smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating (Rx)

Brand and Other Names:Jynneos
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Dosing & Uses

AdultPediatric

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

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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%)
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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

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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.

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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

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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

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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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.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.