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Smallpox and Mpox Vaccine, Live, Nonreplicating
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General Dosing Information
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[64646]
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[67840]
0.1 mL intradermally for 2 doses administered 4 weeks apart.[67840]
0.5 mL subcutaneously for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date. Administration between 4 and 14 days after exposure may still provide some protection against mpox. After 14 days, consider the benefits of receiving the vaccine. The benefits may still outweigh the risks. Individuals with ongoing risk of mpox exposure should be offered vaccination. Vaccination after the onset of symptoms is not expected to provide benefit.[64646] [72125]
Prior to dosing, contact jurisdictional health department to assist in consultation with CDC for guidance. 0.5 mL subcutaneously for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date. Administration between 4 and 14 days after exposure may still provide some protection against mpox. After 14 days, consider the risks and benefits of receiving the vaccine.[67840] [72125]
0.1 mL intradermally for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date. Administration between 4 and 14 days after exposure may still provide some protection against mpox. After 14 days, consider the benefits of receiving the vaccine. The benefits may still outweigh the risks. Individuals with ongoing risk of mpox exposure should be offered vaccination. Vaccination after the onset of symptoms is not expected to provide benefit.[67840] [67847] [72125]
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[64646]
0.5 mL/dose subcutaneous; 0.1 mL/dose intradermal.
0.5 mL/dose subcutaneous; 0.1 mL/dose intradermal.
0.5 mL/dose subcutaneous.
0.5 mL/dose subcutaneous.
0.5 mL/dose subcutaneous.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† Off-label indicationSmallpox and monkeypox vaccine, live, nonreplicating is used for the prevention of smallpox and monkeypox (mpox) infection in high risk individuals. This vaccine does not contain the viruses that cause smallpox or mpox; instead, it is made from a modified form of the vaccinia virus called Modified Vaccinia Ankara. This nonreplicating form does not cause disease in humans and is similar in how it triggers an immune response to the variola virus (which causes smallpox) and the monkeypox virus. Using this modified form allows people with pre-existing conditions, such as immune system disorders, to receive the vaccine, although they may have a diminished immune response. The smallpox and monkeypox vaccine, live, nonreplicating has several advantages compared to the smallpox vaccine. The smallpox and monkeypox vaccine, live, nonreplicating has fewer contraindications, no risk for inadvertent inoculation and autoinoculation, subcutaneous route of administration, and is associated with fewer serious adverse reactions compared to the smallpox vaccine. The vaccine's effectiveness for the prevention of smallpox was found to be not inferior to the FDA-approved vaccine for the prevention of smallpox in a study of approximately 400 healthy adults. Its effectiveness for preventing mpox infection was inferred from the antibody responses in the smallpox clinical study patients and from studies in nonhuman primates. Safety was assessed in more than 7,800 individuals who received at least 1 dose of the vaccine. Injection site reactions, muscle pain, headache, and fatigue were the most commonly reported adverse reactions. Full vaccine protection is not present until 2 weeks after administration of the second dose. Smallpox and monkeypox vaccine, live, nonreplicating was FDA-approved in 2019. It is FDA-approved for subcutaneous injection in patients 18 years and older. Subcutaneous injection in patients younger than 18 years of age and intradermal injection in patients 18 years and older is covered under an Emergency Use Authorization (EUA).[64646][64667][67763][67840][68022]
For storage information, see the specific product information within the How Supplied section.
Preparation
One Vial (Yellow Cap Vial)
Two-Vials (Yellow Cap Vial Plus Blue Cap Vial)
Intradermal Injection
Preparation
One Vial (Yellow Cap Vial)
Two-Vials (Yellow Cap Vial Plus Blue Cap Vial)
Injection site reaction is one of the most common adverse reactions associated with smallpox and monkeypox vaccine, live, nonreplicating. Pain (84.9% to 90.3%; grade 3 6.8% to 10.9%), erythema (60.8% to 79.4%; redness of at least 100 mm 1.5% to 14.6%), swelling (51.6% to 69.5%; swelling of at least 100 mm 0.8% to 7.2%), induration (45.4% to 66.4%; induration of at least 100 mm 0.3% to 1.9%), and pruritus (43.1% to 58.9%; grade 3 1.6% to 3.4%) were reported in individuals receiving smallpox and monkeypox vaccine, live, nonreplicating during clinical trials. Most solicited local and systemic adverse reactions reported after vaccination had a median duration of 1 to 6 days. There were similar proportions of individuals reporting solicited local or systemic reactions of any severity after Dose 2 compared with Dose 1, with the exception of injection site pain. The incidence of injection site pain was higher with the first dose (79.3%) compared to dose 2 (69.9%). In 3 studies (n = 409) involving patients who had previously been vaccinated with a smallpox vaccine, erythema (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and pruritus (32%) were reported. In individuals with active or a history of atopic dermatitis (AD), erythema was reported in 61.2% to 96.8% of individuals with AD vs. 49.3% to 89.7% without AD and swelling was reported in 52.2% of individuals with AD vs. 40.8% without AD. Itching was reported in 25.8% of individuals with AD vs. 13.8% without AD. Hypersensitive reactions including angioedema, rash, and urticaria have been reported during postmarketing use of the smallpox and monkeypox vaccine, live, nonreplicating. Injection site warmth and injection site vesicles have also been reported during postmarketing use.[64646]
Muscle pain (18.4% to 42.8%; grade 3 0.3% to 2.6%), headache (34.8% to 38.8%; grade 3 2.2% to 2.4%), and fatigue (30.4% to 35.1%; grade 3 2.8% to 4.7%) were reported in individuals receiving smallpox and monkeypox vaccine, live, nonreplicating during clinical trials. In 3 studies (n = 409) involving individuals who had previously been vaccinated with a smallpox vaccine, fatigue (33.5%), headache (27.6%), and muscle pain (21.5%) were reported. In individuals with active or a history of atopic dermatitis (AD), headache was reported in 47.2% to 53.8% of individuals with AD vs. 34.8% to 44.8% without AD. Fatigue was reported in 67.7% of individuals with AD vs. 51.7% of individuals without AD and myalgia was reported in 29% of individuals with AD vs. 24.1% of individuals without AD.[64646]
Nausea (15.9% to 17.7%; grade 3 0.6% to 1.5%) was reported in individuals receiving smallpox and monkeypox vaccine, live, nonreplicating during clinical trials. In 3 studies (n = 409) involving individuals who had previously been vaccinated with a smallpox vaccine, nausea was reported in 9.8% of individuals. In individuals with active or a history of atopic dermatitis (AD), 16.1% of individuals with AD reported nausea vs. 10.3% of individuals without AD.[64646]
Chills (10.4% to 11.8%; grade 3 0.6% to 1.6%) and fever (1.7% to 10.3%; grade 3 0.2% to 0.9%) were reported in individuals receiving smallpox and monkeypox vaccine, live, nonreplicating during clinical trials. In 3 studies (n = 409) involving individuals who had previously been vaccinated with a smallpox vaccine, chills (0.7%) and fever (0.5%) were reported. In HIV-infected individuals with previous smallpox vaccine exposure, fever (1.5%) and chills (8.4%) were reported. The frequency of other solicited local and general adverse reactions in this population were similar to those reported in non-HIV-infected individuals who had previously received smallpox vaccination. HIV-infected individuals who had not received the smallpox vaccine had solicited local and systemic adverse reactions at similar or lower frequencies as compared to those in non-HIV-infected individuals. In individuals with active or a history of atopic dermatitis (AD), chills were reported in 15.9% of individuals with AD vs. 7.8% without AD.[64646]
Smallpox and monkeypox vaccine, live, nonreplicating recipients were monitored for cardiac-related signs or symptoms through at least 6 months after the last vaccination. Cardiac adverse events were reported in 1.3% (112/8,988) of vaccine recipients and 0.2% (3/1,220) of placebo recipients who were smallpox vaccine-naive. Cardiac adverse events were reported in 2.1% (16/766) of vaccine recipients who were smallpox vaccine-experienced. The higher number of patients who experienced cardiac adverse events was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I above 2 times the upper limit of normal (ULN) in 2 studies, 1 which enrolled HIV-infected patients and 1 which enrolled patients with atopic dermatitis. An additional 127 cases of asymptomatic post-vaccination elevation of troponin-I above the ULN, but not above 2 times the ULN, were documented in smallpox and monkeypox vaccine, live, nonreplicating recipients, 124 of which occurred in trials which enrolled HIV-infected patients and patients with atopic dermatitis. The clinical significance of the asymptomatic post-vaccination elevations of troponin-I is unknown. Among the cardiac adverse events reported, 6 cases (0.08%) were considered to be causally related to smallpox and monkeypox vaccine, live, nonreplicating vaccination and included sinus tachycardia, electrocardiogram T wave inversion, abnormal electrocardiogram, electrocardiogram ST segment elevation, abnormal electrocardiogram T wave, and palpitations. None of the cardiac adverse events were considered serious. Myocarditis and pericarditis have been reported during postmarketing use of the smallpox and monkeypox vaccine, live, nonreplicating.[64646]
Syncope or fainting has been reported following the administration of the smallpox and monkeypox vaccine, live, nonreplicating. Procedures should be in place to avoid injury from fainting. Dizziness, facial paralysis (Bell's palsy), acute disseminated encephalomyelitis, myelin oligodendrocyte glycoprotein antibody-associated disease, and bilateral optic neuritis have been reported during postmarketing use of the smallpox and monkeypox vaccine, live, nonreplicating.[64646]
Patients suffering significant immunosuppression may have a diminished immune response to vaccination with smallpox and monkeypox vaccine, live, nonreplicating.[64646] [67840] Immunosuppressed persons may include patients with acquired immunodeficiency syndrome (AIDS); asymptomatic or symptomatic human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized neoplastic disease; or an immune system compromised by corticosteroid therapy with greater than physiologic doses, alkylating drugs, antimetabolites, or radiation therapy. Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.[65107]
Data on the administration of smallpox and monkeypox vaccine, live, nonreplicating are insufficient to inform vaccine-associated risks during pregnancy. Animal data have not identified a risk of fetal harm. A single human dose of smallpox and monkeypox vaccine, live, nonreplicating in female rats and rabbits on 2 or 3 different occasions showed no vaccine-related fetal malformations or variations.[64646]
There are no data on the presence of the smallpox and monkeypox vaccine, live, nonreplicating in human milk, its effects on the breast-fed child, or its effects on milk production. Consider the benefits of breast-feeding, the risk of potential exposure in the child, and the risk of not vaccinating the lactating individual.[64646]
The smallpox and monkeypox vaccine is an attenuated, live, nonreplicating vaccine that elicits humoral and cellular immune responses to orthopoxviruses. Vaccinia neutralizing antibody responses in humans were evaluated to establish vaccine effectiveness for prevention of smallpox and monkeypox (mpox).[64646]
Revision Date: 06/30/2025, 08:00:40 AMThe smallpox and monkeypox vaccine, live, nonreplicating is administered subcutaneously and intradermally.[64646][67840]
The geometric mean titer (GMT) of vaccinia neutralizing antibodies assessed by plaque reduction neutralization test (PRNT) 2 weeks after the second dose of smallpox and monkeypox vaccine, live, nonreplicating in smallpox vaccine naive adults was 152.8 compared to 10.1 prevaccination. The GMT of neutralizing antibodies 4 weeks after a single dose of a licensed smallpox vaccine was 84.4 compared to 10 prevaccination. The GMTs at 2 and 4 weeks after the first dose of smallpox and monkeypox vaccine were 23.4 and 23.5, respectively.[64646][67840]
Intradermal Administration
In a clinical study, individuals were randomized to receive 2 intradermal 0.1 mL doses (n = 191) or 2 subcutaneous 0.5 mL doses (n = 167) of smallpox and monkeypox vaccine, live, nonreplicating administered 4 weeks apart. Using 4 different assays to evaluate immunogenicity, the development of the immune response to smallpox and monkeypox vaccine, live, nonreplicating over time after subcutaneous and intradermal administration was nearly identical, and the log2 transformed peak titers obtained after intradermal administration were non-inferior to those obtained after subcutaneous administration.[67840]
Data on the administration of smallpox and monkeypox vaccine, live, nonreplicating are insufficient to inform vaccine-associated risks during pregnancy. Animal data have not identified a risk of fetal harm. A single human dose of smallpox and monkeypox vaccine, live, nonreplicating in female rats and rabbits on 2 or 3 different occasions showed no vaccine-related fetal malformations or variations.[64646]
There are no data on the presence of the smallpox and monkeypox vaccine, live, nonreplicating in human milk, its effects on the breast-fed child, or its effects on milk production. Consider the benefits of breast-feeding, the risk of potential exposure in the child, and the risk of not vaccinating the lactating individual.[64646]
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