Smallpox Vaccinia Vaccine Live

Smallpox (vaccinia) vaccine, live is a prescription vaccine used for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

• Smallpox (vaccinia) vaccine, live is available under the following different brand names: ACAM2000.

Common side effects of the Smallpox (vaccinia) vaccine, live include:

• injection site reactions (itching, redness, pain, swelling)
• enlarged lymph nodes
• feeling of being unwell (malaise)
• fatigue
• fever
• muscle pain
• headache
• arm soreness
• body aches
• rash
• nausea
• vomiting
• diarrhea
• constipation
• feeling hot
• shortness of breath

Serious side effects of the Smallpox (vaccinia) vaccine, live include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness

Rare side effects of the Smallpox (vaccinia) vaccine, live include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest, shortness of breath, sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Lyophilized powder for reconstitution

• Following reconstitution: 2.5-12.5 x 10^5 plaque forming units/0.0025mL.
• Both the vaccine and provided diluent vial stoppers do not contain latex material.

Smallpox immunization

Adult dosage

• A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle

Pediatric dosage

• Children under 16 years: Safety and efficacy not established; use of the vaccine in all pediatric age groups is supported by evidence from adequate and well-controlled studies in adults and with additional historical data with the use of live vaccinia virus smallpox vaccine in pediatrics
• No longer recommended for routine immunization since smallpox disease has been eradicated
• A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Smallpox (vaccinia) vaccine, live has severe interactions with the following drugs:
  • belimumab
  • certolizumab pegol
  • ibrutinib
  • ifosfamide
  • ixekizumab
  • mechlorethamine
  • melphalan
  • methotrexate
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • secukinumab
  • ustekinumab
• Smallpox (vaccinia) vaccine live has serious interactions with at least 67 other drugs.
• Smallpox (vaccinia) vaccine, live has moderate interactions with the following drugs:
  • anthrax immune globulin
  • belatacept
  • betibeglogene autotemcel
  • cytomegalovirus immune globulin (CMV IG)
  • hepatitis B immune globulin (HBIG)
  • immune globulin IM (IGIM)
  • immune globulin IV (IGIV)
  • immune globulin SC
  • leniolisib
  • obinutuzumab
  • rabies immune globulin, human (RIG)
  • tecovirimat
  • tetanus immune globulin (TIG)
  • ublituximab
  • vaccinia immune globulin intravenous
• Smallpox (vaccinia) vaccine, live has minor interactions with the following drugs:
  • chloroquine
  • Rho(D) immune globulin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• There are very few absolute contraindications to the vaccine for those at high risk for smallpox.
• The risk of experiencing serious vaccination complications must be weighed against the risk of experiencing a potentially fatal smallpox infection; for those who are at higher risk of experiencing serious vaccination complications.
• Severe immune deficiency
  • Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in people with weakened immune systems.
  • Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000.
  • These individuals may include those who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Smallpox (vaccinia) vaccine, live?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Smallpox (vaccinia) vaccine, live?”

Cautions

• Serious complications may follow vaccination and may include myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necro sum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, blindness, and fetal death in pregnant women; these complications may rarely lead to severe disability, permanent neurological sequelae, and/or death
• Ischemic cardiac events and nonischemic, dilated cardiomyopathy have been reported following smallpox vaccination; the relationship to the vaccine is unknown
• Accidental infection of the eye (ocular vaccinia) may result in ocular keratitis, corneal scarring, and blindness
• Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in people with weakened immune systems, including those with leukemia, lymphoma, organ transplantation, generalized malignancy, HIV/AIDS, cellular or humoral immune deficiency, radiation therapy, or treatment with antimetabolites, alkylating agents, high-dose corticosteroids (above 10 mg prednisone/day or equivalent for 2 weeks and more), or other immunomodulatory drugs; contraindicated in individuals with severe immunodeficiency (see Contraindications)
• People with eczema of any description (such as atopic dermatitis, neurodermatitis, and other eczematous conditions, regardless of the severity of the condition), or those who have a history of these conditions at any time in the past, are at higher risk of developing eczema vaccinatum
• Not studied in infants or children; risk of serious adverse events is higher in infants; vaccinated individuals who have close contact with infants (e.g., breastfeeding women) must take precautions to avoid inadvertent transmission of live vaccinia virus to infants
• Not studied in pregnant women; live vaccinia virus vaccines can cause fetal vaccinia and fetal death; if administered during pregnancy, the vaccinee should be apprised of the potential hazard to the fetus; pregnant women who are close contacts of vaccinees may be at increased risk because live vaccinia virus can shed and be transmitted to close contacts
• The vaccine contains neomycin and polymyxin B; those with a history of allergy to these components should exercise caution
• Vaccinia immune globulin (VIG) is indicated for certain complications of vaccination live vaccinia virus smallpox vaccine; if VIG is needed or additional information is required, physicians should contact the CDC at (404) 639-3670 (Monday through Friday) or (404) 639-2888 during evenings/weekends
• The most important measure to prevent inadvertent auto-inoculation and contact transmission from vaccinia vaccination is thorough handwashing after changing the bandage or after any other contact with the vaccination site
• Avoid blood and organ donation for at least 30 days following vaccination

Pregnancy and Lactation

• Use in life-threatening emergencies when no safer drug is available; has not been studied in pregnant women
• The only setting in which vaccination of pregnant women should be considered is when exposure to smallpox is considered likely
• Live vaccinia virus vaccines can cause fetal harm when administered to a pregnant woman; congenital infection, principally occurring during the first trimester, has been observed after vaccination with live vaccinia smallpox vaccines although the risk may be low
• Generalized vaccinia of the fetus, early delivery of a stillborn infant, or a high risk of perinatal death has been reported
• If this vaccine is used during pregnancy, or if the vaccinee lives in the same household or has close contact with a pregnant woman, the vaccinee should be apprised of the potential hazard to the fetus
• Lactation
  • Not known if excreted in breast milk, not recommended for nursing women in nonemergency situations
  • Live vaccinia virus can be inadvertently transmitted from a lactating mother to her infant
  • Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination