Jynneos (smallpox and mpox vaccine, live, nonreplicating/PF)

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

Administer by subcutaneous injection. The vaccine also has been administered intradermally+ in select situations for active immunization against mpox disease.

Administer two doses (0.5 mL each) 4 weeks apart.

Supplied in two different presentations (One-Vial and Two-Vial Presentation). One-Vial Presentation does not require reconstitution before use. Two-Vial Presentation must be resconstituted prior to administration.

One-Vial Presentation: allow the vaccine to thaw and reach room temperature before use. Once thawed, the vaccine may be kept at 2-8oC for 4 weeks (protect from light); do not refreeze. Swirl the vial gently before use for at least 30 seconds; withdraw a dose of 0.5 mL into a sterile syringe for injection.

Two-Vial Presentation: Reconstitute the Lyophilized Antigen Component with Diluent Component to form the suspension. After reconstitution, the vaccine may be stored at 2-8oC for 12 hours; protect from light during storage.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Non-Live Or Non-Replicating Vaccines/Efalizumab

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Efalizumab-induced immunosuppression may prevent proper immune response to the vaccine.(1)

CLINICAL EFFECTS: The use of vaccines in patients who have recently received efalizumab may be ineffective.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should receive all appropriate immunizations prior to beginning efalizumab therapy. The use of vaccines in patients who have recently received efalizumab may be ineffective.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: In a small study with intravenous efalizumab, a single dose of 0.3 mg/kg of efalizumab given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. (This dose has comparable pharmacodynamic effects to the recommended subcutaneous dose of 1 mg/kg.) In chimpanzees treated with greater than 10 times the normal clinical exposure level of efalizumab, antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.(1)

Non-Live, Non-Replicating Vaccine/Rebisufligene Etisparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)

DISCUSSION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines.(1)

Vaccines/Pariglasgene Brecaparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)

DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Non-Live Or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Non-Live Or Non-Rep Vaccines/Systemic Corticosteroids; Acth

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)

PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1)

DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)

Non-Live Or Non-Replicating Vaccines/Etrasimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Fingolimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)

DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)

Non-Live Or Non-Replicating Vaccines/Ocrelizumab

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ocrelizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ocrelizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ocrelizumab therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ocrelizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving ocrelizumab. Vaccinations given during ocrelizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ocrelizumab treatment.(1)

Non-Live Or Non-Replicating Vaccines/Ozanimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Ponesimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Satralizumab

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)

Non-Live Or Non-Replicating Vaccines/Siponimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)

Non-Live Or Non-Replicating Vaccines/Ublituximab

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)

Non-Live Or Nonreplicating Vaccine/Vusolimogene Oderparepvec

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The interaction potential of non-live or non-replicating vaccines with vusolimogene oderparepvec is unknown.

CLINICAL EFFECTS: Concurrent administration of non-live or non-replicating vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that non-live and non-replicating vaccines should ideally be delayed until the current course of vusolimogene oderparepvec therapy is completed. If vaccination is required during treatment, separate administration of the vaccine and vusolimogene oderparepvec by at least 14 days.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)

DISCUSSION: The concomitant use of non-live or non-replicating vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is intended to minimize potential interactions and confounding factors in the safety assessments of vaccines and vusolimogene oderparepvec therapy.(2)

Orthopoxvirus Vaccines/Covid-19 Vaccines

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Both the COVID-19 vaccines and orthopoxvirus vaccines have been reported to cause myocarditis and pericarditis.(1,2)

CLINICAL EFFECTS: Concurrent use of COVID-19 vaccines and orthopoxvirus vaccines may increase the risk of myocarditis and pericarditis.(1,2)

PREDISPOSING FACTORS: Myocarditis and pericarditis have been reported more frequently in adolescent and young adult males after the 2nd dose of COVID-19 vaccines and within a week of vaccination.(1) Patients with pre-existing heart disease or 3 or more cardiac risk factors (hypertension, diabetes, hypercholesterolemia, family history of heart disease, and smoking) have a theoretical risk for myopericarditis with the smallpox-mpox vaccine.(2)

PATIENT MANAGEMENT: While there is no required minimum interval between receiving the COVID-19 vaccine and the smallpox or smallpox-mpox vaccine, patients who are predisposed to developing myocarditis or pericarditis may consider waiting 4 weeks between vaccines. However, if an orthopoxvirus vaccine is recommended in the setting of an outbreak, or a patient's risk for severe COVID-19 disease is high, administration of both vaccines should not be delayed. The smallpox-mpox vaccine is preferred over the smallpox vaccine when coadministering with a COVID-19 vaccine.(1,2)

DISCUSSION: Myocarditis and pericarditis have been reported rarely after COVID-19 vaccination in the United States, but available evidence both in the US and internationally supports a causal relationship.(1) After primary vaccination with the smallpox vaccine, there is an estimated rate of myocarditis of 5.7 per 1,000 patients. Myocarditis has not been reported with the smallpox-mpox vaccine, but since the mechanism for myocarditis with the smallpox vaccine is believed to be immune-mediated, there is a possibility that antigens in the smallpox-mpox vaccine may precipitate myopericarditis.(2)

Vaccines/Hepatitis B Vaccine (Fendrix)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)

CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)

DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)

None.

There are no contraindication contraindications for this drug.

• Immunosuppression
• Primary immune deficiency disorder

There are no moderate contraindications for this drug.

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.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Crohn's disease
• Hypersensitivity drug reaction
• Myocarditis
• Paresis of extraocular muscles
• Pericarditis
• Sarcoidosis
• Throat constriction

More Frequent

• Acute pain at drug application site
• Dyspnea
• Erythema
• Headache disorder
• Induration of skin
• Injection site sequelae
• Myalgia
• Pruritus of skin
• Skin swelling

Less Frequent

• Chills
• Injection site erythema
• Injection site pain
• Nausea

Rare or Very Rare

• Abnormal ECG
• Dizziness
• Palpitations
• Syncope
• Tachycardia
• Urticaria

No enhanced messaging available.

Safety and effectiveness of smallpox and mpox vaccine live, non-replicating have not been established in individuals younger than 18 years of age. However, the vaccine (JYNNEOS) is available under an FDA Emergency Use Authorization (EUA) for use in the prevention of mpox disease in individuals younger than 18 years of age who are determined to be at high risk of mpox.

Available human data on smallpox and mpox vaccine live, non-replicating 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, non-replicating 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.

It is not known whether smallpox and mpox vaccine live, non-replicating is distributed in human milk. Data are not available to assess the effects of the vaccine 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, non-replicating 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.

Clinical studies of smallpox and mpox vaccine live, non-replicating 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, non-replicating.