Smallpox Vaccine

A to Z Drug Facts

 Action Introduction of infectious vaccinia virus into superficial layers of the skin results in viral multiplication, immunity and cellular hypersensitivity.

 Indications Immunization against smallpox disease.

 Contraindications Infants less than 12 mo (nonemergency use in children less than 18 yr); 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.

 Route/Dosage

Adults 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.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Postvaccinial encephalitis; encephalomyelitis; encephalopathy; progressive vaccinia; eczema vaccinatum; permanent neurological sequelae. DERMATOLOGIC: 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). EENT: Blindness (from inadvertent infection [autoinoculation] of the eye). OTHER: Fever; death (from complications [eg, encephalitis]).

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Not recommended for use in nonemergency situations and contraindicated in children less than 12 mo in nonemergency situations. Elderly: Not recommended in nonemergency situations. Latex sensitivity: 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. Vaccine complications: The CDC can assist physicians diagnose and manage patients with suspected complications of smallpox vaccination.

 Administration/Storage

• For conventional smallpox vaccination (scarification) only. Not for IM, IV, SC, or intradermal administration.
• Follow manufacturer's instructions for reconstituting the powder for injection. Record date of reconstitution.
• Prepare appropriate vaccination site (skin over insertion of deltoid muscle or posterior aspect of arm over triceps) before withdrawing vaccine. If alcohol is used to prepare the site, the skin must be allowed to dry thoroughly to prevent inactivation of the vaccine.
• Carefully remove rubber stopper from reconstituted vial and aseptically retain stopper in inverted position for subsequent use.
• Obtain 1 confirmed drop of vaccine on bifurcated needle and deposit on prepared skin site. Using same needle and using multiple puncture technique, perform 2 to 3 punctures for primary immunization or 15 punctures for revaccination. Remove any remaining vaccine with dry sterile gauze.
• Do not redip the needle into vaccine if needle has touched skin.
• Vaccine site may be left uncovered or can be covered with a porous bandage (eg, gauze).
• If vaccine is to be stored for subsequent use, carefully restop the vial with rubber stopper and place unused vaccine in refrigerator.
• For reuse, gently swirl suspension to ensure resuspension and then carefully remove rubber stopper.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration, name, and title of person administering vaccine.
• Dispose of any used equipment (eg, gauze, venting needle, immunization needle) in biohazard waste container. The contents of the biohazard waste container must be burned, boiled, or autoclaved before disposal.
• 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.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note presence of or history of the following: latex sensitivity; eczema or any acute, chronic, or exfoliative skin lesion in patient or household contacts of patient; immunosuppressant therapy (eg, corticosteroids, immunosuppressive drugs, radiation therapy) or conditions involving immunosuppression (eg, leukemia, organ transplant, bone marrow transplant, immunity disorders) in patient or household contact of patient; immune deficiency (eg, HIV) in patient or household contact of patient; suspected or confirmed pregnancy in patient or household contact of patient.
• Ensure that a plan for handling vaccine complications is in place before initiating vaccination program.
• Wash hands thoroughly after any contact with the vaccine site (eg, changing dressings).
• Apply and change dressings as appropriate. Discard dressing material in biohazard waste container.
• 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.
• Ensure that vaccination site is inspected 6 to 8 days after vaccination to determine whether patient experienced a major reaction (eg, vesicular or pustular lesion or area of definite palpable induration or congestion) or equivocal reaction (any response other than major reaction).
• 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.
• 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. Inform health care provider immediately if noted.
• Monitor febrile patient's temperature. Acetaminophen or NSAIDs may be administered as ordered to reduce fever. Notify health care provider if temperature exceeds 104°F or if antipyretic measures are ineffective.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.
• No information exists regarding safety or efficacy of simultaneous administration of other live-virus vaccines with small pox vaccine. Defer immunization with other live-virus vaccines if possible.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• 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 q 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.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts