Introduction

Smallpox and mpox vaccine live is a live, attenuated, non-replicating virus vaccine produced using modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus.

Uses for Smallpox and Mpox Vaccine Live

Smallpox and mpox vaccine live has the following uses:

Smallpox and mpox vaccine live is indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.

Smallpox and Mpox Vaccine Live Dosage and Administration

General

Smallpox and mpox vaccine live is available in the following dosage form(s) and strength(s):

Suspension, for subcutaneous use: Single-dose vial containing one 0.5-mL dose.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• For subcutaneous injection only, preferably into the deltoid.

• Administer 2 doses (0.5 mL each) 4 weeks apart.

Contraindications

None.

Warnings/Precautions

Severe Allergic Reactions

Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of smallpox and mpox vaccine live.

Individuals who experienced a severe allergic reaction following a previous dose of smallpox and mpox vaccine live or following exposure to any component of the vaccine may be at increased risk for severe allergic reactions to smallpox and mpox vaccine live. The risk for a severe allergic reaction should be weighed against the risk for disease due to smallpox or mpox.

Altered Immunocompetence

Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to smallpox and mpox vaccine live.

Because smallpox and mpox vaccine live contains non-replicating virus, the vaccine can be used in adults with certain immunodeficiencies or conditions, such as human immunodeficiency virus (HIV) infection or atopic dermatitis.

Limitations of Vaccine Effectiveness

Vaccination with smallpox and mpox vaccine live may not protect all recipients.

For primary immunization, smallpox and mpox vaccine live is administered in a series of 2 doses given 4 weeks apart; full immunity may not develop until 2 weeks after the second dose.

Specific Populations

Pregnancy

Risk Summary: Available human data on smallpox and mpox vaccine live administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

The effect of smallpox and mpox vaccine live on embryofetal and postnatal development was evaluated in 4 developmental toxicity studies conducted in female rats and rabbits. These animal studies revealed no evidence of harm to the fetus.

Animal Data: Developmental toxicity studies were conducted in female rats and rabbits. In one study, female rabbits were administered a single human dose of smallpox and mpox vaccine live (0.5 mL) by the subcutaneous route on three occasions (prior to mating and on gestation days 0 and 14). In three studies, female rats were administered a single human dose of smallpox and mpox vaccine live (0.5 mL) by the subcutaneous route on two or three occasions (prior to mating and on gestation days 0 and 14; prior to mating and on gestation day 0; or on gestation days 0 and 6). No vaccine-related fetal malformations or variations and no adverse effects on female fertility or pre-weaning development were reported in these studies.

Lactation

Risk Summary: It is not known whether smallpox and mpox vaccine live is distributed in human milk. Data are not available to assess the effects of smallpox and mpox vaccine live on the breast-fed infant or on milk production/distribution.

The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for smallpox and mpox vaccine live and any potential adverse effects on the breast-fed infant from the vaccine or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

Safety and effectiveness of smallpox and mpox vaccine live have not been established in individuals younger than 18 years of age.

Geriatric Use

Clinical studies of smallpox and mpox vaccine live did not include sufficient numbers of adults 65 years of age and older to determine whether they respond differently than younger individuals.

In one clinical study, 42 adults 65–80 years of age previously vaccinated with a smallpox vaccine received at least one dose of smallpox and mpox vaccine live.

Common Adverse Effects

Healthy adults not previously vaccinated with a smallpox vaccine: Most common (>10%) solicited injection site reactions were pain (85%), redness (61%), swelling (52%), induration (45%), and itching (43%); most common solicited systemic adverse reactions were muscle pain (43%), headache (35%), fatigue (30%), nausea (17%), and chills (10%).

Healthy adults previously vaccinated with a smallpox vaccine: Most common (>10%) solicited injection site reactions were redness (81%), pain (80%), induration (70%), swelling (67%), and itching (32%); most common solicited systemic adverse reactions were fatigue (34%), headache (28%), and muscle pain (22%).

Adults with HIV infection or atopic dermatitis: Frequencies of solicited local and systemic adverse reactions were generally similar to those observed in healthy adults.

General

Smallpox and mpox vaccine live is available in the following dosage form(s) and strength(s):

Suspension, for subcutaneous use: Single-dose vial containing one 0.5-mL dose.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• For subcutaneous injection only, preferably into the deltoid.

• Administer 2 doses (0.5 mL each) 4 weeks apart.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.