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SMALLPOX
FACT SHEET - Information for Clinicians
Smallpox
(Vaccinia) Vaccine Contraindications |
Because the
vaccinia virus used in smallpox vaccine can be spread to others from the
vaccine site of an immunized person, the contraindications below apply
to both potential vaccinees and their household contacts (“household
contacts” include persons with prolonged intimate contact with the
potential vaccinee, including the potential for direct contact with the
vaccination site, e.g., sexual contacts).
Eczema
or atopic dermatitis and other acute, chronic, or exfoliative skin conditions
- Persons
who have ever been diagnosed with eczema or atopic dermatitis should
not be vaccinated, even if the condition is not currently active. These
patients are at high risk of developing eczema vaccinatum, a potentially
severe and sometimes fatal complication. Additionally, persons with
household contacts that have a history of eczema or atopic dermatitis,
irrespective of disease severity or activity, should not be vaccinated.
- If the
potential vaccinee or any of their household contacts have other acute,
chronic, or exfoliative skin conditions (e.g., burns, impetigo, chicken
pox, contact dermatitis, shingles, herpes, severe acne, severe diaper
dermatitis with extensive areas of denuded skin, or psoriasis), they
are at risk for inadvertent autoinoculation of the affected skin with
vaccinia virus and should not be vaccinated until the condition(s) resolves.
- Persons
with Darier’s disease can develop eczema vaccinatum and therefore
should not be vaccinated.
Diseases
or conditions which cause immunodeficiency or immunosuppression
- If a
potential vaccinee or any of their household contacts have conditions
such as HIV/AIDS, solid organ or stem cell transplant, generalized malignancy,
leukemia, lymphoma, or agammaglobulinemia, they should not be vaccinated.
People with these conditions are at greater risk of developing a serious
adverse reaction resulting from unchecked replication of the vaccine
virus (progressive vaccinia). It is also reported that some patients
with severe clinical manifestations of some autoimmune diseases (e.g.,
systemic lupus erythematosus) may have some degree of immunocompromise
as a component of the disease. These patients should not receive smallpox
vaccine during the pre-event vaccination program.
- HIV testing
should be readily available to all persons considering smallpox vaccination.
HIV testing is recommended for persons who have any history of a risk
factor for HIV infection and who are not sure of their HIV infection
status. Anyone who is concerned that they could have HIV infection also
should be tested. HIV testing should be available in a confidential
or, where permitted by law, anonymous setting with results communicated
to the potential vaccinee before the planned date of vaccination. Persons
with a positive test result should be told not to present to the vaccination
clinic for immunization.
Treatments
which cause immunodeficiency or immunosuppression
- If a
potential vaccinee or any of their household contacts are undergoing
treatment with radiation, antimetabolites, alkylating agents, high-dose
corticosteroids (i.e., > 2 mg/kg body weight or 20 mg/day
of prednisone for > 2 weeks), chemotherapy agents, or organ
transplant medications, they should not be vaccinated. People who are
receiving these therapies are at greater risk of serious adverse reactions
to the smallpox vaccine.
- People
undergoing treatment with high dose corticosteroids, or who have household
contacts undergoing such treatment, should not be vaccinated within
one month of completing corticosteroid therapy. Persons undergoing other
treatments which cause immunosuppression or who have household contacts
undergoing such treatment should not receive smallpox vaccine until
they or their household contact have been off immunosuppressive treatment
for 3 months.
Pregnancy
- Live
virus vaccines are generally contraindicated during pregnancy. Pregnant
women who receive the smallpox vaccine are at risk of fetal vaccinia.
Although this is a very rare condition (fewer than 50 cases have ever
been reported), it usually results in stillbirth or death of the infant
shortly after delivery.
- Before
vaccination, people should be asked if they or any of their household
contacts are pregnant or intend to become pregnant in the next 4 weeks;
those who respond positively should not be vaccinated. In addition,
women who are vaccinated should be counseled not to become pregnant
during the 4 weeks after vaccination, and abstinence or highly effective
contraceptive measures should be recommended to reduce the risk of pregnancy
within four weeks of vaccination.
- Routine
pregnancy testing of women of child-bearing age is not recommended.
- Any woman
who thinks she could be pregnant or who wants additional assurance that
she is not pregnant should perform a urine pregnancy test using a “first
morning” void urine on the day scheduled for vaccination. However,
women should be informed that a negative urine pregnancy test cannot
exclude a very early pregnancy and therefore they and their healthcare
providers should not base a decision about their pregnancy status solely
upon a urine pregnancy test result.
- If a pregnant
woman is inadvertently vaccinated or if she becomes pregnant within
4 weeks after vaccinia vaccination, she should be counseled regarding
the basis of concern for the fetus. However, vaccination during pregnancy
should not ordinarily be a reason to terminate pregnancy.
The
contraindications above apply to potential vaccinees and their household
contacts. The following additional contraindications apply only to
potential vaccinees:
Previous
allergic reaction to smallpox vaccine or any of the vaccine’s components
- Vaccinia
vaccine (Dryvax®) contains small amounts of polymyxin B sulfate,
streptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate,
and phenol. Anyone who has experienced an anaphylactic reaction to these
components should not be vaccinated.
- In addition,
anyone who has experienced a previous allergic reaction to the smallpox
vaccine should not be vaccinated.
Moderate
or severe acute illness
- Moderate
or severe acute illness is generally a contraindication to vaccination.
- Vaccination
should be deferred until the acute illness has resolved.
Infants
and children
- Smallpox
vaccine is contraindicated for children under 12 months of age.
- The Advisory
Committee on Immunization Practices (ACIP) advises against non-emergency
use of smallpox vaccine in persons younger than 18 years of age.
Breastfeeding
- Breastfeeding
mothers should not receive the smallpox vaccine. The close physical
contact that occurs during breastfeeding increases the chance of inadvertent
inoculation. It is not known whether vaccine virus or antibodies are
excreted in human milk.
Heart
disease, temporary deferral
- CDC recommends
that persons with known cardiac disease such as previous myocardial
infarction, angina, congestive heart failure, or cardiomyopathy not
be vaccinated at this time. This recommendation follows reports of cardiac
events following smallpox vaccinations including myocardial infarctions
and angina without myocardial infarction. It is unclear whether or not
there is any association between smallpox vaccination and these cardiac
events. Experts are exploring these issues more in depth. This exclusion
may be removed as more information becomes available.
General
precautions:
- The vaccine
vial stopper contains dry natural rubber that may cause hypersensitivity
reactions when handled by, or when the product is administered to, persons
with known or possible latex sensitivity.
- Persons
with inflammatory eye diseases may be at increased risk for inadvertent
inoculation due to touching or rubbing of the eye. Therefore it may
be prudent to defer vaccination of persons with inflammatory eye diseases
requiring steroid treatment until the condition resolves and the course
of therapy is complete.
Contraindications
to Vaccination During a Smallpox Emergency
During a smallpox emergency, all contraindications to vaccination would
be reconsidered in the light of the risk of smallpox exposure. Persons
would be advised by public health authorities on recommendations for vaccination.
Careful screening is essential to minimize complications from the smallpox
vaccine. If you have any questions about whether or not someone should
receive the smallpox vaccine, visit the CDC website at www.cdc.gov/smallpox.
CDC public response hotline: |
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English:
(888) 246-2675 |
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Español:
(888) 246-2857 |
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TTY:
(866) 874-2646 |
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Page last reviewed August 5, 2004
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