OrimuneŽ Vaccine
(Live Poliovirus Oral
Vaccine-
OPV)
Lederle Labs
Available as a mixture of
three types of attenuated
polioviruses in a 0.5 ml
single-dose Dispette
Description: Oral
poliovirus vaccine (OPV)
contains live attenuated
poliovirus (Sabin strain
types 1, 2 and 3) and is
intended for polio
prophylaxis in infants 6-12
weeks of age, all
unimmunized children up to
18 years of age, and
high-risk adults. Adults,
however, should receive the
inactivated poliovirus
vaccine (IPV). The
attenuated virus particles
in
OPV are harvested from
monkey kidney cell cultures
and undergo an extensive
purification process.
OPV is administered
multiple times to ensure
immunity to all three types
of poliovirus. Clinical
studies reveal that
OPV is highly effective
in preventing natural
poliovirus-induced
neurologic sequelae.
OPV received FDA
approval in1963.
Mechanism of Action:
The oral poliovirus vaccine
stimulates the immune system
to produce anti-poliovirus
antibodies against Sabin
poliovirus types 1, 2, and
3. The live virus persists
in the gastrointestinal
tract for 4-6 weeks,
inducing both mucosal and
serum anti-poliovirus
antibodies capable of
opsonization,
neutralization, and
complement activation. It is
likely that reinfection with
naturally occurring
poliovirus or vaccine
strains reinforces
OPV-induced humoral
immunity.
Pharmacokinetics:
Antibody stimulation after
oral administration of
OPV occurs within 7-10
days and peaks at
approximately 3 weeks.
Poliovirus antibodies are
distributed into breast
milk. It is unknown if
poliovirus antibodies cross
the placenta (see
Contraindications). Most
individuals are protected
after one dose, and the
majority of vaccinees are
protected after two doses.
The duration of immunity is
not known, but studies in
children have revealed that
95% of vaccinees have
protective antibodies to all
three virus types 5 years
after vaccination.
Several studies suggest
that intestinal resistance
can persist for 6 years
after vaccination.
Indications/Dosage
Dosage:
Administration
ˇPoliovirus vaccine live
oral,
OPV is administered
orally.
OPV must not be
administered parenterally.
ˇMay be administered
directly into the mouth
using the single-dose
pipette supplied by the
manufacturer. Alternatively,
mix with distilled or
chlorine-free water, syrup,
or milk, or adsorbed on
bread, cake, or sugar cube.
ˇIf a dose is not
swallowed, spat out, or a
substantial portion is
regurgitated or vomited
shortly after administration
(i.e., within 5-10 minutes),
a second dose should be
given. If the second dose is
not retained, do not count
either dose, readminister on
the next visit.
For poliovirus
prophylaxis:
Adults: 0.5 mL PO
initially, then repeated 8
weeks later. The third dose
should be given 8-12 months
after the second dose. When
less than 4 weeks is
available before
immunization is required, a
single 0.5 ml PO dose should
be given.
Infants: The first 0.5 ml
PO dose should be
administered at 6-12 weeks
of age. The second 0.5 ml PO
dose should be administered
preferably 8 weeks after the
first dose. The third 0.5 ml
PO dose should be
administered at 6 months of
age, however, if this time
cannot be met, the third
dose may be administered as
late as 18 months of age.
Children up to age 18 years:
0.5 mL PO initially,
followed by the second dose
preferably 8 weeks after the
first dose. The third dose
is given 8-12 months after
the second dose (adolescents
and older children may
receive the third dose 6-8
weeks after the second dose
if there is an increased
risk of poliomyelitis).
Booster doses are suggested
upon starting school at 4-6
years of age, unless the
third dose of the primary
series was given after the
recipient's fourth birthday.
Patients with renal
impairment:
Specific guidelines for
dosage adjustments in renal
impairment are not
available; it appears that
no dosage adjustments are
needed.
Contraindications/Precautions
The poliovirus vaccine
should be used with caution
in patients with a history
of neomycin hypersensitivity
or streptomycin
hypersensitivity because
these agents may be used in
the preparation of
OPV. A history of
delayed-type allergic
reactions is not an
absolute contraindication to
OPV administration.
OPV may not be as
immunogenic in elderly
patients or in patients
suffering from
immunosuppression
(congenital, acquired, or
iatrogenic). Furthermore,
virus particle production
can be potentiated in
immunosuppressed patients,
so
OPV use is not
recommended in these
individuals. Patients with
HIV infection may receive
IPV or enhanced-potency IPV;
however,
OPV should be avoided.
Patients with evidence of
viral infection (diarrhea,
vomiting) should not be
given
OPV because other
enteroviruses within the
intestinal tract can inhibit
immunity by preventing
OPV replication.
Similarly,
OPV inoculation should
be postponed in patients
with fever or a severe
respiratory infection,
although minor illness does
not preclude
OPV administration.
Intramuscular injections,
especially antibiotics,
should be avoided for at
least 30 days in patients
who have received the
poliovirus vaccine live oral
(OPV)
or for 60 days in patients
who acquired the disease by
contact with vaccine
recipients. Intramuscular
injections were associated
with an increased risk of
developing paralytic
poliomyelitis in patients
receiving IM injections 30
days prior to the onset of
paralysis.
OPV is classified as
pregnancy category C.
Studies in humans have not
been conducted. Problems in
humans have not been
reported, but routine
administration of
OPV during pregnancy is
not recommended unless the
benefits from vaccination
outweigh the potential risks
to the fetus. Poliovirus
antibodies may be excreted
into breast milk, and
breast-feeding is not
recommended for 2-3 hours
before or after inoculation
in neonates immunized at
birth.
Use of
OPV is not recommended
in neonates less than 6
weeks of age.
Poliomyelitis has
occurred after
OPV administration both
in vaccinees and in their
close contacts. Poliovirus
may be shed in the feces
(and possibly from the
pharynx) of vaccinees for
6-8 weeks after
OPV administration.
Contact individuals should
be warned of the small risk
of developing poliomyelitis
and informed to wash hands
carefully when exposed to
feces or saliva of recently
inoculated vaccinees.
Drug Interactions
Concomitant
administration of
immunosuppressives
(corticosteroids, alkylating
agents, antimetabolites,
radiation therapy) can
decrease the immunological
response to
OPV and potentiate viral
replication. Immunization
should be deferred until the
completion of
immunosuppressive therapy,
if possible.
When administered within
1 month of other live virus
vaccines (such as MMR),
OPV may not induce an
adequate immune response.
Although specific studies of
the effect of simultaneous
vaccination with oral
poliovirus vaccine and other
vaccines are not always
available, in most cases,
simultaneous vaccination
does not pose a problem.
Whenever possible, however,
OPV and other live virus
vaccines should be
administered at least 1
month apart. The
OPV can be administered
concurrently with the
following preparations:
hepatitis B vaccines; immune
globulin; DTP; influenza
vaccine (split or whole);
polysaccharide vaccines
(Haemophilus b,
meningococcal, and
pneumococcal
vaccines); and
inactivated vaccines.
However, concurrent
administration of
OPV with cholera
vaccine, typhoid vaccine, or
plague vaccine may be
associated with significant
adverse
reactions and should be
avoided.
Adverse
Reactions
Administration of
OPV is associated with a
low incidence of paralytic
poliomyelitis in vaccinees.
Also, individuals in close
contact with recently
inoculated vaccinees may be
at a small risk of
developing paralytic
poliomyelitis because
poliovirus can be shed in
the feces (and possibly from
the pharynx) for 6-8 weeks
after
OPV administration.
Immunocompromised patients
are also susceptible to this
adverse reaction. The
incidence of poliomyelitis
is approximately 1 case per
2.6-5 million doses of
OPV administered. Most
cases of poliomyelitis
occur after the first
dose. The risk of developing
paralytic poliomyelitis has
also been associated with
intramuscular injections of
medications received 30 days
prior to the onset of
paralysis.[926]
Intramuscular injections
should be avoided for at
least 30 days in patients
who have received the
poliovirus vaccine live oral
(OPV)
or for 60 days in patients
who acquired the disease by
contact with vaccine
recipients.
In rare cases,
Guillain-Barre syndrome has
occurred after
OPV administration,
although a causal
relationship has not been
established.
Anaphylactic shock has
occurred rarely after
OPV administration and
is manifest as urticaria,
pruritus, erythematous skin,
conjunctivitis, and sudden
or severe fatigue.
Cell-mediated, delayed-type
allergic
reactions (pruritus and
rash) also have occurred but
are less severe.
Fever can occur in as
many as 5% of recipients
receiving the injectable
form of poliovirus vaccine.
Fevers greater than 101.3
degrees F have been
reported.
