 10 (9.8%)
puppies showing adverse reactions and death. Another six
puppies received a polyvalent all-killed vaccine product (no
longer commercially available) with no reactors, and 19 pup-
pies received homeopathic nbsodes initially followed by
kil1ed canine parvovirus (CPV) vaccine, with one reactor
that died and one that became ill but survived)
A genetic basis for immune-mediated diseases and
immunodeficiencies states is well known.l,2,12,13,!5,17,18 The
mechanism for triggering immune-mediated disease is poorly
understood, but predisposing factors have been implicated
Guest Editorial 213
when genetically susceptible individuals encounter environ-
mental agents that induce nonspecific inflammation, molecu-
lar mimicry, or both.3,17 The combined effects of these
genetic and environmental factors override normal self-toler-
ance and are usually mediated by T-cell imbalance or dys-
regulation.17
Since the modern Akita arose from a relatively small gene
pool, understanding the potential environmental triggers of
juvenile-onset IMPA has immediate importance. Numerous
agents have been implicated, including dmgs, vaccines,
vimses, bacteria, chemicals, and other toxins.l-3,1 0,11
Although the littern1ates from affected families typically end
up in different locales, all undergo relatively standardized
immunization procedures at a similar age.
Vaccine-Associated Disease in Young Weimaraners
The Weimaraner breed appears to be especially prone to both
immune deficiency and autoirrmmne diseases, which have
been recognized with increasing frequency in related mem-
bers of the breed over the past 15 years.3 Autoimmune thy-
roiditis leading to clinically expressed hypothyroidism is
probably the most corrm1on of these disorders, along with
vaccine-associated HOD ofyoung Weimaraners.2,3,17
During a 2-year period (1986-1988), Couto evaluated 170
related Weimaraners, including affected puppies and their
relatives, and the findings were relayed in a breed newsletter
as discussed in an earlier reference. 3 Clinical signs of the
affected dogs included high fevers, polyarthritis with pain
and swelling typical of HOD, coughing and respiratory dis-
tress from pneun1onia, enlarged lyn1ph nodes, diarrhea, pyo-
derma, and mouth ulcers. In most cases, c.linical signs were
first detected shortly after vaccination with a second dose of
polyvalent MLV vaccine when the puppies were between 2
and 5 months of age. This author has studied more than 60
Weimaraners with vaccine-associated disease. In 24 cases
described in a previous article, 3 the mean age of onset of
clinical signs was 13.5 weeks, with a mean reaction time of
10.5 days postvaccination. Males were predominantly
affected. All affected puppies showed high-spiking fevers,
cyclic episodes of pain, and polyarthritis (HOD)-a group of
signs identical to those of the affected young Akitas
described previously. Most affected puppies also showed
leukocytosis (with neutrophilia or neutropenia), dianhea,
lethargy, anorexia, and enlarged lymph nodes. Some puppies
also had levels of immunoglobulin A, immunoglobulin M, or
both below those expected for their age, and one puppy had
immunoglobulin G (IgG) deficiency as well. Other signs
included coughing, pneumonia, depression, seizures or
"spaced-out" behavior, refusal to stand or move, and hyper-
esthesia ("walking on eggshells"). The outcome for half of
these cases was good (12 of the 24 are healthy adults),
although two died, three were euthanized as puppies, and
three remained cl.ironically ill as adults. Another four cases
were lost to follow-up.
Management of this clinical syndrome is best accom-
plished with an initial dose of parenteral corticosteroids fol-
lowed by a tapering course of corticosteroids over 4 to 6
214
JOURNAL of the American Animal Hospital Association
weeks. Systemic broad-spectrum antibiotic may be given
prophylactically, and vitamin C (500 to 1,000 mg daily) can
be included to promote immune support. Recurring episodes
are treated by increasing the cmticosteroid dosage for a few
days until the flare-up has subsided. The response to initial
corticosteroid treatment is always dramatic, with fever and
joint pain usually subsiding within a matter of hours.
Serological titers for canine distemper virus (CDV) and
CPV were determined in 19 of the 24 affected Weimaraner
puppies, and all were adequate. Upon reaching adulthood,
semm antibody titers were reevaluated, and detectable CDV-
and CPV-specific IgG persisted. Several of these dogs have
subsequently developed hypothyroidism and are receiving
thyroid replacement.3,4;17 Thus, to avoid recmTence of
adverse effects, which has been shown to be even more
severe if another vaccine booster is given, serological titers
for CDV and CPV are measured.
7
Another approach recommended by Weimaraner breeders
and this author is to modifY the vaccination protocol, espe-
cially for puppies from families known to have experienced
adverse vaccine reactioiJ.S. Examples would be to limit the
number of antigens used in the vaccine series to those infec-
tious agents of most clinical concern (i.e., CDV, CPV, and
rabies virus), separating these and other antigens by 2- to 3-
week intervals, and giving rabies vaccine by itself at 6 months
of age. A booster series is administered at I year by separating
the CDV, CPV, rabies vims, and other vaccine components,
where possible, and giving them on separate visits at least 2
weeks apart. Thereafter, serological antibody titers can be
measured (except for those vaccines required by law, unless a
specific exemption is made on an individual case basis).
Recommendations
Practitioners should be encouraged during the initial VISit
with a new puppy owner or breeder to review current infor-
mation about the breed's known congenital and heritable
traits. Several databases, veterinary textbooks, and review
articles contain the relevant infonnation to assist here.2 For
those breeds at increased risk, the potential for adverse reac-
tions to routine vaccinations should be discussed as part of
this wellness progran1. Because breeders of at-risk breeds
have likely alerted the new puppy buyer to this possibility,
we should be mindful and respectful of their vieVv'J)Oint,
which may be more informed than ours about a specific
breed or family issue. To ignore or dismiss these issues can
jeopardize the client-patient relationship and result in the
client going elsewhere for veterinary services or even turning
away from seeking professional care for these preventive
health measures. As a minimum, if we are unaware of the
particular concern expressed, we can research the matter or
ask the client for any relevant scientific or medical documen-
tation. The accumulated evidence .indicates that vaccination
protocols should no longer be considered as a "one size fits
all" program.
For these special cases, appropriate alternatives to current
vaccine practices include: measuring serum antibody titers;
avoidance of unnecessary vaccines or overvaccinating; using
J\Tay/June 2001, Vol. 37
caution in vaccinating sick, very old, debilitated, or febrile
individuals; and tailoring a specific minimal vaccination pro-
tocol for dogs of breeds or families knm.vn to be at increased
risk for adverse reactions.3,5-8 Considerations include stmting
the vaceination series later, such as at 9 or I 0 weeks of age,
when the immune system is more able to handle antigenic
challenge; alerting the earegiver to pay particular attention to
the puppy's behavior and overall health after the second or
subsequent boosters; and avoiding revaccination of individu-
als already experiencing a significant adverse event. Litter-
mates of affected puppies should be closely monitored after
receiving additional vaccines in a puppy series, as they, too,
are at higher risk. Altering the puppy vaccination protocol, as
suggested previously for the Weimaraner, is also advisable.
Following these recommendations may be a prudent way
for our profession to balance the need for individual patient
disease prevention with the age-old physician's adage, for-
warded by Hippocrates, of "to help, or at least do no harm."
References
1. Dodds \VJ. Immune-mediated diseases of the blood. Adv Vet Sci Cornp
Med 1983;27:163-196.
2. Dodds WJ. Estimating disease prevalence with health surveys and
genetic screening. Adv Vel Sci Comp Med 1995;39:29-96.
3. Dodds WJ. More bumps on the vaccine road. Adv Vet Med
1999;41 :715-732.
4. Hogenesch H, Azcona-Olivera J, Scott-MoncrieffC, Snyder PW, Glick-
man LT. Vaccine-induced autoimmunity in the dog. Adv Vet Med
1999;41 :733-744.
5. Schultz R. Cmrent and future canine and feline vaccination programs.
Vet Med I 998;93:233-254.
6. Tizard I. Risks associated with use of live vaccines. J Am Vet Med
Assoc 1990; 196: I 851- I 858.
7. Twark L, Dodds WJ. Clinical use of serum parvovirus and distemper
virus antibody titers for detennining revaccination strategies in healthy
dogs. JAm Vet MedAssoc 2000;217:1021-1024.
8. Tizard I, Ni Y. Use of serologic testing to assess immune status of com-
panion animals. JAm Vet Med Assoc 1998;213:54-60.
9. Phillips TR, Jensen JL, Rubino MJ, Yang WC, Schultz RD. Effects of
vaccines on the canine immune system. Can J Vet Res 1989;53:154-
160.
I 0. Duval D, Giger U. Vaccine-associated immune-mediated hemolytic
anemia in the dog. J Vet Intern Med 1996;10:290-295.
11. Cohen AD, Shoenfeld Y. Vaccine-induced autoimmunity. J Autoimmun
1996;9:699-703.
12. May C, Hammill J, Bennett, D. Chinese shar pei fever syndrome: a pre-
limina!J' report. Vet Rec I 992;131 :586-587.
13. Day MJ, Penhale WJ. Immune-mediated disease in the old English
sheepdog. Res Vet Sci 1992;53:87-92.
14. Dougherty SA, Center SA. Juvenile onset polyarthritis in akitas.
JAm Vet Med Assoc 1991;198:849-855.
15. Scott-Moncrieff JCR, Snyder PW, Glickman LT, Davis EL, Felsburg
PJ. Systemic necrotizing vasculitis in nine young beagles. JAm Vet
Med Assoc 1992;201 :1553-1558.
16. Wilbur LA, EvemJann JF, Levings RL, eta/. Abortion and death in
pregnant bitches associated with a canine vaccine contaminated with
blue tongue virus. JAm Vet MedAssoc 1994;204:1762-1765.
I 7. Happ GM. TI1yroiditis-a model canine autoimmune disease. Adv Vet
Sci Comp Med 1995;39:97-139.
18. Rivas AL, Tintle L, Meyers-Wallen V, Scarlett JM, van Tassell CP.
Inheritance of renal amyloidosis in Chinese shar-pei dogs. J Hered
1993;84:438-442.
4
5
CLINICAL APPROACHES TO MANAGING AND TREATING ADVERSE VACCINE REACTIONS
Background
W. Jean Dodds, DVM
HEMOPET
938 Stanford Street
Santa Monica, CA 90403
(31 0) 828-4804; FAX (31 0)-453-5240
www.hemopet.org; hemopet@hotmail.com
There is no doubt that application of modern vaccine technology has permitted us to protect companion
animals effectively against serious infectious diseases.
Viral disease and recent vaccination with single or combination modified live-virus (MLV) vaccines,
especially those containing distemper virus, adenovirus 1 or 2, and parvovirus are increasingly
recognized contributors, albeit relatively rare, to immune-mediated blood disease, bone marrow failure,
and organ dysfunction. Potent adjuvanted killed vaccines like those for rabies virus also can trigger
immediate .and delayed (vaccinosis) adverse vaccine reactions. Genetic predisposition to these
disorders in humans has been linked to the leucocyte antigen D-related gene locus of the major
histocompatibility complex, and is likely to have parallel associations in domestic animals.
It must be recognized, however, that we have the luxury of asking such questions today only because
the risk of disease has been effectively reduced by the widespread use of vaccination programs.
Adverse Events Associated with Vaccination
The clinical signs associated with vaccine reactions typically include fever, stiffness, sore joints and
abdominal tenderness, susceptibility to infections, neurological disorders and encephalitis, collapse with
autoagglutinated red blood cells and icterus (autoimmune hemolytic anemia, AIHA, also called immune-
mediated hemolytic anemia, IMHA), or generalized petechiae and ecchymotic hemorrhages (immune-
mediated thrombocytopenia , ITP). Hepatic enzymes may be markedly elevated, and liver or kidney
failure may occur by itself or accompany bone marrow suppression.
Furthermore, ML V vaccination has been associated with the development of transient seizures in
puppies and adult dogs of breeds or cross-breeds susceptible to immune-mediated diseases especially
those involving hematologic or endocrine tissues (e.g. AIHA, ITP, autoimmune thyroiditis). Post-
vaccinal polyneuropathy is a recognized entity associated occasionally with the use of distemper,
parvovirus, rabies and presumably other vaccines. This can result in various clinical signs including
muscular atrophy, inhibition or interruption of neuronal control of tissue and organ function, muscular
excitation, incoordination and weakness, as well as seizures.
Certain breeds or families of dogs appear to be more susceptible to adverse vaccine reactions,
particularly post-vaccinal sei;;::ures, high fevers, and painful episodes of hypertrophic osteodystrophy
(HOD). Therefore, we have the responsibility to advise companion animal breeders and caregivers of
1
'I
I
the potential for genetically susceptible littermates and relatives to be at increased risk for similar
adverse vaccine reactions. In popular (or rare) inbred and linebred animals, the breed in general can
be at increased risk as illustrated in the examples below.
Polyvalent MLV vaccines which multiply in the host elicit a stronger antigenic challenge to the animal
and should mount a more effective and sustained immune response. However, this can overwhelm the
immunocompromised or even a healthy host that has ongoing exposure to other environmental stimuli
as well as a genetic predisposition that promotes adverse response to viral challenge. The recently
weaned young puppy or kitten being placed in a new environment may be at particular risk.
Furthermore, while the frequency of vaccinations is usually spaced 2-3 weeks apart, some
veterinarians have advocated vaccination once a week in stressful situations; a practice makes little
sense scientifically or medically.
An augmented immune response to vaccination is seen in dogs with pre-existing inhalant allergies
(atopy) to pollens. Furthermore, the increasing current problems with allergic and immunological
diseases have been linked to the introduction of MLV vaccines more than 20 years ago. While other
environmental factors no doubt have a contributing role, the introduction ofthese vaccine antigens and
their environmental shedding may provide the final insult that exceeds the immunological tolerance
threshold of some individuals in the pet population. The accumulated evidence indicates that
vaccination protocols should no longer be considered as a "one size fits all" program.
In cats, while adverse vaccine reactions may be less common, aggressive tumors (fibrosarcomas) can
occasionally arise at the site of vaccination. A recent study from Italy reported finding similar tumors in
dogs at the injection sites of vaccinations (Vascellari et al, 2003). These investigators stated that their
"study identified distinct similarities between canine fibrosarcomas from presumed injection sites and
feline post-vaccinal fibrosarcomas, suggesting the possibility of the development of post-injection
sarcomas not only in cats, but also in dogs".
Additionally, vaccination of pet and research dogs with polyvalent vaccines containing rabies virus or
rabies vaccine alone was shown to induce production of antithyroglobulin autoantibodies, a provocative
and important finding with implications for the subsequent development of hypothyroidism (Scott-
Moncrieff et al, 2002).
For these special cases, appropriate alternatives to current vaccine practices include:
1) measuring serum antibody titers;
2) avoidance of unnecessary vaccines or over vaccinating;
3) caution in vaccinating sick or febrile individuals; and
4) tailoring a specific minimal vaccination protocol for dogs of breeds or families known to be at
increased risk for adverse reactions.
2
5) considerations include starting the vaccination series later, such as at nine or ten weeks of age
when the immune system is more able to handle antigenic challenge;
6) alerting the caregiver to pay particular attention to the puppy's behavior and overall health after
the second or subsequent boosters; and
7) avoiding revaccination of individuals already experiencing a significant adverse event.
Littermates of affected puppies should be closely monitored after receiving additional vaccines
in a puppy series, as they too are at higher risk.
Serologic Vaccine Titer Testing
Some veterinarians have challenged the validity of using vaccine titer testing to assess the
immunologic status of animals against the common, clinically important infectious diseases.
With all due respect, this represents a misunderstanding of what has been called the "fallacy of titer
testing", because research has shown that once an animal's titer stabilizes it is likely to remain constant
for many years. Properly immunized animals have sterilizing immunity that not only prevents clinical-
disease but also prevents infection, and only the presence of antibody can prevent infection. As stated
by eminent expert Dr. Ronald Schultz in discussing the value of vaccine titer testing, these tests "show
that an animal with a positive test has sterilizing immunity and should be protected from infection. If
that animal were vaccinated it would not respond with a significant increase in antibody titer, but may
develop a hypersensitivity to vaccine components (e.g. fetal bovine serum). Furthermore, the animal
doesn't need to be revaccinated and should not be revaccinated since the vaccine could cause an
adverse reaction (hypersensitivity disorder). You should avoid vaccinating animals that are already
protected. It is often said that the antibody level detected is "only a snapshot in time". That's simply not
true; it is more a "motion picture that plays for years".
Furthermore, protection as indicated by a positive titer result is not likely to suddenly drop-off unless an
animal develops a medical problem such as cancer or receives high or prolonged doses of
immunosuppressive drugs. Viral vaccines prompt an immune response that lasts much longer than
that elicited by classic antigen. Lack of distinction between the two kinds of responses may be why
practitioners think titers can suddenly disappear.
But, not all vaccines produce sterilizing immunity. Those that do include: distemper virus, adenovirus,
and parvovirus in the dog, and panleukopenia virus in the cat. Examples of vaccines that produced
non-sterile immunity would be leptospirosis, bordetella, rabies virus, herpesvirus and calicivirus --- the
latter two being upper respiratory viruses of cats. While non-sterile immunity may not protect the
animal from infection, it should keep the infection from progressing to severe clinical disease.
Therefore, interpreting titers correctly depends upon the disease in question. Some titers must reach a
certain level to indicate immunity, but with other agents like those that produce sterile immunity, the
presence of any measurable antibody shows protection. The positive titer test result is fairly
straightforward, but a negative titer test result is more difficult to interpret, because a negative titer is
not the same thing as a zero titer and it doesn't necessarily mean that animal is unprotected. A
3
negative result usually means the titer has failed to reach the threshold of providing sterile immunity.
This is an important distinction, because for the clinically important distemper and parvovirus diseases
of dogs, and panleukopenia of cats, a negative or zero antibody titer indicates that the animal is not
protected against canine parvovirus and may not be protected against canine distemper virus or feline
panleukopenia virus.
Finally, what does more than a decade of experience with vaccine titer testing reveal ? Published
studies in refereed journals show that 90-98% of dogs and cats that have been properly vaccinated
develop good measurable antibody titers to the infectious agent measured. So, in contrast to the
concerns of some practitioners, using vaccine titer testing as a means to assess vaccine-induced
protection will likely result in the animal avoiding needless and unwise booster vaccinations.
Our recent study (Twark and Dodds, 2000), evaluated 1441 dogs for CPV antibody titer and 1379 dogs
for CDV antibody titer. Of these, 95.1 %were judged to have adequate CPV titers, and nearly all (97.6
%) had adequate CDV titers. Vaccine histories were available for 444 dogs (CPV) and 433 dogs (CDV).
Only 43 dogs had been vaccinated within the previous year, with the majority of dogs (268 or 60%)
having received a booster vaccination 1-2 years beforehand. On the basis of our data, we concluded
that annual revaccination is unnecessary. Similar findings and conclusions have been published
recently for dogs in New Zealand (Kyle et al, 2002), and cats (Scott and Geissinger; 1999; Lappin et al,
2002). Comprehensive studies of the duration of serologic response to five viral vaccine antigens in
dogs and three viral vaccine antigens in cats were recently published by researchers at Pfizer Animal
Health (Mouzin et al, 2004).
When an adequate immune memory has already been established, there is little reason to introduce
unnecessary antigen, adjuvant, and preservatives by administering booster vaccines. By titering
triennially or more often, if needed, one can assess whether a given animal's humoral immune
response has fallen below levels of adequate immune memory. In that event, an appropriate vaccine
booster can be administered.
Other Issues with Over Vaccination
. Other issues arise from over vaccination, as the increased cost in time and dollars spent needs to be
considered, despite the well-intentioned solicitation of clie;:nts to encourage annual booster vaccinations
so that pets also can receive a. wellness examination. Giving annual boosters when they are not
necessary has the client paying for a service which is likely to be of little benefit to the pet's existing
level of protection against these infectious diseases. It also increases the risk of adverse -reactions
from the repeated exposure to foreign substances.
Compliance or Resistence to Current Vaccine Guidelines?
For more than a decade, the issues discussed above on overvaccination and vaccine safety for
companion animals have been raised by vaccinologists and veterinary clinicians. But, how has this still
controversial knowledge impacted the veterinary profession and pet owner today? Have veterinarians
really embraced the national policies on vaccination guidelines? Does the public trust veterinarians to
be up-to-date on these issues or are they unsure? Do they believe veterinarians have a conflict of
4
interest if they seek the income from annual booster vaccinations? Given media information regarding
autism and measles vaccination, the public is more aware and worried about vaccine safety.
Some veterinarians today still tell their clients there is no scientific evidence linking vaccinations with
adverse effects and serious illness. This is ignorance, and confuses an impressionable client. On the
other hand, vaccine zealots abound with hysteria and misinformation. None of these polarized views is
helpful.
Veterinarians are still routinely vaccinating ill dogs and those with chronic diseases or prior adverse
vaccine reactions. This is especially problematic for rabies boosters, as many colleagues believe they
have no legal alternative, even though the product label states it's intended for healthy animals. See
www.rabieschallengefund.org
New Breakthroughs
Failure to standardize the legal mandate for rabies vaccinations nationwide is medically and
scientifically unwarranted. The fact that individual states, counties and cities elect to mandate annual
rabies boosters despite federally licensed three-year rabies vaccines is misguided.
Now that Arkansas passed a new rabies law authorizing the State Health Department to establish
rabies vaccination schedules which adopt a 3-year rabies protocol for dogs and cats (February 2009),
Alabama just changed their rabies law to 3 years on August 1, 2009. However, some individual cities
and counties still require annual rabies booster vaccination. For Cheyenne, WY and Wichita, KS,
pressure from the public and the local veterinary associations effected a recent change to every three
years.
Despite these recent changes, the practice of rabies booster vaccination in these states and local areas
has been left as optional at the discretion of the client's veterinarian. So this is a Catch-22 situation,
because if the veterinarian still believes the rabies booster should be given annually instead of as
.licensed, they usually can talk their client into doing so.
Rabies Vaccines and the USDAICVB
Rabies vaccines are the most common group of biological products identified in adverse event reports
received by the USDA's Center for Veterinary Biologics (CVB). Currently, 14 rabies vaccines are
labeled for use in dogs. These vaccines must meet the standard requirements established in the Title 9
Code of Federal Regulations. This requires that the vaccine provide a protected fraction of;::: 83% when
comparing vaccinated animals versus control animals. Also, all rabies vaccines are evaluated for safety
prior to licensure, which includes performance of a field safety trial. Additionally, each serial of rabies
vaccine is tested for potency by use of the National Institutes of Health potency test or another test
approved by the CVB, and is tested for safety in the host and laboratory animals.
Safety Review
Before licensure, a product must be shown to be safe through a combination of safety evaluations. The
field safety trial is the most comprehensive evaluation and has the objective of assessing the safety of
the product in its target population under the conditions of its intended use. However, safety studies
before licensure may not detect all safety concerns for a number of reasons, as follows: insufficient
5
number of animals for low frequency events, insufficient duration of observation, sensitivities of
subpopulations (eg, breed, reproductive status, and unintended species), or interactions with
concomitantly administered products.
State and Local Authority for Rabies Control Programs
Although the CVB licenses veterinary biological products for use in the prevention of rabies, it is the
state and local authorities govern and administer their respective rabies animal control programs. Some
of these programs allow exemptions to the vaccination requirements, if medical concerns exist related
to potential adverse events, but more commonly, others do not allow exemptions, regardless of the
justification.
Reporting Adverse Vaccine Reaction to Manufacturer and the Government
There is no mandatory reporting of adverse reactions in veterinary medicine. The 2007 World Small
Animal Veterinary Association (WSAVA) Vaccine Guidelines states that there is: "gross under-
reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of
these products." WSAVA 2007 Vaccine Guidelines http://www.wsava.org/SAC.htm,
Even in humans, where mandatory reporting of adverse vaccine reactions is required, Dr. David
Kessler, former head of the Food & Drug Administration, reported that "only about 1% of serious events
are reported to the FDA". [JAMA .269:.2785, 1993]. This problem of under-reporting has persisted for
many years.
Despite the serious under-reporting of vaccinal adverse reactions, the 2008 Report from the USDA's
CVB [JAVMA 232:1000-1002, 2008], states that between April 1, 2004 and March 31, 2007, they
"requested manufacturers of rabies vaccines to provide adverse event report summaries for their
products. During this period, nearly 10,000 adverse event reports (all animal species) were received by
manufacturers of rabies vaccines. Approximately 65% of the manufacturer's reports involved dogs."
The USDA/CVB 2008 Report further states that "Rabies vaccines are the most common group of
biological products identified in adverse event reports received by the CVB." During the 3-year period
covered in this report, the CVB received 246 adverse event reports for dogs in which a rabies vaccine
was identified as one of the products administered. Reports were assessed for causality, and of these,
217 reports were considered possibly related to ;::: 1 of the vaccines given, 7 were considered
unlikely, and 22 were assessed as unknown. Of reports with age information (n = 206), 21.4%
of the dogs were s; 6 months old, 33.5% were > 6 months old but s; 2 years old, and 45.1%
were > 2 years old. Of reports with sex information (n = 209), 54.5% of the dogs were female.
The following clinical terms were listed "to describe possibly related adverse events in dogs vaccinated
against rabies" and reported to the USDA/CVB between April 1, 2004-March 31, 2007. For 217 adverse
event reports- the clinical term is followed by the% of dogs affected:
Vomiting-28.1%; facial swelling-26.3%; injection site swelling or lump-19.4%; lethargy-12%;
urticaria-10.1%; circulatory shock-8.3%; injection site pain-7.4%; pruritus-7.4%; injection site
alopecia or hair loss-6.9%; death-5.5%; lack of consciousness-5.5; diarrhea-4.6%;
6
hypersensitivity (not specified)-4.6%; fever-4.1 %;, anaphylaxis-2.8%; ataxia-2.8%; lameness-
2.8%; general signs of pain-2.3%; hyperactivity-2.3%; injection site scab or crust-2.3%;, muscle
tremor-2.3%; tachycardia-2.3%; and thrombocytopenia-2.3%.
The overall adverse report rate for rabies vaccines was determined to be 8.3 reports/1 00,000 doses
sold. Adverse events considered possibly related to vaccination included acute hypersensitivity (59%);
local reactions (27%); systemic reactions, which refers to short-term lethargy, fever, general pain,
anorexia, or behavioral changes, with or without gastrointestinal disturbances starting within 3 days
after vaccination (9%); autoimmune disorders (3%); and other (2%). In nearly 72% of the dogs of these
reports, other vaccine or medicinal products were administered in conjunction with the rabies vaccine.
In those instances, it was generally not possible to determine which product or products might be most
closely linked to the adverse event. Additionally, in some instances, dogs had > 1 clinical sign,
resulting in the coding of several clinical signs in a single report.
But, IF one applied the only 1% estimated reporting figure of "serious" events from the former head of
the FDA to the 10,000 adverse events reported for animal rabies vaccines, 65% of which were in dogs,
then the actual number of dogs that had adverse reactions to the vaccine could be as high as 650,000
in that 3 year period with 3,575 (5.5%) of the dogs dying from their adverse reaction.
Treatment of Vaccinosis
The diagnosis of vaccinosis is an exclusionary one -- i.e. nothing will be found upon other testing to
explain the symptoms. The animal is given the oral homeopathies, Thuja (for all vaccines other than
rabies), and Lyssin to detox the rab.ies "miasm". IF there are no holistic veterinarians in the area, these
homeopathies can be obtained from www.naturalrearing.com.
Our therapy typically uses steroids in tapering doses over 4-6 weeks to stop the inflammatory process
and clinical symptoms. Therapy begins with an injection of dexamethasone phosphate first, and if the
animal improves right away, is continued with prednisone at 0.5 mg per pound twice daily for 5-7 days,
then tapered gradually over the next month to every other day. The use of steroids will cause an
increase in water intake and urination, but the animal should be able to handle the drug at these
tapering doses for a few weeks. IF a holistic veterinarian wants to try an alternative therapy to steroids,
this approach can also work. Try it for several days to see if it will work.
We advise that these patients receive no further vaccine boosters, except for rabies, where exemption
can be sought on a case-by-case basis but may not be granted in the specific locale.
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CANINE VACCINE ADVERSE EVENTS *
retrospective cohort study; 1.25 million dogs vaccinated at 360 veterinary hospitals
38 adverse events per 10,000 dogs vaccinated
inversely related to dog weight
vaccines prescribed on a 1-dose-fits-all basis, rather than by body weight.
increased for dogs up to 2 yr of age, then declined
greater for neutered versus sexually intact dogs
increased as number of vaccines given together increased
e increased after the 3 rd or 4 th vaccination
genetic predisposition to adverse events documented
* from Moore et al, JAVMA 227:1102-1108, 2005
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