Smallpox Vaccine

Table of contents

  • Brand Names
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Drug Interactions
  • Dosage
  • Special Considerations

Brand Names

North America

USA: ACAM2000, Dryvax.

Drug combinations


Pharmacologic Category

Serums, Toxoids, and Vaccines; Vaccines. (ATC-Code: J07B).

Mechanism of action

Vaccinia virus similar to variola (smallpox) virus. Induces localized infection with vaccinia virus, thus immunizing to both vaccinia and smallpox. Vaccination results in viral replication, production of neutralizing antibodies, immunity, and cellular hypersensitivity.

Therapeutic use

Active immunization against vaccinia virus, causative agent of smallpox in persons determined to be at risk for smallpox infection.

Pregnancy and lactiation implications

Pregnant women should not be vaccinated in nonemergency situations. Animal reproduction studies not conducted. Excretion in breast milk unknown (not recommended in nursing women).

Unlabeled use


There are no absolute contraindications regarding vaccination of individuals with high-risk exposure to smallpox. For non-emergent use, contraindications include hypersensitivity to vaccine or any component of the formulation, history of eczema or patients whose household contacts have acute or chronic exfoliative skin conditions, history of Darier disease, immunosuppressed patients and their household contacts, including patients with congenital or acquired immune deficiencies, patients receiving radiation, immunosuppressive drugs, or systemic corticosteroids ≥20 mg/day or ≥2 mg/kg body weight of prednisone for >2 weeks, or using ocular steroid medications, moderate-to-severe intercurrent illness, cardiac disease, including previous MI, angina, CHF, cardiomyopathy, chest pain, or shortness of breath requiring medical therapy, pregnancy or suspected pregnancy (including household contacts of pregnant women), and breast-feeding.

Warnings and precautions

Following vaccination, encephalitis, encephalomyelitis, and encephalopathy, acute myopericarditis and/or pericarditis, accidental infection of the eye (keratitis, corneal scarring, and blindness; higher risk if topical steroids), progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome) observed. Patients with cardiovascular disease or at risk for cardiovascular disease may be at increased risk for severe adverse reactions. Patients with eczema of any type/severity may be at increased risk for severe skin infections (should not be vaccinated in nonemergency situations). Immunocompromised patients may be at increased risk for progressive vaccinia (should not be vaccinated in nonemergency situations). Infants <12 months of age may be at increased risk for severe adverse reactions. Vaccine not recommended for use in infants <12 months of age (emergency situations) or in pediatric patients <18 years of age (nonemergency situations). Pregnant women should not be vaccinated in nonemergency situations. In utero transmission of virus observed. Pregnant women should be warned about possibility of inadvertent transmission of vaccinia virus from recently vaccinated individuals. Some dosage forms may contain chlortetracycline, dihydrostreptomycin, neomycin, or polymyxin B. Some dosage forms may contain human albumin. For vaccination by scarification (multiple punctures into superficial layers of skin) only (not for I.M., I.V., or SubQ injection). Patients should not donate blood or organs for 21-30 days following vaccination (contacts who inadvertently contracted vaccinia should avoid donating blood for 14 days). Virus may be cultured from vaccination sites until scab separates from lesion. Individuals should be instructed to avoid contact with patients at high risk of transmission/adverse effects, including eczema or immunodeficiency during this time. Smallpox vaccine may induce false-positive RPR (rapid plasma reagin) test for syphilis. Smallpox vaccine may diminish diagnostic utility of tuberculin skin and blood tests.



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