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Pronunciation: SMAHL-pocks vak-SEEN
Class: Viral vaccine
- Powder for injection Dried, calf lymph type live-virus preparation of vaccinia virus (polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, and neomycin sulfate are added in trace amounts). The reconstituted vaccine contains approximately 100 million infectious vaccinia viruses/mL.
Introduction of infectious vaccinia virus into superficial layers of the skin results in viral multiplication, immunity and cellular hypersensitivity.
Indications and Usage
Immunization against smallpox disease.
Infants less than 12 mo (nonemergency use in children younger than 18 yr of age); individuals with eczema or history of eczema or whose household contacts have eczema, other acute, chronic, or exfoliative skin conditions (eg, atopic dermatitis) and siblings or other household contacts of such individuals; individuals and household contacts of individuals receiving systemic corticosteroid therapy at certain doses (eg, at least 2 mg/kg body weight or at least 20 mg/day of prednisone for 2 wk or longer), immunosuppressive drugs (eg, alkylating agents), or radiation; individuals and household contacts of individuals with congenital or acquired deficiencies of immune system, including individuals infected with HIV; individuals with immunosuppression (eg, leukemia) or household contacts of such individuals; during pregnancy, suspected pregnancy, or household contacts of such individuals; hypersensitivity to any component of the product, including polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, and neomycin sulfate.
Dosage and AdministrationAdults
Scarification Using bifurcated end of needle, deposit drop of vaccine onto clean, dry site previously prepared for vaccination. With same end of needle, and using multiple-puncture technique, vaccinate through drop of vaccine. Holding needle perpendicular to the skin, rapidly make punctures with strokes vigorous enough to allow a trace of blood to appear after 15 to 20 sec. Two or 3 punctures are recommended for primary vaccinations; 15 punctures for revaccinations. Wipe off any remaining vaccine with dry sterile gauze and dispose of gauze in a biohazard waste container.
- Repeat vaccination using vaccine from another vial or lot (if possible) in patient who develops equivocal reaction. If this fails to generate a major reaction consult the CDC or state or local health department before giving another vaccination.
Store unreconstituted and reconstituted vaccine in refrigerator (36° to 46°F). Do not freeze. Reconstituted vaccine may be used for no more than 15 days after reconstitution. Do not use vaccine after expiration date regardless of whether it is in the dry or reconstituted form.
None well documented.
Laboratory Test Interactions
None well documented.
Postvaccinial encephalitis; encephalomyelitis; encephalopathy; progressive vaccinia; eczema vaccinatum; permanent neurological sequelae.
Generalize rashes; secondary pyogenic infections at the site of vaccination; bullous erythema multiforme (Stevens-Johnson syndrome); inadvertent inoculation at other sites (eg, face, eyelids, genitalia).
Blindness (from inadvertent infection [autoinoculation] of the eye).
Fever; death (from complications [eg, encephalitis]).
Monitor patient for evidence of autoinoculation of virus from vaccine site to other sites (eg, face, eyelid, nose, mouth, genitalia, rectum), generalized vaccinia (vesicular rash), or evidence of encephalopathy.
Category C .
Not recommended for use in nonemergency situations and contraindicated in children less than 12 mo in nonemergency situations.
Not recommended in nonemergency situations.
Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy if noted. Be prepared to treat appropriately.
Monitor febrile patient's temperature. Acetaminophen or NSAIDs may be administered as ordered to reduce fever. Note temperature exceeding 104°F or if antipyretic measures are ineffective.
Vial stopper is dry, natural rubber that may produce hypersensitivity when handled or administered by individuals with latex sensitivity.
Prevention of transmission
Vaccinia virus may be cultured from the site of primary vaccination beginning at the time of development of a papule (2 to 5 days after vaccination) until the scab separates from the skin (14 to 21 days after vaccination). During this time, care must be taken to prevent spread of the virus to another area of the body or to another individual.
The CDC can assist health care providers diagnose and manage patients with suspected complications of smallpox vaccination.
- Educate patient regarding expected progressive response to initial vaccination: a small, solid elevation (papule) should form 2 to 5 days after vaccination; this should become a blister (vesicle) by day 5 or 6; this progresses and the blister fills with pus, becomes harder and redder between days 8 to 12 during which fever, general body discomfort, and swollen glands may be noted; the pus and redness then go away and a scab (crust) forms over the vaccination site which then come off between days 14 and 21.
- Advise patient that OTC acetaminophen or NSAIDs may be used for fever or general body discomfort but to notify health care provider if symptoms persist or worsen.
- Caution patient that the vaccine site is infectious from the time the papule develops (2 to 5 days after vaccination) until the scab separates from the skin lesion (14 to 21 days after vaccination) during which time care must be taken to prevent spread of the virus to another area of the body or another person.
- Instruct patient to thoroughly wash hands after changing bandages or any other contact with the vaccination site.
- Instruct patient to not apply any salves or ointments to the vaccination site.
- Advise patient that vaccine site may be left uncovered or can be covered with a porous bandage (eg, gauze) until the scab has separated and the underlying skin has healed. Caution patient to not use an occlusive bandage unless it is changed every 1 to 2 days to prevent maceration of the vaccine site.
- Instruct patient to place any contaminated bandages or wraps in a sealed plastic bag before disposal in trash.
- Advise patient that clothing or other cloth materials than have had contact with the vaccine site while it is infectious can be decontaminated with routine laundering in hot water and bleach.
- Advise patient that normal bathing can continue but to keep vaccination site dry at other times.
- Instruct patient to notify health care provider if the following occur: papules are noted on any part of the body other than the vaccination site (autoinoculation); vesicular (blisters) rash develops; or if headache, changes in behavior or alertness, stiff neck, or other unexplained feelings or symptoms occur.
- If patient is a health care worker, avoid contact with patients, particularly those with immunodeficiencies, until the scab has separated from the skin at the vaccination site. If this is not possible, then the vaccination site must be well covered (semipermeable polyurethane dressing over gauze pad) and good hand-washing technique must be maintained.
- Provide patient with immunization history record.
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