Vaccine
Contraindications
Five groups
of persons are ordinarily considered at special risk of smallpox
vaccine complications: (9:9)
- Persons
with eczema or other significant exfoliative skin conditions.
- Patients
with leukemia, lymphoma, or generalized malignancy who are receiving
therapy with alkylating, antimetobolites, radiation, or large
doses of corticosteroids.
- Patients
with HIV infection.
- Persons with
hereditary immune deficiency disorders.
- Pregnancy
in the recipient or a household contact.
Healthcare providers
who have a contraindication to vaccination should not handle or
administer the vaccine. (22:V6:43)
Pregnancy
Regarding
pregnancy, smallpox vaccine should not be administered to pregnant
women or people with pregnant household contacts for non-emergency
indications. (22:V6:26) Pregnancy should
also be avoided for at least 4 weeks after vaccination. (22:V6:26) Pregnancy
is a contraindication because of the risk of fetal vaccinia, a
very rare complication of smallpox vaccination. (22:V6:26) To
further reduce the risk of inadvertently vaccinating a woman who
is pregnant, at the time of pre-screening, women of child-bearing
age should be educated about fetal vaccinia, and abstinence or
contraception to reduce the risk of pregnancy before or within
four weeks after vaccination. (22:V6:28)

Allergic
Reactions
The vaccine
is contraindicated for persons who have experienced a serious allergic
reaction to a prior dose of smallpox vaccine, or to a smallpox
vaccine component. By serious reaction, we mean anaphylaxis or
symptoms of an anaphylaxis-like reaction, such as generalized urticaria,
wheezing, or difficulty breathing. (22:V6:20) In
addition to live vaccinia virus, the reconstituted Dryvax vaccine
contains trace amounts of the antibiotics polymyxin B, streptomycin,
tetracycline, and neomycin. It also contains phenol as a preservative.
People with serious allergy to any of these products shold not
be vaccinated. The newer cell culture vaccines do not contain antibiotics.
No smallpox vaccine in the United States contains sulfa-type antibiotics
or penicillin.
Immunosuppression
Contraindicated
for people with significant immunosuppression, or who have an immunosuppressed
household contact. Replication of vaccinia virus can be enhanced
among people with immunodeficiency diseases and immunosuppression,
and result in serious adverse reactions. (22:V6:22)
Significant
immunosuppression can be caused by many diseases, including leukemia,
lymphoma, generalized malignancy; solid organ or stem cell transplantation;
and humoral or cellular immunity disorders, including HIV infection.
Certain autoimmune diseases and/or treatment for autoimmune diseases
may also be immunosuppressive. (22:V6:23)
Therapies that
can cause immunosuppression include alkylating agents, antimetabolites,
radiation, or high dose corticosteriod therapy. Prednisone doses
of 2 milligrams per kilogram of body weight per day or higher or
20 milligrams per day or higher fo r14 days or more should be considered
immunosuppressive. As with other live vaccines, those on high levels
of these drugs should not be immunized for three months after their
last dose. (22:V6:24)
Persons with
HIV infection or AIDS are at increased risk of progressive vaccinia
(vaccinia necrosum) following vaccinia vaccination. Therefore,
vaccinia vaccine should not be administered to persons with HIV
infection or AIDS. Before vaccination, potential vaccinees should
be educated about the risk of severe vaccinial complications among
persons with HIV infection or other immunosuppressive conditions;
persons who think they may have one of these conditions should
not be vaccinated.
The Advisory
Committee on Immunization Practices (ACIP) does not recommend mandatory
HIV testing prior to smallpox vaccination, but recommends that
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. Because known risk factors
cannot be identified for some persons with HIV infection, 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 site for immunization. Information about local
testing options should be provided to all potential vaccinees,
including sites where testing is performed at no cost. (22:V6:25)
Eczema
Those
people with eczema or a past history of eczema should not be vaccinated,
or those whose household contacts have a history of eczema because
of the risk of inadvertent transmission.
People with other types of acute, chronic, or exfoliative skin conditions,
such as psoriasis, contact dermatitis, burns, impetigo, or herpes zoster (shingles)
might be at higher risk for inadvertent inoculation from the vaccine. People
with exfoliative skin conditions, or whose household contacts has this condition,
should not be vaccinated until the condition resolves or is under good control. (22:V6:30)
To assist providers
in identifying persons that should defer smallpox (vaccinia) vaccination,
the ACIP offers the following two screening questions: (22:V6:31)
- Have you,
or a member of your household ever been diagnosed with eczema
or atopic dermatitis – if you answered “yes,” you
may NOT receive
the smallpox (vaccinia) vaccine due to the risk that you or your
household contact might develop a severe and potentially life-threatening
illness called eczema vaccinatum;
- Eczema/atopic
dermatitis usually is an itchy red, scaly rash that lasts more
than 2 weeks and often comes and goes. If you or a member of
your household have ever had a rash like this – you should NOT receive
the smallpox (vaccinia) vaccine at this time unless you and a
healthcare provider are sure that this rash is not atopic dermatitis
or eczema.
In cases where
the dermatological risk factor or diagnosis is uncertain, some
organizations, such as the military or CDC, may elect to develop
more precise screening tools. Theses secondary screening tools
should weigh the individual’s risk of developing an adverse
event with the requirement of occupational readiness through safe
smallpox vaccination to ensure national security.
Age
People less
than 18 years of age should not be vaccinated. Children less than
12 months of age should not be vaccinated. (22:V6:32) All
vaccinated people should take precautions to prevent virus transmission
to young children and other household contacts. (22:V6:32) Infants
are at risk of post-vaccinial encephalitis if infected. (22:V6:32)
Other Contraindications
People with
moderate or severe acute illnesses should defer vaccination. People
acute or chronic skin conditions that cause breaks in the skin
like, burns, impetigo, or contact dermatitis (until the condition
is resolved) (22:V1:36)Breastfeeding in the
vaccinee (due to close skin contact) (22:V1:36) In
the event of an exposure to smallpox, there would be no contraindications
to vaccination. In this situation, the benefit of vaccination would
outweigh the risk of a complication from the vaccine. (22:V1:37)
For more information
on smallpox vaccine, contraindications, and adverse events refer
to the CDC’s
pre-clinic screening packet. (Note: you need Microsoft PowerPoint
in order to view this link.) (22:V6:36) The
packet contains: a participant advice letter, a vaccine information
sheet and a pre-clinic checklist. The vaccine information sheet
includes information on the smallpox vaccine, immune system problems,
skin conditions and pregnancy.
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