II. Indications

  1. Postexposure Prophylaxis
  2. High risk of exposure as Biological Weapon

III. Contraindications (Relative if actual Smallpox exposure)

  1. Also applies to conditions in household or sex contacts
  2. Consider concurrent Variola Immunoglobulin 0.3 ml/kg
  3. Eczematous Dermatitis
  4. Exfoliative condition (e.g. Burn Injury, Shingles)
  5. Immunodeficiency
    1. Chemotherapy or Radiation Therapy
    2. Immunosuppresant use within 3 months of Vaccine
    3. Corticosteroids (including ocular Corticosteroids)
      1. Prednisone >2 mg/kg/day for over 2 weeks or
      2. Prednisone 20 mg/day for over 2 weeks
    4. Human Immunodeficiency Virus (HIV)
    5. Hereditary Immunodeficiency
    6. Pregnancy
    7. Concurrent moderate to severe illness
  6. Heart disease or 3 or more Cardiac Risk Factors
  7. Age under 12 months
  8. Unless emergency, avoid use if age under 18 or over 65
  9. Breastfeeding
  10. Allergy to Vaccine components
    1. Polymyxin B, Streptomycin, Tetracycline or Neomycin
    2. Phenol
    3. Latex Allergy (Latex in Vaccine vial stopper)

IV. Technique

  1. Obtain sterile bifurcated needle
  2. Dip needle into reconstituted Vaccine ampule
  3. Limit Vaccine to 5 mm area
  4. Scratch skin with 15 perpendicular needle strokes
    1. Trace of blood should appear with 15-30 seconds
  5. Wipe excess Vaccine from skin
  6. Apply bandage securely to inoculation site

V. Site care post vaccination

  1. Keep site always covered to prevent virus transmission
    1. Change dressing every 1-3 days
    2. Dispose of dressings as infectious waste
    3. Do not apply any topical agents (e.g. cream) to site
  2. Site care to prevent autoinoculation or transmission
    1. Infectious from day 3 to 28 (when scab falls off)
    2. Avoid touching or exposing others to site
    3. Wash skin carefully if accidental exposure occurs
  3. Other measures to prevent transmission
    1. Isolate linen and clothing from others in house
    2. Avoid public swimming until scab falls off (4 weeks)
    3. Wear long sleeve clothing over bandaged site
  4. Should not disrupt work in most occupations
    1. Food preparation may continue
    2. Travel is not contraindicated
    3. Healthcare workers may still care for patients

VI. Adverse effects

  1. Uniform skin response (Jennerian response, "Take")
    1. Red Papule at Vaccine site by 3 days
    2. Vesicle by day 5
    3. Jennerian Pustule by day 7
      1. White, umbilicated Pustule on erythematous base
    4. Dark crust forms and falls off by 3 weeks
    5. Full progression timing depends on prior exposure
      1. Primary vaccination: 15 days
      2. Revaccination: 8 days
  2. Inadequate Vaccination (Requires re-vaccination)
    1. Peak erythema within 48 hours (hypersensitivity)
  3. Common Constitutional symptoms
    1. Fever between days 4-14 (70% of children)
    2. Regional Lymphadenopathy

VII. Complications

  1. Post-vaccine Encephalitis (15 per 1 million Vaccinees)
    1. Occurs within 2 weeks of Vaccine
    2. Mortality: 25%
    3. Morbidity: Serious neurologic sequelae in 25%
    4. No treatment other than supportive care
  2. Progressive Vaccinia (Vaccinia gangrenosa)
    1. Only occurs in immunodeficient patients
    2. Suspect if lesions progress beyond 2 weeks
    3. Non-healing skin lesions progressing to skin necrosis
    4. Frequently fatal
    5. May respond to medications
      1. Variola Immunoglobulin 0.6 ml/kg divided over 24 h
      2. Cidofovir (Vistide)
      3. Ribavirin
  3. Eczema Vaccinatum (10-39 per 1 million Vaccinees)
    1. Occurs if patient has Atopic Dermatitis
    2. Variola skin lesions involve Eczematous skin
    3. Variola Immunoglobulin 0.6 ml/kg divided over 24 hour
      1. Reduces potential mortality from 40% to 1%
  4. Autoinoculation (600 per 1 million Vaccinees)
    1. Accidental inoculation of face, eyes, mouth, genitals
  5. Other complications
    1. Generalized Vaccinia
      1. Onset 6-9 days after vaccination
      2. Benign with resolution within 2 weeks
    2. Ocular Vaccinia
      1. Opthalmology referral
      2. Avoid VIG (Corneal Opacity risk)
      3. Consider ocular antiviral (e.g. Trifluridine)
    3. Myopericarditis
      1. Presents within 30 days of vaccination
      2. Recently reported as more common adverse effect

VIII. Storage of Vaccine

  1. Vaccine may be refrigerated 60 days post-reconstitution

IX. Efficacy

  1. Single dose results in protection by 10 days in 95%
  2. Immunity lasts 5 years or more after vaccination
    1. Booster dose extends duration of immunity

X. Drug Interactions

  1. Most vaccinations are safe to concurrently administer
  2. Do not administer with Varicella Vaccine
    1. Due to differentiating potential reactions
  3. Do not use with immunosuppressants or Corticosteroids
    1. See contraindications above

XI. Reporting

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Ontology: Smallpox Vaccine (C0037355)

Definition (HL7V3.0) <p>smallpox vaccine</p>
Definition (MSH) A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)
Definition (CSP) frequently a live vaccinia virus vaccine of calf lymph or chick embryo origin, used for immunization against smallpox.
Concepts Pharmacologic Substance (T121) , Immunologic Factor (T129)
MSH D012900
SnomedCT 33234009, 396439006
HL7 75
English Vaccine, Smallpox, Smallpox Vaccine [Chemical/Ingredient], smallpox vaccines, vaccinia (smallpox) vaccine, vaccinia (smallpox), smallpox vaccine,live, smallpox vaccine (medication), vaccines viral smallpox, smallpox vaccine, Smallpox vaccine, Var/Vac, Smallpox vaccine (product), Smallpox vaccine (substance), smallpox, Smallpox Vaccine, SMALLPOX VACCINE
Swedish Smittkoppsvaccin
Czech neštovice pravé - vakcína, variola - vakcína
Finnish Isorokkorokote
Russian OSPENNAIA VAKTSINA, VAKTSINA OSPENNAIA, ВАКЦИНА ОСПЕННАЯ, ОСПЕННАЯ ВАКЦИНА
Croatian VARIOLA, CJEPIVO
Polish Szczepionka przeciw ospie
Spanish Vacuna de la Viruela, Vacuna contra la Viruela, Vacuna Antivariólica, vacuna antivariólica (producto), vacuna antivariólica (sustancia), vacuna antivariólica, Vacuna contra Viruela
Portuguese Vacina contra a Varíola, Vacina da Varíola, Vacina contra Varíola, Vacina Antivariólica
French Vaccin antivariolique
German Pocken-Vakzine, Pockenimpfstoff
Italian Vaccino vaioloso

Ontology: Vaccination against smallpox (C0042207)

Concepts Therapeutic or Preventive Procedure (T061)
ICD9 99.42
SnomedCT 147604007, 170362005, 147599001, 40001004
English Vaccination against smallpox, Smallpox vaccination NOS, immunizations smallpox, smallpox immunisation, smallpox immunization, vaccination smallpox, smallpox vaccination, smallpox vaccinations, Smallpox vaccination NOS (procedure), Smallpox vaccination, Smallpox immunization, Smallpox immunisation, Smallpox vaccination (procedure)
Spanish Inmunización antiviruela, Inmunización contra la viruela, vacunación antivariólica, SAI, vacunación antivariólica, SAI (procedimiento), Smallpox vaccination NOS, inmunización antivariólica, vacunación antivariólica (procedimiento), vacunación antivariólica, vacunación contra la viruela
Portuguese Imunização contra a varíola
French Immunisation contre la variole
Italian Vaccinazione contro il vaiolo
German Immunisierung gegen Pocken
Dutch immunisatie tegen pokken, pokkenimmunisatie
Czech Očkování proti pravým neštovicím
Japanese 痘瘡免疫, トウソウメンエキ
Hungarian Variola immunisatio, Variola vera immunisatio