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Black Box Warnings .
Serious Adverse Effects
myocarditis and pericarditis in healthy adult primary vaccinees; encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infection, and erythema multiforme major (incl. Stevens-Johnson syndrome) and eczema resulting in permanent sequelae or death, ocular complications, blindness, and fetal death after primary dose or revaccination; adverse effect risk incr. and may result in severe disability, permanent neurological sequelae and/or death w/ concomitant conditions: cardiac dz (active/hx), eye dz treated w/ topical steroids, immunodeficiency, immunosuppressant use, eczema (active/hx), acute or chronic exfoliative skin conditions, infants <1 yo, pregnancy; weigh risk of serious vaccination complications against risk of potentially fatal smallpox infection
Transmission Risk
contains live vaccinia virus transmittable to vaccinee's close contacts; adverse event risks in contacts are same as those for vaccinee
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [distributed directly to CDC and US Dept. of Defense]
smallpox dz prevention
- [primary]
- Dose: 1 drop percutaneously via 15 bifurcated needle jabs for scarification x1 dose; Info: for high-risk pts; repeat dose from different vial or vaccine lot if no cutaneous major rxn in 6-8 days, consult CDC or local health dept. if no cutaneous major rxn after repeat dose
- [booster, low-risk pts]
- Dose: 1 drop percutaneously via 15 bifurcated needle jabs for scarification q10y; Info: for individuals w/ ongoing occupational exposure to less virulent orthopoxviruses
- [booster, high-risk pts]
- Dose: 1 drop percutaneously via 15 bifurcated needle jabs for scarification q3y; Info: for individuals w/ ongoing occupational exposure to more virulent orthopoxviruses
mpox dz prevention
- [1 drop percutaneously via 15 bifurcated needle jabs for scarification x1 dose]
- Info: for high-risk pts
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [distributed directly to CDC and US Dept. of Defense]
smallpox dz prevention
- [primary]
- Dose: 1 drop percutaneously via 15 bifurcated needle jabs for scarification x1 dose; Info: for high-risk pts; repeat dose from different vial or vaccine lot if no cutaneous major rxn in 6-8 days, consult CDC or local health dept. if no cutaneous major rxn after repeat dose
mpox dz prevention
- [1 yo and older]
- Dose: 1 drop percutaneously via 15 bifurcated needle jabs for scarification x1 dose; Info: for high-risk pts
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]