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Ebola Zaire Vaccine (Live)

Medically reviewed by Drugs.com. Last updated on Nov 12, 2021.

Pronunciation

(e BO luh za IR vak SEEN live)

Index Terms

  • Ervebo
  • Live Ebola Zaire Vaccine
  • rVSV-ZEBOV
  • rVSVΔG-ZEBOV-GP
  • Zaire Ebolavirus Vaccine

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

Provides active immunization against Zaire ebolavirus.

Efficacy: 100% (95% CI, 63.5% to 100%); no cases of Ebola virus disease in 2,108 patients immunized immediately, and 10 cases in the 1,429 patients who received delayed vaccination.

Duration of Action

Unknown.

Use: Labeled Indications

Ebola virus disease, prevention: Active immunization against disease caused by Zaire ebolavirus in adults.

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.

Contraindications

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including rice protein.

Dosing: Adult

Ebola virus disease, prevention (immunization): IM: 1 mL as a single dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Zaire ebolavirus, prevention (immunization): Adolescents ≥18 years: IM: 1 mL as a single dose.

Reconstitution

Thaw vaccine at room temperature (not in the refrigerator) until no visible ice is present. Gently invert several times. Solution should be particle free and colorless to slightly brownish-yellow.

Administration

IM: Administer IM, preferably in the deltoid muscle. 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 (ACIP [Ezeanolue 2020]). 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 (ACIP [Ezeanolue 2020]).

Storage

Store frozen at -80°C to -60°C (-112°F to -76°F). Protect from light. Thaw the vial at room temperature (not in the refrigerator) until no visible ice is present. Use immediately after thawing or store thawed vial refrigerated at 2°C to 8°C (35.6°F to 46.4°F) for up to 2 weeks or at room temperature (up to 25°C [77°F]) for up to 4 hours. Protect from light. Do not refreeze thawed vaccine.

Drug Interactions

Atoltivimab, Maftivimab, and Odesivimab: May diminish the therapeutic effect of Vaccines (Live). Management: Wait several months (3 to 6 months, and even as long as 11 months) after use of atoltivimab, maftivimab, and odesivimab before administering live vaccines. Consider therapy modification

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Brexucabtagene Autoleucel: May enhance the adverse/toxic effect of Vaccines (Live). Brexucabtagene Autoleucel may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). 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 prior to therapy whenever possible. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Deflazacort: May enhance the adverse/toxic effect of Vaccines (Live). Deflazacort may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating deflazacort. Live vaccines should be administered at least 4 to 6 weeks prior to initiating deflazacort. 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. Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Consider therapy modification

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

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. Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

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. Consider therapy modification

Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). 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). Avoid combination

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, do administer a scheduled PPD skin test for at least 4-6 weeks following administration of the vaccine. Simultaneous administration of a parenteral live vaccine and PPD skin test is acceptable. 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. Monitor therapy

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Hematologic & oncologic: Lymphocytopenia, neutropenia

Local: Erythema at injection site (2% to 12%), pain at injection site (34% to 70%; severe: 3%), swelling at injection site (2% to 17%)

Nervous system: Fatigue (19%), headache (37%)

Neuromuscular & skeletal: Arthralgia (7% to 18% [placebo: 3% to 6%]; severe:1%), myalgia (33%)

Miscellaneous: Fever (34%)

1% to 10%:

Dermatologic: Skin rash (4%), vesicular eruption (2%)

Gastrointestinal: Nausea (8%)

Nervous system: Chills (7%), paresthesia (1%)

Neuromuscular & skeletal: Arthritis (5% [placebo: 0%]; severe: <1%)

<1%: Hypersensitivity: Anaphylaxis

Warnings/Precautions

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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

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. Defer 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 [Ezeanolue 2020]).

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 inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Ezeanolue 2020]).

Special populations:

• Altered immunocompetence: 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 [Ezeanolue 2020]; 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

• 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 at least ≥14 days after vaccination.

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

There is limited information related to pregnancy outcomes in women who became pregnant following vaccination with an Ebola virus vaccine (Juan-Giner 2019). In general, vaccination with live, attenuated virus vaccines is contraindicated during pregnancy (ACIP [Ezeanolue 2020]). A decision to vaccinate a woman who is pregnant should consider the woman's risk of exposure to Zaire ebolavirus. It is not known if virus from this vaccine can be transmitted from the mother to the fetus.

Ebola infection is associated with adverse pregnancy outcomes, including miscarriage, stillbirth, and maternal death (Haddad 2018). Women with Ebola virus infection can transmit the virus during childbirth (WHO 2018).

Patient Education

What is this drug used for?

• It is used to prevent disease caused by Ebola virus.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Injection site pain, redness, or swelling

• Headache

• Muscle pain

• Loss of strength and energy

• Nausea

• Sweating a lot

• Joint pain or swelling

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

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