Version May 2024
Ebola virus disease, prevention (immunization): IM: 1 mL as a single dose.
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 "Ebola Zaire vaccine (live) (United States: Availability limited to Strategic National Stockpile distribution): Pediatric drug information")
Zaire ebolavirus, prevention (immunization): Children and Adolescents: IM: 1 mL as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Arthritis and arthralgia (including joint pain/tenderness) have been reported. Arthralgia is usually mild to moderate intensity; however, severe arthralgia has also been observed. Arthralgia typically resolves within a week after onset, whereas arthritis typically resolves within days to weeks after onset (Ref).
Onset: Arthralgia: Usually in the few days following vaccination (median: 2 days; range: 0 to 42 days). Arthritis: Usually in the second week following vaccination (median: 11 days; range: 5 to 56 days) (Ref).
Risk factors:
Arthritis:
• Females (Ref)
• History of arthritis (Ref)
Anaphylaxis has been reported (Ref). Immediate treatment (including epinephrine 1 mg/mL) for anaphylaxis should be available during vaccine use (Ref).
Mechanism: Immediate hypersensitivity reactions (eg, anaphylaxis) are often IgE-mediated and non–dose-related (Ref).
Onset: Immediate hypersensitivity reactions: Rapid; IgE-mediated reactions (eg, anaphylaxis) generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref).
Risk factors:
• Previous hypersensitivity reaction to another vaccine or vaccine component (Ref)
Skin rash (including maculopapular rash) and vesicular eruption have been reported in some patients following vaccination. Since live vaccine virus has been isolated in skin vesicles in vaccinated patients up to 9 days after vaccination, rashes should be covered with a bandage until healed and contaminated bandages should be disposed of properly (ie, sealed in plastic bag prior to disposing in the trash and hands washed with soap and water) (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults, unless otherwise noted.
>10%:
Gastrointestinal: Abdominal pain (children and adolescents: 16% to 21%; adults: 13%), decreased appetite (children and adolescents: 21% to 27%; adults: 15%), diarrhea (children and adolescents: 19%), vomiting (children and adolescents: 4% to 17%; adults: 4%)
Hematologic & oncologic: Decreased neutrophils, lymphocytopenia
Local: Erythema at injection site (children and adolescents: <1%; adults: ≤12%), pain at injection site (children and adolescents: 26% to 52%; adults: 21% to 70%, severe: 3%), swelling at injection site (children and adolescents: 3% to 5%; adults: ≤17%)
Nervous system: Chills (children and adolescents: 5% to 19%; adults: 17%), dizziness (children and adolescents: 8% to 17%), drowsiness (children and adolescents: 20% to 28%; adults: 26%), fatigue (19%), headache (children and adolescents: 50% to 59%; adults: 37% to 55%), irritability (children and adolescents: 1% to 11%)
Neuromuscular & skeletal: Arthralgia (children and adolescents: 3% to 16%; adults: 7% to 19%, severe: 1%; literature suggests that incidence of arthralgia, regardless of severity, may be as high as 40% [CDC/ACIP (Choi 2021)]) (table 1), myalgia (children and adolescents: 12% to 30%; adults: 30% to 33%)
|
Drug (Ebola Zaire Vaccine [Live]) |
Placebo |
Population |
Number of Patients (Ebola Zaire Vaccine [Live]) |
Number of Patients (Placebo) |
|---|---|---|---|---|
|
3% |
2% |
Children |
310 |
205 |
|
16% |
8% |
Adolescents |
203 |
123 |
|
19% |
11% |
Adults |
592 |
412 |
|
18% |
3% |
Adults |
1,051 |
133 |
|
7% |
6% |
Adults |
500 |
500 |
Miscellaneous: : Crying (children and adolescents: 3% to 31%; including screaming), fever (including feverishness: children and adolescents: 1% to 83%; adults: 34% to 39%;)
1% to 10%:
Dermatologic: Diaphoresis (children and adolescents: 5%), skin rash (4%), vesicular eruption (2%)
Gastrointestinal: Nausea (children and adolescents: 8%; adults: 8% to 10%), oral mucosa ulcer (children and adolescents: 2% to 6%; adults: 2%)
Local: Injection-site pruritus (children and adolescents: 3% to 7%)
Neuromuscular & skeletal: Arthritis (5%; severe: <1%; literature suggests incidence may be as high as 24%) (CDC/ACIP [Choi 2021]) (table 2)
|
Drug (Ebola Zaire Vaccine [Live]) |
Placebo |
Number of Patients (Ebola Zaire Vaccine [Live]) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|
|
5% |
0% |
1,051 |
133 |
Includes arthritis, monoarthritis, polyarthritis, osteoarthritis, joint swelling, or joint effusion |
<1%: Neuromuscular & skeletal: Joint swelling
Postmarketing: Hypersensitivity: Anaphylaxis (CDC/ACIP [Choi 2021])
Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including rice protein.
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]).
• Rash: Maculopapular and vesicular rashes have occurred. Rash should be covered with a bandage until healed. Place contaminated bandages in a sealed plastic bag and dispose of in the trash; wash hands with soap and water after disposing of the plastic bag (CDC/ACIP [Choi 2021]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• 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]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
Concurrent drug therapy issues:
• Vaccines: In order to maximize vaccination rates, the 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 visit, unless contraindications exist (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Ebola Zaire vaccine (live) has not been adequately studied in immunosuppressed patients but has been studied in a small number of individuals infected with HIV; risks and benefits should be weighed (CDC/ACIP [Choi 2021]; Kennedy 2017). In general, live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for ≥3 months after immunosuppressive therapy (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
Other warnings/precautions:
• 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]).
• Transmission of virus: Transmission of vaccine virus is a theoretical risk; vaccine virus RNA was present in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults for 7 to 20 days after vaccination. For ≥6 weeks postvaccination, vaccine recipients should not donate blood and should avoid exposing high-risk persons (ie, neonates and infants, immunocompromised persons) or livestock to their blood/bodily fluids. For 2 months postvaccination, recipients should use effective barrier contraception during any sexual contact (regardless of childbearing status or sexual orientation). For 2 weeks after vaccination, the vaccine recipient should avoid sharing needles, razors, eating utensils, cups, or toothbrushes with others and avoid open-mouth kissing; if oral sores develop following vaccination, these activities should be avoided until the sores heal (CDC/ACIP [Choi 2021]).
Ervebo is not commercially available in the United States. Supplies are owned by the US federal government and are included in the Strategic National Stockpile.
IM: Administer IM. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Cover injection site with bandage; may remove once there is no visible fluid leakage and place used bandage in sealed plastic bag and dispose of in trash. Wash hands well after disposing of plastic bag (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, and the administering person's name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Parenteral: IM: Administer as soon as possible following thawing; discard if not used within 4 hours of thawing. Administer IM. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). Cover injection site with bandage; may remove once there is no visible fluid leakage and place used bandage in sealed plastic bag and dispose of in trash. Wash hands well after disposing of plastic bag (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
Ebola virus disease, prevention: Active immunization against disease caused by Zaire ebolavirus in persons ≥12 months of age.
Limitations of use: Duration of protection is unknown; does not protect against other species of Ebolavirus or Marburgvirus; effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown.
The Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following individuals ≥18 years of age (CDC/ACIP [Choi 2021]; CDC/ACIP [Malenfant 2022]):
- Persons responding to Ebola virus disease outbreak
- Health care professionals working at a federally designated Ebola treatment center
- Health care professionals caring for or transporting patients with confirmed or suspected Ebola virus disease at a special pathogen treatment center
- Laboratory or other personnel working at a biosafety level 4 facility
- Laboratory or other personnel handling specimens that may contain replication-competent Ebola virus (species Zaire ebolavirus) at a Laboratory Response Network facility.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect 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 enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Ebola-Directed Monoclonal Antibodies: May diminish the therapeutic effect of Ebola Zaire Vaccine (Live). Management: Wait several months (3 to 6 months, and up to 11 months) after use of Ebola-directed antibodies before administering the live Ebola Zaire vaccine. Repeat vaccination may be required if antibody therapy and vaccination cannot be adequately separated. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect 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 combination
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect 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
Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Risk D: Consider therapy modification
Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Risk C: Monitor therapy
Following infection, the Ebola virus can be detected in body fluids, including vaginal secretions and semen; male to female sexual transmission has been documented. The Ebola virus vaccine contains a live attenuated virus, and there is a potential for transmission of the vaccine virus via sexual contact. Until additional data are available, it is recommended that vaccine recipients use effective barrier contraception during any sexual contact (regardless of childbearing status or sexual orientation) for 2 months after vaccination. In addition, vaccine recipients should avoid exposing high-risk persons to body fluids, including saliva (eg, from open mouth kissing), for up to 6 weeks after vaccination (CDC/ACIP [Choi 2021]).
There is limited information related to pregnancy outcomes in persons who became pregnant following vaccination with an Ebola virus vaccine (CDC/ACIP [Choi 2021]; WHO 2020).
Following maternal infection, the Ebola virus can be detected in maternal body fluids and transmitted to the fetus. Maternal Ebola infection carries a high rate of mortality for both the fetus and the mother. Maternal Ebola virus infection may result in miscarriage, stillbirth, and maternal and/or neonatal death (Olgun 2018).
It is not known if the vaccine virus can be transmitted to others via close personal contact. Until additional data are available, vaccine recipients should avoid exposing high-risk persons (including pregnant patients) to body fluids for up to 6 weeks after vaccination (CDC/ACIP [Choi 2021]).
In general, vaccination with live, attenuated virus vaccines is contraindicated during pregnancy (CDC/ACIP [Kroger 2023]). A decision to vaccinate a patient who is pregnant should consider the risk of exposure to Zaire ebolavirus (CDC/ACIP [Choi 2021]). In areas with an active outbreak, pregnant patients may be offered the vaccine in the context of clinical research or as part of a compassionate use protocol (WHO 2020).
It is not known if the vaccine virus is present in breast milk.
A decision to vaccinate a patient who is breastfeeding should consider their risk of exposure to Zaire ebolavirus (CDC/ACIP [Choi 2021]). According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother. In areas with an active outbreak, breastfeeding patients may be offered the vaccine in the context of clinical research or as part of a compassionate use protocol (WHO 2020).
It is not known if the vaccine virus can be transmitted to others via close personal contact. Until additional data are available, vaccine recipients should avoid exposing high-risk persons (including breastfeeding patients) to body fluids for up to 6 weeks after vaccination (CDC/ACIP [Choi 2021]).
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2023]). Monitor for development of rash. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Provides active immunization against Zaire ebolavirus.
Duration: Unknown (CDC/ACIP [Choi 2021]).
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