Version July 2025
Primary immunization:
Jynneos :
Primary vaccination: Note: Emergency Use Authorization was issued in August 2022 for intradermal administration to extend vaccine supply during initial outbreak response. In the United States, there is currently adequate supply of Jynneos vaccine; therefore, clinicians can preferentially administer via the SUBQ route. SUBQ administration is recommended for persons with a history of keloid scars (Ref). For postexposure prophylaxis, administration within 4 days of exposure is the most effective. If given 4 to 14 days after exposure, the vaccine may reduce symptoms but not prevent disease. Refer to CDC for additional information (Ref).
Intradermal (alternative route): 0.1 mL per dose given as 2 doses separated by 4 weeks (but no more than 35 days) (Ref).
SUBQ: 0.5 mL per dose given as 2 doses separated by 4 weeks (but no more than 35 days) (Ref).
Note: Routes of administration are interchangeable if necessary (eg, if first dose administered as 0.5 mL SUBQ, then second dose may be administered as either 0.5 mL SUBQ or 0.1 mL intradermally) (Ref).
Booster dose (off-label): SUBQ: 0.5 mL every 2 years for persons at continued risk of occupational exposure (eg, certain research laboratorians) for more virulent strains (eg, Variola virus, Monkeypox virus) or at least every 10 years for less virulent strains (eg, Vaccinia virus, Cowpox virus) (Ref). Note: Booster doses are not currently recommended for the general public during the ongoing mpox outbreak (Ref).
Imvamune (Canadian product):
Primary vaccination:
Preexposure prophylaxis: SUBQ: 0.5 mL per dose given as 2 doses separated by 4 weeks (Ref).
Postexposure prophylaxis: SUBQ: 0.5 mL as a single dose. After 28 days, a second 0.5 mL dose should be offered if mpox infection did not develop. Note: Administer as soon as possible and within 4 days of exposure; may consider use up to 14 days after exposure (Ref).
Booster dose: SUBQ: 0.5 mL every 2 years if the person remains at high risk of occupational exposure (Ref).
Interchangeability: Jynneos or Imvamune may be used as a booster dose for those persons who received a primary series with the smallpox vaccine (ACAM2000) and who are at continued risk for occupational exposure (eg, certain research laboratorians) (Ref).
Dosing recommendations for deviations in dosage or storage:
|
Deviation |
Adjustment |
|---|---|
|
a CDC 2024b. | |
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b Dose administered up to 4 days before the minimum interval is considered a valid dose; do not repeat. | |
|
Dose | |
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Dose too high |
Do not repeat dose. Counsel recipient regarding adverse event potential. |
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Dose too low – Intradermal (eg, injection-site leakage, syringe leakage) NOTE: Absence of a wheal without evidence of vaccine leakage may be considered a valid administration |
Repeat dose immediately (no minimum interval); administer ≥2 inches away from the previous site of administration. If vaccine leakage after 2 intradermal injections on same day, then administer 0.5 mL SUBQ. |
|
Dose too low – SUBQ (eg, 0.1 mL dose given SUBQ when intradermal route intended, syringe leakage) |
Repeat dose immediately with the correct dose and intended route of administration (no minimum interval); administer ≥2 inches away from the previous site of administration. Alternatively, if a partial dose was administered, may administer the remainder of the dose (on the same clinic day) to equal a full dose. |
|
Dosing interval | |
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Dose administered too early (ie, more than 4 days prior to the recommended interval)b |
For patients who are not immunocompromised, do not repeat dose. For patients who are severely immunocompromised, administer a repeat dose ≥28 days from dose given in error. |
|
Dose administered after recommended interval |
Do not repeat dose or restart the series; no maximum interval. Give second dose as soon as possible. |
|
Storage | |
|
Improper storage or handling of vaccine (eg, temperature excursion, dose administered past expiration date) |
Contact manufacturer; if no data to support stability, repeat dose immediately (no minimum interval). |
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Smallpox and mpox (MVA) vaccine (live, nonreplicating): Pediatric drug information")
Dosage guidance:
Clinical considerations: Safety and effectiveness have not been assessed in ages <18 years; emergency use authorization is based on adult data and historical use of live vaccinia virus smallpox vaccine in pediatric populations.
Primary immunization:
Jynneos:
Primary vaccination: Note: Authorized route of administration varies based on age; use caution when ordering and administering. For patients <18 years of age, only SUBQ administration is authorized. For patients ≥18 years of age, intradermal administration was authorized to extend vaccine supply during initial outbreak response in 2022. In the United States, there is currently adequate supply of Jynneos vaccine; therefore, clinicians can preferentially administer via the SUBQ route. SUBQ administration is recommended for persons with a history of keloid scars (Ref). For postexposure prophylaxis, administration within 4 days of exposure is the most effective. If given 4 to 14 days after exposure, the vaccine may still provide some protection against mpox (Ref).
Infants, Children, and Adolescents <18 years: SUBQ: 0.5 mL per dose given as 2 doses separated by 4 weeks (Ref). The second dose is recommended to be administered within 35 days of the first; if interval is longer, it is not necessary to restart the series or add doses (Ref).
Adolescents ≥18 years: Note: Dose varies by route of administration; use caution. Routes of administration are interchangeable within a vaccination series (Ref).
SUBQ: 0.5 mL per dose given as 2 doses separated by 4 weeks (Ref). The second dose is recommended to be administered within 35 days of the first; if interval is longer, it is not necessary to restart the series or add doses (Ref).
Intradermal: 0.1 mL per dose given as 2 doses separated by 4 weeks (Ref). The second dose is recommended to be administered within 35 days of the first; if interval is longer, it is not necessary to restart the series or add doses (Ref).
Booster dose: Limited data available: Adolescents ≥18 years: SUBQ: 0.5 mL every 2 years for persons at continued risk of occupational exposure (eg, certain research laboratorians) for more virulent strains (eg, variola virus, monkeypox virus) or at least every 10 years for less virulent strains (eg, vaccinia virus, cowpox virus) (Ref). Note: Booster doses are not currently recommended for the general public during the ongoing mpox outbreak (Ref).
Imvamune (Canadian product): Note: Canadian product administration is SUBQ for all approved ages.
Primary vaccination:
Preexposure prophylaxis: Adolescents ≥18 years: SUBQ: 0.5 mL per dose given as 2 doses separated by at least 4 weeks (Ref).
Postexposure prophylaxis: Adolescents ≥18 years: SUBQ: 0.5 mL as a single dose. After 28 days, a second 0.5 mL dose may be offered to persons at ongoing risk of exposure; a second dose is not recommended if patient developed symptomatic mpox infection. Note: Administer as soon as possible and within 4 days of exposure; may consider use up to 14 days after exposure (Ref).
Booster dose: Adolescents ≥18 years: SUBQ: 0.5 mL every 2 years if the person remains at high risk of occupational exposure (Ref).
Interchangeability: Jynneos or Imvamune may be used as a booster dose (as age-appropriate) for those persons who received a primary series with the smallpox vaccine (ACAM2000) and who are at continued risk for occupational exposure (eg, certain research laboratorians) (Ref).
Dosing recommendations for deviations in dosage or storage:
|
Deviation |
Adjustment |
|---|---|
|
a CDC 2024a. b Dose administered up to 4 days before the minimum interval is considered a valid dose; do not repeat. | |
|
Dose | |
|
Dose too high |
Do not repeat dose. Counsel recipient regarding adverse event potential. |
|
Dose too low – Intradermal (eg, injection site leakage, syringe leakage) |
Repeat dose immediately (no minimum interval); administer ≥2 inches away from the previous site of administration. If vaccine leakage after 2 intradermal injections on same day, then administer 0.5 mL SUBQ. |
|
Dose too low – SUBQ (eg, 0.1 mL dose given SUBQ when intradermal route intended, syringe leakage) |
Repeat dose immediately with the correct dose (no minimum interval); administer ≥2 inches away from the previous site of administration. Alternatively, if a partial dose was administered, may administer the remainder of the dose (on the same clinic day) to equal a full dose. |
|
Dosing interval | |
|
Dose administered too early (ie, more than 4 days prior to the recommended interval)b |
For patients who are not immunocompromised, do not repeat dose. For patients who are severely immunocompromised, administer a repeat dose ≥28 days from dose given in error. |
|
Dose administered after recommended interval |
Do not repeat dose or restart the series; no maximum interval. Give second dose as soon as possible. |
|
Storage | |
|
Improper storage or handling of vaccine (eg, temperature excursion, dose administered past expiration date) |
Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval). |
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Cardiovascular effects, including ECG abnormality (abnormal T waves on ECG, increased ST segment on ECG, inversion T wave on ECG), myocarditis, palpitations, pericarditis, and tachycardia have been reported with smallpox and mpox vaccination. Asymptomatic troponin increases ≤2 times ULN have also been reported; the clinical significance is unclear.
The following adverse reactions and incidences are derived from product labeling and the FDA issued emergency use authorization (EUA) unless otherwise specified. Refer to EUA for information regarding reporting adverse reactions (Ref). Adverse reactions reported in adults for SUBQ and intradermal routes of administration, unless otherwise noted.
>10%:
Gastrointestinal: Change in appetite (15% to 20%), nausea (10% to 23%)
Local: Erythema at injection site (SUBQ: 61% to 81%; intradermal: 100%), induration at injection site (SUBQ: 45% to 70%; intradermal: 100%), injection-site pruritus (SUBQ: 32% to 49%; intradermal: 89%), local swelling (underarm: 6% to 11%), pain at injection site (SUBQ: 80% to 91%; intradermal: 65%), swelling at injection site (SUBQ: 52% to 67%)
Nervous system: Chills (≤15%), fatigue (30% to 51%), headache (28% to 43%)
Neuromuscular & skeletal: Arm and/or wrist pain (underarm pain: 18% to 21%), arthralgia (9% to 18%), myalgia (22% to 43%)
1% to 10%:
Cardiovascular: Cardiac disorder (SUBQ: 1% to 2%; including ECG abnormality [abnormal T waves on ECG, increased ST segment on ECG, inversion T wave on ECG], palpitations, tachycardia, troponin increased in blood specimen)
Miscellaneous: Fever (SUBQ: ≤2%)
Postmarketing:
Cardiovascular: Myocarditis, pericarditis, syncope
Hypersensitivity: Hypersensitivity reactions (including angioedema)
Local: Localized vesiculation (injection site), warm sensation at injection site
Nervous system: Bell palsy, dizziness
Serious hypersensitivity to any component of the formulation (CDC/ACIP [Rao 2022]).
Canadian labeling: Additional contraindications (not in US labeling): Acute febrile illness if used for nonemergency (preexposure) prophylaxis.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices (ACIP) generally recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Kroger 2023]). There is no minimum interval between administration of a COVID-19 vaccine and an orthopoxvirus vaccine (Jynneos or ACAM2000). Because of the risk for myocarditis and pericarditis related to the COVID-19 vaccines and the unknown risk related to Jynneos or Imvamune, consider separating the orthopoxvirus vaccine by 4 weeks from the COVID-19 vaccines (especially for adolescent/young adult males). However, vaccination with either agent should not be delayed if the patient is at increased risk for mpox or severe COVID-19. The CDC recommends prioritizing the use of Jynneos over ACAM2000 when coadministering with a COVID-19 vaccine (CDC/ACIP [Rao 2022]).
Special populations:
• Altered immunocompetence: The vaccine has been shown to be safe to administer in persons with an immunocompromising condition if no contraindications exist. Immunocompromised persons may have a diminished immune response to the vaccine; consider risk:benefit ratio (CDC/ACIP [Rao 2022]). For management of postexposure to smallpox virus, vaccination with the live, nonreplicating vaccine (eg, Jynneos) is recommended in patients who are severely immunodeficient (including HIV infection with CD4 cell counts between 50 to 199 cells/mm3)(CDC/ACIP [Petersen 2015]). However, for routine immunization in applicable individuals, consider postponing vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
Dosage form specific issues:
• Chicken egg protein: Jynneos is produced using chicken embryo fibroblast cells.
• Ciprofloxacin: Manufactured with ciprofloxacin.
• Gentamicin: Manufactured with gentamicin.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Subcutaneous:
Jynneos: 0.5 mL (0.5 mL) [contains serratia marcescens nuclease (benzonase)]
No
Suspension (Jynneos Subcutaneous)
0.5 mL (per 0.5 mL): $324.00
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Subcutaneous:
Imvamune: 0.5 mL (0.5 mL) [contains benzonase]
Swirl vial gently for ≥30 seconds before each use. Do not administer IM or intravascularly.
Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement edition date and date it was provided, and the administering person's name, title, and address be entered into the patient's permanent medical record.
Intradermal (alternative route): Inject preferably into the inner side of the forearm. Alternatively, may administer in the upper back (below the scapula) or deltoid area. After administration, formation of a wheal is desired but not required (Ref). Extract doses from vial preferably using a low dead-volume syringe and/or needle. If standard syringes and needles are used, there may not be sufficient volume for all stated doses. Do not pool partial doses remaining in vials into a full dose (Ref).
SUBQ: Inject preferably into the upper arm (typically over the triceps area) (Ref).
Inappropriate administration technique:
If administered into an incorrect site, do not repeat dose (Ref).
If incorrect route of administration results in a lower than intended dosage (eg, SUBQ administration of the intradermal dose of 0.1 mL), then immediately repeat dose using the intended route of administration (≥2 inches away from the unintended site placement). If other incorrect route (eg, IM administration), do not repeat dose (Ref).
Parenteral: Swirl vial gently for ≥30 seconds before each use. In pediatric patients, authorized route of administration varies based on age (SUBQ vs intradermal); use caution. Do not administer IM or intravascularly. Note: SUBQ administration is recommended for persons with a history of keloid scars.
SUBQ: Infants, Children, and Adolescents:
Infants: Inject preferably over the anterolateral thigh (Ref).
Children and Adolescents: Inject preferably into the upper arm (typically over the triceps area) (Ref).
Intradermal (alternative route): Adolescents ≥18 years: Inject preferably into the inner side of the forearm. Alternatively, may administer in the upper back (below the scapula) or deltoid area. After administration, formation of a wheal is desired but not required (Ref). Extract doses from vial preferably using a low dead-volume syringe and/or needle. If standard syringes and needles are used, there may not be sufficient volume for all stated doses. Do not pool partial doses remaining in vials into a full dose (Ref).
Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement edition date and date it was provided, and the administering person's name, title, and address be entered into the patient's permanent medical record.
Inappropriate administration technique:
If administered into an incorrect site, do not repeat dose (Ref).
If incorrect route of administration resulting in a lower than intended dosage (eg, SUBQ administration of the intradermal dose of 0.1 mL), then immediately repeat dose using the intended route of administration (≥2 inches away from the unintended site placement). If other incorrect route (eg, IM administration), do not repeat dose (Ref).
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/current-vis/smallpox-monkeypox.html.
Smallpox and mpox (monkeypox), prevention: Prevention of smallpox and mpox (monkeypox) disease in adults determined to be at high risk for smallpox or monkeypox virus infection. Note: Jynneos is available under emergency use authorization for persons <18 years of age (FDA 2022).
The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following persons at risk for occupational exposure to orthopoxviruses (CDC/ACIP [Rao 2022]):
• Research laboratory personnel working with orthopoxviruses
• Clinical laboratory personnel performing diagnostic testing for orthopoxviruses
• Designated public health and health care worker response team members
• Health care personnel who administer the live smallpox vaccine (ACAM2000) or who care for patients infected with orthopoxviruses (eg, monkeypox virus) (per shared clinical decision making)
The ACIP also recommends vaccination for persons ≥18 years of age at risk for mpox infection (CDC 2024a):
• Persons who are gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past 6 months have had one of the following:
- A new diagnosis of ≥1 sexually transmitted disease.
- More than 1 sex partner.
- Sex at a commercial sex venue.
- Sex in association with a large public event in a geographic area where mpox transmission is occurring.
• Persons who are sexual partners of the persons described above.
• Persons who anticipate experiencing any of the situations above.
• Persons at increased risk of mpox exposure and traveling to specific countries experiencing mpox outbreak.
• Persons traveling to specific countries experiencing mpox outbreak and who anticipate the following activities: sex with a new partner; sex at a commercial sex venue (eg, sex club or bathhouse); sex in exchange for money, goods, drugs, or other trade; or sex in association with a large public event (eg, rave, party, or festival).
Note: The ACIP currently does not recommend routine mpox vaccination for the general public or for health care personnel unless sexual risk factors are present.
The Canadian National Advisory Committee on Immunization (NACI) recommends vaccination for persons at high risk for occupational exposure to orthopoxviruses in a laboratory setting. In addition, NACI also makes recommendations on populations who should receive routine mpox vaccination based on mpox virus exposure risk; see recommendations for details (NACI 2024).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification
Anti-CD20 B-Cell Depleting Therapies: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider Therapy Modification
Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid
Brincidofovir: May decrease therapeutic effects of Smallpox and Mpox Vaccine (Live/Attenuated). Risk C: Monitor
Cladribine: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
COVID-19 Vaccine (mRNA): Smallpox and Mpox Vaccine (Live/Attenuated) may increase adverse/toxic effects of COVID-19 Vaccine (mRNA). Specifically, the risk of myocarditis may be increased. Risk C: Monitor
Dinutuximab Beta: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Risk X: Avoid
Elivaldogene Autotemcel: May increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid
Fingolimod: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider Therapy Modification
Immunosuppressants (Cytotoxic Chemotherapy): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Methotrexate: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
Propacetamol: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification
Siponimod: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Avoid administration of non-live/inactivated/non-replicating vaccines during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider Therapy Modification
Teplizumab: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Vaccination with non-live/inactivated/non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider Therapy Modification
Outcome data following maternal exposure to this vaccine in humans are limited (Volkmann 2021).
Infection with the monkeypox virus may lead to adverse pregnancy outcomes, including spontaneous pregnancy loss, stillbirth, and transmission of the monkeypox virus to the fetus or newborn. When a pregnant patient is diagnosed with mpox (monkeypox), neonatal health care providers should be informed of the diagnosis (CDC 2024d; Mbala 2017).
Smallpox infection during pregnancy increases the risk of severe maternal disease (including hemorrhagic smallpox) and death; the fatality rate in unvaccinated pregnant patients can be up to 70%. Pregnant health care workers should avoid direct patient care during an initial emergency response to a smallpox outbreak (CDC [Petersen 2015]).
Pregnancy is not a specific contraindication for vaccination (CDC/ACIP [Rao 2022]). The smallpox and mpox vaccine (live, attenuated) (Jynneos) is a nonreplicating live viral vaccine; pregnant patients who otherwise meet the criteria for monkeypox vaccination can be vaccinated following a discussion of the risks and benefits of pre- or postexposure prophylaxis (CDC 2024d). Following vaccination, patients should continue to avoid conditions with high-risk exposure while pregnant (CDC/ACIP [Rao 2022]).
It is not known if the vaccine virus is present in breast milk.
Data are available following vaccination of one lactating patient following intradermal administration of the smallpox and mpox vaccine (live, attenuated) (Jynneos). Breast milk was sampled on the day prior to and at specified intervals over 10 weeks following the first dose and 12 weeks following the second dose of the vaccine. Maternal blood was also sampled. Antibodies generated in response to the vaccine were present in breast milk and followed the pattern observed in the maternal blood. Viral DNA from the vaccine was not detected in breast milk (Yang 2024).
According to the manufacturer, the decision to breastfeed following vaccination should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breastfeeding is not a specific contraindication for vaccination (CDC/ACIP [Rao 2022]). The smallpox and mpox vaccine (live, attenuated) (Jynneos) is a nonreplicating live viral vaccine and is not expected to have a risk of transmission to a breastfed infant. Lactating patients who otherwise meet the criteria for monkeypox vaccination can be vaccinated following a discussion of the risks and benefits of pre- or postexposure prophylaxis (CDC 2024d).
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2023]). Observe for 30 minutes after vaccination in patients with a history of severe allergic reaction to gentamicin, ciprofloxacin, or to chicken or egg protein (CDC 2024c). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion (ACIP [Kroger 2023]).
Vaccination elicits humoral and cellular immune responses to orthopoxviruses. Smallpox and monkeypox vaccine is a live, third-generation smallpox vaccine containing Modified Vaccinia Ankara, which is replication deficient and cannot cause disease in humans or reproduce in human cells.
Onset of action: Peak antibody response for Jynneos is typically achieved 2 weeks after completion of the 2-dose series (CDC/ACIP [Rao 2022]).
