Dosing & Uses
Dosage 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
Adverse Effects
>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%)
Warnings
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 & Lactation
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/excretion
Pregnancy 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.Pharmacology
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
Administration
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
Images
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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