AdultPediatricDosage Forms & Strengths injectable, suspension 0.5mL/single-dose vial Prevention of Smallpox and Monkeypox Disease Indicated for prevention of smallpox and monkeypox disease in adults who are at high risk for smallpox or monkeypox infection 0.5 mL SC x2 doses 4 weeks apart Monkeypox EUA (intradermal administration) August 9, 2022: Emergency use authorization granted for active immunization by intradermal injection for prevention of monkeypox disease in individuals aged >18 years determined to be at high risk for infection The smaller alternant dose is intended to increase vaccine supply by up to 5-fold 0.1 mL ID x2 doses 4 weeks apart Dosage Forms & Strengths injectable, suspension 0.5mL/single-dose vial Monkeypox EUA August 9, 2022: Emergency use authorization granted for active immunization by subcutaneous injection for prevention of monkeypox disease in individuals aged <18 years determined to be at high risk for infection 0.5 mL SC x2 doses 4 weeks apart >10% Injection site Pain (84.9%) Redness (60.8%) Swelling (51.6%) Induration (45.4%) Itching (43.1%) Systemic Muscle pain (42.8%) Headache (34.8%) Fatigue (30.4%) Nausea (17.3%) Chills (10.4%) 1-10% Injection site Pain, grade 3 (7.4%) Redness ≥100 mm (1.5%) Itching, grade 3 (1.6%) Systemic Muscle pain, grade 3 (2.6%) Headache, grade 3 (2.4%) Fever (1.7%) Fatigue, grade 3 (1.5%) Chills, grade 3 (1%) <1% Injection site Swelling ≥100 mm (0.8%) Induration ≥100 mm (0.3%) Systemic Fever, grade ≥3 (0.2%) Contraindications None Cautions Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration; those who experienced a severe allergic reaction following a previous dose or following exposure to any vaccine component may be at increased risk for severe allergic reactions after administering Immunocompromised individuals, including those receiving immunosuppressive therapy, may have diminished response Vaccination may not protect all recipients Pregnancy Human data are insufficient to inform vaccine-associated risks in pregnancy Animal studies Studies in animals revealed no evidence of harm to the fetus Embryofetal and postnatal development was evaluated in 4 developmental toxicity studies conducted in female rats and rabbits In 2 studies, rats were administered a single human dose (0.5 mL) once prior to mating and on 1-2 occasions during gestation In the third study, rats were administered a single human dose on 2 occasions during gestation In the fourth study, rabbits were administered a single human dose once prior to mating and on 2 occasions during gestation Lactation Unknown if excreted in human milk; data are not available to assess vaccine effects in breastfed infants or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Attenuated, live, nonreplicating smallpox and monkeypox vaccine that elicits humoral and cellular immune responses to orthopoxviruses Vaccinia-neutralizing antibody responses in humans were evaluated to establish the effectiveness for prevention of smallpox and monkeypox SC Preparation Allow vial to thaw and reach room temperature before use Once thawed, may refrigerate vaccine at 2-8ºC (36-46ºF) for up to 12 hr; do not refreeze When thawed, suspension appears as milky, light yellow-to-pale white Inspect visually for particulate matter and discoloration before administration; if either of these conditions exists, discard vaccine Swirl vial gently before use for at least 30 seconds; withdraw 0.5 mL into sterile syringe for injection SC Administration Inject SC into the upper arm (deltoid) Do not inject IV Intradermal Preparation Allow vial to thaw and reach room temperature before use Once thawed, may refrigerate vaccine at 2-8ºC (36-46ºF) for up to 12 hr; do not refreeze and discarded within 8 hr of first puncture Withdraw 0.1 mL-dose into sterile syringe for injection; low dead volume syringes and/or needles (eg, tuberculin syringe) can be used to extract 5 doses (0.1 mL each) for ID injection from a single vial If standard syringes and needles are used, there may not be sufficient volume to extract 5 doses from a single vial Irrespective of syringe and needle type Each dose must contain 0.1 mL of vaccine If vaccine amount remaining in vial cannot provide a full dose of 0.1 mL, discard vialand its contents; do not pool excess vaccine from multiple vials Intradermal Administration Inject ID, preferably into volar aspect (inner side) of forearm Storage Keep frozen at -25 to -15ºC (-13 to +5ºF) Store in original package to protect from light Do not refreeze vial once thawed; once thawed, may refrigerate at 2-8ºC (36-46ºF) for 12 up to 12 hr No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. 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