Ervebo(Pf)(National Stockpile) (ebola (Zaire) recombinant vaccine, live, vero cell/PF)

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

*For IM administration only, preferably into the deltoid area of the non-dominant arm.

*Administer a single 1-mL dose.

No dosing information is available for this tab.

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.

Live Vaccines/Bevacizumab

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: Systemic bevacizumab suppresses the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function. For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Live Vaccines/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 suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1) The vaccine may result in illness.(1,2)

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 pose a risk for vaccine-derived infections and decrease the effectiveness of vaccines.(1)

Live Vaccines/Vusolimogene Oderparepvec

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: The interaction potential of live virus vaccines with vusolimogene oderparepvec is unknown.

CLINICAL EFFECTS: Concurrent administration of live 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 vaccines containing live attenuated viruses should be avoided during vusolimogene oderparepvec therapy.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)

DISCUSSION: The concomitant use of live attenuated vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is based on vaccine guidance used in clinical trials.(2)

Live Vaccines; Live Bcg/Selected Immunosuppressive Agents

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: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(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.

Live Vaccines/Brensocatib

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

MECHANISM OF ACTION: Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1). Brensocatib prevents the activation of neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness. Immune response to live vaccines may be decreased during periods of immunocompromise.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The coadministration of live vaccines and brensocatib should be avoided.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(2)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) The concomitant use of live attenuated vaccines and brensocatib has not been evaluated. Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1).(1)

Live Vaccines/Leniolisib

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

MECHANISM OF ACTION: Leniolisib modifies the immune system. Immune response to live vaccines may be decreased during treatment with leniolisib.(1)

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

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The manufacturer of leniolisib states live, attenuated vaccinations may be less effective if administered during leniolisib treatment.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Live Vaccines/Live Vaccines

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

MECHANISM OF ACTION: The immune response to an injectable or nasally administered live vaccine may be impaired if it is administered within 28 days of another injectable or nasally administered live vaccine.(1)

CLINICAL EFFECTS: Non-simultaneous administration (i.e. given on different days) of an injectable or nasally administered live vaccine to an individual who has received another injectable or nasally administered live vaccine in the previous 28 days may result in the second vaccine being ineffective.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The CDC states that multiple injectable or nasal live vaccines (e.g. MMR and varicella) may be administered on the same day. However, injectable or nasally administered live vaccines not administered on the same day should be administered at least 4 weeks apart whenever possible. If injectable or nasal live vaccines are administered less than 4 weeks apart and not on the same day, the vaccine administered second should be considered invalid and be repeated at least 4 weeks after the last, invalid dose.(1)

DISCUSSION: The immune response to a live vaccine may be impaired if it is administered within 28 days of another live vaccine. In a study, patients who received varicella vaccine less than 28 days after MMR vaccination had an increased risk for varicella vaccine failure (i.e., varicella disease in a vaccinated person) of 2.5-fold compared with those who received varicella vaccine before or more than 28 days after MMR.(1)

Live Vaccines/Methotrexate (Low Strength Injection, Oral)

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

MECHANISM OF ACTION: A variety of disease modifying agents such as methotrexate suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) CDC recommendations for zoster vaccine state it may be administered to patients receiving methotrexate if the dose is < or = to 0.4 mg/kg/week for treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease or other conditions.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Live Vaccines/Systemic Corticosteroids; Corticotropin (Acth)

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

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system. In severely immunocompromised patients, virus replication after administration of live, attenuated-virus vaccines can be enhanced and/or the immune response to the vaccine may be decreased.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(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 live-virus and live, attenuated vaccines should not be administered to 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. Live vaccines should be deferred for at least 1 month after discontinuation of high-dose systemic steroids administered for 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 4 weeks after a live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines. 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.(1) The US manufacturer of corticotropin(2) and triamcinolone(3) and the Australian manufacturer of dexamethasone(4) state that administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids or corticotropin. The manufacturer of deflazacort states that live or live-attenuated vaccines should be administered at least 4 to 6 weeks prior to initiation of therapy with deflazacort.(5)

DISCUSSION: 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) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Live Vaccines/Tuberculin Testing

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

MECHANISM OF ACTION: Measles infection and severe acute and chronic infections may induce an anergic state resulting in a false-negative tuberculin test. The live measles vaccine, as well as other live vaccines (e.g. smallpox, varicella, yellow fever) theoretically may also suppress response to tuberculin testing, though the degree of suppression may be less than that expected from acute infection with wild-type virus.(1-4)

CLINICAL EFFECTS: Tuberculin testing that is performed more than one day but less than 28 days after administration of a live vaccine may result in a false negative tuberculin response. Tuberculin testing may be administered simultaneously with live vaccines.(1-4)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The CDC states that live vaccines (e.g. MMR and varicella) and tuberculin testing may be administered within one day of each other at separate administration sites. If it has been more than one day since tuberculin testing has been administered, the live vaccine can be given at any interval after the tuberculin test. However, if the live vaccine has been administered more than one day previously and tuberculin testing is indicated, tuberculin testing should be deferred for at least 4-6 weeks.(1-4)

DISCUSSION: Suppression of response to tuberculin testing has been observed following measles infection, live measles vaccination, and live smallpox vaccination. The degree of suppression after live virus vaccination is likely to be less than that from an acute infection with wild-type virus. There is no data on suppression of response to tuberculin testing with other live vaccines. In the absence of data, the CDC recommends tuberculin testing within one day that a live vaccine is administered. Otherwise the tuberculin test should be deferred for at least 4-6 weeks.(1-4)

Live Vaccines; Live Bcg/Hydroxyurea

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

MECHANISM OF ACTION: Hydroxyurea may suppress the immune system.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies), treatments (e.g. radiation) and cytotoxic drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: Recommendations for administration of live vaccines in patients on hydroxyurea are dependent on the indication. The US manufacturers of hydroxyurea recommend avoiding live vaccine use in patients taking hydroxyurea. Evaluate hematologic status prior to and during treatment with hydroxyurea. Provide supportive care and modify the dose or discontinue hydroxyurea as needed.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician. 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.(2) The ACIP recommendations state that routine vaccinations patients with secondary immunodeficiency such as sickle cell disease are likely effective. Live viral and bacterial vaccines are contraindicated in patients with generalized malignant neoplasm, immunosuppressive, or radiation therapy, depending on immune status.(4)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(2) A multicenter, randomized, double-blind, placebo-controlled trial in infants and young children with sickle cell disease (BABY HUG) studied the response to pneumococcal and measles, mumps, and rubella vaccines in patients using hydroxyurea. The authors concluded that hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with sickle cell disease. Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted. No changes in current immunization schedules are recommended; however, for endemic disease or epidemics, adherence to accelerated immunization schedules for the measles, mumps, and rubella vaccine should be reinforced.(5)

Live Vaccines; Live Bcg/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 suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1,2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness.(1,2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Vaccination should ideally precede the initiation of teplizumab therapy by 8 weeks. Live vaccines are not recommended within the 8 weeks prior to, during, or for 52 weeks after stopping teplizumab therapy.(2)

DISCUSSION: Vaccinations may be less effective if administered within 8 weeks before, during, and for 52 weeks following teplizumab therapy.(2) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

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

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)

Do not administer to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of Ebola Zaire vaccine live, including rice protein.

There are no contraindication contraindications for this drug.

• Immunosuppression

There are no moderate contraindications for this drug.

The most commonly reported local and systemic adverse events inclinical trials of individuals 18 years of age and older: injection-site pain (70%);headache (55%); feverishness (39%); muscle pain (33%);somnolence, reduced activity, fatigue (26%); joint pain, arthralgia(19%); chills (17%); injection-site swelling (17%); decreasedappetite (15%); abdominal pain (13%); injection-site redness (12%);nausea (10%); arthritis (5%); vomiting (4%), rash (4%); abnormalsweating (3%) and mouth ulceration (2%).

The most commonly reported local and systemic adverse events inclinical trials of individuals 12 months through 2 years of age: feverishness (83%);crying (31%); decreased appetite (27%); injection-site pain (26%);somnolence, reduced activity, fatigue (20%); diarrhea (19%);vomiting (17%); irritability (11%); screaming (10%); mouthulceration (6%); chills (5%); injection-site swelling (5%); headache(4%); abdominal pain (2%); abnormal sweating (2%) and injectionsiteerythema (1%).

The most commonly reported local and systemic adverse events inclinical trials of individuals 3 years through 11 years of age: feverishness (65%);headache (50%); injection-site pain (40%); decreased appetite(24%); somnolence, reduced activity, fatigue (22%); abdominal pain(21%); chills (14%); myalgia (12%); vomiting (11%);dizziness (8%);nausea (8%); injection-site pruritus (7%); crying (3%); arthralgia(3%); diarrhea (3%); injection-site swelling (3%); abnormalsweating (1%); mouth ulceration (2%) and irritability (1%).

The most commonly reported local and systemic adverse events inclinical trials of individuals 12 years through 17 years of age: headache (59%);injection-site pain (52%); feverishness (48%); myalgia (30%);somnolence, reduced activity, fatigue (28%); decreased appetite(21%); chills (19%); dizziness (17%); abdominal pain (16%);arthralgia (16%); nausea (8%); abnormal sweating (5%); diarrhea(4%); vomiting (4%); injection-site pruritus (3%); injection-siteswelling (3%) and mouth ulceration (2%).

More Frequent

• Lymphopenia
• Neutropenic disorder

Rare or Very Rare

• Anaphylaxis

More Frequent

• Fatigue
• Fever
• Headache disorder
• Injection site pain
• Myalgia

Less Frequent

• Arthralgia
• Arthritis
• Hyperhidrosis
• Injection site erythema
• Injection site inflammation
• Injection site sequelae
• Nausea
• Paresthesia
• Skin rash

No enhanced messaging available.

The safety and effectiveness of Ebola Zaire vaccine live in individuals younger than 12 months of age have not been established.

Risk Summary: There are no adequate and well-controlled studies of Ebola Zaire vaccine live in pregnant women, and human data available from clinical trials with Ebola Zaire vaccine live are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy. The decision to vaccinate a woman who is pregnant should consider the woman's risk of exposure to Zaire ebolavirus.

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.

Clinical Considerations: Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus. The majority of such pregnancies end in miscarriage or stillbirth. In pregnancies where live birth does occur, neonates generally do not survive.

The potential for transmission of the vaccine virus from a vaccinated mother to the fetus/neonate is unknown.

Risk Summary: Human data are not available to assess the impact of Ebola Zaire vaccine live on milk production, its presence in breast milk, or its effects on the breast-fed child.

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

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

Across the clinical development program, a total of554 individuals 65 years of age and older received at least one dose of Ebola Zaire vaccine live.