Fort Dodge ~ Final Comments 2003Following is, what would appear, the final correspondence from Fort Dodge sent to Dot Sweeney which includes her response. Dot response is shown in bold text, as she addressed points of concern in the report. The codes used within this document are as follows: Report on the Possible Adverse Event
following Vaccination of a Litter of Black
Russian Terrier Pups
16 May 2003
All manufacturers of veterinary products
receive a small number of reports of
possible adverse events or reactions
following the use of their products. Fort
Dodge treats all reports of possible
adverse events following the use of our
products seriously. The cases are
investigated to the fullest possible
extent and the details of the owners, and
the medical history of their animals are
kept in the strictest confidence. One
recent case, involving some pups becoming
ill after vaccination with one of our
products, has received considerable public
discussion among the dog breeding and
veterinary communities following the
breeder's comments on the case in a number
of widely disseminated emails, and some
postings on a website. Although we do not
usually release our findings to people not
directly involved in these cases, we have
decided to take the unusual step of
releasing our findings in this instance
because of the concern this case has
generated.
We have concluded our investigation into
the report of an adverse experience
following vaccination in a litter of Black
Russian Terrier pups. We have compiled a
history of events from the breeder's
recollections and from records from the
five veterinary clinics where the pups
were treated.
The 11 Black Russian Terrier pups, 7 males
(M) and 4 females (F), were born 28
December 2002 and vaccinated at 5 weeks
and 5 days of age on 6 February 2003 with
Protech ® Duramune ® C4 vaccine. Within
24-72 hours after vaccination, they
developed mild diarrhoea and decreased
appetite. A1 This is not quite correct,
as I explained to Mr Preshaw the day he
visited my premises, most pups yelped and
cried when vaccinated at around 3-3.30pm,
I commented on this to the vet at the
time. By nightfall all pups were crying
and in pain and distressed. I spent most
of the night with the pups and by the time
I retired at around 3.30am I had already
been cleaning up diarrhoea, by daylight
the next morning ALL pups had diarrhoea.
This was 12-14 hours after vaccination not
24 -72 hours.
The runt of the litter (M3) Nik, was
the most severely affected with more
severe diarrhoea and vomiting. A2 M3, Nik
was the first to show signs of diarrhoea
and vomiting at around 6.30pm. M4,
Ollie, was removed from the breeder's
household on 8 February and was reported
to have mild diarrhoea at that time which
had resolved by 14 February. Veterinary
treatment was sought on 14 February as the
pup was depressed and appeared to have
mild abdominal pain. M4 responded to
treatment with fluids, ( IV drip )
antibiotics and an antiemetic by the
following day and was discharged on 15
February. There is no report of any
further illness in this pup. F3, Mindi,
was removed from the breeder's household
on 9 February and had mild diarrhoea and
anorexia. She was treated with
antibiotics, an antidiarrhoeal suspension
and rehydration liquids. She responded
within a few days and was fine six days
later. Two other pups, M3, Nik and F4,
Dotti left the breeder's household briefly
on 7 February and then permanently on 10
February. M3 continued to deteriorate and
was hospitalized on 15 February with
haemorrhagic diarrhoea, dehydration and
weight loss. Coccidiosis was diagnosed on
19 February and treatment with toltrazuril
(a coccidiocidal drug) was commenced, but
M3 was euthanased on 20 February. F4 was
also reported to have diarrhoea on 19
February and was also treated with
toltrazuril and responded. The other seven
pups remained at the breeder's household
until at least 27 February. Veterinary
treatment was sought on 10, 14 and 19
February as the pups remained ill with
enteritis and diarrhoea. A faecal smear
performed on 14 February failed to detect
coccidia oocysts or worm eggs. On 19
February, coccidiosis was diagnosed by the
veterinary clinic and confirmed by a
commercial pathology laboratory and
toltrazuril treatment was commenced. A3
Coccidiosis was confirmed in one pup, Nik,
the day before he was euthanised and it
was presumed that all the other pups had
this as well, M4 Ollie and F3 Mindi were
never treated specifically for
coccidiosis.
It is understood that all these pups
responded well to this treatment. A4
This is also not quite correct, I
explained to Mr Preshaw that of the seven
remaining pups at my premises 3 males
responded to treatment, 2 males were
better but still passing loose stools and
the 2 females never responded to treatment
but continued to deteriorate. Two
adult dogs were also on the property at
this time. Neither dog was vaccinated
during this period. A5 ( both adult
dogs were fully vaccinated ) The
records do not indicate that either dog
was treated with toltrazuril on 19
February. Adult F, the mother of the pups,
vomited clear fluid with bile and a small
A6 ( large enough to ring the vet
immediately ) amount of blood on 20
February. Adult F and Adult M, an adult
male dog, were treated with toltrazuril on
21 February. Adult M vomited after
treatment, a suspected reaction to the
alkalinity of the medication, but both
were healthy after this.
By 23 February all the pups (apart from M3
the runt which had died) had responded to
the toltrazuril treatment for coccidiosis
and were healthy. A7 As I stated
earlier this is not correct, my report
submitted to both Fort Dodge and the APVMA
states:
On 25 February two female pups at the
breeder's household (F1 and F2) Bushka and
Missy were depressed and veterinary
treatment was sought. The following day
one of the pups, F1, had watery diarrhoea
and was presented comatose and dehydrated.
The pup died and parvovirus enteritis was
diagnosed on post-mortem histopathology.
Secondary bacterial infection was also
noted. The second female pup, F2, was
reported to have died on 1 March, but no
parvovirus test was conducted.
Two other pups, M5 and M6, Ben and Fergus
left the breeder's household on 1 March
and became ill
M5 (M6) was diagnosed with parvovirus and
recovered with veterinary treatment and
was discharged on 10 March. M6 (M5)
received veterinary treatment but did not
respond well and was euthanased on 10
March. It was assumed by the attending
veterinarian that M6 (M5) also suffered
from parvovirus enteritis but no
definitive diagnostic test for parvovirus
was performed on this dog. This is not
correct M5 was positively diagnosed with
parvo on 2/2/03 and was treated
unsuccessfully for same.
All other pups were not affected by this
second wave of serious illness. F3 and M7
had some sporadic mild enteritis signs
between 1-8 March, but their illness was
not severe. Four of the other six dogs
(F3, M7, M1 and M2) were tested for
parvovirus on 1 March and were negative.
We have no records of parvovirus testing
for M4 or F4.
Our assessment of the case is as follows.
The pups developed clinical signs of
coccidiosis shortly after vaccination. It
is not possible to identify exactly when
they were infected but they may have been
incubating the disease at the time they
were vaccinated. M4 and F3 which were
removed from the breeder's premises and
treated early, recovered before the other
pups. Although M3 was also removed from
the breeder's, he was a runt and it is not
unusual for runts to be more severely
affected by disease. F4 and the other pups
that remained at the breeder's were sick
until treated with toltrazuril on 19
February, after which they responded well
to this treatment. Not correct, see
Answer 7
The second wave of illness that affected
four pups and commenced on 25 February
See Answer 8 was due to parvovirus
in at least two of the cases, F1 and M6
(no definitive diagnosis was made in the
other two pups, F2 and M5). M5
positively diagnosed There is no
evidence of parvovirus in any of the pups
until this time. As the vet was
presuming coccidiosis no testing was done
for parvo until the autopsy of the first
female to die. The pups that succumbed
to parvovirus did not develop a protective
response after their first vaccination. It
is not unusual for 6-week-old pups to fail
to respond to vaccination, and this is the
reason why a number of vaccines need to be
given to pups until they are at least 12
weeks of age. No pup should be considered
immune to parvovirus until 7-10 days after
it has completed its full course of
vaccinations. Why the hell are we
vaccinating at 6 weeks then if it has a
good chance of not working and an even
better chance of it shedding into the
environment and infecting other dogs and
pups. Why are owners NOT told of this
possibility. In your instruction leaflet
it states " These vaccines can be used for
the prevention of clinical disease,
however they may fail to prevent infection
or organism shedding." Coccidiosis is a gastroenteritis disease caused by protozoal parasites collectively known as coccidia. The life cycle varies between different species however the overall pattern is the same. Dogs become infected through the ingestion of oocysts. The reproduction cycle is complex, but the simplified story is different stages of the organism infect the epithelial cells of the small intestine, sequentially multiplying and infecting neighbouring cells. The life-cycle is completed by the production of oocysts that are excreted in the faeces, and then act as a source of infection for other dogs. Some species of coccidia can infect other species such as rats and mice. Dormant tissue stages in these hosts can then act as a source of infection if eaten by a dog. Pups are most severely affected. Clinical disease is most commonly seen in weaning age animals, associated with high stress conditions such as weaning, high density housing, malnutrition or housing in wet environments. The only stress these pups had was a painful vaccination, they had been fully weaned for over a week, there was no ' high density housing ' situation, no malnutrition or wet environment, these were perfectly normal, happy, healthy pups on the day of vaccination.
Adults can develop immunity and become
carriers, acting as sources of infection
for others. However, not all dogs infected
develop clinical signs. Diagnosis of
coccidiosis is made by the identification
of oocysts in the faeces, or at post
mortem examination of the intestine.
Although oocysts were not identified in
faecal samples of these dogs on 14
February a negative result does not rule
out the disease. Dogs will not excrete
oocysts in the early stages of the disease
as the prepatent period (time from
infection to appearance of oocysts in the
faeces) is 7-8 days. Oocysts are then
excreted for 10-11 days (this is known as
the patent period) but it is possible that
they are not seen in a faecal sample
during this time. The disease is generally
self-limiting as the end of the patent
period indicates the end of the infection
in the animal. Part of a private e-mail
to me from a well known and respected US
research vet. D S
Some antibiotics can be used to treat
coccidiosis. Toltrazuril is probably the
most effective; a single dose is needed,
with The author notes that one of the effects of vaccines, the alteration of white cell trafficking (movement of white cells out of the blood stream into other compartments), has been confused with immunosuppression in the past. This is not immunosuppression; it is a normal part of the immune response. However, the author goes on to mention a few specific cases in the history of vaccination where immunosuppression has been documented. In dogs, of the hundreds of scientific papers on canine vaccines, there has only been one published study that indicated that polyvalent dog vaccines (vaccines for a number of diseases) containing a particular strain of distemper virus (not produced by Fort Dodge) may result in a short period of immunosuppression.{5} The comments about the ONE published study which showed immunosuppression following vaccination versus two other studies which failed to show this, is a poor point, because the same investigator (the world-renowned Dr. Ron Schultz) published all of them AND the one that showed immunosuppression was from 1989, when the other two were earlier (1987 and 1976). Obviously, the later paper is more current, especially when coming from the same place !!! Furthermore, the reference you cite for Dr. Carmichael (#1), on page 293 has a lot to say about safety issues with today's vaccines. In talking about MLV vaccines which are "attenuated " (page 293), he states " Because "attenuation" means reduction, not absolute loss of capacity to produce disease, safety problems may not be revealed until extensive field tests have been conducted; unfortunately, this has occurred after a product has been licensed and marketed. However, the authors acknowledge that their observations may have been due to alteration of white cell trafficking, a non-immunosuppressive effect of vaccination discussed above. They also note that because of the short duration of this effect, the practical significance of their results is unknown, and it is concluded {2} that in regards to immunosuppression, "vaccination by itself is unlikely to cause detectable adverse reactions in animals". From AVMA Journal 15/11/02 Introduction: Principles of Vaccination " Adverse events may be associated with the antigen, adjuvant, carrier, preservative, or a combination thereof. Possible adverse events include failure to immunize, anaphylaxis, immunosuppression ,autoimmune disorders, transient infections, and/or long term infected carrier states."
From The Immune System and Disease
Resistance, a paper by Dr W Jean Dodds,
DVM
From What Vets Don`t Tell You About
Vaccines: by Catherine O`Driscoll The authors also state that their results do not suggest dogs should not receive polyvalent vaccines. It is also worth noting that the same authors have published two other studies where they failed to demonstrate any immunosuppressive effects of canine vaccines.{4,6} With regards to immunosuppression and canine parvovirus strains in vaccines, the association is best described by DR Carmichael, a leading expert in canine vaccination from the College of Veterinary Medicine, Cornell University, New York. A question, could you tell us if it is true that Cornell University OWNS the PATENT on the parvo vaccine. He states that "the myth of 'immunosuppression' by virulent CPV-2 (canine parvovirus), or vaccine virus, has been discredited".{1} "Report of the American Animal Hospital Association (AAHA) Canine Vaccine Task Force: 2003 Canine Vaccine Guidelines, Recommendations, and Supporting Literature", 28 pages, published April 2003. Page 16 states " Modified live virus vaccines can and do cause disease because attenuation is a balance between maintaining infectivity while eliminating its pathogenicity. Individual response is dependent on the status of the recipient's immune system. Thus, an attenuated pathogen in a host which is severely immunosuppressed, or genetically more susceptible, may result in the vaccine causing the disease for which it was designed to prevent.' A Study at the School of Veterinary Medicine University of Wisconsin-Madison in 1993/1994 showed with at least one vaccine that while it provided protection against death it caused infection and clinical disease occurred.
Our research supports the conclusions of
these well-recognised researchers in
regards to immunosuppression and the
safety of vaccines. The results of our
safety studies with Protech Duramune have
not demonstrated immunosuppression in dogs
following vaccination. Canine parvovirus
can only multiply in the cells of an
animal. The host animal is the dog, but it
has also been demonstrated to replicate in
cats, and may also be spread by cats.
Infection occurs by ingestion of the
virus. When a dog is infected, the virus
enters the blood stream, replicates in the
lymphatic cells in the lymph nodes before
spreading through the blood stream again
and infecting the epithelial cells lining
the small intestine. This produces the
gastroenteritis (vomiting, then diarrhoea,
often haemorrhagic), and the virus is
passed out in the faeces in large numbers.
These contaminated faeces then act as a
source of infection for other dogs. The
incubation period of parvovirus is 4-7
days. This is the time that it takes
between ingestion of the virus to the
onset of the first clinical signs. There
is no specific treatment for parvovirus,
only supportive therapy to prevent
dehydration and ensure adequate nutrition.
If dogs do not die, they will develop
immunity, eliminate the viral infection
and recover over a period of up to 7 days
or so. Canine parvovirus is a particularly
hardy virus and can survive for months and
even years in the environment under the
right conditions. It was suggested that
the vaccine was responsible for producing
parvovirus diagnosed in some of the pups
after 25 February. To assess this
possibility, a number of points must be
examined including the details of the case
itself, the historical records of the
safety of parvovirus vaccines and the
development and manufacture of vaccines.
The most conclusive evidence that the
vaccine did not cause parvovirus in this
case is the history of the case itself. A
number of points are worth noting:
In your instruction leaflet it states "
These vaccines can be used for the
prevention of clinical disease, however
they may fail to prevent infection or
organism shedding." In that case is it
possible that one or more of the puppies
shed the virus after vaccination and
contaminated the environment for a weaker
pup to be exposed to the shed virus and
become infected, and as some of the pups
were progressively weakened by the
diarrhoea they in turn were also infected
by the shed virus or the infected pup.
This would explain why the 3 males who
responded to treatment and the pups who
had already left my premises did not
contract the parvovirus.
Comments please. DR Carmichael ( of Cornell University ) supports this view and states (with regards to virulence of vaccines): "No modified live CPV-2 vaccine has been reported to cause adverse reactions".{1}
What about MLV C3 or C4 or higher From Vaccination issues of concern to practitioners, COBTA and DAC special educational session on vaccine issues 1998: "Adverse reactions occur in some patients after vaccine administration. These reactions range from simple, self-limiting responses that are rather commonplace to complex, potentially life-threatening events that are uncommon".
From Vaccination: Helpful or Harmful?
By DR Don Hamilton, DVM
Due to the prevalence of this highly
infections virus, the situation where pups
have succumbed to parvovirus after
vaccination is not unique. However,
investigations of cases such as this
invariably identify a virus other than the
vaccine strain as the cause of the
disease. DR Parrish is reported to have
"isolated virus from many dogs with
clinical disease after vaccination, but
has never isolated vaccine virus as the
aetiology (cause) of clinical disease".{7}
An explanation of how pups may develop
parvovirus after vaccination is best
summarized by DR Carmichael: "Parvovirus
vaccines are exceptionally safe. Dogs that
develop signs and symptoms of parvovirus
infection within 5 days of vaccination
should be considered as infected with
virulent virus prior to, or at the time
of, vaccination. This is still a common
occurrence where parvovirus is likely to
be present in the environment".{1} In
other words this proves at least that the
pups were not incubating parvo at the time
of vaccination which indicates that the
pups must have been exposed about 12-13
days after vaccination, this appears to
fit the timeline of shedding and
infection. The reason that
modified-live viral vaccines are so safe
is that they contain attenuated
(Modified live virus vaccines can and
do cause disease because attenuation is a
balance between maintaining infectivity
while eliminating its pathogenicity. AAHA
report 2003) (weakened) strains of
virus that stimulate a protective immune
response, but do not produce clinical
signs of disease. Prior to marketing,
every precaution is taken to ensure
vaccines are safe. Extensive safety
studies must be conducted on a vaccine to
demonstrate that the vaccine strain does
not contain "residual virulence" (the
ability to produce clinical disease). The
parvovirus antigens used in vaccines must
be nonpathogenic, and must not cause
enteritis (vomiting and diarrhoea) in
dogs. Tests are also performed on all live
vaccines to ensure there is no "reversion
to virulence" (mutation into a form that
can cause disease). This is done by
isolating the vaccine virus from a
vaccinated dog, and inoculating another
dog (back passage) a number of times. Each
lot of vaccine is always made from the
same seed stock, so there is no variation
in the strain present between different
batches. Similarly, vaccines have to
satisfy strict quality assurance and
safety guidelines, and so there is minimal
variation in composition between batches.
Fort Dodge has conducted all these studies
on the vaccines it produces to ensure
their safety, and the results of these
studies support the conclusions held by
vaccine experts that canine parvovirus
vaccines do not produce parvovirus
enteritis. Finally, is also worth noting that the bitch Adult F, who was not vaccinated, ( the mother was fully vaccinated, a fact that Mr Preshaw is aware of) also had a gastrointestinal illness with clinical signs on 20 February. No definitive diagnosis for her illness was made, however the attending veterinarian suggested on 20 February that it may have been coccidiosis. It is also possible that Adult F's illness was caused by parvovirus, and that she acted as a source of parvovirus for the pups, as she was ill during the probable time of the pup's exposure to parvovirus (18-21 February). Is it also possible that if it was parvo that the virus shed by the recently vaccinated pups caused the mothers illness? We have reported this case to the Australian Pesticides and Veterinary Medicines Authority (APVMA; formerly the National Registration Authority for Agricultural and Veterinary Chemicals, NRA) Adverse Experience Reporting Program. Their report supports our conclusions. In regards to coccidiosis they state "there is no scientific evidence to support a direct link between administration of this vaccine and the development of coccidiosis post vaccination." In regards to source of parvovirus they concluded that the affected pups succumbed to a field parvovirus strain and state that "there is no evidence to support the tenet that live parvovirus vaccines can revert and cause disease". The APVMA have not at this time advised me of their finding on this case, if as you say they support your conclusions I would like to know the thoughts of both yourself and the APVMA ( I will e-mail them on this ) on the studies showing that parvovirus can shed from recently vaccinated animals and infect the environment and other animals. Also your comments on the American Animal Hospital Association (AAHA) Canine Vaccine Task Force: 2003 Canine Vaccine Guidelines, Recommendations, and Supporting Literature which states, as I have quoted above " Modified live virus vaccines can and do cause disease" and also "may result in the vaccine causing the disease for which it was designed to prevent" We understand that this unfortunate episode must have been extremely distressing to the breeder, the pups and the other owners. However, the history demonstrates that the diseases the pups suffered from are not directly related to vaccination and we do not believe that the vaccine is responsible. I have just received the assessment of the APVMA, it says
" the puppies initial clinical signs (
pain at injection site, diarrhea,
depression and anorexia) are possibly
related to the use of this product."
While I do not agree with this
assessment I do have to accept it. I await
answers from Mr Preshaw and the APVMA to
the points I have raised and will forward
them for inclusion on the site when and if
I receive them. I will also keep everyone
informed if I do not receive any
answers. Answers from Fort Dodge and APVMA follow
{1} Carmichael, LE. (1999). Canine viral
vaccines at a turning point--a personal
perspective. Adv. Vet. Med. 41 (1-2):
289-307.
Answers from Fort Dodge and the Apvma
Fort Dodge
Dear Mrs Sweeney,
The other issues you raise in your reply
have either been addressed in our report
(immunosuppression by vaccines, and
residual virulence and reversion to
virulence of canine parvovirus vaccines),
or are not relevant to this case (eg:
immune mediated disease).
Dear Mrs Sweeney, We would like to express our gratitude to Dot Sweeney for allowing us to reproduce her experiences. Disclaimer: Information contained here is obtained from various sources and does not replace the advice from a qualified professional. If the health of your dog/s is ever in question, you should consult your veterinarian first and foremost. No liability is accepted by Britfeld Weimaraners, owners of Britfeld Weimaraners, their families and/or their associates for any information contained here which may result in adverse outcome/s for your dog/s. [ Home
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