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Nov.30.2022

Smallpox Vaccine, Vaccinia Vaccine

Indications/Dosage

Labeled

  • variola (smallpox) prophylaxis

General Dosing Information

  • Vaccination with the smallpox vaccine is recommended for people at risk for occupational exposure to orthopoxviruses. At-risk people include research laboratory personnel, clinical laboratory personnel performing diagnostic testing for orthopoxviruses, designated response team members at risk for occupational exposure to orthopoxviruses, and health care personnel who administer the smallpox vaccine or care for patients with orthopoxviruses. For laboratory personnel and designated response team members, the use of the smallpox and monkeypox vaccine as an alternative to the smallpox vaccine is recommended. For healthcare personnel administering the smallpox vaccine or those caring for patients infected with orthopoxviruses, the smallpox and monkeypox vaccine is recommended as an alternative to the smallpox vaccine, based on shared clinical decision-making.
  • People who received the 1-dose smallpox primary vaccine series and who are at ongoing risk for occupational exposure to more virulent orthopoxvirus should receive a smallpox vaccine booster dose every 3 years. People who received the 1-dose smallpox primary vaccine series and who are at ongoing risk for occupational exposure to the less virulent orthopoxviruses, should receive booster doses of smallpox vaccine every 10 years.
    • A booster dose of smallpox and monkeypox vaccine may be given as an alternative to a booster dose of the smallpox vaccine. People who transition to receiving the smallpox and monkeypox vaccine boosters are expected to continue receiving the smallpox and monkeypox vaccine boosters and should not revert to the smallpox vaccine.
  • Carefully screen patients for contraindications prior to routine primary or booster vaccination. Since the vaccinia virus is used in smallpox vaccine, vaccinia virus can be spread to others from the vaccine site of an immunized person. Although secondary transmission of vaccinia virus occurs infrequently, transmission occurs after close interaction, most often in the home, and often involves children.
    • People with contraindications to vaccination with the smallpox vaccine (e.g., atopic dermatitis, immunocompromising conditions, breastfeeding, or pregnancy) may receive vaccination with the smallpox and monkeypox vaccine.
  • Clinical studies have shown maximal antibody titers 28 days after administration of the 1-dose smallpox primary vaccination series; an immunocompetent person is considered fully immunized at that time.
  • Due to the documented risk for myocarditis after both the smallpox and mRNA COVID-19 vaccines, patients, in particular adolescents or young adult males, may consider waiting 4 weeks after smallpox vaccination before getting an mRNA COVID-19 vaccine. However, if vaccination with the smallpox vaccine is recommended for prophylaxis during an outbreak, administration of the smallpox vaccine should not be delayed because of recent mRNA COVID-19 vaccination. No minimum interval between mRNA COVID-19 vaccination and smallpox vaccination is necessary.[33514][67647][67763]

Off-Label

  • monkeypox virus (mpox) prophylaxis
† Off-label indication

For variola (smallpox) prophylaxis in patients who are at risk for smallpox infection

Percutaneous dosage (ACAM2000 only)

Adults

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who are at continued high risk of smallpox exposure may be revaccinated every 3 years. For booster vaccination, 15 needle punctures should be made. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515]

Adolescents 16 to 17 years

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who are at continued high risk of smallpox exposure may be revaccinated every 3 years. For booster vaccination, 15 needle punctures should be made. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515]

For monkeypox virus (mpox) prophylaxis in patients who are at high risk for monkeypox infection†

for pre-exposure prophylaxis

Percutaneous dosage (ACAM2000)

Adults

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who are at continued high risk of monkeypox virus (mpox) exposure may be revaccinated every 3 years. For booster vaccination, 15 needle punctures should be made. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515] [67647]

Adolescents 16 and 17 years

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who are at continued high risk of monkeypox virus (mpox) exposure may be revaccinated every 3 years. For booster vaccination, 15 needle punctures should be made. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515] [67647]

for post-exposure prophylaxis

Percutaneous dosage (ACAM2000)

Adults

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease. If it has been more than 3 years since vaccination, consider revaccinating. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515] [67647] [67650]

Adolescents 16 and 17 years

0.0025 mL (a droplet of vaccine) administered percutaneously onto the arm by rapidly making 15 needle punctures. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease. If it has been more than 3 years since vaccination, consider revaccinating. A major cutaneous reaction characterized by a pustule at the inoculation site by day 6 to 8 is evidence of acquisition of protective immunity. If a major reaction is not obtained after primary vaccination, check vaccination procedures, and repeat vaccination with vaccine from another vial or vaccine lot, if available. If a repeat vaccination using vaccine from another vial or vaccine lot fails to produce a major reaction, consult the CDC or the state or local health department before giving another vaccination. Patients who have previously received the vaccine may have a reduced cutaneous response to revaccination. Do not revaccinate these individuals in an attempt to elicit a cutaneous response.[33515] [67647] [67650]

Therapeutic Drug Monitoring

Maximum Dosage Limits

  • Adults

    15 needle punctures made through one drop of vaccine.

  • Elderly

    15 needle punctures made through one drop of vaccine.

  • Adolescents

    >= 16 years: 15 needle punctures made through one drop of vaccine.

    < 16 years: Safe and effective use has not been established; however, 15 needle punctures made through one drop of vaccine may be used in emergency situations.

  • Children

    Safe and effective use has not been established; however, 15 needle punctures made through one drop of vaccine may be used in emergency situations.

  • Infants

    Safe and effective use has not been established; however, 15 needle punctures made through one drop of vaccine may be used in emergency situations.

Patients with Hepatic Impairment Dosing

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with Renal Impairment Dosing

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

† Off-label indication
Revision Date: 11/30/2022, 04:04:53 PM

References

33514 - Centers for Disease Control and Prevention (CDC). Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(RR07):1-16.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.67647 - Center for Disease Control and Prevention (CDC). 2022 United States Monkeypox response and recommendations. Retrieved May 26, 2022. Available on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html.67650 - Center for Disease Control and Prevention (CDC). Monkeypox and smallpox vaccine guidance. Retrieved May 26, 2022. Available on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html.67763 - Centers for Disease Control and Prevention. Use of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on imunization practices - United States, 2022. MMWR 2022;71:734-42.

How Supplied

Smallpox Vaccine (Live), Dried Powder for solution for injection

Dryvax Intradermal Injection (00008-0348) (Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc) (off market)

Vaccinia Virus Strain New York City Board of Health Live Antigen Lyophilisate for solution for percutaneous scarification

ACAM2000 Smallpox (Vaccinia) Live Vaccine Powder for Solution (71665-0330) (Emergent Product Development Gaithersburg Inc) null

Description/Classification

Description

Smallpox vaccine, vaccinia vaccine is used for prophylaxis against smallpox. It is a parenteral preparation of live, laboratory-derived vaccinia virus. Vaccinia virus is used because it is antigenically similar to the variola virus, which causes smallpox. The smallpox vaccine does not contain smallpox virus (variola) and cannot spread or cause smallpox. Naturally occurring smallpox infection was eradicated from the world in 1977; world certification regarding the eradication of disease occurred in 1980. In the US, routine vaccination of the public against smallpox ended in 1972. The level of immunity, if any, among persons who were vaccinated before 1972 is uncertain; therefore, it is assumed that these persons are susceptible to smallpox. Most estimates suggest immunity from the vaccinia vaccine lasts 3 to 5 years. Immunity can be boosted effectively with revaccination. Postexposure vaccination may be effective if given within 4 days of exposure to smallpox. Vaccinia vaccination is generally considered safe; serious complications are rare but include a risk of fatality in roughly 1 to 2 per million persons receiving primary vaccination and 0.25 deaths/million persons receiving revaccination. However, some people with pre-existing conditions such as eczema or immune system disorders have a higher risk for having complications from the vaccine. The vaccinia vaccine should not be used for the treatment of smallpox. When administered as pre-exposure, smallpox and monkeypox vaccines are effective at protecting patients against monkeypox. Due to the similarities in the smallpox and monkeypox viruses, the smallpox vaccine is at least 85% effective in preventing monkeypox. Vaccination postmonkeypox virus exposure may help prevent the disease or decrease severity.[27212][33514][33515][61952][67647][67650][67754]

Classifications

  • General Anti-infectives Systemic
    • Vaccines
      • Pure Vaccines
        • Smallpox Vaccines
Revision Date: 07/13/2022, 06:55:15 PM

References

27212 - Centers for Disease Control and Prevention (CDC). Vaccinia (Smallpox) Vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2001;50(no. RR-10):1-25.33514 - Centers for Disease Control and Prevention (CDC). Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(RR07):1-16.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.61952 - Centers for Disease Control and Prevention (CDC). Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel at Risk for Occupational Exposure to Orthopoxviruses. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2016;65:257-262.67647 - Center for Disease Control and Prevention (CDC). 2022 United States Monkeypox response and recommendations. Retrieved May 26, 2022. Available on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html.67650 - Center for Disease Control and Prevention (CDC). Monkeypox and smallpox vaccine guidance. Retrieved May 26, 2022. Available on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html.67754 - Centers for Disease Control and Prevention (CDC). Vaccine Basics. July 12, 2017. Retrieved from the World Wide Web June 28, 2022 at:https://www.cdc.gov/smallpox/vaccine-basics/index.html

Administration Information

General Administration Information

For storage information, see specific product information within the How Supplied section.

 

  • According to US federal laws, the healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
  • The smallpox vaccine, vaccinia vaccine must be administered only by vaccine providers with training to safely and effectively administer the vaccine by the percutaneous route. Use protective gloves and aseptic technique when reconstituting and administering the vaccine. Training is available to all vaccine providers. In the event of an actual smallpox emergency declared by the Secretary of the US Department of Health and Human Services, vaccine providers may follow educational instructions they receive from the manufacturer.

Route-Specific Administration

Injectable Administration

  • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.[33515]
  • Due to the documented risk for myocarditis after both the smallpox and mRNA COVID-19 vaccines, patients, in particular adolescents or young adult males, may consider waiting 4 weeks after smallpox vaccination before getting an mRNA COVID-19 vaccine. However, if vaccination with the smallpox vaccine is recommended for prophylaxis during an outbreak, administration of the smallpox vaccine should not be delayed because of recent mRNA COVID-19 vaccination. No minimum interval between mRNA COVID-19 vaccination and smallpox vaccination is necessary.[67763]

Other Administration Route(s)

Percutaneous Administration

NOTE: Care must be taken to prevent spread of the virus to another area of the body or to another person. Wash hands with soap and warm water or with alcohol-based hand rubs such as gels or foams after direct contact with the vaccination site; the bandage; or clothes, towels, or sheets that might be contaminated with virus from the vaccination site. Clothing, towels, bedding, or other items that may have come in direct contact with the vaccination site or drainage from the site need to be washed separately using hot water with detergent and/or bleach.

 

Reconstitution

  • Remove the vial from cold storage and allow the vial to reach room temperature.
  • Remove flip cap seals of vaccine and diluent vials. Wipe the rubber stoppers of both vials with isopropyl alcohol swab and let dry.
  • Using the supplied needle, add 0.3 mL of the provided diluent and gently swirl. Use only the sterile vaccine diluent supplied with this vaccine. This diluent is free from preservatives or anti-viral substances that might inactivate the vaccine virus.
  • The reconstituted vaccine should be a clear to slightly hazy, colorless to straw-colored liquid free from extraneous matter. Do not use the vaccine if discoloration or particulate matter are observed.
  • Handle the vaccine as an infectious agent once the vial is open. Wear surgical or protective gloves, and avoid contact of the vaccine with skin, eyes, or mucous membranes.
  • Once reconstituted, each vial of smallpox vaccine contains approximately 100 doses of 0.0025 mL of live vaccinia virus containing 2.5 to 12.5 x105 plaque forming units per dose.
  • Storage after reconstitution: May store at room temperature (20 to 25 degrees C [68 to 77 degrees F]) if used within 6 to 8 hours; place in the refrigerator or on ice between patient administrations to minimize exposure to room temperature. May also store in a refrigerator (2 to 8 degrees C [36 to 46 degrees F]) for up to 30 days.[33515]

 

Percutaneous administration

  • If alcohol is used to clean the intended vaccine site, allow the site to completely dry before vaccine administration.
  • The smallpox vaccine, vaccinia vaccine is administered using a multiple-puncture technique with a bifurcated needle. Using aseptic technique, insert a supplied bifurcated needle into a vial of reconstituted vaccine. On removal of the needle, confirm that a droplet of vaccine is held between the 2 prongs. Rest the wrist of the hand holding the needle against the patient's upper arm over the insertion of the deltoid muscle, and rapidly make 15 jabs of the needle perpendicular to the skin within a diameter of about 5 mm. The needle jabs deliver the dose percutaneously. A drop of blood should appear at the site within 15 to 20 seconds. Do not administer the vaccine by the intradermal, subcutaneous, intramuscular, or intravenous route. Do not reinsert the needle into the vial once the needle has touched the skin. After administration, remove excess vaccine by gentle blotting with clean, dry gauze or cotton.
  • Loosely cover the vaccination site with a gauze bandage, and use first aid adhesive tape to keep it in place. If the vaccinee is involved in direct patient care, cover the gauze with a dressing that allows for the passage of air but not fluids (semipermeable or semiocclusive). Do not use an occlusive bandage, as the skin may break down. Accumulation of exudate may be decreased by first covering the vaccination with dry gauze, then applying the dressing over the gauze. Change the dressing every 1 to 3 days. Don't put salves or ointments on the vaccination site. The vaccinia virus is shed from the injection site for 14 to 21 days after vaccination; keep the site covered and dry, and always wash hands thoroughly.
  • Discard the vaccine vial, its stopper, the diluent syringe, the vented needle used for reconstitution, the bifurcated needle used for administration, and any gauze or cotton that came in contact with the vaccine in leak-proof, puncture-proof biohazard containers. A new bifurcated needle must be used for each patient.[33515]

Clinical Pharmaceutics Information

From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
    Revision Date: 08/02/2022, 04:34:16 PM

    References

    33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.67763 - Centers for Disease Control and Prevention. Use of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on imunization practices - United States, 2022. MMWR 2022;71:734-42.

    Adverse Reactions

    Mild

    • arthralgia
    • back pain
    • chills
    • diarrhea
    • dizziness
    • drowsiness
    • fatigue
    • fever
    • folliculitis
    • headache
    • infection
    • injection site reaction
    • maculopapular rash
    • malaise
    • myalgia
    • nausea
    • paresthesias
    • pruritus
    • rash
    • urticaria
    • vertigo
    • vomiting

    Moderate

    • angina
    • chest pain (unspecified)
    • constipation
    • encephalopathy
    • erythema
    • lymphadenopathy
    • meningitis
    • photophobia

    Severe

    • cardiomyopathy
    • coma
    • eczema vaccinatum
    • erythema multiforme
    • fetal death
    • generalized vaccinia
    • Guillain-Barre syndrome
    • muscle paralysis
    • myelitis
    • myocardial infarction
    • myocarditis
    • pericardial effusion
    • pericarditis
    • seizures
    • Stevens-Johnson syndrome
    • vaccinia necrosum (progressive vaccinia)

    Lymphadenopathy or lymph node pain is a common adverse effect of the smallpox vaccine, vaccinia vaccine. Among 873 primary vaccine recipients who received the smallpox vaccine (ACAM2000), 8% had lymphadenopathy and 57% had lymph node pain. Among 1,371 previously vaccinated subjects who got revaccinated with the smallpox vaccine (ACAM2000), 6% had lymphadenopathy and 19% had lymph node pain. Severe lymph node pain and lymphadenopathy were rare (less than 1%).

    An injection site reaction is an expected and desired adverse reaction of the smallpox vaccine, vaccinia vaccine. Major cutaneous reactions are desired and are characterized by a large area of erythema, induration, and streaking inflammation of draining lymphatics. Injection site reactions were common among 873 primary vaccine recipients who received the smallpox vaccine (ACAM2000); 92% had pruritus, 74% had erythema, 67% had pain, and 48% had swelling. Injection site signs and symptoms are less frequent in revaccinated persons than persons receiving the vaccine for the first time. Among 1,371 previously vaccinated subjects who got revaccinated with the smallpox vaccine (ACAM2000), 82% had pruritus, 61% had erythema, 37% had pain, and 28% had swelling. Benign and malignant lesions have been reported to occur at the smallpox vaccination site. Any lesion other than a smooth scar, regardless of duration since vaccination, warrants further evaluation. Major cutaneous reactions at the site of inoculation may resemble cellulitis. One percent of vaccinia-naive and less than 1% of previously vaccinated subjects (receiving the smallpox vaccine, ACAM2000) experienced at least 1 severe dermatologic adverse event. Erythema and rash accounted for all severe events except for 1 case of contact dermatitis and 1 case of urticaria. Generalized rashes are common after smallpox vaccination and are presumed to be hypersensitivity reactions in patients without underlying illnesses. In general, rashes are self-limited and do not require treatment. Rashes of many different types have been associated with smallpox vaccination with the most common being erythema multiforme, maculopapular rash, urticarial rash, papulovesicular, and blotchy erythematous eruptions. Most rashes clear without therapy.[27217] Serious dermatologic complications that may follow either primary live vaccinia smallpox vaccination or revaccination include severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), and eczema vaccinatum. Eczema vaccinatum is a sometimes serious adverse reaction to smallpox vaccine in patients with a history of atopic dermatitis (e.g., eczema). Vaccinial lesions usually occur at all or most areas of the skin that is or has been afflicted with atopic dermatitis. Eczema vaccinatum occurs more frequently in younger children (1 to 5 years of age) and in males. Vaccinia immune globulin (VIG) can be used to treat this condition.[27217] [27218] Rarely, eczema vaccinatum leads to severe disability, permanent neurological sequelae, and death. One fatality may be expected per 1 to 2 million persons receiving primary vaccination and 0.25 deaths per million persons receiving revaccination. Death is most often the result of sudden cardiac death, postvaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

    Focal and generalized folliculitis is reported to be a common adverse reaction in patients receiving the smallpox vaccine, vaccinia vaccine for the first time. Folliculitis was noticed during a multicenter, randomized controlled study (n =148) evaluating the efficacy of various dilutions of the vaccine. Generalized folliculitis was observed in 2.7% of patients and focal folliculitis in 7.4%. Cultured sample lesions were negative for vaccinia. Skin biopsy from 1 subject with generalized rash showed suppurative folliculitis without evidence of viral infection. All lesions were benign and resolved without scarring.[27621]

    Chills and fatigue are common adverse reactions associated with the smallpox vaccine, vaccinia vaccine.[27216] Among 873 primary vaccine recipients receiving the smallpox vaccine (ACAM2000), 37% had malaise, 48% had fatigue, and 32% reported feeling hot. Malaise, fatigue, and fever are less frequent in revaccinated persons than persons receiving the vaccine for the first time. Among 1,371 previously vaccinated subjects who got revaccinated with the smallpox vaccine (ACAM2000), 28% had malaise, 34% had fatigue, and 20% reported feeling hot.

    Nausea/vomiting is a common adverse effect of the smallpox vaccine, vaccinia vaccine. Among 873 primary vaccine recipients who received the smallpox vaccine (ACAM2000), 19% had nausea, 16% had diarrhea, 6% had constipation, and 5% had vomiting. Among 1,371 previously vaccinated subjects who got revaccinated with the smallpox vaccine (ACAM2000), nausea occurred in 10%, diarrhea in 12%, constipation in 6%, and vomiting in 3%. Severe abdominal pain, nausea, vomiting, constipation, or diarrhea occurred in less than 1% of patients.

    Among 873 primary vaccine recipients who received the smallpox vaccine, vaccinia vaccine (ACAM2000), 46% had myalgia. Myalgia appears to be less common among revaccinated persons as compared with patients receiving the vaccine for the first time. For example, among 1,371 previously vaccinated subjects who got revaccinated with the smallpox vaccine (ACAM2000), 27% had myalgia. Severe, vaccine-related myalgia was seen in 1% of vaccinia-naive subjects and in less than 1% of previously vaccinated subjects. Back pain, arthralgia, and extremity pain occurred in 2% or less of either vaccinia-naive or previously vaccinated patients.

    Myocarditis or pericarditis may occur after primary vaccination or revaccination with the smallpox vaccine, vaccinia vaccine. Patients naive to vaccinia who received the smallpox vaccine (ACAM2000) (5 of 873) or Dryvax (3 of 289) vaccine and were actively monitored had suspected myocarditis and pericarditis. Of the 3 Dryvax cases, 2 were asymptomatic. The rate of myocarditis and pericarditis for the ACAM2000 group (5.7, 95% CI: 1.9 to 13.3 per 1,000 vaccinees) was similar to the rate for the Dryvax group (10.4, 95% CI: 2.1 to 30 per 1,000 vaccinees). No cases of myocarditis and/or pericarditis were identified in 1,819 previously vaccinated subjects. Among phase 3 trial recipients, 7 of 2,983 patients who got ACAM2000 and 3 of 868 patients who got Dryvax had suspected myocarditis. The mean time to onset of suspected myocarditis or pericarditis from vaccination was 11 days (range, 9 to 20 days), and all patients with myocarditis/pericarditis were naive to vaccinia. Most (8 of the 10) patients were asymptomatic and only had raised troponin/cardiac enzymes and/or ECG abnormalities; some patients had chest pain (unspecified). Myocarditis/pericarditis resolved by 9 months in 9 patients; 1 patient had persistent borderline abnormal left ventricular ejection fraction on echocardiogram after getting the Dryvax vaccine. Among 540,824 military personnel who got the Dryvax vaccine, 67 were evaluated for myopericarditis at a mean of 10.4 days (range, 3 to 25 days) after vaccination. All patients presented with chest pain or substernal pressure, and 57 were evaluated with echocardiography during the acute illness. Thirty-two percent had mild to moderate depression of ejection fraction, and 12% had pericardial effusion. At follow-up echocardiography (n = 40), no patient had an ejection fraction less than 54%, and no patient had evidence of ventricular dilatation, diastolic dysfunction, regional wall motion abnormality, or pericardial effusion. Fourteen percent of patients reported continued subjective symptoms such as chest discomfort, fatigue, and headache.[33487] The long-term outcome of myocarditis and pericarditis after vaccination is currently unknown. In addition to myocarditis and pericarditis, non-ischemic, dilated cardiomyopathy and ischemic cardiac events including fatalities have been reported after smallpox vaccination; the relationship of these events, if any, to vaccination has not been established. As of March 21, 2003, 25,645 civilian persons received the vaccine and 7 cardiac adverse reactions were reported. These included 2 cases of myocarditis, 3 cases of acute myocardial infarction, and 2 cases of angina without myocardial infarction. Two patients with myocardial infarction died. Onset of these cardiac events ranged from 2 to 17 days after vaccination. Patients with cardiac or cerebrovascular disease or risk factors for these diseases may have increased risks of adverse events from the smallpox vaccine.[33515] [67771]

    Receipt of the smallpox vaccine, vaccinia vaccine may cause generalized vaccinia, which is a secondary, widespread, vesicular, vaccinia rash. This rash results from dissemination of the virus through the blood. Generalized vaccinia is usually self-limiting. In severe cases, vaccinia immune globulin (VIG) can been used.[27217] Rarely, generalized vaccinia leads to severe disability, permanent neurological sequelae, and death. One fatality may be expected per 1 to 2 million persons receiving primary vaccination and 0.25 deaths per million persons receiving revaccination. Death is most often the result of sudden cardiac death, postvaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

    Vaccinia necrosum (progressive vaccinia) (also known as vaccinia gangrenosa) is a serious complication of smallpox vaccine, vaccinia vaccine that occurred in both primary and revaccinees. It is frequently fatal in patients with immune deficiency disorders. In cases of vaccinia gangrenosa, the vaccinial lesion fails to heal and progresses to involve adjacent skin with necrosis of tissue. The infection spreads to other parts of the skin, to bones, and to viscera. Vaccinia immune globulin (VIG) has been used to treat this complication.[27217] Rarely, progressive vaccinia leads to severe disability, permanent neurological sequelae, and death. One fatality may be expected per 1 to 2 million persons receiving primary vaccination and 0.25 deaths per million persons receiving revaccination. Death is most often the result of sudden cardiac death, postvaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

    Smallpox vaccine, vaccinia vaccine is not known to cause congenital malformations. On rare occasions, vaccinia virus has been reported to cause fetal infection; fetal infection has been reported among first-time vaccinees, revaccinees, and among unvaccinated close contacts of vaccinees. Fetal vaccinia was not reported among 185 live births born to vaccinated mothers who were followed in the CDC pregnancy registry. When fetal vaccinia does occur, it usually results in fetal death (stillbirth) or death of the infant soon after delivery. Generalized vaccinia of the fetus, early delivery of a stillborn infant, or a high risk of perinatal death has been reported.

    Headache is a common adverse effect of the smallpox vaccine, vaccinia vaccine and is usually transient. Among 873 primary vaccine recipients who got the smallpox vaccine (ACAM2000), 50% had a headache. Headache appears to be less common among revaccinated persons as compared with patients receiving the vaccine for the first time. For example, among 1371 previously vaccinated subjects who got revaccinated with ACAM2000, 32% had a headache. Less than 1% of patients experienced severe headaches. Among 655,000 patients vaccinated with Dryvax, 95 cases of headache were reported. Other neurological adverse events that were temporally associated with smallpox vaccination included non-serious limb paresthesias (17 cases), pain (13 cases), and dizziness or vertigo (13 cases). Photophobia has been reported to occur after smallpox vaccination. Serious neurologic adverse events included 13 cases of suspected meningitis, 3 cases of suspected encephalitis or myelitis, 11 cases of Bell palsy, 9 seizures (including 1 death), and 3 cases of Guillain-Barre syndrome. Among these 39 events, 27 occurred in primary vaccinees, and all but 2 occurred within 12 days of vaccination. Serious complications that may follow either primary live vaccinia smallpox vaccination or revaccination include encephalitis, encephalomyelitis, and encephalopathy. Symptoms associated with postvaccinial encephalopathy occur between 8 and 15 days after vaccination and include drowsiness, fever, headache, nausea/vomiting, and sometimes spastic muscle paralysis, meningitis, coma, and seizures. Cerebrospinal fluid usually shows a pleocytosis. Recovery may be complete or associated with residual paralysis and other CNS symptoms and sometimes death.[27217] Encephalitis, encephalomyelitis, or encephalopathy may rarely lead to severe disability, permanent neurological sequela, and death. One fatality may be expected per 1 to 2 million persons receiving primary vaccination and 0.25 deaths per million persons receiving revaccination. Death is most often the result of sudden cardiac death, postvaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

    The risk of experiencing serious vaccination complications must be weighed against the risks of experiencing a potentially fatal smallpox infection. Persons at greatest risk of experiencing serious vaccination complications are often those at greatest risk for death from smallpox. Virus is shed from the vaccination site during the period starting with the development of a papule (day 2 to 5); shedding ceases when the scab separates and the lesion is re-epithelialized, which occurs 14 to 21 days after vaccination. Steps should be taken to reduce the risk of accidental infection of other sites in the vaccinated patient and of contact spread to other individuals. Inadvertent inoculation of close contacts and autoinoculation, especially eyelid, face, genital, anal, and periocular inoculation, have occurred. Accidental infection of the eye (ocular vaccinia) may cause keratitis, corneal scarring, and blindness. Death has been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated. Fatal adverse reactions are more frequent in infants. Proper management of the vaccination site is imperative.[33515]

    Revision Date: 07/13/2022, 05:25:46 PM

    References

    27216 - Frey SE, Couch RB, Tacket CO, et al. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med 2002;346:1265-1274.27217 - Henderson DA, Inglesby TV, Bartlett JG, et al. Smallpox as a biological weapon: Medical and public health management. JAMA 1999;281:2127-2137.27218 - Engler RJM, Kenner J, Leung DYM. Smallpox vaccination: Risk considerations for patients with atopic dermatitis. J Allergy Clin Immunol 2002;110:357-365.27621 - Talbot TR, Bredenberg HK, Smith M, et al. Focal and generalized folliculitis following smallpox vaccination among vaccinia-naive recipients. JAMA 2003;289:3290-4.33487 - Eckart RE, Love SS, Atwood E, et al. Incidence and follow-up of inflammatory cardiac complications after smallpox vaccination. J Am Coll Cardiol 2004:44:201-5.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.67771 - Centers for Disease Control and Prevention (CDC). Cardiac adverse events following Smallpox vaccination United States, 2003. Retreived June 24, 2022 at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5212a2.htm.

    Contraindications/Precautions

    Absolute contraindications are italicized.

    • breast-feeding
    • acne vulgaris
    • acquired immunodeficiency syndrome (AIDS)
    • agammaglobulinemia
    • angina
    • atopy
    • autoimmune disease
    • blood donation
    • burns
    • cardiac disease
    • cardiomyopathy
    • chemotherapy
    • children
    • coronary artery disease
    • corticosteroid therapy
    • diabetes mellitus
    • eczema
    • encephalopathy
    • exfoliative dermatitis
    • heart failure
    • herpes infection
    • human immunodeficiency virus (HIV) infection
    • hypercholesterolemia
    • hyperglycemia
    • hypertension
    • immunosuppression
    • infants
    • infection
    • leukemia
    • lymphoma
    • myocardial infarction
    • myocarditis
    • neomycin hypersensitivity
    • neonates
    • neoplastic disease
    • ocular disease
    • organ transplant
    • pericarditis
    • polymyxin hypersensitivity
    • pregnancy
    • psoriasis
    • radiation therapy
    • severe combined immunodeficiency (SCID)
    • stroke
    • syphilis
    • systemic lupus erythematosus (SLE)
    • tobacco smoking
    • tuberculosis
    • varicella

    Because the vaccinia virus used in smallpox vaccine can be spread to others from the vaccine site of an immunized person, the contraindications below apply to both potential vaccinees and to their household contacts. If a potential vaccinee or someone they live with has any of the following conditions, that person should generally not receive the smallpox vaccine. However, there are no contraindications to the use of smallpox vaccination in the case of known exposure of the patient to the smallpox virus, and there are no absolute contraindications regarding vaccination of a person with a high-risk exposure to smallpox. Persons at greatest risk for experiencing serious vaccination complications are often those at greatest risk for death from smallpox. Use of the vaccine in patients with routine contraindications may be warranted in some cases (e.g., emergency use, bioterrorism, epidemic circumstances) given the high risk of adverse outcomes associated with smallpox disease.[27215][27217] If a relative contraindication to vaccination exists, the risk for experiencing serious vaccination complications must be weighed against the risks for experiencing potentially fatal smallpox disease. The administration of vaccinia immune globulin (VIG) concomitantly with the vaccine may be used under such circumstances to try to minimize complications in persons with contraindications.[27217]

    Patients with eczema (atopic dermatitis, neurodermatitis, and other eczematous conditions), a history of eczema, or other acute or chronic exfoliative skin conditions are at an increased risk of severe adverse reactions from smallpox vaccine, vaccinia vaccine that may cause severe disability, permanent neurological sequelae, or death. Examples of severe adverse reactions include encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, and eczema vaccinatum. Because of the increased risk for eczema vaccinatum, routine primary and booster vaccinations with smallpox vaccine are contraindicated for nonemergency vaccine use in persons with eczema to any degree, including those with a past history of eczema, those with household contacts with active eczema, or whose household contacts have a past history of eczema. Routine primary and booster vaccinations are also contraindicated for nonemergency vaccine use in patients with other acute, chronic, or exfoliative skin conditions such as atopic dermatitis, wounds, burns, impetigo, or Varicella zoster. Other persons with acute or chronic skin conditions or exfoliative dermatitis (e.g., atopy, herpes infection, psoriasis, severe acne vulgaris, severe diaper dermatitis with extensive areas of denuded skin, seborrheic dermatitis, erythroderma, pustular dermatitis, varicella (chickenpox), or Darier's disease (keratosis follicularis)) may also be at increased risk for eczema vaccinatum via inadvertent inoculation of the skin and should not be routinely vaccinated until the condition resolves. Household contacts of such persons should also not be vaccinated.[27212] [33514] [33515] Identify household contacts of patients with eczema and take measures to avoid contact between a patient with eczema and persons with active vaccination lesions.

    Routine primary and booster vaccinations with smallpox vaccine, vaccinia vaccine are contraindicated for nonemergency vaccine use in patients with known cardiac disease or a history of cardiac disease such as patients with previous myocardial infarction, angina, congestive heart failure, cardiomyopathy, shortness of breath with activity, or other heart conditions such as coronary artery disease being treated by a doctor. Patients with these heart conditions, stroke, or transient ischemic attack may have increased risks of adverse events from the smallpox vaccine. Also, patients with at least 3 of the following risk factors for ischemic coronary disease may have increased risks of adverse events with smallpox vaccine: hypertension, hypercholesterolemia, diabetes mellitus, hyperglycemia, first degree relative who had a heart condition before the age of 50, or tobacco smoking. Identify household contacts of patients with cardiac disease and take measures to avoid contact between a patient with cardiac disease and persons with active vaccination lesions. Patients with cardiac disease or a history of cardiac disease are at an increased risk of severe adverse reactions that may cause severe disability, permanent neurological sequelae, or death. Examples of severe adverse reactions include encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, and eczema vaccinatum. Reports of cardiac events have occurred after smallpox vaccination, but it is not clear whether smallpox vaccine is the cause. Acute myopericarditis has been observed after smallpox vaccine administration to healthy adults, and suspected cases of myocarditis and/or pericarditis have been observed at an approximate rate of 5.7 per 1,000 (95% CI, 1.9 to 13.3) in healthy adult primary vaccinees. Persons receiving smallpox vaccination should be informed that myopericarditis is a potential complication of smallpox vaccination and that they should seek medical attention if they develop chest pain, shortness breath, or other symptoms of cardiac disease within 2 weeks after vaccination.[33515]

    The smallpox vaccine is contraindicated for use by patients with severe immunodeficiency/immunosuppression who are not expected to benefit from the vaccine. This may include patients undergoing bone marrow transplantation or those with primary or acquired immunodeficiency who require isolation.[33515] Patients with congenital or acquired immune deficiency disorders, including leukemia, lymphoma, organ transplant, generalized neoplastic disease, human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), cellular or humoral immune deficiency (e.g., agammaglobulinemia, severe combined immunodeficiency (SCID)), patients receiving radiation therapy, chemotherapy, high-dose corticosteroid therapy (2 mg/kg or more or 20 mg/day of prednisone for 2 weeks or longer), or other immunosuppressive medications, are at an increased risk of severe adverse reactions that may cause severe disability, permanent neurological sequelae, or death. Examples of severe adverse reactions include encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, and eczema vaccinatum; these events have occurred after primary vaccination or revaccination. Wait at least 1 month after discontinuation of high-dose corticosteroid therapy given for more than 2 weeks and at least 3 moths after completion of other immunosuppressive medications before administering smallpox vaccine. Patients with severe clinical manifestations of autoimmune disease (e.g., systemic lupus erythematosus (SLE)) might have a degree of immunocompromise as a component of the disease. Do not vaccinate household contacts of such persons. Identify household contacts of patients with immunosuppression and take measures to avoid contact between a patient with immunosuppression and persons with active vaccination lesions. Also, advise healthcare workers who have been vaccinated to avoid contact with immunocompromised patients until the scab has separated from the skin at the vaccination site.[33514] [33515] [65107]

    Use smallpox vaccine cautiously, if at all, in patients with polymyxin hypersensitivity or neomycin hypersensitivity. Trace amounts of neomycin and polymyxin B are present in the smallpox vaccine.[33515]

    Patients who receive smallpox vaccine, vaccinia vaccine and have an ocular disease treated with topical steroids may be at an increased risk of severe adverse reactions including keratitis, corneal scarring, and blindness. Persons with inflammatory ocular disease might be at increased risk for inadvertent inoculation as a result of touching or rubbing the eye. Therefore, deferring vaccination is prudent for persons with inflammatory ocular diseases requiring steroid treatment until the condition resolves and the course of therapy is complete. Identify household contacts with ocular disease and take measures to avoid contact between a patient with ocular disease and persons with active vaccination lesions.[33514] [33515]

    The smallpox vaccine, vaccinia vaccine for either primary vaccination or revaccination is contraindicated for use in a nonemergency scenario during pregnancy, in patients who are suspected to be pregnant, and in household contacts of pregnant women. Identify household contacts of vaccinees who are pregnant and take measures to avoid contact between a pregnant patient and persons with active vaccination lesions. The smallpox vaccine is known to cause fetal harm when administered to pregnant patients. The vaccine has rarely been reported to cause fetal infection, usually after primary immunization of the pregnant patient. When fetal vaccinia does occur, it usually results in fetal death (stillbirth) or death of the infant soon after delivery. Administration of the vaccine to pregnant patients during the first trimester may be most problematic. However, use of the vaccine in pregnant patients may be warranted in some cases (e.g., epidemic circumstances) given the high risk of adverse outcomes associated with smallpox infection, which may be more severe in pregnant vs. nonpregnant patients. Patients of childbearing potential who receive the smallpox vaccine are recommended to take precautions against pregnancy for the month after vaccination. If the smallpox vaccine is inadvertently administered to a pregnant person or if pregnancy occurs within 1 month of receiving the vaccine, apprise the vaccinee of the potential risks to the fetus. Report all cases of pregnant persons who received the smallpox vaccine within 42 days before conception, during pregnancy, or were exposed to a person who received the vaccine within 28 days after vaccination to the National Smallpox Vaccine in Pregnancy Registry by calling 404-639-8253. Also, report all cases to the Department of Defense by calling 619-553-9255.[27212] [33514] [33515] [65107]

    The safety and effectiveness of smallpox vaccine, vaccinia vaccine have not been established in neonates, infants, children, or adolescents younger than 16 years old. Smallpox vaccine should not be used in infants unless they are at risk of contracting smallpox. Data regarding the use of smallpox vaccine in pediatric patients are limited, and infants are at an increased risk of severe adverse reactions that may cause severe disability, permanent neurological sequelae, or death. Examples of severe adverse reactions include encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, and eczema vaccinatum. The Advisory Committee on Immunization Practices (ACIP) advises against nonemergency (elective) use of smallpox vaccine in patients younger than 18 years of age. Advise vaccine recipients to avoid contact with any infant until active vaccination lesions have resolved. Use of the vaccine in pediatric patients may be warranted in some cases (e.g., bioterrorism or known exposure to the smallpox virus) given the high risk of adverse outcomes associated with smallpox infection.[27212] [33514] [33515]

    Although excretion of vaccine virus and/or antibodies into human milk is unknown, the smallpox vaccine, vaccinia vaccine (a live-virus vaccine) is contraindicated in patients who are breast-feeding. The close contact that occurs during nursing increases the risk of inadvertent inoculation of the breast-fed infant. Given the risk of adverse outcomes associated with smallpox, vaccination of smallpox-susceptible mothers may be needed if the potential for exposure is high; in these cases, patients are advised to discontinue breast-feeding. Handling of any infant by vaccine recipients should be avoided until the scab has separated from vaccination site (at least 3 to 4 weeks).[33514] [33515] [65107]

    The product labeling for smallpox vaccine, vaccinia vaccine recommends avoiding blood donation and organ donation for at least 30 days after vaccination. Some persons who are given blood or blood products from patients who have recently received the smallpox vaccine, vaccinia vaccine may experience harmful effects. The risk of transmission of vaccinia virus through transfused blood or plasma is uncertain. FDA guidance recommends smallpox vaccine recipients without vaccine complications be deferred from donating blood for at least 21 days or until the scab has spontaneously separated. Blood donation should be deferred for 2 months after vaccination if the scab was removed before separating spontaneously. Smallpox vaccine recipients with vaccine complications or persons who have experienced complications of vaccinia infection acquired through close contact with a vaccine recipient should be deferred from donating blood for 14 days after all vaccine complications have completely resolved. Persons who acquire a clinically recognizable vaccinia virus infection (localized skin lesions with no other symptoms or complications) by close contact with a vaccine recipient and whose scab did NOT spontaneously separate should not donate blood for at least 3 months from the date of vaccine recipient vaccination; no deferral period for blood donation is needed if the scab spontaneously separates and is no longer present. If the vaccine recipient vaccination date is not known but could have been within the last 3 months, defer blood donation for 2 months from the present time.[27231] [33514] [33515]

    A patient who receives the smallpox vaccine, vaccinia vaccine may have a false-negative test result for the tuberculin skin test (purified protein derivative (PPD)) and for tuberculosis blood tests.[33515] Suppression of PPD reactivity has been demonstrated after administration of the smallpox vaccine. If possible, delay tuberculin testing for 1 month after smallpox vaccination.[33514]

    A patient who is vaccinated with smallpox vaccine, vaccinia vaccine may have a false-positive test result for syphilis. If the RPR test result is positive, confirm the result by the use of a more specific test, such as the FTA assay.[33515]

    Revision Date: 08/03/2022, 02:01:45 PM

    References

    27212 - Centers for Disease Control and Prevention (CDC). Vaccinia (Smallpox) Vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2001;50(no. RR-10):1-25.27215 - Centers for Disease Control and Prevention (CDC). Smallpox home page. Accessed February 15, 2022. Available on the World Wide Web at: www.cdc.gov/smallpox/27217 - Henderson DA, Inglesby TV, Bartlett JG, et al. Smallpox as a biological weapon: Medical and public health management. JAMA 1999;281:2127-2137.27231 - Food and Drug Administration (FDA). FDA Guidance for Industry. Recommendations for deferral of donors and quarantine and retrieval of blood and blood products in recent recepients of smallpox vaccine (Vaccinia virus vaccine) and certain contacts of smallpox vaccine recipents. Retrieved January 8, 2003. Available on the World Wide Web at: www.fda.gov/cber/gdlns/smpoxdefquar.htm.33514 - Centers for Disease Control and Prevention (CDC). Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(RR07):1-16.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP).Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Revised April 27, 2022. Accessed on July 14, 2022.

    Mechanism of Action

    Smallpox disease is caused by the variola virus. Smallpox vaccine contains vaccinia virus, which is antigenically similar to variola virus. The vaccinia virus and the variola virus are members of the Orthopox genus. Immunity induced by vaccinia virus cross-protects against variola virus. Introduction of the live vaccinia virus into the superficial layers of the skin causes an infection at the inoculation site and at draining lymph nodes; transient viremia may be present. Vaccinia virus replicates in Langerhans cells in the epidermis, and viral antigens are presented to the immune system. Cellular immune responses are elicited by vaccination and may contribute to protection and to immunological memory. Also, at least 95% of primary vaccinees develop neutralizing or hemagglutination inhibiting antibodies to vaccinia, but the concentration of neutralizing antibody that protects against smallpox is unknown; antibody titers greater than 1:32 may be protective. Neutralizing antibodies are known to mediate protection against smallpox. Neutralizing antibodies against vaccinia appear by day 15 to 20 after vaccination, are highly variable, and may be boosted on revaccination. Detectable vaccinia-specific antibodies were found in all 14 adults who had received the smallpox vaccine 24 to 50 years ago, and revaccination with 3 to 5 jabs of the vaccine led to the presence of a definite vesicle or pustule in all patients. A 4-fold greater antibody increase was seen among recipients of a repeat inoculation as compared with recipients of an initial vaccination.[33485][33515]

    Revision Date: 08/01/2022, 02:59:06 PM

    References

    33485 - Simpson EL, Hercher M, Hammarlund EK, et al. Cutaneous responses to vaccinia in individuals with previous smallpox vaccination. J Am Acad Dermatol 2007:57:442-4.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.

    Pharmacokinetics

    Smallpox vaccine, vaccinia vaccine is administered percutaneously.

    Route-Specific Pharmacokinetics

    Other Route(s)

    Cutaneous responses after smallpox vaccine receipt are dependent on the vaccine potency, vaccination technique, and the patient's immune status. The expected response after primary vaccination is the development of a major cutaneous reaction that is characterized by a pustule at the inoculation site. A papule at the vaccination site develops after 2 to 5 days. The papule becomes vesicular and pustular and reaches its maximum size 8 to 10 days after vaccination. The pustule dries and forms a scab, which usually falls off within 14 to 21 days. Virus is shed from the vaccination site from the development of the papule (as early as day 2) to the separation of the scab and lesion re-epithelialization (14 to 21 days after vaccination). Care must be taken to reduce the risk of accidental infection of other sites in the vaccinated patient or of contact spread to other individuals. Formation of a major cutaneous reaction by day 6 to 8 is evidence of a successful vaccination and acquisition of protective immunity.[33515]

     

    Previous vaccination may reduce the cutaneous response upon revaccination, and the absence of a cutaneous response does not necessarily indicate vaccination failure. Absence of a major cutaneous reaction upon revaccination may be a consequence of pre-existing immunity adequate to suppress viral multiplication, vaccination technique failure, or use of inactive vaccine or vaccine that has lost potency. In a small study, revaccination with the smallpox vaccine led to the presence of a definite vesicle or pustule in all 14 adults who had received the smallpox vaccine 24 to 50 years ago. As compared with the response from 9 previously unvaccinated adults, the development of an erythematous response peaked about 3 days earlier, but the mean maximum erythema diameter was smaller.[33485][33515] Previously vaccinated individuals who do not have a cutaneous response on revaccination with the smallpox vaccine do not require revaccination to try to elicit a cutaneous response.[33515]

    Revision Date: 08/02/2022, 09:18:31 AM

    References

    33485 - Simpson EL, Hercher M, Hammarlund EK, et al. Cutaneous responses to vaccinia in individuals with previous smallpox vaccination. J Am Acad Dermatol 2007:57:442-4.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.

    Pregnancy/Breast-feeding

    pregnancy

    The smallpox vaccine, vaccinia vaccine for either primary vaccination or revaccination is contraindicated for use in a nonemergency scenario during pregnancy, in patients who are suspected to be pregnant, and in household contacts of pregnant women. Identify household contacts of vaccinees who are pregnant and take measures to avoid contact between a pregnant patient and persons with active vaccination lesions. The smallpox vaccine is known to cause fetal harm when administered to pregnant patients. The vaccine has rarely been reported to cause fetal infection, usually after primary immunization of the pregnant patient. When fetal vaccinia does occur, it usually results in fetal death (stillbirth) or death of the infant soon after delivery. Administration of the vaccine to pregnant patients during the first trimester may be most problematic. However, use of the vaccine in pregnant patients may be warranted in some cases (e.g., epidemic circumstances) given the high risk of adverse outcomes associated with smallpox infection, which may be more severe in pregnant vs. nonpregnant patients. Patients of childbearing potential who receive the smallpox vaccine are recommended to take precautions against pregnancy for the month after vaccination. If the smallpox vaccine is inadvertently administered to a pregnant person or if pregnancy occurs within 1 month of receiving the vaccine, apprise the vaccinee of the potential risks to the fetus. Report all cases of pregnant persons who received the smallpox vaccine within 42 days before conception, during pregnancy, or were exposed to a person who received the vaccine within 28 days after vaccination to the National Smallpox Vaccine in Pregnancy Registry by calling 404-639-8253. Also, report all cases to the Department of Defense by calling 619-553-9255.[27212] [33514] [33515] [65107]

    breast-feeding

    Although excretion of vaccine virus and/or antibodies into human milk is unknown, the smallpox vaccine, vaccinia vaccine (a live-virus vaccine) is contraindicated in patients who are breast-feeding. The close contact that occurs during nursing increases the risk of inadvertent inoculation of the breast-fed infant. Given the risk of adverse outcomes associated with smallpox, vaccination of smallpox-susceptible mothers may be needed if the potential for exposure is high; in these cases, patients are advised to discontinue breast-feeding. Handling of any infant by vaccine recipients should be avoided until the scab has separated from vaccination site (at least 3 to 4 weeks).[33514] [33515] [65107]

    Revision Date: 08/03/2022, 02:01:45 PM

    References

    27212 - Centers for Disease Control and Prevention (CDC). Vaccinia (Smallpox) Vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2001;50(no. RR-10):1-25.27215 - Centers for Disease Control and Prevention (CDC). Smallpox home page. Accessed February 15, 2022. Available on the World Wide Web at: www.cdc.gov/smallpox/27217 - Henderson DA, Inglesby TV, Bartlett JG, et al. Smallpox as a biological weapon: Medical and public health management. JAMA 1999;281:2127-2137.33514 - Centers for Disease Control and Prevention (CDC). Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(RR07):1-16.33515 - ACAM2000 (smallpox (vaccinia) vaccine, live) package insert. Cambridge, MA: Acambis, Inc.; 2018 March.65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP).Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Revised April 27, 2022. Accessed on July 14, 2022.

    Interactions

    Level 1 (Severe)

    • Abatacept
    • Abrocitinib
    • Adalimumab
    • Aldesleukin, IL-2
    • Alemtuzumab
    • Alkylating agents
    • Alpha interferons
    • Altretamine
    • Antimetabolites
    • Antithymocyte Globulin
    • Axicabtagene Ciloleucel
    • Azathioprine
    • Basiliximab
    • Belatacept
    • Bexarotene
    • Blinatumomab
    • Brexucabtagene Autoleucel
    • Busulfan
    • Carmustine, BCNU
    • Certolizumab pegol
    • Chlorambucil
    • Ciltacabtagene Autoleucel
    • Cisplatin
    • Clofarabine
    • Cortisone
    • Cyclosporine
    • Cytarabine, ARA-C
    • Dacarbazine, DTIC
    • Daclizumab
    • Deflazacort
    • Dexamethasone
    • Docetaxel
    • Estramustine
    • Etanercept
    • Everolimus
    • Fingolimod
    • Floxuridine
    • Fludrocortisone
    • Fluorouracil, 5-FU
    • Folate analogs
    • Golimumab
    • Hydrocortisone
    • Idecabtagene Vicleucel
    • Ifosfamide
    • Imatinib
    • Infliximab
    • Ixabepilone
    • Leflunomide
    • Lenalidomide
    • Lisocabtagene Maraleucel
    • Lomustine, CCNU
    • Mechlorethamine, Nitrogen Mustard
    • Melphalan
    • Melphalan Flufenamide
    • Methylprednisolone
    • Mitoxantrone
    • Mycophenolate
    • Nanoparticle Albumin-Bound Sirolimus
    • Natalizumab
    • Nelarabine
    • Nilotinib
    • Obinutuzumab
    • Paclitaxel
    • Ponesimod
    • Prednisolone
    • Prednisone
    • Procarbazine
    • Purine analogs
    • Rilonacept
    • Rituximab
    • Rituximab; Hyaluronidase
    • Siltuximab
    • Sirolimus
    • Streptozocin
    • Tacrolimus
    • Temozolomide
    • Temsirolimus
    • Thiotepa
    • Tisagenlecleucel
    • Tositumomab
    • Triamcinolone
    • Upadacitinib
    • Ustekinumab
    • Vincristine
    • Vincristine Liposomal
    • Vinorelbine

    Level 2 (Major)

    • Anakinra
    • Anifrolumab
    • Baricitinib
    • Belimumab
    • Brodalumab
    • Canakinumab
    • Deucravacitinib
    • Dupilumab
    • Efgartigimod Alfa
    • Emapalumab
    • Guselkumab
    • Inebilizumab
    • Interferon Gamma-1b
    • Ixekizumab
    • Ocrelizumab
    • Ofatumumab
    • Ozanimod
    • Risankizumab
    • Sarilumab
    • Satralizumab
    • Secukinumab
    • Siponimod
    • Spesolimab
    • Teriflunomide
    • Tezepelumab
    • Tildrakizumab
    • Tocilizumab
    • Tofacitinib
    • Tralokinumab
    • Vaccinia Immune Globulin, VIG
    • Vedolizumab
    • Venetoclax
    • Voclosporin

    Level 3 (Moderate)

    • Tecovirimat
    Abatacept: (Contraindicated) If possible, administer all needed vaccines before abatacept initiation. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. The immune response of the immunocompromised patient to vaccines may be decreased and adjusted doses or boosters that are more frequent may be required. The immune response to an inactive vaccine may still be suboptimal. Live virus vaccines may induce the illness they are intended to prevent and are contraindicated for use during immunosuppressive treatment. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [31761] [43236] Abrocitinib: (Contraindicated) Avoid administration of live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [67277] Adalimumab: (Contraindicated) Do not administer live vaccines to adalimumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving adalimumab. Before initiation of adalimumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Adalimumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27939] [43236] Aldesleukin, IL-2: (Contraindicated) Aldesleukin, IL-2 is associated with impaired neutrophil function. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [41853] [43236] Alemtuzumab: (Contraindicated) Do not administer live vaccines to alemtuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving alemtuzumab. At least 6 weeks before initiation of alemtuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Alemtuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58461] Alkylating agents: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Alpha interferons: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient, including those receiving Interferon therapy. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Altretamine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Anakinra: (Major) Avoid concurrent use of live vaccines during treatment with anakinra due to potentially increased risk of infections; clinical safety of live vaccines during anakinra treatment has not been established. Live virus vaccines should generally not be administered to an immunosuppressed patient, as they may induce the illness they are intended to prevent. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving anakinra. The interval between live vaccinations and initiation of anakinra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [27940] [43236] Anifrolumab: (Major) Avoid concurrent use of live vaccines during treatment with anifrolumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving anifrolumab. Before initiation of anifrolumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. [43236] [66846] Antimetabolites: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Antithymocyte Globulin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Axicabtagene Ciloleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during axicabtagene ciloleucel therapy, and prior to immune recovery following treatment with axicabtagene ciloleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62530] [65107] Azathioprine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Baricitinib: (Major) Do not administer live virus vaccines to patients taking baricitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during baricitinib receipt. Before baricitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [63229] Basiliximab: (Contraindicated) Do not administer live vaccines to basiliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving basiliximab. At least 2 weeks before initiation of basiliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Basiliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [41849] [43236] Belatacept: (Contraindicated) Avoid the use of live vaccines such as the intranasal influenza vaccine; measles/mumps/rubella vaccines, MMR; Bacillus Calmette-Guerin Live, BCG; yellow fever vaccine; oral polio vaccine; varicella virus vaccine live; and TY21a typhoid vaccine during belatacept treatment. Further, inactive vaccine receipt may not illicit an acceptable response; belatacept may blunt the effectiveness of some immunizations. Consult the most current CDC guidances for vaccination recommendations. [44667] Belimumab: (Major) Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. Because of its mechanism of action, belimumab may interfere with the response to immunizations. No data are available on the secondary transmission of infection from persons receiving live vaccines. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [43658] Bexarotene: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Blinatumomab: (Contraindicated) Do not administer live vaccines to blinatumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving blinatumomab. At least 2 weeks before initiation of blinatumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Blinatumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58559] Brexucabtagene Autoleucel : (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel therapy, and prior to immune recovery following treatment with brexucabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [65739] Brodalumab: (Major) Avoid administration of live vaccines to brodalumab recipients. Before initiation of brodalumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving brodalumab therapy. [61762] Busulfan: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Canakinumab: (Major) Do not administer live vaccines to a patient who is receiving canakinumab; other vaccination schedules should be complete as recommended prior to initiating canakinumab treatment. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving canakinumab. The immune response to vaccines or toxoids may be decreased, as canakinumab may interfere with normal immune response to new antigens. Limited data are available on the effectiveness of vaccination with inactivated antigens in patients receiving canakinumab. Because interleukin-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with canakinumab, adult and pediatric patients receive any recommended vaccination (including pneumococcal vaccine and inactivated influenza vaccines). [41378] [43236] Carmustine, BCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Certolizumab pegol: (Contraindicated) Do not administer live vaccines concurrently with certolizumab. No data are available on the response to vaccinations or to the secondary transmission of infection by live vaccines in patients receiving certolizumab. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33930] [43236] Chlorambucil: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Ciltacabtagene Autoleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during ciltacabtagene autoleucel therapy, and prior to immune recovery following treatment with ciltacabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] Cisplatin: (Contraindicated) Do not administer live vaccines to cisplatin recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cisplatin. At least 2 weeks before initiation of cisplatin therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cisplatin recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28393] [43236] Clofarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system [43236] Cortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49489] Cyclosporine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Cytarabine, ARA-C: (Contraindicated) Do not administer live vaccines to cytarabine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cytarabine. At least 2 weeks before initiation of cytarabine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cytarabine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48339] Dacarbazine, DTIC: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Daclizumab: (Contraindicated) Do not administer live vaccines to daclizumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving daclizumab. At least 2 weeks before initiation of daclizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Daclizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60841] Deflazacort: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [61750] Deucravacitinib: (Major) Avoid administration of live vaccines to deucravacitinib recipients. Before initiation of deucravacitinib therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving deucravacitinib therapy. [67943] Dexamethasone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [54286] Docetaxel: (Contraindicated) Do not administer live vaccines to docetaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving docetaxel. At least 2 weeks before initiation of docetaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Docetaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58408] Dupilumab: (Major) Avoid administration of live vaccines to dupilumab recipients. Before initiation of dupilumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving dupilumab therapy. [61836] Efgartigimod Alfa: (Major) Avoid the use of live vaccines and live attenuated vaccines during efgartigimod treatment. Live vaccinations may be less effective during efgartigimod treatment and may carry the risk of infection. Administer indicated vaccines prior to initiating efgartigimod. [67194] Emapalumab: (Major) Do not administer live or live attenuated vaccines to patients receiving emapalumab and for at least 4 weeks after the last dose of emapalumab. The safety of immunization with live vaccines during or after emapalumab therapy has not been studied. [63767] Estramustine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Etanercept: (Contraindicated) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune syste [28060] [29646] [43236] Everolimus: (Contraindicated) Do not administer live vaccines to everolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving everolimus. Before initiation of everolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Everolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [49823] [49903] Fingolimod: (Contraindicated) Do not administer live vaccines to a patient who is receiving fingolimod or has discontinued the drug in the last 2 months because of the risk of infection. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving fingolimod. Before fingolimod initiation, test patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) for antibodies to VZV. Consider VZV vaccination of antibody-negative patients before fingolimod initiation, and do not start fingolimod for 1 month to allow the full effect of vaccination to occur. In addition to the concerns with live virus vaccines, the immune response to inactive vaccines or toxoids may be decreased, as fingolimod may interfere with normal immune response to new antigens. No data are available on the effectiveness of vaccination with inactivated antigens in patients receiving fingolimod. Vaccination may be less effective during and for up to 2 months after fingolimod discontinuation. For example, as compared with the response of placebo recipients, the capacity to mount a skin delayed-type hypersensitivity reaction to Candida and to tetanus toxoid was decreased by approximately 30% among fingolimod 0.5 mg daily recipients. Further, in healthy patients, antigen-specific IgM titers were decreased by 25% in response to pneumococcal polysaccharide vaccine (PPV-23) immunization as compared with the response by placebo recipients. Similarly, IgG titers were decreased by 50% among fingolimod recipients as compared with placebo. [41823] [43236] Floxuridine: (Contraindicated) Do not administer live vaccines to floxuridine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving floxuridine. At least 2 weeks before initiation of floxuridine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Floxuridine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48344] Fludrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49507] Fluorouracil, 5-FU: (Contraindicated) Do not administer live vaccines to fluorouracil recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving fluorouracil. At least 2 weeks before initiation of fluorouracil therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Fluorouracil recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [53824] Folate analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Golimumab: (Contraindicated) Do not administer live vaccines to golimumab recipients. Limited data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [35501] [43236] Guselkumab: (Major) Avoid use of live vaccines in patients being treated with guselkumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving guselkumab. In addition, guselkumab may decrease the vaccine-induced immune response. Before initiation of guselkumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. [62120] Hydrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [32057] [43236] [54049] Idecabtagene Vicleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel therapy, and prior to immune recovery following treatment with idecabtagene vicleucell. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] Ifosfamide: (Contraindicated) Do not administer live vaccines to ifosfamide recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving ifosfamide. Before initiation of ifosfamide therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Ifosfamide recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [51027] Imatinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Inebilizumab: (Major) Administer all immunizations according to immunization guidelines at least 4 weeks before initiation of inebilizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. In a neonate or infant with in utero exposure to inebilizumab, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in the exposed infant may increase the risks from live or live-attenuated vaccines. [43236] [60092] [65576] Infliximab: (Contraindicated) Do not administer live vaccines to infliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving infliximab. Before initiation of infliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Infliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27994] [43236] Interferon Gamma-1b: (Major) Avoid the concomitant use of interferon gamma-1b with other immunological preparations such as live vaccines due to the risk of an unpredictable or amplified, immune response. [49610] Ixabepilone: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Ixekizumab: (Major) Do not administer live vaccines to ixekizumab recipients. Before initiation of ixekizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving Ixekizumab therapy. [60658] Leflunomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [49634] Lenalidomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Lisocabtagene Maraleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during lisocabtagene maraleucel therapy, and prior to immune recovery following treatment with lisocabtagene maraleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [66383] Lomustine, CCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Mechlorethamine, Nitrogen Mustard: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Melphalan Flufenamide: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Melphalan: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Methylprednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [41361] [43236] Mitoxantrone: (Contraindicated) Do not administer live vaccines to mitoxantrone recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mitoxantrone. At least 2 weeks before initiation of mitoxantrone therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mitoxantrone recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48215] Mycophenolate: (Contraindicated) Do not administer live vaccines to mycophenolate recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mycophenolate. At least 2 weeks before initiation of mycophenolate therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mycophenolate recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27985] [43236] Nanoparticle Albumin-Bound Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28610] [43236] Natalizumab: (Contraindicated) The immune response to vaccines or toxoids may be decreased in patients who receive natalizumab; however, no data are available. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [30470] [43236] Nelarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Nilotinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Obinutuzumab: (Contraindicated) Do not administer live vaccines to obinutuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving obinutuzumab. Before initiation of obinutuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Obinutuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56353] Ocrelizumab: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. [43236] [60092] [61838] Ofatumumab: (Major) Administer all live and live-attenuated vaccines according to immunization guidelines at least 4 weeks before initiation of ofatumumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with ofatumumab; wait until B-cell recovery occurs after discontinuation of ofatumumab before administering these vaccines to a patient. [43236] [60092] [65850] Ozanimod: (Major) Avoid the use of live vaccines and live attenuated vaccines during ozanimod treatment and for up to 3 months after discontinuation of ozanimod treatment. Live vaccinations may be less effective during ozanimod treatment and also may carry the risk of infection. [65169] Paclitaxel: (Contraindicated) Do not administer live vaccines to paclitaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving paclitaxel. At least 2 weeks before initiation of paclitaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Paclitaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29200] [43236] Ponesimod: (Contraindicated) Avoid vaccines containing live virus (live attenuated vaccines) during treatment with ponesimod. If a live attenuated vaccine is required, administer at least 1 month (4 weeks) before initiation of ponesimod. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ponesimod treatment and for 1 to 2 weeks after discontinuation of ponesimod. During treatment, and for up to 1 to 2 weeks after discontinuation of ponesimod, vaccinations may also be less effective. [60092] [65107] [66527] Prednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43740] [45339] Prednisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43319] Procarbazine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Purine analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Rilonacept: (Contraindicated) Do not administer live vaccines to a patient who is receiving rilonacept. No data are available regarding the use of live vaccines during rilonacept treatment. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33837] [43236] Risankizumab: (Major) Avoid administration of live vaccines to risankizumab recipients. Before initiation of risankizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving risankizumab therapy. [64073] Rituximab: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Rituximab; Hyaluronidase: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Sarilumab: (Major) Avoid concurrent use of live vaccines during treatment with sarilumab due to potentially increased risk of infections; clinical safety of live vaccines during sarilumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving sarilumab. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [51778] [61976] Satralizumab: (Major) Administer all live vaccines according to immunization guidelines at least 4 weeks before initiation of satralizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with satralizumab. [43236] [60092] [65841] Secukinumab: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab. [58739] Siltuximab: (Contraindicated) Do not administer live vaccines to siltuximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving siltuximab. Before initiation of siltuximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Siltuximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57062] Siponimod: (Major) Avoid the use of live vaccines during treatment with siponomid and for 4 weeks after stopping treatment due to the risk of secondary infection. Additionally, vaccines may be less effective if administered during siponimod treatment and for 4 weeks after siponimod treatment discontinuation. [64031] Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28610] [43236] Spesolimab: (Major) Avoid administration of live vaccines to spesolimab recipients. Before initiation of spesolimab therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving spesolimab therapy. [67922] Streptozocin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tacrolimus: (Contraindicated) Do not administer live vaccines to tacrolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tacrolimus. At least 2 weeks before initiation of tacrolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tacrolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60497] Tecovirimat: (Moderate) Data from animal studies suggest tecovirimat may decrease the immune response to the smallpox vaccine (live). The clinical impact of this interaction on vaccine efficacy is unknown. [63353] Temozolomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Temsirolimus: (Contraindicated) The use of live vaccines should be avoided during treatment with temsirolimus. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33280] [43236] Teriflunomide: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during teriflunomide use, concomitant vaccination with live vaccines is not recommended. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping the medication if the teriflunomide drug elimination procedure has not been performed. [51794] Tezepelumab: (Major) Avoid administration of live vaccines to tezepelumab recipients. Before initiation of tezepelumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available regarding the response to live vaccines in patients receiving tezepelumab therapy. [67195] Thiotepa: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tildrakizumab: (Major) Avoid administration of live vaccines to tildrakizumab recipients. Before initiation of tildrakizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving tildrakizumab therapy. [62970] Tisagenlecleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel therapy, and prior to immune recovery following treatment with tisagenlecleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62282] [65107] Tocilizumab: (Major) Avoid concurrent use of live vaccines during treatment with tocilizumab due to potentially increased risk of infections; clinical safety of live vaccines during tocilizumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [38283] [51778] Tofacitinib: (Major) Do not administer live virus vaccines to patients taking tofacitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during tofacitinib receipt. Before tofacitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [52315] Tositumomab: (Contraindicated) Do not administer live vaccines to tositumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tositumomab. At least 2 weeks before initiation of tositumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tositumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [55836] Tralokinumab: (Major) Avoid administration of live vaccines to tralokinumab recipients. Before initiation of tralokinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving tralokinumab therapy. [67217] Triamcinolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [56146] Upadacitinib: (Contraindicated) Avoid administration of live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [64572] [65107] Ustekinumab: (Contraindicated) If possible, administer all recommended vaccines before ustekinumab initiation. Ustekinumab recipients may receive inactive vaccines, but the elicited immune response may be insufficient to prevent disease. Do not administer live vaccines to a ustekinumab recipient. Furthermore, do not administer BCG live vaccines for either 1 year before or 1 year after ustekinumab receipt, due to the infectious risk for Mycobacteria. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration of other live vaccines to ustekinumab recipients. Cautious administration of ustekinumab to household contacts of ustekinumab recipients may be warranted due to the potential risk for shedding from the household contact and transmission to the patient. Practitioners should also refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [36889] [43236] Vaccinia Immune Globulin, VIG: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Vedolizumab: (Major) Avoid administering live vaccines to vedolizumab recipients unless the benefits outweigh the risks; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vedolizumab. Before initiation of vedolizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vedolizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57235] Venetoclax: (Major) Avoid live vaccines to venetoclax recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving venetoclax. Before initiation of venetoclax therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Venetoclax recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60706] Vincristine Liposomal: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vincristine: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vinorelbine: (Contraindicated) Do not administer live vaccines to vinorelbine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vinorelbine. Before initiation of vinorelbine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vinorelbine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56871] Voclosporin: (Major) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [66336]
    Revision Date: 11/18/2022, 02:26:00 AM

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    Monitoring Parameters

    • laboratory monitoring not necessary

    US Drug Names

    • ACAM2000
    • Dryvax
    ;