WEBCAST TRANSCRIPT

Transcript of "Smallpox Vaccine Contraindications and Screening"\
Presented by Dr. William Atkinson, 6 December 2002, on the satellite
broadcast of "CDC Bioterrorism Update: Smallpox Preparedness"

(Associated graphics can be found at
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/contra-and-screening.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/contra-and-screening.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/contra-and-screening.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/contra-and-screening.pdf).)

(Slides 1 and 2 are title and objectives, respectively)

# ATKINSON:

In this segment I would like to expand on a few of the issues discussed
on the tape, primarily screening for contraindications to smallpox
vaccination. Careful screening for contraindications is the best way to
reduce the risk of adverse reactions, and MUST be done for EVERY person
prior to vaccination.

## Slide 3

Let\'s review briefly the contraindications and precautions to smallpox
vaccination. In non-emergency situations, smallpox vaccine should not be
administered to persons known to have a serious allergy to a prior dose
of vaccine or vaccine component; persons with significant
immunosuppression from any cause or someone with an immunosuppressed
household contact; a woman who is pregnant or attempting to become
pregnant, or someone with a household contact who is pregnant; and women
who are breastfeeding.

## Slide 4

Smallpox vaccine should not be administered to persons with a diagnosis
of eczema or atopic dermatitis, including eczema or atopic dermatitis
that is not currently active; or a person who has a household contact
who has eczema or atopic dermatitis or a history of these diseases;
persons with other extensive exfoliative skin conditions or a person who
has a household contact with one of these conditions; children less than
12 months of age; and persons with a moderate or severe acute illness.

## Slide 5

As you heard in earlier presentations, state health departments will
identify volunteers willing to serve on public health smallpox response
teams. States will also identify hospitals willing to assemble
healthcare smallpox response teams. After volunteers are identified,
they should be given information about the vaccine, and some time to
consider whether or not they wish to receive the vaccine. We refer to
this as "pre-screening". The idea behind this pre-screening period is to
allow volunteers to withdraw without revealing any personal medical
information.

## Slide 6

A large packet of written materials will be provided to each volunteer.
This packet contains a variety of material about smallpox vaccine,
contraindications, and adverse events.

## Slide 7

A lengthy advice letter will be provided that outlines the risks and
benefits of the vaccine; things to consider if the volunteer, or someone
in their family, has possible contraindications, and possible risks
involved with their employment should an adverse reaction occur. Other
written materials will include a Vaccine Information Statement on
smallpox vaccine and detailed information statements about
contraindications; including immune system problems, skin conditions and
pregnancy. Finally, volunteers will be given a checklist asking them to
screen themselves for possible contraindications. They will not return
this form, but can use it as an aid to help them decide whether or not
they should be vaccinated.

## Slide 8

Immunosuppressed persons, including people with HIV infection or AIDS
are at increased risk of progressive vaccinia following smallpox
vaccination. So smallpox vaccine should not be administered to persons
with HIV infection or AIDS, or any other immunosuppressive condition.
Before vaccination, potential vaccinees should be educated about the
risk of severe complications among persons with HIV infection or other
immunosuppressive conditions. Persons who think they may have one of
these conditions should not be vaccinated.

## Slide 9

The Advisory Committee on Immunization Practices (ACIP) does NOT
recommend mandatory HIV testing prior to smallpox vaccination. But HIV
testing IS recommended for people who have a history of a risk factor
for HIV infection and who are not sure of their HIV infection status.
Because risk factors cannot be identified for some people with HIV
infection, testing should be readily available for anyone who is
concerned that they could have HIV infection and wishes to 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. Information about local testing options should be provided
to all potential vaccinees, including sites where testing is performed
at no cost.

## Slide 10

Fetal vaccinia is a rare, but serious, complication of smallpox
vaccination during pregnancy or shortly before conception. So smallpox
vaccine should not be administered in a pre-event setting to pregnant
women or to women who are trying to become pregnant. Before vaccination,
women of child-bearing age should be asked if they are pregnant or
intend to become pregnant in the next 4 weeks. Women who respond
positively should not be vaccinated. In addition, the potential risk to
the fetus should be explained. Women who are vaccinated should be
advised to avoid becoming pregnant during the 4 weeks after vaccination.
Routine pregnancy testing of women of child-bearing age is not
recommended.

## Slide 11

A woman who thinks she could be pregnant or who wants additional
assurance that she is not pregnant should perform a home pregnancy test
with a \"first morning\" void urine on the day scheduled for
vaccination. If a pregnant woman is inadvertently vaccinated or if she
becomes pregnant within 4 weeks after smallpox 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 the pregnancy. To expand our understanding of the risk of
fetal vaccinia, a pregnancy registry should be maintained and any
adverse outcomes carefully investigated.

## Slide 12

Screening for skin conditions in potential vaccinees can be difficult.
Eczema and atopic dermatitis is a risk factor for developing eczema
vaccinatum following smallpox vaccination in either vaccinees or in
their close contacts. This increased risk is independent of the activity
of the skin condition. Due to this increased risk, smallpox vaccine
should not be administered to persons with a history of eczema or atopic
dermatitis, irrespective of disease severity or activity. In addition,
persons with household contacts with a history of eczema or atopic
dermatitis, irrespective of disease severity or activity, should not be
vaccinated. Persons with other acute, chronic, or exfoliative
conditions, such as burns, impetigo, varicella zoster, herpes, severe
acne, or psoriasis, are at higher risk for inadvertent inoculation and
should not be vaccinated until the condition is under good control or
resolves.

## Slide 13

The majority of providers do not routinely make the distinction between
eczema and atopic dermatitis, particularly when describing chronic
exfoliative skin conditions in infants and young children. To assist
providers in identifying persons that should defer smallpox vaccination,
ACIP offers the following two screening questions: 1) Have you, or a
member of your household ever been diagnosed with eczema or atopic
dermatitis. If the person answers \"yes,\" he or she should NOT receive
the smallpox. 2) Eczema and atopic dermatitis usually is an itchy red,
scaly rash that lasts more than 2 weeks and often comes and goes. If the
person or a member of their household has ever had a rash like this they
should be vaccinated unless the person and a healthcare provider are
certain that this rash is not atopic dermatitis or eczema.

My final issue has to do with smallpox vaccination and blood donation.
Like other live virus vaccines, there will be a deferral period for
blood donation following receipt of smallpox vaccine. For this reason,
we encourage individuals to donate PRIOR to being vaccinated. In the
near future, the FDA will be release guidance that will include specific
recommendations for the deferral period for donors who receive smallpox
vaccine.

END

For more information, visit
[www.cdc.gov/smallpox](http://www.cdc.gov/smallpox), or call the CDC
public response hotline\
at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646
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