Chapter 5: Pre-event.
Screening individuals for vaccination
when there is no smallpox emergency,
with Dr. Brett Petersen.
In Chapter 5 of this training video,
we will discuss pre-event vaccination
and screening individuals for contraindications
to receiving ACAM2000 when there is no smallpox emergency.
Examples of populations in which pre-event vaccination might be
needed include laboratory personnel who work directly
with the variola virus or other related orthopoxviruses
and members of smallpox response teams who will be at high risk
for smallpox virus exposure while investigating a smallpox
outbreak and/or caring for smallpox patients.
Warnings and precautions for ACAM2000 will also be discussed.
A careful medical history identifying risk factors
for smallpox vaccination adverse events must be done
for every individual prior to pre-event vaccination
to identify individuals with contraindications to ACAM2000,
to determine whether the risks
of vaccination outweigh the potential benefits,
and to appropriately convey the risks of serious complications.
The risk for experiencing serious vaccination
complications must be weighed against the risks
for experiencing a severe orthopoxvirus infection.
Outside of a smallpox emergency,
the risks of vaccination generally outweigh the benefits
of vaccination in certain individuals.
ACAM2000 is contraindicated in individuals
with severe immunodeficiencies who are not expected
to benefit from the vaccine.
These individuals may include persons
who are undergoing bone marrow transplantation and persons
with primary or acquired immunodeficiency states
who require isolation.
When there is no smallpox emergency,
ACAM2000 should not be given to individuals
who have experienced a serious allergic reaction
to a prior dose of ACAM2000 vaccine
or other replication-competent smallpox vaccines
or to an ACAM2000 vaccine component.
By serious allergic reaction, we mean anaphylaxis or symptoms
of an anaphylaxis-like reaction, such as generalized urticaria,
wheezing, or difficulty breathing.
Reconstituted ACAM2000 vaccine does contain trace amounts
of the antibiotics neomycin, polymyxin B,
and phenol as a preservative.
Individuals with significant immunosuppression
or with household contacts
who are immunosuppressed should not be vaccinated due
to their predisposition
for serious vaccination complications.
Examples of significant immunosuppression include
diseases and conditions, such as leukemia, lymphoma,
generalized malignancy; solid organ
or stem cell transplantation; and HIV infection.
Individuals who are taking drugs that can cause immunosuppression
such as alkylating agents, antimetabolites, radiation,
other immunomodulatory medications,
or high dose corticosteroid therapy such as prednisone doses
of more than 20 milligrams per day or the equivalent
for 14 days or more should also not be vaccinated.
When there is no smallpox emergency,
ACAM2000 should not be administered to pregnant
and breastfeeding women.
This includes women who think they may be pregnant at the time
of vaccination (unless a pregnancy test can be offered
prior to vaccination) and women who are planning
on being pregnant within 4 weeks after vaccination.
ACAM2000 also should not be administered to individuals
with pregnant household contacts.
Women of childbearing age should be counseled
to avoid becoming pregnant
for at least 4 weeks after vaccination.
ACAM2000 has not been studied in breastfeeding women.
It is not known whether the vaccine virus
or antibodies are secreted in breast milk.
In addition, live vaccinia virus could be inadvertently
transmitted from recently vaccinated breastfeeding women
to breastfeeding infants.
Infants are at high risk for developing serious complications
from replication-competent smallpox vaccines.
Therefore, women who are breastfeeding should not be
vaccinated in a non-emergency setting.
Individuals with eczema or history of eczema of any type
such as atopic dermatitis, neurodermatitis,
and other eczematous conditions, regardless of the severity
of the condition or whether the condition is currently active,
are at higher risk for developing eczema vaccinatum
and should not be vaccinated with ACAM2000
in a non-emergency setting.
Close contacts of vaccinees may also be at increased risk
if they have eczematous conditions,
because live vaccinia virus can be shed and transmitted
to these close contacts.
Therefore, individuals with household contacts
with eczema should not be vaccinated.
Vaccinees or their contacts who have other active acute,
chronic, or exfoliative skin disorders (including burns,
impetigo, contact dermatitis, varicella zoster, psoriasis,
or acne vulgaris with open lesions) may also be
at higher risk for eczema vaccinatum
and should not be vaccinated.
ACAM2000 has not been studied in infants or children; however,
in studies from 1968 with a similar smallpox vaccine,
the risk of serious adverse events
such as postvaccinial encephalitis following
vaccination was higher in children less
than 24 months of age.
It is not recommended that children
under 18 years old be vaccinated in a non-emergency setting.
Individuals
with physician-diagnosed cardiac disease with
or without symptoms should be not be vaccinated with ACAM2000.
Cardiac conditions might include recent
or past myocardial infarction or angina,
congestive heart failure, cardiomyopathy,
stroke or transient ischemic attack, or unusual shortness
of breath upon exertion.
Individuals with 3 or more risk factors
for ischemic coronary disease, such as high blood pressure,
elevated blood cholesterol, diabetes mellitus
or high blood sugar, currently smoking,
or first degree relative (for example mother, father, brother,
or sister) who had a heart condition before the age of 50,
might be at an increased risk for severe disease
from vaccination complications
and should not be vaccinated with ACAM2000.
Individuals with moderate or severe acute illness
and individuals with eye disease that is currently being treated
with topical steroids may be at increased risk
and should not be vaccinated until the illness
or disease is resolved.
Persons who are age 65 or older may be at increased risk
for serious vaccination complications due
to the relative immunosuppression
of advanced age and higher likelihood of comorbidities
that may predispose them to vaccination complications.
Following vaccination, educate all vaccinees on how
to properly care for the vaccination site,
on the risk for inadvertent inoculation to themselves
or others, on avoidance of close physical contact
with individuals who are at high risk for serious complications
from exposure
to the replication-competent smallpox vaccines (for example,
people with immunosuppression
or atopic dermatitis, infants, etc.)
until the scab has fallen off,
and on keeping the entire vaccination site covered.
Practicing vigilant hand washing and infection control
after vaccination will be critical.
In summary, ACAM2000 will not be recommended
for the following individuals when no smallpox emergency is
in effect: Individuals who have experienced a serious allergic
reaction to a prior dose of vaccine
or to a vaccine component;
Individuals with significant immunosuppression
or with household contacts who are immunosuppressed;
Pregnant women, women who think they may be pregnant at the time
of vaccination or are planning to be pregnant within 4 weeks
after vaccination, or individuals
who have household contacts who are pregnant;
Women who are breastfeeding; Individuals with eczema
or atopic dermatitis or Darier's disease, or with a history
of these conditions,
or individuals whose household contacts have eczema
or atopic dermatitis or a history of these conditions;
Individuals with acute, chronic, or exfoliative skin conditions
such as burns, impetigo, contact dermatitis, varicella zoster,
psoriasis, or acne vulgaris with open lesions, or individuals
with household contacts with such conditions; Children less
than 18 years old; Individuals with known cardiac disease with
or without symptoms; Individuals with 3 or more risk factors
for ischemic coronary disease; Individuals with moderate
or severe acute illness at the time of vaccination;
and Individuals with active eye disease that is being treated
with topical steroids at the time of vaccination.
For further clinical guidance, please refer
to the CDC MMWR publications on smallpox vaccination
at www.cdc.gov/smallpox.
Additional information about warnings and precautions
for ACAM2000 can also be found
in the ACAM2000 package insert and medication guide.