aaha vaccination guidelines
TRANSCRIPT
Michael A. Paul, DVMChairperson
Max Appel, DVM, PhD
Ralph Barrett, DVM, Diplomate ACVIM
Leland E. Carmichael, DVM, PhD,Diplomate ACVM
Henry Childers, DVM, Diplomate ABVP
Susan Cotter, DVM, Diplomate ACVIM
Autumn Davidson, DVM, Diplomate ACVIM
Richard Ford, DVM, MS, Diplomate ACVIM
Dan Keil, DVM, PhD, Diplomate ACVM
Michael Lappin, DVM, PhD, Diplomate ACVIM
Ronald D. Schultz, PhD, Diplomate ACVM
Eileen Thacker, DVM, Diplomate ACVM
Janice L. Trumpeter, DVM
Link Welborn, DVM, Diplomate ABVP
IntroductionFew in veterinary practice today can recall a time when serious infectiousdiseases were not preventable by the administration of safe immuniza-tions. With the exception of the canine parvovirus (CPV) pandemic in thelate 1970s, widespread morbidity and mortality due to life-threateningdiseases have largely been preventable in recent years. Even when CPVerupted on the scene, the rapid response by researchers and biologics(vaccine) manufacturers allowed our profession to curtail the terriblelosses of dogs to this disease. It is therefore safe to say that no singleachievement has had greater impact on the lives and well-being of ourpatients, our clients, and our ability to prevent infectious diseases than thedevelopment and ongoing improvements in companion animal vaccines.
The evolution of biologics represents a continuum of advances encom-passing efficacy, safety, and usage. Early vaccines did not enjoy the samesafety and efficacy profiles of currently available products, often resultingin adverse reactions or short durations of immunity (DOI). The resultingrecommendations for revaccination reflected these product limitations,and most of the widely accepted recommendations for revaccination werebased on a “better safe than sorry” approach because the diseases thesevaccines were designed to prevent were widespread and devastating.While the evolution of scientific knowledge has resulted in tremendous
REPORT of the American Animal Hospital Association (AAHA) Canine Vaccine Task Force 1
Report of the American Animal HospitalAssociation (AAHA) Canine Vaccine
Task Force: 2003 Canine Vaccine Guidelines, Recommendations,
and Supporting Literature
SPECIALReport
This document was developed by the American Animal Hospital Associationthrough a collaborative effort among Task Force members (see Appendix 1) to aidpractitioners in making decisions about appropriate care of their canine patientswith respect to currently available vaccines.
Limited published scientific information exists on duration of vaccine immunity.Therefore, these guidelines and recommendations are based on limited scientificevidence but are supported by consensus and expert opinion as well as clinicalexperience.
These guidelines and recommendations should not be construed as dictating anexclusive protocol, course of treatment, or procedure. Variations in practice maybe warranted based on the needs of the individual patient, resources, and limita-tions unique to each individual practice setting.
This report was funded in part by the AAHA Foundation.
improvements in the field of vaccinology, the ultimate goalof combining 100% efficacy and 100% safety into the samevaccine product is not a reality at this time. Although it ispossible to develop a vaccine that is virtually free of alladverse side effects, it would likely be a poor stimulant ofimmunity or produce a short DOI. Conversely, vaccines canbe produced that provide higher percentages of long-termimmunity but would exact a price of unacceptable adverseevents. Therefore, current knowledge supports the state-ment that no vaccine is always safe, no vaccine is alwaysprotective, and no vaccine is always indicated. However,the information that this statement is based on is in a con-stant state of flux; hence, the historical and current debateon appropriate vaccine use.
While significant efforts have been expended and real-ized with respect to vaccine efficacy and safety, theirimpact on product use (specifically vaccine protocols) haslargely been ignored until recently; this despite early rec-ommendations for less frequent revaccination. In 1978, “anideal vaccination program” was recommended where dogsand cats would be vaccinated as puppies and kittens andthen revaccinated at 1 year of age and every third yearthereafter.1 In 1998, the American Association of FelinePractitioners (AAFP) debated and subsequently endorsedthis same recommendation for feline core vaccines; theAAFP recommendations were updated in 2000.2 Also in1998, recommendations from a group of canine vaccineexperts were published.3 They recommended revaccinationwith canine core vaccines no more than once every 3 yearsfollowing initial booster revaccination at 1 year of age. Thisproposed vaccination program, and various iterationsthereof, has been adopted to varying degrees by a growingpart of the profession, but misunderstandings, misinforma-tion, and the conservative nature of the profession haveslowed adoption of these protocols advocating decreasedfrequency of revaccination.
In 2002, the American Veterinary Medical Association(AVMA) updated their vaccine guidelines4 after recogniz-ing that traditional guidelines were not compatible with therecommendations of a growing number of veterinary practi-tioners and experts in the fields of vaccinology and infec-tious diseases. Although many of these experts supporttriennial vaccination against core diseases, there is a rela-tive paucity of published scientific documentation to indi-cate that every 3 years is any more rational than every 2years or any less rational than every 7 years. For that reason,the AVMA and AAHA guidelines intentionally allow roomfor individual veterinarians to apply them. Information(including discussions on core/noncore vaccines, immunol-ogy, DOI, vaccine production and licensing, adverse eventreporting, and potential practice impact and opportunity) isprovided in this report for veterinarians to review and use asthey develop a vaccine program for their practices and theirindividual patients.
Many diseases we immunize against are ubiquitous.Many are serious and some even life threatening. Some areof limited demographic concern given the exposure risk for
each patient. These factors have all been considered indeveloping the AAHA Canine Vaccine Guidelines and Rec-ommendations. In the end, each veterinarian must do whathe or she determines to be in the best interest of the patient.Vaccination of individual animals produces not only indi-vidual immunity but also population or herd immunity.Since we have no readily available and reliable way todetermine if each patient has developed an adequateimmune response, we encourage the practice philosophy ofvaccinating more patients while vaccinating each patient nomore than needed.
Task Force Recommendations Regarding theSelection and Use of Canine Vaccine AntigensDecisions on vaccine selection and use require a balanceamong disease incidence and severity, vaccine efficacy(including DOI) and safety, and the health, welfare, andlifestyle of the individual animal. When taking all thesevariables into account, it becomes apparent that a blanket orgeneric statement encompassing the use of all vaccine prod-ucts is impossible to make. However, based on the growingbody of knowledge in the areas of vaccinology andimmunology, general vaccine guidelines are appropriateand useful as a foundation upon which to make specific rec-ommendations for individual patients. The 2003 AAHACanine Vaccine Guidelines and Recommendations are dis-cussed in the following sections as well as presented in aneasy-to-reference table format [Table 1]. These guidelinesare based on current knowledge with respect to disease inci-dence and severity and vaccine efficacy.
Vaccine Selection: Core (Recommended), Noncore(Optional), and Not Generally Recommended Canine VaccinesRecommended or “core” vaccines are those that the com-mittee believes should be administered to all puppies (dogs<6 months of age) or dogs with an unknown vaccinationhistory. The diseases involved have significant morbidityand mortality and are widely distributed. The committeebelieves this group of vaccines comprises canine distempervirus (CDV), CPV, canine adenovirus-2 (CAV-2), andrabies virus.
Optional or “noncore” vaccines are those that the com-mittee believes should be considered only in special cir-cumstances because their use is more dependent on theexposure risk of the individual animal. Issues of geographicdistribution and lifestyle should be considered beforeadministering these vaccines. In addition, the diseasesinvolved are generally self-limiting or respond readily totreatment. The committee believes this group of vaccinescomprises distemper-measles virus (D-MV), canine parain-fluenza virus (CPIV), Leptospira spp., Bordetella bronchi-septica, and Borrelia burgdorferi.
Vaccines identified as “not generally recommended”are those that the committee believes have little or no indi-cation. The diseases involved are either of little clinical sig-nificance or respond readily to treatment. In addition, the
2 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 3
Tab
le 1
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Can
ine
Dis
tem
per
Viru
sA
dmin
iste
r on
e do
se a
tO
ne d
ose
is p
rote
ctiv
e.A
nnua
lly (
man
ufac
ture
r)H
ighl
y R
ecom
men
ded:
Des
pite
(CD
V)
(MLV
)6-
8 w
ks, 9
-11
wks
, and
annu
al b
oost
er r
ecom
men
datio
ns,
12-1
4 w
ks o
f age
.A
fter
a bo
oste
r at
1 y
r,ad
ult d
ogs
chal
leng
ed 7
yrs
reva
ccin
atio
n on
ce e
very
(Roc
kbor
n S
trai
n) a
nd 5
yrs
3 yr
s is
con
side
red
(Ond
erst
epoo
rt S
trai
n) fo
llow
ing
prot
ectiv
e.M
LVva
ccin
atio
n w
ere
prot
ecte
d(D
OI)
.§U
sual
ly c
ombi
ned
with
CD
Van
d C
PV
vac
cina
tions
.
Abo
oste
r va
ccin
atio
n in
terv
al o
f3
yrs
amon
g ad
ult d
ogs
is p
rote
ctiv
ean
d re
ason
able
.
rCan
ine
Dis
tem
per
Viru
sA
dmin
iste
r on
e do
se a
tTw
o do
ses,
2-4
wks
apa
rt.
Ann
ually
(m
anuf
actu
rer)
Rec
omm
ende
d:A
s a
suita
ble
(rC
DV
) (r
ecom
bina
nt)
6-8
wks
, 9-1
1 w
ks, a
ndal
tern
ativ
e to
the
MLV
-CD
V a
nd12
-14
wks
of a
ge.
Afte
r a
boos
ter
at 1
yr,
may
be
used
inte
rcha
ngea
bly
with
annu
al r
evac
cina
tion
the
MLV
-CD
V v
acci
ne.
Ado
se ≥
4 w
ks a
fter
the
is r
ecom
men
ded.
last
dos
e in
this
ser
ies
Doe
s no
t rou
tinel
y pr
ovid
e st
erile
will
sig
nific
antly
incr
ease
imm
unity
and
may
take
long
er to
the
likel
ihoo
d of
ste
rile
prot
ect i
mm
unol
ogic
ally
nai
ve d
ogs.
imm
unity
\w
ith th
is p
rodu
ct.
The
refo
re, n
ot r
ecom
men
ded
whe
reC
DV
is a
ser
ious
thre
at fo
r pu
ppie
s(e
.g.,
shel
ters
, ken
nels
, pup
py/p
etst
ores
).
Min
imum
dem
onst
rate
d D
OIf
orrC
DV
is 1
yr.
The
refo
re, a
t pre
sent
,an
nual
rev
acci
natio
n is
rec
omm
ende
d.A
vacc
inat
ion
prog
ram
that
incl
udes
MLV
-CD
V v
acci
ne fo
r th
e in
itial
vacc
inat
ion
follo
wed
by
boos
ter
vacc
inat
ions
with
rC
DV
wou
ld p
rovi
deex
celle
nt p
rote
ctio
n; r
evac
cina
tion
with
rCD
V e
very
3 y
rs w
ould
be
reas
onab
lein
this
sce
nario
. (co
nti
nu
ed o
n n
ext
pag
e)
4 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Can
ine
Par
vovi
rus
Adm
inis
ter
one
dose
at
Two
dose
s, 3
-4 w
ks a
part
.A
nnua
lly (
man
ufac
ture
r)H
ighl
y R
ecom
men
ded:
Alth
ough
(CP
V-2
) (M
LV)
6-8
wks
, 9-1
1 w
ks, a
ndO
ne d
ose
is p
rote
ctiv
ean
nual
boo
ster
s ar
e re
com
men
ded
12-1
4 w
ks o
f age
.an
d ac
cept
able
.A
fter
a bo
oste
r at
1 y
r,by
vac
cine
man
ufac
ture
rs, s
tudi
esre
vacc
inat
ion
ever
y 3
yrs
have
sho
wn
prot
ectio
n ag
ains
tis
con
side
red
prot
ectiv
e.ch
alle
nge
(DO
I) u
p to
7 y
rspo
stva
ccin
atio
n w
ith M
LV v
acci
ne.
Pro
duct
s w
ith C
PV
-2 r
egar
dles
s of
geno
type
(i.e
., C
PV
-2, 2
a, o
r 2b
) al
lpr
ovid
e ex
celle
nt p
rote
ctio
n ag
ains
tfie
ld is
olat
es.
Can
ine
Par
vovi
rus
Adm
inis
ter
one
dose
at
Two
dose
s, 2
-4 w
ks a
part
,A
nnua
lly (
man
ufac
ture
r)R
ecom
men
ded:
As
a su
itabl
e (C
PV
-2)
(kill
ed)
6-8
wks
, 9-1
1 w
ks,
is r
ecom
men
ded.
alte
rnat
ive
to th
e M
LV c
anin
e 12
-14
wks
, and
15-
17 w
ksA
nnua
l vac
cina
tion
parv
oviru
s va
ccin
e in
low
-ris
kof
age
.re
com
men
ded
until
DO
Ien
viro
nmen
t.st
udie
s sh
ow lo
nger
than
1 yr
of p
rote
ctio
n w
ithN
ot r
ecom
men
ded
for
anim
als
atth
e ki
lled
prod
uct.
high
ris
k fo
r pa
rvov
irus
(e.g
.,sh
elte
rs, k
enne
ls, p
uppy
/pet
sto
res)
.W
hen
pupp
y is
vac
cina
ted
with
MLV
and
rev
acci
nate
dK
illed
par
vovi
rus
prod
ucts
are
at 1
yr
with
MLV
, kill
edsu
scep
tible
to m
ater
nal a
ntib
ody
prod
uct c
ould
be
used
inte
rfer
ence
in p
uppi
es a
s ol
d as
as b
oost
er ≥
3 yr
s.16
-18
wks
of a
ge.
Can
ine
Ade
novi
rus-
2A
dmin
iste
r on
e do
se a
tO
ne d
ose
(if u
sing
MLV
)A
nnua
lly (
man
ufac
ture
r)R
ecom
men
ded:
Dem
onst
rate
d (C
AV
-2)
(MLV
, kill
ed,
6-8
wks
, 9-1
1 w
ks, a
ndcr
oss
prot
ectio
n ag
ains
t can
ine
or M
LV-t
opic
al)
12-1
4 w
ks o
f age
.Tw
o do
ses,
2-4
wks
apa
rtU
pon
com
plet
ion
of th
ehe
patit
is (
CA
V-1
) an
d C
AV
-2, o
ne o
f(if
usi
ng k
illed
)in
itial
ser
ies,
and
th
e ag
ents
kno
wn
to b
e as
soci
ated
follo
win
g a
boos
ter
atw
ith in
fect
ious
trac
heob
ronc
hitis
.1
yr, r
evac
cina
tion
once
Adu
lt do
gs c
halle
nged
7 y
rs fo
llow
ing
ever
y 3
yrs
is c
onsi
dere
dC
AV
-2 M
LV v
acci
natio
n ha
ve b
een
prot
ectiv
e.fo
und
to b
e pr
otec
ted
(DO
I) a
gain
stth
e m
ore
viru
lent
CA
V-1
.
(co
ntin
ued
on
nex
t pag
e)
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 5
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Can
ine
Ade
novi
rus-
2U
sual
ly c
ombi
ned
with
CD
Van
d (c
ontin
ued)
CP
V v
acci
nes;
rev
acci
natio
n ev
ery
3 yr
s w
ould
be
prot
ectiv
e an
dre
ason
able
.
Rab
ies
1-ye
ar (
kille
d)A
dmin
iste
r on
e do
se a
sA
dmin
iste
r a
sing
le d
ose.
Ann
ually
. Sta
te, p
rovi
ncia
l,R
equi
red:
Sta
te, p
rovi
ncia
l, an
dea
rly a
s 3
mos
of a
ge.
and/
or lo
cal l
aws
appl
y.lo
cal s
tatu
tes
gove
rn th
e fr
eque
ncy
of a
dmin
istr
atio
n fo
r pr
oduc
ts la
bele
dT
he 1
-yr
rabi
es v
acci
neas
“1-
year
rab
ies.
”m
ay b
e us
ed a
s a
boos
ter
vacc
ine
whe
n do
gs a
reN
ote:
The
rab
ies
(1-y
r) v
acci
ne is
requ
ired
by s
tatu
te to
be
som
etim
es a
dmin
iste
red
as th
eva
ccin
ated
ann
ually
initi
al d
ose
follo
wed
1 y
r la
ter
byag
ains
t rab
ies.
adm
inis
trat
ion
of th
e ra
bies
3-y
rva
ccin
e. S
tate
, pro
vinc
ial,
and
loca
lst
atut
es m
ay d
icta
te o
ther
wis
e.
One
-yr
rabi
es p
rodu
cts
shou
ld n
otbe
con
side
red
to c
ause
few
er
adve
rse
reac
tions
whe
n gi
ven
annu
ally
than
3-y
r ra
bies
pro
duct
s.
Not
e:R
oute
of a
dmin
istr
atio
n m
ayno
t be
optio
nal—
see
prod
uct
liter
atur
e fo
r de
tails
.
Rab
ies
3-ye
ar (
kille
d)A
dmin
iste
r on
e do
se a
sA
dmin
iste
r a
sing
le d
ose.
The
sec
ond
rabi
esR
equi
red:
Sta
te, p
rovi
ncia
l, an
d lo
cal
early
as
3 m
os o
f age
.va
ccin
atio
n is
rec
omm
ende
dst
atut
es g
over
n th
e fr
eque
ncy
ofN
ote:
The
3-y
r ra
bies
vac
cine
1 yr
follo
win
g ad
min
istr
atio
nad
min
istr
atio
n fo
r pr
oduc
ts la
bele
dN
ote:
The
3-y
r ra
bies
vac
cine
may
be
used
as
anof
the
initi
al d
ose
rega
rdle
ssas
rab
les
3-yr
—th
ese
stat
utes
var
ym
ay b
e us
ed a
s an
alte
rnat
ive
to th
e 1-
yr r
abie
sof
the
anim
al’s
age
at t
heth
roug
hout
the
U.S
. and
Can
ada.
alte
rnat
ive
to th
e 1-
yr r
abie
sva
ccin
e fo
r in
itial
and
time
the
first
dos
e w
asva
ccin
e fo
r in
itial
and
subs
eque
nt d
oses
. Loc
alad
min
iste
red.
Not
e:T
he r
abie
s 1-
yr v
acci
ne is
subs
eque
nt d
oses
. Loc
alst
atut
es a
pply
.so
met
imes
adm
inis
tere
d as
the
stat
utes
app
ly.
(co
ntin
ued
on
nex
t pag
e)
6 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Rab
ies
3-ye
ar
Boo
ster
vac
cine
s sh
ould
be
initi
al d
ose
follo
wed
1 y
r la
ter
by(c
ontin
ued)
adm
inis
tere
d ev
ery
3 yr
s.ad
min
istr
atio
n of
the
rabi
es 3
-yr
vacc
ine.
Sta
te, p
rovi
ncia
l, an
d/or
Sta
te, p
rovi
ncia
l, an
d lo
cal s
tatu
tes
may
loca
l law
s ap
ply.
dict
ate
othe
rwis
e.
Eve
ry e
ffort
sho
uld
be m
ade
to c
hang
ela
ws
that
req
uire
vac
cina
tion
with
this
rabi
es p
rodu
ct m
ore
ofte
n th
an e
very
3yr
s si
nce
annu
al v
acci
natio
ns c
anno
t be
show
n to
incr
ease
effi
cacy
and
it is
kn
own
to in
crea
se a
dver
se e
vent
s.
Not
e:R
oute
of a
dmin
istr
atio
n m
ay n
ot b
eop
tiona
l—se
e pr
oduc
t lite
ratu
re fo
rde
tails
.
Dis
tem
per-
Mea
sles
One
dos
e be
twee
n 4
and
Not
indi
cate
d fo
r us
e in
Rev
acci
natio
n is
not
Opt
iona
l (N
ot R
ecom
men
ded
for
Rou
tine
Viru
s (D
-MV
) (M
LV)
12 w
ks o
f age
on
ly
dogs
ove
r 12
wks
of a
ge.
reco
mm
ende
d. D
-MV
U
se):
Inte
nded
to p
rovi
de te
mpo
rary
(fol
low
with
one
dos
eva
ccin
e w
ould
not
cau
sepr
otec
tion
in y
oung
pup
pies
onl
y.M
LV-C
DV
or
two
dose
sM
ay p
rodu
ce m
ater
nal M
Van
y he
alth
pro
blem
in th
eIn
dica
ted
for
use
in h
ouse
hold
s/ke
nnel
s/rC
DV
vac
cine
afte
ran
tibod
ies
that
wou
ld b
ere
cipi
ent,
but i
f use
d in
ash
elte
rs w
here
CD
V is
a r
ecog
nize
d12
wks
of a
ge).
pass
ed to
sub
sequ
ent p
ups
bree
ding
fem
ale,
pup
pies
prob
lem
.of
fem
ale
dogs
res
ultin
g in
wou
ld a
cqui
re M
V
bloc
king
of p
uppy
res
pons
ean
tibod
y an
d th
e D
o no
t adm
inis
ter
to fe
mal
e do
gs o
ver
to D
-MV
vac
cina
tion.
prot
ectio
n of
fere
d by
the
12 w
ks o
f age
.M
V w
ould
be
lost
.N
ote:
Adm
inis
ter
IMon
ly—
MV
doe
s no
tef
fect
ivel
y im
mun
ize
if ad
min
iste
red
subc
utan
eous
ly.
Par
ainf
luen
za V
irus
Adm
inis
ter
one
dose
at
One
dos
e is
ade
quat
e.A
nnua
lly (
man
ufac
ture
r)R
ecom
men
ded:
Par
ente
ral v
acci
ne is
(CP
IV)
(MLV
or
6-8
wks
, 9-1
1 w
ks, a
ndus
ually
com
bine
d w
ith C
DV,
CP
V-2
, and
MLV
-top
ical
)12
-14
wks
of a
ge.
Par
ente
ral—
Upo
nC
AV
vac
cine
s.co
mpl
etio
n of
the
initi
alse
ries,
and
follo
win
g a
Par
ente
rally
adm
inis
tere
d va
ccin
e is
less
boos
ter
at 1
yr,
reva
ccin
atio
nef
fect
ive
than
topi
cally
(in
tran
asal
)on
ce e
very
3 y
rs is
ad
min
iste
red
vacc
ine.
cons
ider
ed p
rote
ctiv
e (D
OI)
.(c
on
tinu
ed o
n n
ext p
age)
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 7
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Par
ainf
luen
za V
irus
Intr
anas
al c
omm
only
giv
enTo
pica
l is
in c
ombi
natio
n w
ith
(con
tinue
d)an
nual
ly w
ith B
orde
tella
Bor
dete
llaor
Bor
dete
llaan
d C
AV
-2.
bron
chis
eptic
a.D
OI b
y ch
alle
nge
has
been
sho
wn
to b
e at
leas
t 1 y
r (u
npub
lishe
d)fo
r to
pica
l vac
cine
.
Lept
ospi
ra in
terr
ogan
sA
dmin
iste
r on
e do
se a
tTw
o do
ses,
2-4
wks
apa
rtA
nnua
lly (
man
ufac
ture
r)O
ptio
nal:
Dis
ease
pre
vale
nce
is li
kely
to(c
ombi
ned
with
ser
ovar
s12
wks
and
a s
econ
dva
ry fo
r ea
ch s
erov
ar. V
acci
neca
nico
laan
ddo
se a
t 14-
16 w
ks.
Ann
ually
unl
ess
seve
rere
com
men
datio
ns a
re th
eref
ore
diffi
cult
icte
roha
emor
rhag
iae)
inci
denc
e of
lept
ospi
rosi
sto
mak
e du
e to
the
lack
of i
nfor
mat
ion
on(k
illed
bac
terin
)D
o no
t adm
inis
ter
to d
ogs
cont
inue
s. In
situ
atio
ns o
fpr
eval
ance
of s
peci
fic s
erov
ar in
fect
ions
<12
wks
of a
ge fo
r op
timal
sign
ifica
nt h
igh-
risk
in d
ogs
in v
ario
us g
eogr
aphi
c re
gion
s.(A
lso
avai
labl
ere
spon
se.
expo
sure
, adm
inis
ter
aw
ith s
erov
ars
boos
ter
ever
y 6
mos
.A
necd
otal
rep
orts
from
vet
erin
aria
ns a
ndgr
ippo
typh
osa
and
Dis
cont
inue
6 m
os
bree
ders
sug
gest
that
the
inci
denc
e of
pom
ona)
boos
ter
whe
n lo
cal o
rpo
stva
ccin
atio
n re
actio
ns (
acut
ere
gion
al in
cide
nce
prob
lem
anap
hyla
xis)
in p
uppi
es (
<12
wks
of a
ge)
is im
prov
ed s
ince
this
and
smal
l-bre
ed d
ogs
is h
igh.
Rea
ctio
nspr
oduc
t car
ries
high
-ris
kar
e m
ost s
ever
e in
you
ng (<
9 w
ks o
f age
)fo
r ad
vers
e va
ccin
epu
ppie
s. R
outin
e us
e of
the
vacc
ine
even
ts.
shou
ld b
e de
laye
d un
til d
ogs
are
≥9 w
ksof
age
. Old
er d
ogs
are
mor
e lik
ely
tode
velo
p an
opt
imal
imm
une
resp
onse
than
you
nger
ani
mal
s.
Min
imum
DO
I bas
ed o
n ch
alle
nge
stud
ies
has
been
sho
wn
to b
e ap
prox
imat
ely
1 yr
for
sero
vars
cani
cola
and
icte
roha
emor
rhag
iae;
how
ever
, effi
cacy
of
the
prod
ucts
can
be
low
(<7
5%).
DO
I for
ser
ovar
s gr
ippo
gyph
osa
and
pom
ona
are
assu
med
to b
e up
to 1
yr.
Bor
dete
lla b
ronc
hise
ptic
aA
dmin
iste
r on
e do
se a
tTw
o do
ses,
2-4
wks
apa
rtA
nnua
lly (
man
ufac
ture
r)O
ptio
nal (
Rec
omm
ende
d):
(kill
ed b
acte
rin)—
6-8
wks
and
then
at
DO
I is
appr
oxim
atel
y 9
to 1
2 m
os.
pare
nter
al10
-12
wks
of a
ge.
The
re is
no
know
n ad
vant
age
to
(co
ntin
ued
on
nex
t pag
e)
8 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Bor
dete
lla b
ronc
hise
ptic
aA
nnua
lly o
r m
ore
ofte
nad
min
iste
ring
pare
nter
al a
nd(k
illed
bac
terin
)in
ver
y hi
gh-r
isk
anim
als
intr
anas
al B
orde
tella
bro
nchi
sept
ica
(con
tinue
d)no
t pro
tect
ed b
y an
nual
vacc
ines
sim
ulta
neou
sly.
boos
ter.
Bor
dete
lla b
ronc
hise
ptic
aA
dmin
iste
r a
sing
le d
ose
Not
stip
ulat
ed, a
lthou
ghA
nnua
lly (
man
ufac
ture
r)O
ptio
nal (
Rec
omm
ende
d):F
or d
ogs
(live
avi
rule
nt b
acte
ria)
+as
ear
ly a
s 3
wks
of a
gea
sing
le d
ose
isho
used
in k
enne
ls, s
helte
rs, a
nd p
rior
toP
arai
nflu
enza
Viru
s(s
ee p
rodu
ct li
tera
ture
reco
mm
ende
d by
the
If no
t vac
cina
ted
with
inbo
ardi
ng in
ken
nels
.(M
LV)-
topi
cal (
intr
anas
al)
for
spec
ific
age
man
ufac
ture
r.th
e pr
evio
us 6
mos
, aap
plic
atio
nre
com
men
datio
ns).
boos
ter
is r
ecom
men
ded
Not
e:Tr
ansi
ent (
3-10
day
s) c
ough
ing,
1 w
k pr
ior
to k
now
nsn
eezi
ng, o
r na
sal d
isch
arge
occ
urs
inF
or b
est r
esul
ts, i
f the
expo
sure
(e.
g., b
oard
ing,
a sm
all p
erce
ntag
e of
vac
cina
tes.
prod
uct i
s us
ed p
rior
tosh
owin
g, e
tc.)
.A
ntim
icro
bial
ther
apy
may
be
indi
cate
d to
5-6
wks
of a
ge, i
t sho
uld
man
age
post
vacc
inat
ion
uppe
rbe
giv
en a
gain
afte
r 6
wks
resp
irato
ry s
igns
(pe
rsis
tent
cou
gh a
ndof
age
.na
sal d
isch
arge
). D
OIi
s be
lieve
d to
be
appr
oxim
atel
y 10
mos
for
Bor
dete
llabr
onch
isep
tica.
Not
e:To
pica
lly a
dmin
iste
red
vacc
ines
for
cani
ne in
fect
ious
trac
heob
ronc
hitis
may
prov
ide
a su
perio
r lo
cal i
mm
une
resp
onse
com
pare
d to
par
ente
rally
adm
inis
tere
d va
ccin
es.
Bor
dete
lla b
ronc
hise
ptic
aA
dmin
iste
r a
sing
le d
ose
Asi
ngle
dos
e is
A
nnua
lly (
man
ufac
ture
r)O
ptio
nal (
Rec
omm
ende
d):F
or d
ogs
(live
avi
rule
nt b
acte
ria)
+at
≥8
wks
of a
ge.
reco
mm
ende
d.co
nsid
ered
to b
e at
ris
k of
exp
osur
e to
CP
IV (
MLV
) +
CA
V-2
Man
ufac
ture
rs’
Sam
e re
com
men
datio
nan
y of
the
path
ogen
s lis
ted.
(MLV
)-to
pica
lre
com
men
datio
ns o
n th
eas
for
intr
anas
al w
ith(in
tran
asal
) ap
plic
atio
nea
rlies
t age
for
adm
inis
terin
gC
PIV
.T
his
prod
uct h
as n
ot b
een
show
n to
the
first
dos
e va
ries
and
may
prov
ide
any
bene
fit n
ot a
chie
ved
with
the
be a
s ea
rly a
s 3-
4 w
ks.
intr
anas
al B
orde
tella
bro
nchi
sept
ica
plus
Adm
inis
terin
g an
intr
anas
alca
nine
par
ainf
luen
za v
irus
in d
ogs
that
vacc
ine
to d
ogs
this
you
ng is
are
rece
ivin
g C
AV
-2 p
aren
tera
lly.
reco
mm
ende
d on
ly in
situ
atio
ns w
here
ther
e is
Not
e:To
pica
lly a
dmin
iste
red
vacc
ines
for
cons
ider
able
ris
k of
exp
osur
eca
nine
infe
ctio
us tr
ache
obro
nchi
tis m
ayan
d th
e va
ccin
e ca
n be
(co
ntin
ued
on
nex
t pag
e)
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 9
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(b
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
nR
eco
mm
end
atio
ns
Bor
dete
lla b
ronc
hise
ptic
aad
min
iste
red
5 da
yspr
ovid
e a
supe
rior
loca
l im
mun
e (li
ve a
viru
lent
bac
teria
)pr
ior
to a
kno
wn
expo
sure
.re
spon
se c
ompa
red
to p
aren
tera
lly(c
ontin
ued)
adm
inis
tere
d va
ccin
es.
DO
Is a
s no
ted
abov
e fo
r in
divi
dual
vacc
ines
.
Bor
relia
bur
gdor
feri
Initi
al d
ose
may
be
give
nTw
o do
ses,
2-4
wks
apa
rtA
nnua
lly (
man
ufac
ture
r)O
ptio
nal:
Gen
eral
ly r
ecom
men
ded
only
(Lym
e bo
rrel
iosi
s)at
9 o
r 12
wks
of a
ge
for
use
in d
ogs
with
a k
now
n hi
gh r
isk
of(k
illed
who
le b
acte
rin)
(dep
endi
ng o
n m
anuf
actu
rer
Rev
acci
nate
just
prio
r to
expo
sure
; pre
fera
bly
dogs
livi
ng o
rre
com
men
datio
ns)
and
ast
art o
f ins
ect (
tick)
resi
ding
in e
ndem
ic a
reas
or
regi
ons
seco
nd d
ose
is r
equi
red
seas
onw
here
the
risk
of ti
ck e
xpos
ure
is
2-4
wks
late
r.co
nsid
ered
to b
e hi
gh. M
inim
um D
OI
base
d on
cha
lleng
e st
udie
s is
1 y
r.
Bor
relia
bur
gdor
feri
Initi
al d
ose
may
be
give
nTw
o do
ses,
2-4
wks
apa
rtA
nnua
lly (
man
ufac
ture
r)O
ptio
nal:
Gen
eral
ly r
ecom
men
ded
only
(rLy
me
borr
elio
sis)
at 9
wks
of a
ge w
ith a
for
use
in d
ogs
with
a k
now
n hi
gh r
isk
of(r
ecom
bina
nt-O
uter
seco
nd d
ose
requ
ired
2-4
Ann
ually
, jus
t prio
r to
expo
sure
, pre
fera
bly
dogs
livi
ng o
rS
urfa
ce P
rote
in A
wks
late
r. O
ptim
al a
ge fo
rst
art o
f ins
ect (
tick)
resi
ding
in e
ndem
ic a
reas
or
regi
ons
[Osp
A])
the
initi
al d
ose
is ≥
3se
ason
whe
re th
e ris
k of
tick
exp
osur
e is
mos
, with
a s
econ
d do
seco
nsid
ered
to b
e hi
gh.
2-4
wks
late
r.T
he m
inim
um D
OI f
or th
e re
com
bina
ntva
ccin
e is
at l
east
1 y
r, ba
sed
onch
alle
nge.
(co
ntin
ued
on
nex
t pag
e)
10 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Can
ine
Cor
onav
irus
Adm
inis
ter
one
dose
eve
ryO
ne d
ose
(if u
sing
MLV
)A
nnua
lly (
man
ufac
ture
r)N
ot R
ecom
men
ded:
Pre
vale
nce
of(C
CV
)2-
4 w
ks o
f age
unt
il 12
wks
(man
ufac
ture
r)cl
inic
al c
ases
of c
onfir
med
CC
V d
isea
se(k
illed
and
MLV
)of
age
(M
LV a
nd k
illed
).N
ot r
ecom
men
ded
does
not
just
ify v
acci
natio
n. C
linic
alTw
o do
ses,
2-4
wks
apa
rtun
til th
is p
rodu
ct is
di
seas
e ra
rely
occ
urs
but w
hen
seen
isC
an b
egin
as
early
as
(if u
sing
kill
ed)
dem
onst
rate
d to
pro
vide
typi
cally
mild
and
sel
f-lim
iting
.6
wks
of a
ge w
ith(m
anuf
actu
rer)
bene
fit n
ot a
chie
ved
with
boos
ters
eve
ry 2
-3 w
ksa
vacc
ine
com
bina
tion
It is
rec
omm
ende
d th
at a
nim
al s
helte
rsw
ith th
e fin
al d
ose
at(N
ot r
ecom
men
ded
inth
at d
oes
not i
nclu
de C
CV.
not u
tiliz
e th
e C
CV
vac
cine
in r
outin
e12
wks
of a
ge (
kille
d).
adul
t dog
s as
nei
ther
vacc
inat
ion
prog
ram
s du
e to
add
ition
ala
need
nor
ben
efit
has
cost
s in
curr
ed a
nd th
e la
ck o
f def
ined
been
dem
onst
rate
d.)
bene
fit. E
xper
ienc
e ha
s sh
own
noad
ditio
nal i
ncre
ase
in in
fect
ious
ent
eriti
sam
ong
adul
ts o
r pu
ppie
s su
bseq
uent
todi
scon
tinui
ng th
e C
CV
vac
cine
.
Nei
ther
the
MLV
vacc
ine
nor
the
kille
dC
CV
vac
cine
has
bee
n sh
own
tosi
gnifi
cant
ly r
educ
e di
seas
e ca
used
by
aco
mbi
natio
n of
CC
Van
d C
PV
-2. O
nly
CP
V-2
vac
cine
s ha
ve b
een
show
n to
prot
ect d
ogs
agai
nst c
halle
nge
whe
nth
ese
two
viru
ses
are
used
.
The
DO
I for
the
CC
Vva
ccin
e ca
nnot
be
dete
rmin
ed.
Gia
rdia
lam
blia
Initi
al d
ose
may
be
give
nTw
o do
ses,
2-4
wks
apa
rtA
nnua
lly (
man
ufac
ture
r)N
ot R
ecom
men
ded:
The
vac
cine
may
(kill
ed)
at 8
wks
of a
ge a
nd a
prev
ent o
ocys
t she
ddin
g bu
t doe
s no
tse
cond
dos
e sh
ould
be
Boo
ster
s no
t nec
essa
rypr
even
t inf
ectio
n.gi
ven
2-4
wks
late
r.in
dog
s ≥1
yr
of a
geIn
fect
ion
in p
uppi
es a
nd k
itten
s is
ofte
nsu
bclin
ical
.
Alth
ough
gia
rdia
sis
is th
e m
ost c
omm
onin
test
inal
par
asite
am
ong
peop
le in
the
U.S
., th
e so
urce
of h
uman
infe
ctio
n is
(co
ntin
ued
on
nex
t pag
e)
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 11
Tab
le 1
(co
nt’d
)
AA
HA
2003
Can
ine
Vac
cina
tion
Gui
delin
es a
nd R
ecom
men
datio
ns*
Init
ial P
up
py
Vac
cin
atio
n‡
Init
ial A
du
lt V
acci
nat
ion
Rev
acci
nat
ion
(B
oo
ster
)O
vera
ll C
om
men
ts a
nd
Vac
cin
e†(≤
16 w
eeks
)(>
16 w
eeks
)R
eco
mm
end
atio
ns
Rec
om
men
dat
ion
s
Gia
rdia
lam
blia
cont
amin
ated
wat
er. I
nfec
tions
in d
ogs
(con
tinue
d)an
d ca
ts a
re n
ot li
kely
to b
e zo
onot
ic.
Bec
ause
the
vacc
ine
does
not
pre
vent
infe
ctio
n, a
min
imum
DO
I bas
ed o
nch
alle
nge
is n
ot r
epor
ted.
Can
ine
Ade
novi
rus-
1A
dmin
iste
r on
e do
se a
tK
illed
vac
cine
: Tw
o do
ses,
Ann
ually
(m
anuf
actu
rer)
Not
Rec
omm
ende
d:B
ased
on
the
low
(CA
V-1
) (M
LV a
nd6-
8 w
ks, 9
-11
wks
, and
2-4
wks
apa
rtpr
eval
ence
of i
nfec
tious
can
ine
hepa
titis
kille
d)12
-14
wks
of a
ge.
Upo
n co
mpl
etio
n of
the
in N
orth
Am
eric
a an
d th
e si
gnifi
cant
ris
kM
LVva
ccin
e: O
ne d
ose
intia
l ser
ies,
and
follo
win
gof
“he
patit
is b
lue-
eye”
rea
ctio
ns. C
AV
-2a
boos
ter
at 1
yr,
vacc
ines
will
cro
ss-p
rote
ct a
gain
st C
AV
-1re
vacc
inat
ion
once
eve
ryan
d ar
e m
uch
safe
r. Va
ccin
es c
onta
inin
g3
yrs
is c
onsi
dere
dC
AV-
1 ar
e n
ot r
eco
mm
end
ed.
prot
ectiv
e.
*T
he A
AH
A20
03 C
anin
e V
acci
natio
n G
uide
lines
and
Rec
omm
enda
tions
are
pro
vide
d to
ass
ist v
eter
inar
ians
in d
evel
opin
g a
vacc
inat
ion
prot
ocol
for
use
in c
linic
al p
ract
ice.
The
y ar
e n
ot
inte
nded
to r
epre
sent
vac
cina
tion
stan
dard
s fo
r al
l dog
s.†
MLV
=m
odifi
ed li
ve v
irus;
r=
reco
mbi
nant
‡R
oute
of a
dmin
istr
atio
n is
SQ
or
IM u
nles
s ot
herw
ise
note
d by
the
man
ufac
ture
r.§
DO
I=du
ratio
n of
imm
unity
\S
teril
e im
mun
ity=
com
plet
e pr
even
tion
of in
fect
ion
vaccines available against these diseases have not demon-strated clinical efficacy in the prevention of disease andmay produce adverse events with limited benefit. The vac-cines that the committee believes fall into this category areGiardia spp., canine coronavirus (CCV), and canine aden-ovirus-1 (CAV-1).
Vaccine Frequency of UseAll commercially available vaccine products have attendantvaccine protocols as defined by their manufacturers. Thesegenerally involve an initial (often puppy) series, followed byrecommendations for revaccination (booster) at 1 year of ageand annually (or less) thereafter. Regardless of product cho-sen, the current controversy over vaccination protocols cen-ters on the traditional recommendation regardingrevaccination schedules for dogs >1 year of age. The cur-rently recommended vaccination schedules (with respect tofrequency, not product choice) for dogs <1 year of age havenot been questioned. Based on a growing body of informa-tion regarding immunology and product DOI in both animalsand humans, the need for annual revaccination has beenplaced in doubt. Duration of immunity is the critical deter-mining factor, but it defies simple definition, principally,because it is derived from a complex interplay between thehost’s immune response (see The Immune System as itApplies to Vaccination section) and the vaccine in question,and it is difficult to measure in an individual animal withoutdirect challenge. Current scientific knowledge demonstratesthat DOI varies among vaccines and is influenced by vaccinetype (e.g., modified live virus [MLV], killed, or recombi-nant), route of administration, and antigen content and oftenextends for >1 year. This information is summarized in thefollowing section on specific vaccine recommendations.
Specific Vaccine Recommendations: Core VaccinesCanine Distemper Virus (CDV): Infection with CDVcauses significant morbidity in unprotected animals and isassociated with high rates of mortality from respiratory,gastrointestinal, and neurological abnormalities; there isminimal geographic difference in its distribution. Therefore,all puppies should be vaccinated with a CDV vaccine, andboosters should be administered throughout the dog’s life[Table 1]. Dogs with unknown vaccine histories should beconsidered at risk and vaccinated, and boosters should beadministered throughout the dog’s life [Table 1].
Challenge of immunity studies have shown that the mini-mum DOI for MLV-CDV vaccines derived from the Rock-born strain and the Onderstepoort strain are 7 and 5 years,respectively, and for the canarypox-vectored CDV vaccine,it is 1 year (not tested beyond 1 year). The minimum DOIfor these same vaccines, using antibody titers at levels thatprovide sterilizing immunity, are 12 to 15 years for Rock-born and 9 years for Onderstepoort [Table 2]. The canary-pox-vectored CDV vaccine does not provide sterilizingimmunity in the majority of puppies receiving the requiredtwo doses of this vaccine. The recombinant vaccine doesprovide excellent immunity—infection occurs, but
anamnestic (memory) humoral and CMI responses developand the challenged dog is protected from disease.
Therefore, following the initial vaccination series, revac-cination every 3 years is considered protective for MLV-CDV vaccines and, due to the lack of information,revaccination every year for recombinant CDV vaccines isconsidered protective.
Canine Parvovirus (CPV-2): Infection with CPV-2 causeshigh morbidity and mortality in unprotected dogs primarilyfrom gastrointestinal disease; the organism has worldwidedistribution. Therefore, all puppies should be vaccinatedwith a CPV vaccine, and boosters should be administeredthroughout the dog’s life [Table 1]. Dogs with unknownvaccine histories should be considered at risk and vacci-nated, and boosters should be administered throughout thedog’s life [Table 1].
Challenge studies have shown that the minimum DOI forMLV-CPV-2 vaccines is 7 years. The minimum DOI forthese same vaccines based on serological data for sterilizingimmunity is up to 10 years [Table 2].
Therefore, following the initial vaccination series, revac-cination with an MLV-CPV-2 vaccine every 3 years is con-sidered protective. However, if a killed CPV-2 is beingused, due to lack of DOI information, annual revaccinationis recommended unless it is used as a booster following aninitial series with an MLV-CPV-2 vaccine. In this scenario,revaccination every 3 years is considered protective.
Canine Adenovirus-2 (CAV-2): Infection with CAV-2causes a self-limiting respiratory disease in some infecteddogs but produces an immune response that cross-protectsagainst canine adenovirus-1 (CAV-1) infection, the etiologyof canine infectious hepatitis, which has worldwide distri-bution. The CAV-1 vaccine has been associated with anunacceptable rate of serious adverse events (e.g., interstitialnephritis, anterior uveitis) and should not be administered;however, CAV-2 vaccines are safer. Therefore, all puppiesshould be vaccinated with a CAV-2 vaccine, and boostersshould be administered throughout the dog’s life [Table 1].Dogs with unknown vaccine histories should be consideredat risk and vaccinated, and boosters should be administeredthroughout the dog’s life [Table 1].
The minimum DOI for CAV-1 and CAV-2 vaccines,based on challenge immunity for CAV-1, is 7 years. Theminimum DOI based on antibody titers is at least 9 years[Table 2].
Therefore, following the initial vaccination series, revac-cination every 3 years is considered protective.
Rabies Virus (RV): Infection with RV causes a fatal neuro-logical disease, and infected dogs are a potential source forhuman infection, resulting in state and provincial laws man-dating RV vaccination. Therefore, all puppies should bevaccinated with an RV vaccine, and boosters should beadministered throughout the dog’s life [Table 1]. Boosterrevaccination should be administered 12 months following
12 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
initial vaccine and then as required by local, state, or provin-cial law. Dogs with unknown vaccine histories should beconsidered at risk and vaccinated, an initial booster shouldbe administered 12 months later, and boosters should beadministered throughout the dog’s life [Table 1].
The minimum DOI for killed rabies vaccine based onchallenge studies is 3 years; based on antibody titers, it isconsidered to be up to 7 years [Table 2].
Specific Vaccine Recommendations: Optional VaccinesDistemper-Measles Virus (D-MV) Combination Vaccine:When the D-MV vaccine is given to a puppy between 6 and12 weeks of age, the measles component of the vaccinecross-protects against CDV and is not inactivated by mater-nal antibodies directed at CDV. Protection occurs within 72hours of vaccination; however, the vaccine is not effective <4
weeks of age. Puppies vaccinated with a D-MV vaccineshould be vaccinated at 3- to 4-week intervals using CDVvaccines until the immunization series is completed [Table1]. The D-MV vaccine is not indicated for use in dogs >12weeks of age, especially female dogs destined as breedingstock, as it may result in the production of maternal anti-bodies to MV that would be passed on to future puppiesnegating vaccine efficacy. The D-MV vaccine may play arole in the prevention and control of CDV in high-risk set-tings such as shelters.
Canine Parainfluenza Virus (CPV): Canine parainfluenzavirus is one cause of the “kennel cough” syndrome, aninfection in susceptible, unprotected dogs causing a mild,self-limiting upper respiratory disease; the agent rarelycauses life-threatening disease in otherwise healthy dogs.
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 13
Table 2
Estimated Minimum Duration of Immunity (DOI) of Select Commercially AvailableCanine Vaccine Antigens
Vaccine* Estimated Minimum DOI† Estimate of Relative Efficacy‡ (%)
CoreCanine Distemper (MLV) ≥7 yr27-29 >90rCanine Distemper (R) ≥1 yr >90Canine Parvovirus-2 (MLV) ≥7 yr27-29 >90 Canine Adenovirus-2 (MLV) ≥7 yr27-29 >90Rabies Virus (K) ≥3 yr27-29 >85
NoncoreCanine Coronavirus (K or MLV) NA37,38§ NACanine Parainfluenza (MLV) ≥3 yr27-29 >80Bordetella bronchiseptica (ML)\ ≤1 yr27-29¶ ≤70Leptospira canicola (K) ≤1 yr¶ ≤50L. grippotyphosa (K) ≤1 yr# NAL. icterohaemorrhagiae (K) ≤1 yr¶ ≤75L. pomona (K) ≤1 yr# NABorrelia burgdorferi (K) 1 yr27-29 ≤75B. burgdorferi OspA (R) 1 yr ≥75Giardia lamblia (K) ≤1 yr# NA
* MLV=modified live virus; K=killed; R=recombinant † Experimental challenge studies and/or serological studies have been performed. Field experiences during outbreaks confirm
experimental challenge studies; NA=not available‡ Based primarily on observational, not controlled studies; however, when controlled studies were performed, efficacy was some-
times correlated with challenge and at other times with serology.§ This infectious agent cannot be shown experimentally to cause significant disease; therefore, it is not possible to determine DOI
or efficacy. Observations and studies to demonstrate the efficacy and/or need for the vaccine suggests the vaccine is not effective and therefore not needed.
\ This is a ML (avirulent) bacteria.¶ Based on field experience and observations from outbreak studies and clinical records. Reliable experimental or controlled studies
are often not available. Serological data for Leptospira spp. suggest vaccines have ≤6 mos DOI.# Information from company data and limited experimental and field observations due to the fact these vaccines were recently
licensed (products available for ≤3 yrs).
Parenteral CPIV vaccines do not block infection but onlylessen clinical disease, and vaccines produce only a shortDOI. This vaccine antigen is generally administered alongwith CDV, CPV-2, and CAV-2. Since these three vaccinesare recommended, the CPIV vaccine is considered optionalbut recommended [Table 1].
The minimum DOI for CPIV is difficult to determine bychallenge studies, and serum antibody titers correlatepoorly with protection, but the duration of serum antibodywithout vaccination was up to 3 years [Table 2]. Therefore,the value of revaccinating dogs annually with CPIV cannotbe demonstrated; however, it is often combined with B.bronchiseptica vaccines in dogs considered susceptible.
Leptospira spp.: Infection with Leptospira spp. can causeclinical disease in some unprotected dogs. The organismcan infect both dogs and humans; therefore, infected dogscan serve as a source for human infection (i.e., zoonosis)via contaminated urine. There are multiple Leptospiraserovars and minimal cross-protection is induced by indi-vidual serovars, especially those defined to be the etiologyof recent leptospirosis outbreaks in specific geographicregions.a,5 Currently available vaccines do not contain allknown serovars; therefore, dogs considered to be at risk forinfection can be vaccinated, but current products do notprovide assurance of protection [Table 1].
Leptospira spp. products include two to four serovars;the efficacies of these products are estimated to be between50% to 75% and the DOI <1 year for the majority of ani-mals that do develop immunity [Table 2]. Immunity is anill-defined term for Leptospira spp. products. If immunity isdefined as protection from infection or prevention of bacter-ial shedding, then there is little or no enduring immunity. Ifprotection is defined as prevention of clinical signs of dis-ease, then duration of immunity could be >1 year. Thus,DOI for Leptospira spp. becomes a problem of definition asto whether the goal of vaccination is interruption of bacter-ial shedding and public health concerns, or the preventionof clinical disease in the dog. It is generally agreed thatimmunity, however defined, is serovar specific; thus, if onlyone serovar is present in the vaccine, any protection, if pro-vided at all, is for that serovar (e.g., Leptospira canicola)and not the many others that can infect the dog.
Bordetella bronchiseptica (B. bronchiseptica): Bordetellabronchiseptica is another cause of the “kennel cough” syn-drome. Infection in some susceptible dogs generally causesa self-limiting, upper respiratory disease and rarely causeslife-threatening disease in otherwise healthy animals. Clini-cal disease resolves quickly when treated with appropriateantibiotics. Vaccination does not block infection but appearsto lessen clinical disease, and vaccines provide a short DOI(<1 year) [Table 2]. It is also unknown whether current vac-cine strains protect against all field strains. Animals consid-ered to be at risk may benefit from vaccination followed byboosters at intervals in line with their risk of exposure[Table 1].
Borrelia burgdorferi (B. burgdorferi): Infection with B.burgdorferi can cause clinical disease syndromes in some sus-ceptible dogs; most dogs infected are subclinically infected.While the organism infects both humans and dogs, it is not adirect zoonosis but a shared-vector zoonosis. The distributionof the tick vector involved is geographically limited and there-fore the incidence of exposure is similarly geographically lim-ited. Dogs previously exposed to B. burgdorferi do not benefitfrom vaccination and prevention of exposure to the tick vectoris an effective preventive approach. Animals considered to beat risk may benefit from vaccination followed by boosters atintervals in line with their risk of exposure [Table 1]. Theminimum DOI for B. burgdorferi vaccines is 1 year [Table 2].
Specific Vaccine Recommendations: Not Recommended VaccinesCanine Coronavirus (CCV): Infection with CCV causesmild gastrointestinal disease unless concurrent infectionwith CPV occurs. The virus does not generally cause dis-ease in dogs >6 weeks of age and is not indicated in adultdogs. In at least one study, it was shown that vaccinationwith CPV protected puppies against challenges with bothviruses. The incidence of disease and DOI is not known.Vaccination is not indicated in puppies >6 weeks of age,and vaccination of adult dogs is not indicated [Table 1]. Atpresent, there is no indication that this organism produces adisease of clinical significance; therefore, administration ofa CCV vaccine is not recommended.
Similar to CPIV, CCV does not cause clinical disease inexperimentally challenged susceptible puppies, even thoseas young as 4 to 6 weeks of age; thus, challenge studiescannot be done unless pups are given immunosuppressivedoses of corticosteroids. Serum antibody titers do not corre-late with protection from CCV infection. Thus, for a virusthat has not been shown to cause significant disease, andwhere serum antibodies don’t correlate with resistance toinfection, DOI is impossible to determine [Table 2]. Dura-tion of immunity for CCV is a moot point since a need forthe vaccine has not been demonstrated. It has been reportedthat DOI for CCV is the lifetime of the animal whether vac-cinated or not as a result of natural subclinical infection andage-related resistance. Revaccination with a CCV vaccinein the adult dog cannot be justified, nor has it been shownto have value in preventing disease.
Giardia spp.: Infection with Giardia spp. can be subclinicalor can cause small bowel diarrhea. The incidence of diseaseis generally <10% and approximately 90% of dogs respondto therapy; the disease is usually not life-threatening. Thereare multiple strains of Giardia, and it is unknown whetherthe vaccine is of value in more than one heterogeneous iso-late. The vaccine does not prevent infection but may reduceor eliminate shedding of the organism and reduce clinicalsigns, which are rarely seen except in very young puppiesconcurrently infected with certain viruses and/or bacteria.The DOI is considered to be 1 year [Table 2]. Vaccinationagainst Giardia spp. is not generally recommended [Table 1].
14 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Canine Adenovirus-1 (CAV-1): Infection with CAV-1 cancause acute and potentially fatal hepatic disease in unpro-tected animals, and some dogs can experience chronicdebilitating disease. Although CAV-1 infection is rarelydocumented in dogs in North America, the organism is stillmaintained in nature, and if widespread vaccination werediscontinued, it is likely that the incidence of the diseasewould become common. Nevertheless, since excellent crossimmunity is provided against CAV-1 by administering theCAV-2 vaccine and the use of CAV-2 results in less frequentadverse events, vaccination using a CAV-1 vaccine is notrecommended [Table 1].
Discussion and Supporting LiteratureThe genesis of these canine vaccine guidelines and recom-mendations was to inform practitioners of the current vac-cine controversy, clarify any misunderstandings, andencourage practitioners to recognize that immunization ofpatients is a medical procedure. In addition, the Task Forcemembers felt it was important to provide practitioners withrelevant supporting information. While it is beyond thescope of this report to thoroughly discuss the extensivebody of knowledge with respect to vaccinology, certain keyconcepts and principles are fundamental to the understand-ing and critical evaluation of these guidelines and recom-mendations. What follows is a synopsis of some integralconcepts pertaining to immunology, DOI, serological test-ing, vaccine production, adverse event reporting, legalimplications of biological use, and potential practice impactand opportunities of adopting these guidelines. Someimportant vaccination “do’s and don’ts” are summarized inAppendix 2.
The Immune System as it Applies to VaccinationUnderstanding the immune system provides a basis forcomprehending the nature of vaccine immunity. The fol-lowing summary of the salient principles is further sup-ported by suggested texts with more comprehensivediscussions and explanations.6-13
Two major types of immunity prevent or limit infectiousdiseases: nonspecific (innate) immunity and specific (adap-tive) immunity. In nature, it is innate immunity (includingskin, hair, tears, normal microbial flora, and mucus andacidity of the gut) that prevents a majority of pathogensfrom infecting and/or causing disease in animals. Innateimmunity also includes type-1 interferons (IFNs), somecytokines (e.g., interleukin-1 [IL-1], tumor necrosis factor[TNF]), complement components, neutrophils, and naturalkiller (NK) cells. This first line of defense is already activeor immediately activated in response to inherent or elabo-rated chemical substances of the infectious agent. Unfortu-nately, current vaccines only occasionally have a significantbeneficial effect on innate immunity; however,immunomodulators (i.e., nonspecific immune stimulants),some new experimental vaccines, and certain drugs arebeing designed and targeted toward enhancing innateimmunity as a nonspecific method for disease prevention.
Adaptive immunity is characterized by specificity andmemory and is primarily or exclusively the type of immu-nity stimulated when an animal receives a vaccine. Thisspecific immune system is comprised of:
1. Humoral (antibody) immunity, where differentiated Blymphocytes (plasma cells) produce the fourimmunoglobulin classes: IgG, IgM, IgA, and IgE;phagocytic cells and effector molecules (e.g., comple-ment) also play an important role.
2. Cell-mediated immunity (CMI) is comprised of T lym-phocytes and their effector molecules, including T helpercells, T regulatory cells, T cytotoxic cells, macrophages,and a number of products of the cells called cytokines(e.g., IFN-γ, IL-2, IL-4, IL-12, TNF).
The Immune Response to Vaccination or Infection
When an animal is vaccinated or infected, the immuneresponse includes differentiation and expansion of clones ofantigen-specific T and B cells that serve as effector cells forimmediate protection and memory cells that provide long-term immunity. The effector cells themselves are usuallyshort lived, dying in days or weeks after stimulation. Mem-ory cells, on the other hand, survive for years, often for thelife of an animal for some vaccines and infections. MemoryT and B cells and the antibodies produced by long-livedmemory effector B cells cooperate to provide protectionfrom challenge at a later time in life for the vaccinated ani-mals that come in contact with the pathogen. Availableinformation suggests that vaccinal protection from infectionand/or disease in the dog is regulated primarily by humoralimmunity and secondarily by cell-mediated immunity. Thisfinding is particularly true when vaccination is known toprevent reinfection (sterilizing immunity). This is the ulti-mate form of immunity because disease cannot developwhen infection is blocked or infection is significantly lim-ited. Sterilizing immunity occurs after effective vaccination(protection) against certain pathogens such as CDV, infec-tious canine hepatitis, and CPV.
However, when vaccination fails to protect against infec-tion and instead protects against the development of clinicaldisease (as is the case for parenteral CPIV vaccination), sys-temic and local CMI together with humoral immunity(including local IgA antibodies) all play a critical role inpreventing or reducing the severity of disease—not by pre-venting infection but by limiting its effects or keeping theinfection localized. A CMI response is generally most effec-tive against intracellular pathogens, while antibodies areusually most effective against toxins or pathogens in theextracellular areas. Whether a CMI or humoral response orboth are responsible for controlling or preventing the clinicaldisease depends on the route of infection and the pathogene-sis (the colonization and replication) of the infectious agent.For instance, prevention of clinical disease by many of therespiratory or gastrointestinal tract pathogens requires gen-eration of mucosal CMI and/or humoral immune responses,with IgA being the most effective antibody class.
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 15
It is essential to note that the mechanism of protectiveimmunity in a vaccinated dog is very different from immu-nity in a naive dog that strives to recover from a naturalinfection. Antibody is usually present in a vaccinated dogand functions to limit or prevent infection. It is never pres-ent at the time of infection in a naive animal. Furthermore,CMI and humoral immunity due to memory cells is stimu-lated in minutes to hours (i.e., anamnestic response) when avaccinated animal is infected; whereas it takes days orweeks (primary response) to be stimulated in a nonvacci-nated, immunologically naive dog.14,15
Types of VaccinesJust as the natural immune response depends on the type ofantigen and the pathogenesis of the organism, these factorsmust also be considered in order for a vaccine to induce anappropriate immune response. There are several differenttypes of commercially available canine vaccines. The mostcommon vaccines currently in use are infectious vaccines,including MLV and live vectored vaccines. There are alsononinfectious vaccines, including killed whole cell vac-cines, subunit killed vaccines, and recombinant subunit vac-cines.3,7,11-13
Modified live virus vaccines, consisting of avirulent orattenuated viruses that infect the host, are the most commoncanine viral vaccines. Such vaccines are highly efficacious,inducing stronger local immune responses than comparablekilled products through the induction of serum neutralizingantibodies, local antibodies, and systemic and local CMIresponses. The MLV vaccines create an immunity that issimilar to immunity after an animal recovers from naturalinfection. There are also modified live bacterial vaccinesconsisting of avirulent or attenuated bacteria (e.g., B. bron-chiseptica) and, similar to MLV vaccines, the modified livebacterial vaccines are often more effective than their killedcounterparts.
The canarypox viral vectored vaccine for canine distem-per virus has the ability to induce CMI and humoral immu-nity, but the humoral response is not as rapid or robust asthe antibody responses engendered by MLV-CDV vaccines.When the canarypox viral vectored vaccine is used in pup-pies, at least two doses are required for immunity; whereasone dose of the MLV-CDV vaccine induces a strong, long-lasting immunity when passively acquired CDV antibody isnot present in the puppy (e.g., ≥12 weeks; see Duration ofImmunity section). Recent serological data showed that athird dose of CDV recombinant canarypox viral vectoredvaccine induces an anamnestic antibody response equiva-lent to the response achieved with a dose of MLV-CDV,suggesting immunity for the recombinant product will lastfor >1 year and likely up to 3 years.b,16
Killed canine viral vaccines include vaccines for CPV-2,CCV, and rabies virus. Killed vaccines generally requiretwo doses (rabies is an exception), because the response isslower and the immunity is predominantly but not exclu-sively systemic antibody with CMI limited to T helper type-1 effector cells and little or no IgA antibody on mucosal
surfaces. Similarly, the killed bacterial products produce pre-dominantly a systemic antibody response. The killed andsubunit products include two to four serovars of Leptospiraspp., killed B. burgdorferi (Lyme disease), B. bronchiseptica,and a killed parasite vaccine for Giardia. There is also anOspA Borrelia burgdorferi recombinant subunit vaccine.
Immunological Factors Determining Vaccine SafetySeveral characteristics of vaccines are integral to determin-ing product safety and efficacy, including the nature anddose of the antigen, the use of adjuvants, and the number ofvaccinal components in any given product. Althoughincreasing the number of components in a vaccine may bemore convenient for the practitioner or owner, the likeli-hood for adverse effects may increase. Also, interferencecan occur among the components. Care must be taken notto administer a product containing too many vaccinessimultaneously if adverse events are to be avoided and opti-mal immune responses are sought.
It is often stated that MLV vaccines are the most effica-cious but that killed vaccines are the safest products; how-ever, in light of advances in vaccine technology, thisstatement should be carefully re-examined.11,13,14 Presum-ably, killed vaccines are safest because they cannot causethe disease for which the vaccine was designed to prevent;however, killed vaccines are much more likely to causehypersensitivity reactions (e.g., immune-mediated disease).If they fail to protect because of poor or no CMI or localhumoral immunity, or because it takes much longer to pro-vide protection (e.g., the requirement for two doses ofkilled CPV-2 for protection), then they clearly are not“safer.” Modified live virus vaccines can and do cause dis-ease because attenuation is a balance between maintaininginfectivity while eliminating its pathogenicity. Individualresponse is dependent on the status of the recipient’simmune system. Thus, an attenuated pathogen in a hostwhich is severely immunosuppressed, or genetically moresusceptible, may result in the vaccine causing the diseasefor which it was designed to prevent. For example, an MLVcanine distemper vaccine given to black-footed ferrets willinduce clinical disease and death.17 Furthermore, in a smallpercentage (estimated 0.01%) of dogs, the MLV-CDV vac-cine may cause postvaccinal encephalitis.15,18
The Immune System and Frequency of Revaccination When vaccinating an animal, the age of the animal, the ani-mal’s immune status, and interference by maternal antibod-ies in the development of immunity must be considered.Research has demonstrated that the presence of passivelyacquired maternal antibodies significantly interferes with theimmune response to many canine vaccines including CPV,CDV, CAV-2, and rabies vaccines. Age of the animal is alsoan important consideration. Puppies <4 months of age maybe more susceptible to disease, and they are the main targetfor core vaccines. Also, very young and possibly very oldanimals may have a diminished response to vaccination dueto age-related suppression of the immune system. Several
16 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
other illnesses (e.g., neoplasia, immune-mediated disease,endocrine diseases) and their treatments (e.g., chemothera-peutic medications, immunosuppressive drugs) can influ-ence the immune response to vaccines and should be takeninto account when vaccinating individual animals.11-13,18,19
When a healthy puppy’s immune system is initially acti-vated by vaccines through antigenic stimulation, a robusthumoral and CMI response is expected to develop with con-comitant effector and memory cells. If a pup fails torespond, primarily due to interference by passively acquiredmaternal antibody, it is necessary to revaccinate at a latertime to ensure adequate immunity. Multiple vaccinationswith MLV vaccines are required at various ages only toensure that one dose of the vaccine reaches the puppy’simmune system without interference from passivelyacquired antibody. Two or more doses of killed vaccines(except rabies) and vectored vaccines are often required toinduce an immune response, and both doses should be givenat a time when the passively acquired antibody can nolonger interfere. Thus, when puppies are first vaccinated at>16 weeks of age (an age when passively acquired antibod-ies generally don’t cause interference), one dose of an MLVvaccine, or two doses of a killed vaccine, are adequate tostimulate an immune response. When MLV vaccines areused to immunize a dog, memory cells develop and likelypersist for the life of the animal. Resident memory cellsrespond rapidly providing an anamnestic immune responseat the time of challenge (infection) with the pathogen.
So why revaccinate animals with these products annuallywhen the minimum DOI (memory cells and antibody) ismany years, if not a lifetime, for some of the vaccines? Iron-ically, there is no scientific basis for the recommendation torevaccinate dogs annually with many of the current vaccinesthat provide years of immunity (e.g., CDV, CPV-2, rabies);however, there are other vaccines that often provide <1 yearof immunity (e.g., B. bronchiseptica, Leptospira spp.).3,14,15
Vaccinating an animal multiple times at intervals <2weeks is likely to cause a hypersensitivity reaction in geneti-cally predisposed animals, and a less than robust protectiveimmune response develops.15
The Critical Interplay Among Vaccine Efficacy, Safety,and Frequency of Administration (CDV as an example)Obviously, a killed CDV vaccine (none are available com-mercially) will not cause disease, but the killed CDV vac-cines produced prior to the 1960s failed to protect mostdogs from disease, and when protection was inferred, it wasshort lived. That is the main reason why killed CDV vac-cines are currently not produced. Another reason is theinability of biologics producers to make an efficaciousproduct for dogs although effective killed CDV vaccineshave been produced for use in zoo and wildlife species.17,18
In contrast to both conventional MLV and killed CDV vac-cines, the canarypox viral vectored CDV vaccine won’tcause disease (e.g., postvaccinal encephalitis), but, unlikekilled vaccines, it does provide immunity. The kinetics of
the immune response are much slower with the vectoredCDV vaccine than with the MLV-CDV vaccine, because forimmunity to develop, a second dose of vectored vaccine isrequired. Thus, in humane shelters or puppy rearing facili-ties where exposure to CDV is common, MLV vaccines areessential if a vaccine is expected to protect prior to infectionwith wild type (i.e., street virus) CDV. In fact, the best prod-uct in an environment where CDV is prevalent is a com-bined vaccine that contains both measles virus (MV) andCDV. This type of vaccine is recommended because MVwill provide protection from disease with CDV at a muchearlier age than CDV-only vaccines, as the MV vaccine isnot inhibited by passively acquired CDV antibody.15,17
Duration of Immunity
Estimating Duration of Immunity and Frequency ofRevaccinationIt’s believed that the annual revaccination recommendationoriginated in the late 1950s when MLV-CDV vaccines werefirst introduced. This recommendation was based in part onthe observation that approximately one-third of the dogsvaccinated with a first generation CDV vaccine as part of alimited experimental trial did not have antibody titers con-sidered protective 1 year after vaccination. Therefore, toensure the canine population had a protective antibody titer,James A. Baker recommended that all dogs should berevaccinated annually as it was not practical nor cost effec-tive to test each animal for antibody.20 At that time, therewere very few vaccines (notably CDV and CAV-1), fewpeople were vaccinating their dogs, and the practice of vac-cination for companion animals was not well established oraccepted. In 1961, Piercy wrote the following regardingannual administration of the canine distemper vaccine:
“It is felt, therefore, that the usefulness of booster injec-tions in dogs already immune is still open to question andcannot be truly evaluated until considerably more researchhas been done. The value of revaccinating dogs whose anti-bodies have declined to a low level, however, is not indoubt. Although a serum analysis (antibody titer) is themost scientific way of judging the need for revaccination, inpractice the owner would presumably be obliged to pay afee for the examination and a further fee should revaccina-tion be advised. The alternative, and less expensive way tothe owner, is simply to have the animal revaccinated if thereis a reason to doubt its immune status and it is likely to beexposed to infection. The practitioner is favorably placed toadvise what should be done in light of such local circum-stances as the incidence of canine distemper in his district,the history of the animal concerned, the risk involved ingoing to shows and kennels and other similar hazards.”21
Thus, the practice of annual revaccination was acceptedas a “principal of vaccination.” Forty years later, we arefinally reviewing the recommendation of annual revaccina-tion. This critical review is based on scientific informationand the knowledge of vaccines and immunity which haveaccumulated over that period.
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 17
As we analyze Piercy’s statements, it is obvious that asignificant amount of information has been developed toanswer the questions posed 40 years ago, but the practice ofvaccinating dogs has not changed.
1. Piercy stated: “The usefulness of booster injections indogs already immune is still open to question and can-not be truly evaluated until considerable more researchhas been done.” This statement was made with specificreference to the CDV vaccine. We now know thatbooster injections are of no value in dogs alreadyimmune, and immunity from distemper infection andvaccination lasts for a minimum of 7 years based onchallenge studies and up to 15 years (a lifetime) basedon antibody titer [Table 2].
2. Piercy comments: “The value of revaccinating dogswhose antibodies have declined to a low level, however,is not in doubt.” Indeed, it is in doubt! Dogs with a CDVantibody titer, no matter how low when challenged, maybecome infected if antibody levels are below titers whichprovide sterilizing immunity (i.e., resistance to infec-tion), but they will have protection from clinical diseasemediated by an anamnestic humoral and CMI response.However, if after vaccination “no antibody” is detectedin the dog’s serum, then there is “no doubt,” as sug-gested by Piercy, that revaccination will be of value inboosting the animal’s immune response.
3. Piercy was very perceptive when he stated, “a serumanalysis is the most scientific way of judging the needfor revaccination.” This is absolutely correct, and anti-body titer is of great scientific value in determining if thedog has sterilizing immunity. Piercy emphasized theimportance of antibodies since he didn’t know aboutCMI; however, antibody is very important for protectingthe vaccinated dog from CDV, as well as several othercanine viral infections.
4. The economics of the 1960s remains unchanged today.Piercy’s statement that “it would be less expensive tovaccinate than to have the animal bled and an antibodytiter performed” remains, for the most part, relevant totoday’s practice economics. However, the ethical issuethat our profession struggles with today is whether eco-nomics justifies giving an animal a drug (vaccines arebiologic drugs) that is not necessarily required. As aminimum, we should allow pet owners to make thischoice rather than make it for them.
5. Piercy’s advice on risk assessment analysis and makingthe decision to vaccinate is an important medical issueand excellent advice that should receive careful attentionwhenever vaccines are administered. Which vaccinesshould be given? When and how often do they need tobe given? The answers will undoubtedly vary accordingto which geographic region the dog resides, the lifestyleof the dog, the age and medical history of the dog, aswell as the needs and expectations of the owner. Suchquestions must be asked if the animal is to receive thebest medical care.
There are very few published studies on the minimumDOI for canine and feline vaccines and this is compoundedby the fact that the criteria for determining DOI cannot beeasily agreed on. Some researchers suggest that the onlytrue way to determine DOI is by way of a prospective studythat would be comprised of two (one group vaccinated; onegroup nonvaccinated) relatively large groups of dogs (repre-senting common breeds) housed within a pathogen-freeenvironment; therefore, at the end of the study, the nonvac-cinated group would remain antibody-negative. Bothgroups would then be challenged with virulent isolates ofeach of the pathogens for which the vaccines were designedto provide protective immunity. Few minimum DOI studiesusing this study design have been done, and few, or none,will be done due to the high cost and difficulty of maintain-ing control (i.e., negative) animals. More important, basedon current knowledge of immunity resulting from vaccina-tion, studies of this type need not be done.17,18,22-26
There is no indication that the immune system of caninepatients functions in any way different from the humanimmune system. In humans, the epidemiological vigilanceassociated with vaccination is extremely well-developedand far exceeds similar efforts in animals whether compan-ion or agricultural. This vigilance in humans indicates thatimmunity induced by vaccination in humans is extremelylong lasting and, in most cases, life-long. Current informa-tion (as presented in the section on Task Force Recommen-dations Regarding the Selection and Use of Canine VaccineAntigens and Table 2) supports the contention that immu-nity to canine vaccines persists for years.
The canine core viral vaccines have been demonstrated bychallenge studies to provide a minimum DOI of at least 3years, and up to 7 years for some vaccine antigens.3,14,15,27-29
When antibody titers considered to provide sterilizingimmunity are evaluated, this minimum DOI is even longer[Table 2].3,14,15,18,30 Duration of immunity for bacterialvaccines is considerably different than for viral vaccines. Incontrast to viral immunity, bacterial immunity from vacci-nation is generally limited to ≤1 year, and the efficacy ofmost of the bacterial products is considerably less than forthe viral products and directed at minimizing clinical signsof the disease in question. Protection from reinfection (ster-ilizing immunity) generally does not occur with canine bac-terial vaccines.
Antibody titers from bacterial vaccines generally do notcorrelate directly with sterilizing immunity, and they wouldbe significant only if there was no antibody detected aftervaccination.30 This would be a clear indication that the vac-cine failed to stimulate an immune response. Such vaccinesshould be given again or another product should be used.Bacterial vaccines, especially killed whole organism prod-ucts like certain Leptospira spp. products or B. bronchisep-tica given systemically, are much more likely to causeadverse reactions than subunit or live bacterial vaccines orMLV vaccines, especially if given topically. Several killedbacterial products are used as immunomodulators/adjuvants.Thus, their presence in a combination vaccine product may
18 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
enhance or suppress the immune response or may cause anundesired immune response (e.g., IgE hypersensitivity or aclass of antibody that is not protective).3,14
Serological Tests to Monitor ImmunityAntibody titer tests are controversial, generally because manyindividuals fail to understand their significance. Furthermore,there is substantial confusion regarding the roles of humoralimmunity and CMI in vaccinated versus naive animals.31
When the protective mechanism of immunity in a naive doginfected with CDV is considered, the mechanism of recov-ery involves CMI and antibody, with CMI playing a pri-mary and critical role. When one considers protectiveimmunity to CDV in a vaccinated animal, antibody playsthe primary role, because it prevents infection (sterilizingimmunity) or limits the infection, and CMI plays a minorrole.17,18,31 When naive animals are infected with CPV-2,virus-neutralizing antibody promotes recovery and viralelimination; CMI plays a limited role in this scenario.32
Conversely, in a vaccinated animal, antibody preventsinfection. If infection occurs, antibody increases rapidlyand restricts infection (often to lymphoid cells) so there islittle or no viral infection of gut epithelial cells and no fecalshed of the virus. These are only two examples, but thereare many more examples where antibody plays the princi-ple role in protective immunity in the vaccinated, but notnecessarily the naive, animal.14,15
How then should antibody titers be used in clinical prac-tice to monitor vaccine immunity? They can be helpful inthe following ways:
• to determine if there has been an immune response fol-lowing vaccination
• to determine the duration of immunity• to ensure the vaccine is immunogenic• to know precisely when to vaccinate the puppy• to determine whether the animal is a “low or nonrespon-
der” to certain vaccines
The important issue regarding antibody titers is not theirvalue but the accuracy of the results reported from variouslaboratories. To have any clinical value, any test used todetermine an individual’s immunity must be standardizedagainst an accepted reference and demonstrate a very highdegree of specificity and sensitivity. It is reported in the lit-erature that titers of 20 for CDV and 80 for CPV are protec-tive.30,32 However, what is often not reported, or littleunderstood, is that the test for CDV must be the virus neu-tralization (VN) test, and the test for CPV-2 should be thehemagglutination inhibition (HI) test performed with pig ormonkey erythrocytes or the VN test, if those titer values areto be used. Those are the tests (VN and HI) that correlatewith immunity by challenge studies. None, or few, of thecommercial laboratories perform these tests, and the resultsof enzyme-linked immunosorbent assay (ELISA) or fluores-cent antibody (FA) tests may not correlate with the titersfrom the VN and HI tests. Thus, antibody titers are useful if
you have a laboratory that performs the correct test, or if atest like the VN and HI or another test that has been stan-dardized to correlate with protective immunity were avail-able. Veterinarians should be sure that the laboratories theyuse for serological testing adhere to these principles.
Recently an “in-office test” was approved for detectionof antibody to CDV and CPV-2 in dogs.c The test isdesigned so that a positive sample indicates that the anti-body level in the sample is above the titer that provides ster-ilizing immunity for these respective viruses. A negativetest result shows the titer to be below the level providingsterilizing immunity but does not indicate the animal wouldbe susceptible to developing clinical disease if challengedby exposure, because infection could lead to an anamnestic(secondary) response, thus no clinical disease. The test isuseful if the clinician needs to have some assurance that avaccinated animal has immunity to CDV and/or CPV-2.These are the two most important viruses in the list of corevaccines. It is not necessary to determine a titer for rabiessince revaccination once every 3 years after the first year isrequired and the 3-year rabies vaccines have that period as aminimum DOI. The CAV-1/CAV-2 titers need not be done,because exposure as well as vaccination with CAV-2ensures protection from CAV-1, the more importantpathogen of the two CAVs.
Although the committee does not feel it is necessary todetermine titers to these core viruses on an annual basisbecause of the long minimum DOI for these products, titerscan be used for your and/or your client’s assurance that theanimal has immunity. Experience with postvaccinationtiters for CDV, CAV, and CPV shows that sterile immunitylasts for years; thus, if the test is positive 1 year after vacci-nation, it is likely to be positive ≥3 years after vaccination.The primary reason for the test is to ensure that you have apositive test after completing the puppy vaccination series.For example, if you have vaccinated at 6 to 8, 9 to 11, and12 to 14 weeks of age and test the serum ≥2 weeks after thefinal vaccination at 14 to 16 weeks, the test should be posi-tive. If the test is negative, then you should revaccinateagain immediately. If the test is not positive shortly (≥2weeks) after the final vaccination, it suggests that the ani-mal was not immunized. If you waited until 1 year of age,as we do now, the animal would potentially be susceptibleduring the most critical time in its life, the time when theanimal needs to have vaccinal immunity. Experience withthe test demonstrates greater than 90% of the dogs testedafter the puppy series and up to 3 years after vaccination arepositive, an indication they have sterile immunity and don’tneed to be revaccinated with core vaccines.33
Licensing of Vaccine ProductsThe licensing and production of veterinary biological prod-ucts is regulated by the U.S. Department of Agriculture(USDA) under federal legislation, 21 U.S.C. § 151, et. seq.,commonly known as the Virus-Serum-Toxin Act (VSTA) of1913 (amended in 1985 and again in 1988).34 This legisla-tion gives the Secretary of Agriculture the ability to prohibit
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 19
the sale of any “worthless, contaminated, dangerous, orharmful virus, serum, toxin, or analogous product intendedfor use in the treatment of domestic animals.” The regula-tions created by the Secretary of Agriculture under theVSTA are found in Title 9 of the Code of Federal Regula-tions (9 CFR).34 These regulations define “biological prod-ucts” as all viruses, serums, toxins, or analogous productswhich are intended for use in the treatment of animals andwhich act primarily through the direct stimulation, supple-mentation, enhancement, or modulation of the immune sys-tem or immune response. The Center for VeterinaryBiologics (CVB) is the regulatory agency within the USDAresponsible for overseeing veterinary biological products. Itsmission is to ensure that pure, safe, potent, and effective vet-erinary biologics are available for the diagnosis, prevention,and treatment of animal diseases. The CVB reviews licenseapplications for production facilities and biological prod-ucts, establishes licensing and testing requirements and pro-cedures, reviews supporting data involved in the licensingprocess, works to ensure that veterinary biological productsare produced and maintained in compliance with regula-tions, and conducts assays on veterinary biological products.
The following is intended to provide a general overviewof the considerations used by the CVB for licensure of bio-logical products. In order to provide pure, safe, potent, andefficacious products, the CVB requires each manufacturerto file an “Outline of Production” for each product, whichdetails how and where the product will be manufactured.Products can only be manufactured in an approved facilitythat undergoes periodic inspection. However, in the licen-sure of biological products, the exception is the rule. This isdue to the nature of biological products and evolving tech-nologies. The requirements set forth in the regulations canbe modified by agreement of the CVB and the manufactureras specified in the Outline of Production.
OverviewIn order to market a veterinary biological product, a firm mustobtain a product license and an establishment license from theCVB. In order to obtain an establishment license, firms mustestablish the appropriateness of the facility for the product inquestion as well as the appropriateness of the qualifications ofthe personnel involved in developing and producing the prod-uct, and the facility must be inspected by the CVB. In order toobtain a product license, firms must submit:
• An application that includes an Outline of Production,which is a detailed analysis of the proposed production.Once approved, firms cannot deviate from the Outline ofProduction without permission from the CVB.
• The labels and claims to be used with the product, whichmust be reviewed against data submitted and approvedby the CVB.
• Supporting data, including data from studies to supportefficacy, safety, and field studies. The CVB reviews andapproves protocols prior to the initiation of the studies toensure quality of design and acceptability of the data
generated. Applicants must demonstrate to the satisfac-tion of the CVB that the proposed product is pure, safe,potent, and efficacious.
• Three consecutive serials for testing by the CVB. A“serial” is an identifiable, homogeneous quantity ofcompleted commercial product. Each serial must be pro-duced according to the Outline of Production from sepa-rate batches of medium, cells, production serum, andother applicable production components. The purpose isto demonstrate commercial consistency of production.
• Samples and the firm’s test results from each serial mustbe sent to the CVB once the product and establishmentare licensed. The serial cannot be released for commer-cial sale until the firm is notified by the CVB.
PurityPurity is the quality of a biological product (in its finalform) that ensures the product is free of extraneousmicroorganisms and material (organic or inorganic) whichcan adversely affect safety, potency, or efficacy (9 CFR1.101.5 (c)). Purity of biological products is determined bytest methods or procedures established by the Animal PlantHealth Inspection Agency (APHIS) or established in theapproved Outline of Production for the product. Purity isfirst determined (by the firm) and confirmed (at the CVB)by testing of Bacterial Master Seeds, Viral Master Seeds,and/or viral Master Cell Stocks created (in a licensed bio-logical production facility) and used to produce the product.
Purity evaluations of biological products continuethroughout the production process and conclude with finalproduct testing. This testing ensures, to a reasonable levelof confidence, that all components of biological productsare correctly identified and free of contaminating agents(pathogenic or not). The exact specifications of the testingperformed depend to a great extent on the nature of theantigen (or microorganism).
SafetySafety is defined as freedom from properties causing unduelocal or systemic reactions when used as recommended orsuggested by the manufacturer (9 CFR 1.101.5 (d)). As withpurity, safety testing begins with evaluation of the MasterSeed and concludes with testing of each serial prior torelease. For Master Seed evaluation, an amount of MasterSeed equivalent to one dose is administered to each of 10susceptible dogs, followed by daily observation for 14 days.The Master Seed is found unsatisfactory if unfavorablereactions occur in any of the dogs during the observationperiod. This test is designed to detect major safety prob-lems. Relatively rare safety issues will be seen either duringfield safety tests that involve larger numbers of animals orby postmarketing surveillance. One of the requirements forproduct licensure is to test the final product (at the titer anddose for commercially released product) using vaccine fromat least two prelicensing serials in a minimum of 600 ani-mals, of which at least one-third needs to be of minimumage. Many companies use 1,000 or more animals. Safety
20 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
testing for serial release involves the administration of 10dog doses to each of two healthy dogs for 14 days.
PotencyPotency is the relative strength of a biological product asdetermined by test methods or procedures established by theCVB, or in the approved Outline of Production for a product(9 CFR 1.101.5 (f)). The purpose of potency testing is toensure that each serial of vaccine produced is equal to, ormore potent than, a reference serial (equal to or more antigenthan a reference) or the minimum antigenic content as speci-fied through licensure. The type of potency assay used can beboth product (antigen) and firm specific. Standard potencyassay requirements for some established canine antigens canbe found in 9 CFR. As standard assays are developed foremerging antigens, the procedures should become availablefrom the Center for Veterinary Biologics-Laboratory (CVB-L) as a “supplemental assay method” (SAM).
Due to the heterogeneity of antigens required to protectthe health of canine patients, a multitude of potency assayformats exist. These include laboratory animal based in vivotests, target animal based in vivo tests, and in vitro tests.Regardless of the format, all potency assays must beapproved by the CVB and be correlated to efficacy. Makingthe reference vaccine a serial that was used to demonstrateefficacy generally allows a firm to make this correlation.While this system of potency testing ensures that eachserial produced contains a minimum amount of antigen, noupper limits to antigen content currently exist. This shouldbe given further consideration as excessive amounts of anti-gen could result in both safety and efficacy concerns.
EfficacyThe efficacy of a biological product is the specific ability orcapacity of the product to effect the result for which it isoffered when used under the conditions recommended bythe manufacturer (9 CFR 1.101.5 (g)). In other words, effi-cacy is generally thought of as the ability of a product tostimulate the immune response required to provide protec-tion from challenge (i.e., protective immunity). In contrast,immunogenicity is the ability of a product to elicit animmune response whether or not the response is correlatedto protection. As with potency, standard efficacy require-ments for some established canine antigens can be found in9 CFR, Part 113. Where they exist, these standard require-ments for efficacy determinations must be followed.
In general, two types of standard procedures exist for effi-cacy testing. In the first case, a product can be approvedbased on a serological response in which at least 75% of vac-cinated animals develop an antibody titer greater than a refer-ence value. In the second case, efficacy of a product can beestablished using a challenge model where 80% of the vacci-nated animals are protected while 80% of the nonvaccinatedcontrol animals develop clinical disease or lesions. In manycases, challenge typically occurs within a month of complet-ing the vaccination schedule and typically only a small num-ber of animals are evaluated due to animal welfare concerns.
While these standard procedures allow at least a limitedcomparison of efficacy between vaccines, they do not existfor all canine antigens. For antigens that fall outside stan-dard procedures, the variety of efficacy tests becomes muchmore complex and any ability to compare vaccines is lost.For these antigens, each firm is given an opportunity todevelop their own efficacy data in support of licensure, usu-ally based upon standards developed from information pub-lished in the scientific literature. All procedures forgenerating efficacy data must be approved by the CVB.However, considerable variability could exist in how similarproducts are evaluated for efficacy. In addition, there is cur-rently no method or requirement that would allow for thesimultaneous evaluation of products with similar antigeniccomponents using a single efficacy study.
Vaccine Adverse Event ReportingBackgroundThe National Childhood Vaccine Injury Act (NCVIA) of1986 mandated the reporting of certain adverse events fol-lowing the vaccination of children to help ensure the safetyof vaccines distributed in the United States. The Act led tothe establishment of the Vaccine Adverse Event ReportingSystem (VAERS) in November 1990 by the Department ofHealth and Human Services. Today, VAERS provides a data-base management system for the collection and analysis ofdata from reports of adverse events following vaccination ofhumans. However, there is currently no federal or state man-date for veterinarians to report adverse events associatedwith animal vaccination. Practitioner reports of known orsuspected vaccine adverse events in animals may be volun-tarily submitted to either the vaccine manufacturer, the U.S.Department of Agriculture Center for Veterinary Biologics,or the United States Pharmacopeia (USP) through the Veteri-nary Practitioners’ Reporting Program (VPRP).
At the time of this writing, an amendment35 to the Virus-Serum-Toxin Act has been proposed by the U.S. Animaland Plant Health Inspection Service to:
1. require veterinary biologics manufacturers (licenseesand permittees) to record and submit reports to theAPHIS concerning adverse events associated with theuse of biological products they produce or distribute,
2. require veterinary biologics manufacturers to report tothe APHIS the number of doses of each licensed productthey distribute, and
3. provide definitions for adverse event and adverse eventreport.
NOTE: The definitions and information provided below onvaccine adverse events and adverse event reporting are sub-ject to change if this amendment is approved.
DefinitionFor purposes of this discussion, a vaccine adverse event isdefined as any undesirable side effect or unintended effect(including lack of desired result) associated with theadministration of a licensed biological product (vaccine).
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 21
For vaccines administered to animals, adverse events arethose involving the health of the treated animal and includethe apparent failure to protect against a disease. It is impor-tant to note that an adverse event includes any injury, toxic-ity, or sensitivity reaction associated with the use of avaccine, whether or not the event can be directly attributedto the vaccine. In other words, it is appropriate to report anyknown or suspected event associated with vaccination. Avaccine adverse event report may be defined as a source ofcommunication concerning the occurrence of one or moresuspected adverse events, which identifies the product(s),animal(s), and person making the report.
Purpose of ReportingReporting field observations of unexpected vaccine perform-ance is the most important means through which the manufac-turer and the regulating agency (and the American VeterinaryMedical Association) can be made aware of potential vaccinesafety or efficacy problems that, if necessary, warrant furtherinvestigation. If a particular adverse event is well documented,reporting serves to provide a baseline against which futurereports can be compared. In addition, reported adverse eventscould lead to the detection of previously unrecognized reac-tions, to the detection of increases in known reactions, to therecognition of risk factors associated with reactions, to theidentification of vaccine lots with unusual events or unex-pected numbers of adverse events, and to further clinical, epi-demiological, or laboratory studies. Therefore, veterinariansare encouraged to report any clinically significant adverseevent occurring during or after administration of any vaccinelicensed in the United States. Reporting a vaccine adverseevent is not an indictment against a particular vaccine. Report-ing simply facilitates review of temporally associated condi-tions and adds to the safety database of the product.
Reporting a Vaccine Adverse EventThe AVMA Council on Biologic and Therapeutic Agentshas reported that the current adverse event reporting systemneeds significant improvement in the capture, analysis, andreporting of adverse events.36 Veterinarians are encouragedto participate in the vaccine adverse event reporting processby reporting suspected and known adverse events to any ofthe following three locations:
1. The vaccine manufacturer, usually through telephonecommunication with technical services [Table 3];
2. the USDA-CVB by toll-free call (800-752-6255); or3. the United States Pharmacopeia (USP) Veterinary Practi-
tioners’ Reporting Program (VPRP) by toll-free call(800-487-7776; press #3), by fax (301-816-8373), oronline (www.usp.org/vprp).
Reports made to the USDA are forwarded directly to thevaccine manufacturer without specific action. Althoughadverse event reports made to the USP VPRP are collectedand maintained in a database, individual vaccine adverseevent reports are not necessarily forwarded by USP to thevaccine manufacturer. While still available, the future of theUSP VPRP is currently under review.
Event CriteriaReporting a known or suspected vaccine adverse eventshould include the:
1. Manufacturer’s name2. Product brand name, lot/serial number, and expiration
date3. U.S. veterinary license number and product code4. Signalment (age, species, breed, gender) of patient
affected5. A description of the clinical signs or diagnosis associ-
ated with administration of the vaccine. Although spe-cific reporting criteria are not defined for clinical events,the type of reaction and length of time between adminis-tration of the vaccine and onset of the adverse eventshould be documented using the following guidelines:a. Local (injection-site) reactions occur exclusively at or
around the site of inoculation. They may occur at thetime of injection, or several minutes, hours, or dayslater and may persist from minutes (e.g., pruritus) tomonths (e.g., granuloma). Reports should include theroute of administration (i.e., subcutaneous, intramus-cular, or topical [oral, conjunctival, or nasal]). Exam-ples of injection-site (local) reactions followingvaccination include pain, pruritus, swelling, injection-site alopecia, abscess formation, granuloma forma-tion, and neoplasia. Infection and skin necrosis arerare but have been reported. Vaccines licensed foradministration by the topical (conjunctival/intranasal)route have been associated with sneezing (persisting≥3 days), nasal and oral ulceration, ocular discharge,and cough (persisting >24 hours).
b. Systemic reactions are events that involve the entirebody or a defined location/region other than the injec-tion site. Like injection-site reactions, systemic reac-tions typically don’t occur at the time of injection butcan develop within minutes or hours and may persistfor hours or days. Examples of systemic reactions fol-lowing vaccination include angioedema, especiallyinvolving the face, muzzle, and ears (most oftenreported in dogs); anaphylaxis and collapse; poly-arthritis (lameness); vomiting with or without diar-rhea (most often reported in cats); respiratorydistress; fever; and lethargy. Severe events that maybe vaccine associated requiring long-term medicalintervention and patient follow-up include immune-mediated hemolytic anemia, immune-mediatedthrombocytopenia, icterus, renal failure, and glomerulo-nephritis.
c. Vaccine-associated death, although rare, does occur.In dogs, anaphylactic shock is the most commonlyreported adverse event leading to death. There hasbeen no trend to suggest an association between ana-phylaxis and a particular manufacturer’s vaccine. Vet-erinarians are strongly encouraged to report any deathsuspected or known to be associated with vaccinationto the vaccine manufacturer [Table 3].
22 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Legal Implications of the Discretional Use of BiologicsAs a general rule, the use of biological products by smallanimal veterinary practitioners is left to their professionaljudgment. The latitude afforded practitioners is broad, butthere are boundaries.
The analysis of the law governing use is complicated.The USDA-CVB regulates the licensure and preparation ofmost veterinary biologics. The Virus-Serum-Toxin Actempowers the CVB to stop the sale, barter, or exchange of“any worthless, contaminated, dangerous, or harmful virus,serum, toxin, or analogous product.” If veterinary use of aCVB-regulated product was viewed as unsafe, the CVBcould initiate an enforcement action; however, unless asafety issue is implicated, the USDA has historically notconsidered such enforcement to be a priority. In addition,some vaccines are licensed with specific restrictions regard-ing their use, which will be noted in their labeling.
The FDA’s Center for Veterinary Medicine (CVM) alsoregulates some products that most practitioners would con-sider biologics. The jurisdictional gray zone between thetwo agencies is confusing, constantly blurred, and evolving.Products regulated by the CVM are covered by the AnimalMedicinal Drug Use Clarification Act, which establishedspecific rules for “extra-label” drug use.
Potential LiabilityPotential liability for medical decision making is a fact oflife for any health-care provider, including veterinarians.This potential professional liability encompasses all aspectsof veterinary practice, including the selection and use ofvaccines and other biological products. Generalizationsabout potential legal liability are as difficult to make as gen-eralizations about medical practice. The range of possible
legal liability theories used in litigation is broad and limitedonly by the creativity of the plaintiff’s attorney. To furthercomplicate matters, there are variations, some subtle andsome not, between states. However, most lawsuits againstpractitioners are grounded in negligence theory, althoughother possibilities include product liability, breach ofexpress or implied contract, breach of express or impliedwarranty, guaranty, battery, and breach of fiduciary relation-ship. These principles apply to all aspects of professionalveterinary practice, not simply vaccine or biological issues.Discussed below are some types of negligence suits thatcould arise out of use of biological products.
Malpractice: Negligence actions involving veterinariansare usually cast as traditional medical malpractice cases.The law of professional medical negligence has evolved inthe context of human medicine. Most jurisdictions willapply the legal concepts developed in the litigation ofphysician malpractice cases to veterinary malpractice cases.The traditional elements of a medical malpractice lawsuitare the duty to conform to a certain standard of care, a fail-ure to conform to the required standard, actual injury ordamage, and a legally sufficient causal connection betweenthe conduct and the injury. The duty arises out of the veteri-nary-client-patient relationship (VCPR) and is typicallystated as the duty to exercise reasonable care. That is, theduty to exercise the same level of care and competence as areasonably prudent practitioner, with the same or similartraining, under the same or similar circumstances. This dutyis often referred to as the “standard of care.” In this context,standard of care is a legal term of art and does not necessar-ily equate with professional practices or standards. Estab-lishment of the relevant standard of care and whether apractitioner deviated from it, with few exceptions, must beestablished by competent expert testimony.
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 23
Table 3
Technical Services Toll-Free Phone Numbers (U.S.) for Major Vaccine Manufacturers
Manufacturer Toll-Free Number
Bayer Corporation 800-422-9874Elanco Animal Health 800-428-4441Evsco Pharmaceuticals 800-387-2607Fort Dodge Animal Health 800-477-1365Heska Corporation 888-437-5287Intervet 800-992-8051Merial Ltd. 888-637-4251Novartis Animal Health 800-637-0281Pfizer Animal Health 800-366-5288 Pharmacia & Upjohn 866-493-1954Schering-Plough Animal Health 800-224-5318Synbiotics 800-228-4305
In practice, many medical negligence cases become a“battle of experts.” The plaintiff, using an expert witness,presents a standard of care and the opinion that the practi-tioner failed to meet the standard, and that such failurecaused the plaintiff’s injury or damages. In turn, the defen-dant practitioner offers differing expert testimony, establish-ing a different standard of care, that the defendantveterinarian met the standard, and that the defendant’s con-duct did not legally cause the plaintiff’s injury or damage.Faced with conflicting evidence, the jury resolves the issuebased on innumerable variables, including the qualificationsand presentation of the various experts and the defendant.
The scenarios that could give rise to a lawsuit are as var-ied as the imagination allows. For example, a practitionerwho chooses not to vaccinate an animal could be poten-tially sued for negligence if the animal contracts the dis-ease the vaccination could have prevented. In such a case,the plaintiff would be required to have expert testimonythat the defendant’s failure to vaccinate the animal was adeparture from the standard of care and the cause of theinjury to the animal. On the other hand, a practitioner whovaccinates an animal could potentially be sued for negli-gence if the animal has a complication from the use of thevaccine. In such a case, the plaintiff would be required tohave expert testimony that the defendant’s vaccination ofthe animal was a departure from the standard of care andthe cause of the injury to the animal. Whether a plaintiffwould prevail on such theories will depend on the facts ofthe individual case, the qualifications of the defendant andthe experts, and the intangible items that always come intoplay in trials.
Informed Consent: The legal doctrine of informed consentarises out of the obligation to obtain consent prior to pro-viding care to a patient. The essence of informed consent isthat a practitioner informs the client of the material risks ofa proposed treatment or procedure and potential alterna-tives, including the risk of no treatment, and theclient/patient, having been informed, either gives or with-holds consent. It is important to remember that theinformed consent of the patient/client is the goal, not sim-ply the act of obtaining a signature on a form. One of thebest deterrents to an informed consent lawsuit (or any otherfor that matter) is to communicate with, not talk at, clientsand document the discussions.
The laws governing this area developed as human medi-cine evolved from a paternalistic profession to one that rec-ognizes the importance of a patient’s self determination.Informed consent cases are common in human medicineand could also be brought against veterinarians. These casesare often based on negligence principles, due to the mannerin which they developed in physician malpractice cases. Insome jurisdictions, they may be brought under other legalprincipals, such as battery. Most informed consent casesarise out of a patient’s/client’s misunderstanding, misper-ception, and from the practitioner’s perspective, sometimesunreasonable expectations.
The complicating factor is a split of authority on thestandard by which a practitioner’s actions are judged ininformed consent cases. There are two primary standardsutilized, with a fairly even split between those states thatuse a practitioner-focused inquiry and those that use apatient/client-focused inquiry. Thus, the standard by whicha veterinarian’s conduct will be evaluated depends upon thestate in which one practices.
Under the practitioner-focused standard, the inquiry iswhether the defendant provided the information that a rea-sonable practitioner would disclose under the circum-stances. The level of the required disclosure is establishedby expert testimony. Under the patient/client-focused stan-dard, the inquiry is whether the practitioner provided suffi-cient information (in understandable terms) to allow a“reasonable person” to make decisions about the course oftreatment. The real issue becomes, under the circumstances,what information would a reasonable person need to makeinformed, rational decisions. Regardless of which standardis employed, the other elements of a negligence case,including the causal connection, would have to be estab-lished in order for a plaintiff to prevail.
Whether the use of written consent forms deter informedconsent cases is often discussed. Documentation ofinformed consent discussions is always helpful in thedefense of an informed consent case. The documentationoften ranges from a note in the chart (with or without cosig-nature by the client), to a generic consent form signed bythe client, to a very detailed document specific to the treat-ment or procedure contemplated. The more general the lan-guage used, the less helpful, and, conversely, the morespecific the language the more helpful in the defense of acase. It is important to note that in human medicine, mostinformed consent lawsuits have signed consent forms in thechart. While they are helpful tools, they do not preempt alllawsuits over consent issues. In fact, there are times thatconsent documents could be harmful to the defense of acase. Some consent forms for vaccination estimate the oddsof disease exposure or the chance of an adverse eventoccurring following vaccination. The practitioner shouldhave a medically or scientifically defensible basis for mak-ing any such precise representations in a consent document.If precise numbers cannot be justified, more general state-ments are preferable. For example, a statement indicatingthat the true incidence of a particular adverse reaction is notknown, but is believed to be low, or has been reported in theliterature to be in the range of “X%–Y%” would be appro-priate. In addition, a statement that the exact chances ofexposure to a particular disease cannot be quantified butshould be less where the animal is not exposed to other ani-mals would be more defensible. Such statements may beharder to craft, but a practitioner would not want to be inthe unenviable position of explaining to a jury that the rep-resentations made to a client prior to a treatment or proce-dure were simply a “guesstimate,” leaving the practitionerto explain the basis for the statements. There is obviouslyroom for professional judgment, but very specific numbers
24 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
based solely on experience or judgment will be harder todefend. One of the best methods for crafting consent formsfor use in a practice is to talk with an attorney who hasdefended informed consent cases in your state. They canprovide invaluable assistance in understanding the laws inyour jurisdiction and crafting consent documents that bestmeet your particular needs.
Vaccinations as a Component of Comprehensive,Individualized CareFor many years, the practice of veterinary medicine hasbenefited from the annual administration of vaccines. Byencouraging dog owners to bring their pets in yearly forvaccinations, veterinarians have been able to recognize andtreat disease earlier than might otherwise have been thecase. The annual visit has also provided an opportunity toinform clients of important aspects of canine health care;therefore, vaccinations are a component but not the princi-ple aspect of a comprehensive, individualized wellness pro-gram for patients. This annual general examination andclient interaction is good veterinary medicine and good vet-erinary business practice.
Unfortunately, many clients have come to believe thatvaccination is the most important reason for annual veteri-nary visits. Veterinarians are justifiably concerned that areduction in vaccination frequency will cause clients toforego routine annual visits for their dogs and that thequality of care they deliver will be diminished. To avoidthis consequence, it is vital that veterinarians stress theimportance of all aspects of a comprehensive, individual-ized health-care program. Clients should be informed thatdogs with serious disease often appear healthy and thatregularly scheduled health evaluations facilitate earlydetection. Emphasis should be placed on a comprehensivephysical examination performed by the veterinarian as wellas individualized patient care. The importance of dentalcare, proper nutrition, appropriate diagnostic testing, andthe control of parasites and other zoonotic diseases shouldalso be addressed during each patient evaluation. Behaviorconcerns should be discussed, as should the necessity formore frequent examination of puppies and geriatric dogs.
Each patient’s vaccination needs should be assessed atleast yearly and, if appropriate, vaccination schedulesshould be modified on the basis of changes in the dog’s age,health status, home and travel environment, and lifestyle.An explanation of the types of vaccines currently available,their potential benefits and risks, and their applicability tothe particular dog given its lifestyle and risk of exposureshould be undertaken. The regional incidence and risk fac-tors for various infectious diseases should also be dis-cussed. With a focus on the welfare of the patient, thesediscussions should take place even with clients who chooseto vaccinate their pets themselves or have them vaccinatedby individuals other than the primary care veterinarian.Ways to reduce the impact of acquired disease (e.g., avoid-ing overcrowding, improving nutrition, and restrictingaccess to infected animals) should also be reviewed.
Vaccinations should be considered just one componentof an individualized, comprehensive preventive health-careplan based on the age, breed, health status, environment(potential exposure to harmful agents), lifestyle (contactwith other animals), and travel habits of the dog.
Age Obviously age has a significant effect on the preventivehealth-care needs of any individual. Puppy programs havetraditionally focused on vaccinations, parasite control, andsterilization. Today, opportunity exists to incorporatebehavior counseling and zoonotic disease management aswell. With aging pets, tiered senior care programs areincreasingly popular. Nutritional, dental disease, and para-site control assessment and counseling should take placethroughout the life of the pet.
BreedIt’s common knowledge that certain breeds are predisposedto various diseases. Early detection and management ofbreed-associated disease can significantly improve the qual-ity of a dog’s life.
Health Status Dogs with chronic medical conditions, such as diabetesmellitus, hypothyroidism, heart disease, renal failure,hyperadrenocorticism, hypoadrenocorticism, glaucoma, andkeratoconjunctivitis sicca, warrant periodically scheduledmedical examinations and testing designed to monitor theprogression of diseases and provide for therapeutic adjust-ments. Dogs receiving certain medications also warranttherapeutic monitoring of blood levels and/or organ sys-tems. The development of recheck protocols for chronicdiseases and medications, which can be included inreminder systems, can greatly improve client complianceand accordingly patient care.
Environment The environment in which a pet resides can profoundlyaffect the health status of that pet. Exposure to trauma(e.g., automobiles, animal fights, high rise syndrome),weather (e.g., heat stroke, frostbite), water (e.g., drown-ing), toxins (e.g., antifreeze, human medications, poison-ous plants, household and industrial toxins), sunlight (e.g.,solar dermatitis), as well as internal and external parasitesshould be assessed during annual health-care visits inorder to define risk factors and appropriate preventivemeasures.
Lifestyle By determining the extent to which dogs come in contactwith other animals either in controlled or unobserved cir-cumstances, veterinarians can assess the need for noncorevaccinations. Dogs that visit kennels, grooming salons,common areas, and wooded, tick-infested areas are atgreater risk from certain infectious diseases than dogs thatdo not frequent these areas.
REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 25
Travel Habits Just as the human population has become much moremobile, so has the canine population, resulting in potentialexposure to infectious agents, parasites, and environmentalhazards not found in the home environment. The determina-tion of past and anticipated future travel of dogs duringeach preventive care visit allows for greater individualiza-tion of preventive care and diagnostic testing plans.
Medical Record DocumentationAt the time of vaccine administration, the following infor-mation should be recorded in the patient’s permanent med-ical record: date of vaccine administration, identity(employee name, initials, or code) of the person administer-ing the vaccine, vaccine name, lot or serial number, manu-facturer and expiration date, and site and route of vaccineadministration. The use of peel-off vaccine labels andstamps that imprint the medical record with the outline of adog facilitate this type of record keeping. Adverse eventsshould be recorded in a manner that will alert all staff mem-bers during future visits. Informed consent should be docu-mented in the medical record in order to demonstrate thatrelevant information was provided to the client and that theclient authorized the procedure. At the very least, this nota-tion should indicate that a discussion of risks and benefitstook place prior to vaccination.
ConclusionThe burgeoning knowledge in the fields of vaccinology andimmunology, together with the continued enhancements ofvaccine efficacy and safety, have placed the traditionalapproaches to vaccine use in doubt and engaged our profes-sion in a long overdue debate. What is clear is that the com-plexity of the issues involved make it impossible for ourprofession to make blanket statements with respect to vac-cine selection and use—one size simply does not fit all.This underscores the fact that vaccination is a medical pro-cedure and, as such, needs to be tailored to the individualand administered under a valid VCPR on the basis ofinformed consent. Not all vaccines are indicated in all ani-mals and no vaccine should be given without a thoroughknowledge of the risks of acquiring the disease, the poten-tial for adverse reactions to vaccination, and the health ofthe animal in question. Current knowledge clearly indicatesthe need to refine vaccine selection and to re-establish vac-cine protocols when revaccinating animals >1 year of agethat have undergone an initial vaccine series. In the case ofcore vaccines (i.e., CDV, CPV, CAV-2, and rabies virus),every 3 years is considered adequate to maintain appropri-ate protection. Regardless of your eventual decision, wechallenge you to keep an open mind and critically evaluateand incorporate new information as it becomes available.
a McDonough P, personal communication; Cornell University DiagnosticLaboratory, Ithaca, NY
b Schultz RD, unpublished results; University of Wisconsin, Madison, WIc Titercheck; Synbiotics Corp., San Diego, CA
AcknowledgmentsThe members of the Task Force would like to recognizeDrs. W. Jean Dodds, Larry Glickman, Craig Greene, DennisMacy, Niels Pedersen, Larry Swango, and Alice Wolf fortheir pioneering work to raise both the knowledge andawareness of vaccinology and issues pertaining to DOIwithin the veterinary profession. The members of the TaskForce would also like to thank Dr. Walt Ingwersen for hiseditorial assistance.
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grams. Vet Med 1998;93(3):233-254.14. Klingborg DJ, Hustead DR, Curry-Galvin EA, et al. AVMA Council
on Biologic and Therapeutic Agents’ report on cat and dog vaccines. JAm Vet Med Assoc 2002;221(10):1401-1407.
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16. Ford, RB (ed). Vaccines and vaccinations. Vet Clin North Am SmAnim Pract 2001;31(3).
17. Day MJ. Clinical immunology of the dog and cat. Ames: Iowa StateUniversity Press, 1999.
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19. Goldsby RA, Kindt TJ, Osborne BA (ed). Kuby-immunology, 4th ed.New York: W.H. Freeman and Co., 2000.
10. Janeway CA, Travers LJ, Walport M (ed). Immunobiology, 5th ed.New York: Garland Publishing, 2001.
11. Pastoret PP (ed). Veterinary vaccinology. Amsterdam: Elsevier Sci-ence, 1997.
12. Schultz RD (ed). Veterinary vaccines and diagnostics. Advances inveterinary medicine, Vol. 41. San Diego: Academic Press, 1999.
13. Tizard I. Veterinary immunology, 6th ed. Philadelphia: WB Saundersand Co., 2000.
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16. Hageny T, Larson LJ, Bonds MD, Schultz RD. Recombinant vaccinesprovide unique opportunities in companion animal vaccination pro-grams. Abstract 68P. The Conference of Research Workers in AnimalDiseases 82nd Annual Meeting, St. Louis, Missouri, 2001.
17. Appel MJG, Parish CR. Virus infections of carnivores. MJG Appel(ed). Elsevier, Amsterdam 1987:29-51;69-92.
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21. Piercy SE. An appraisal of the value and method of use of livingattenuated canine distemper vaccines. Vet Rec 1961;73:944-949.
22. Carmichael LE. Canine viral vaccines at a turning point – A personalperspective. In: Schultz RD (ed), Advances in veterinary medicine 41:Veterinary vaccines and diagnostics. San Diego: Academic Press,1999:289-307.
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23. Gillespie JH, Baker JA, Burgher J, Robson D, Gilman B. The immuneresponse of dogs to distemper virus. Corn Vet 1958;48:103-126.
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REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations 27
Appendix 1
AAHA Canine Vaccine Task Force Members and Affiliations
Michael A. Paul, DVM, ChairpersonP.O. Box 1479The ValleyAnguilla, British West Indies
Max Appel, DVM, PhDJames A. Baker Institute of HealthNew York State College of Veterinary Medicine122 Pine Tree RoadIthaca, New York 14853-6401
Ralph Barrett, DVM, Diplomate ACVIMSacramento Animal Medical Group4990 Manzanita AvenueCarmichael, California 95608
Leland E. Carmichael, DVM, PhD, Diplomate ACVMJames A. Baker Institute of HealthNew York State College of Veterinary Medicine122 Pine Tree RoadIthaca, New York 14853-6401
Henry Childers, DVM, Diplomate ABVPCranston Animal Hospital, Inc.1119 Park AvenueCranston, Rhode Island 02910
Susan Cotter, DVM, Diplomate ACVIMSchool of Veterinary MedicineTufts University200 Westboro RoadNorth Grafton, Massachusetts 01536
Autumn Davidson, DVM, Diplomate ACVIMGuide Dogs for the Blind350 Los Ranchitos RoadSan Rafael, California 94903
Richard Ford, DVM, MS, Diplomate ACVIMCollege of Veterinary MedicineNorth Carolina State University4700 Hillsborough StreetRaleigh, North Carolina 27606
Dan Keil, DVM, Diplomate ACVMNovartis Animal Vaccines, Inc.23805 Antioch RoadBucyrus, Kansas 66013
Michael Lappin, DVM, PhD, Diplomate ACVIMCVMBS-VTH, Clinical SciencesColorado State University300 West Drake RoadFort Collins, Colorado 80523
Ronald D. Schultz, PhD, Diplomate ACVMDepartment of Pathobiological SciencesSchool of Veterinary MedicineUniversity of Wisconsin2015 Linden DriveMadison, Wisconsin 53706
Eileen Thacker, DVM, Diplomate ACVMVeterinary Medical Research InstituteCollege of Veterinary MedicineIowa State UniversityAmes, Iowa 50011-1250
Janice L. Trumpeter, DVMAmerican Animal Hospital Association12575 West Bayaud AvenueLakewood, Colorado 80228
Link Welborn, DVM, Diplomate ABVPNorth Bay Animal and Bird Hospital9801 West Hillsborough AvenueTampa, Florida 33615
28 REPORT of the AAHA Canine Vaccine Task Force 2003 Canine Vaccine Guidelines and Recommendations
Appendix 2
Important Vaccination “Do’s and Don’ts”
11. Do Not Vaccinate NeedlesslyDon’t revaccinate more often than is needed and only with the vaccines that prevent diseases for which that ani-mal is at risk.
12. Do Not Mix Vaccines in a Single SyringeIf the vaccines are not combined by the company as a multicomponent licensed product, do not combine themprior to administration. Follow the manufacturer’s administration recommendations.
13. Do Not Split Doses For miniature/toy or any other breeds. If you are concerned about the volume, reconstitute vaccine with 1⁄4 or 1⁄2 therecommended diluent (e.g., sterile water).
14. Do Not Vaccinate Anesthetized PatientsShould an anesthetized animal develop a hypersensitivity reaction, they may vomit and are at increased risk ofaspirating.
15. Do Not Vaccinate Pregnant DogsThe dog may abort or fetuses may get infected.
16. Do Not Vaccinate Animals on Immunosuppressive TherapyThese animals may not develop an adequate immune response, but even worse, they could develop disease(e.g., postvaccinal distemper, clinical canine parvovirus).
17. Do Not Administer Multiple Dose Vaccines Any More Frequently Than Every 2 Weeks
18. Do Not Vaccinate Puppies <2 Weeks of Age
19. Do Make Sure the Last Dose of a Puppy Immunization Series is Administered ≥12 Weeks of Age At ≥12 weeks of age, interference by maternal antibody is less of a concern and the puppy’s immune system ismore mature; thus, there is a greater opportunity for a robust immune response to the vaccine.
10. Do Not Give an Inactivated Product Prior to a Modified Live Product This will interfere with the ability of the modified live product to immunize (e.g., canine parvovirus-2).
11. Do Not Administer a Canine Distemper-Measles Vaccine Subcutaneously (SC)It has been shown that poor immunity results when this product is administered SC.
12. Do Not Assume that Vaccines Cannot Harm a PatientVaccines are potent medically active agents and have the very real potential of producing adverse events.
13. Do Not Use Nosodes (Holistic Vaccines) to Vaccinate a PuppyNosodes do not provide immunity; thus, the puppy will remain susceptible to the disease the nosode wasdesigned to prevent. Use a USDA-licensed vaccine to immunize puppies.
14. Do Not Revaccinate a Dog With Vaccines Previously Known to Induce Anaphylaxis in that DogTest the animal’s serum for antibody to determine if the animal is immune. The risk from vaccine-induced anaphylaxis may be much greater than the risk of infection.