Ervebo

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ervebo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ebola Zaire vaccine, live recombinant (contains a minimum of 72million plaque forming units of vaccine virus in a stabilizer solution containing 10mM tromethamine and 2.5mg/mL rice-derived recombinant human serum albumin); per 1mL; susp for IM inj; may contain trace amounts of rice protein; preservative-, and latex-free.

    Pharmacological Class

    Ebola Zaire vaccine.

    How Supplied

    Single-dose vials—10

    Storage

    Store frozen at -80° C to -60° C (-112° F to -76° F). 
    Store in the original carton to protect from light.

    Do not thaw the vial in a refrigerator. Thaw the vial at room temperature until no visible ice is present. Use the vaccine immediately after thawing. If not used immediately, a thawed vial can be stored refrigerated at 2° C to 8° C (35.6° F to 46.4° F) for a total time of no more than 2 weeks and at room temperature (up to 25° C; 77° F) for a total time of no more than 4 hours. Protect from light. Do not re-freeze thawed vaccine.

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Mechanism of Action

    Ervebo vaccination results in an immune response and protection from disease caused by Zaire ebolavirus. The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire ebolavirus are unknown.

    Ervebo Indications

    Indications

    Prevention of disease due to Zaire ebolavirus.

    Limitations of Use

    The duration of protection conferred by Ervebo is unknown. Does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the vaccine when administered concurrently with antiviral medication, immuneglobulin, and/or blood or plasma transfusions is unknown.

    Ervebo Dosage and Administration

    Adults and Children

    <12mos: not established. Give by IM inj. ≥12mos: administer a single (1mL) dose.

    Ervebo Contraindications

    Contraindications

    Allergy to rice protein.

    Ervebo Boxed Warnings

    Not Applicable

    Ervebo Warnings/Precautions

    Warnings/Precautions

    Immunization may not protect all individuals. Have appropriate medical treatment and supervision readily available. Immunocompromised. Possible transmission of vaccine virus. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Monitor for signs/symptoms of hypersensitivity reactions following vaccination with Ervebo.
    • Have appropriate medical treatment and supervision readily available in case of an anaphylactic event following the administration of Ervebo.

    Limitations of Vaccine Effectiveness

    • Ervebo vaccination may not protect all individuals.
    • Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission.

    Immunocompromised

    • The safety and effectiveness of Ervebo have not been assessed in immunocompromised individuals.
    • The effectiveness of Ervebo in immunocompromised individuals may be diminished.
    • Weigh the risk of vaccination with Ervebo in immunocompromised individuals against the risk of disease due to Zaire ebolavirus.

    Transmission

    • Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults.
    • Transmission of vaccine virus is a theoretical possibility.

    Pregnancy Considerations

    There are no adequate and well-controlled studies of Ervebo in pregnant women, and human data available from clinical trials with Ervebo 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.

    Nursing Mother Considerations

    Human data are not available to assess the impact of Ervebo on milk production, its presence in breast milk, or its effects on the breastfed child.

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

    Pediatric Considerations

    The safety and effectiveness of Ervebo in individuals <12 months of age have not been established.

    Geriatric Considerations

    Clinical studies of Ervebo did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients.

    Ervebo Pharmacokinetics

    See Literature

    Ervebo Interactions

    Interactions

    May test (+) results for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens.

    Ervebo Adverse Reactions

    Adverse Reactions

    Inj site reactions (pain, swelling, redness), headache, feverishness, muscle pain, fatigue, joint pain, nausea, arthritis, rash, abnormal sweating; also for children: decreased appetite, crying, somnolence, reduced activity, diarrhea, vomiting, mouth ulceration, chills, irritability.

    Ervebo Clinical Trials

    Clinical Trials

    Clinical efficacy of Ervebo was assessed in Study 3.

    • Study 3 (Ring vaccination study) was an open-label, randomized cluster (ring) vaccination study conducted in the Republic of Guinea during the 2014 outbreak.
    • Each cluster was composed of contacts and contacts of contacts of individuals with laboratory-confirmed Ebola virus disease (EVD).
    • Clusters were randomly assigned to receive either an "immediate" vaccination or a 21-day "delayed" vaccination.
    • In the primary efficacy analysis, 3,537 patients ≥18 years of age were considered contacts and contacts of contacts of an index case with laboratory-confirmed EVD. Of these, 2,108 were included in 51 immediate vaccination clusters, and 1,429 were included in 46 delayed vaccination clusters.

    In the primary efficacy analysis, the number of cases of laboratory-confirmed EVD in patients vaccinated in immediate vaccination clusters was compared to the number of cases in patients in delayed vaccination clusters. Cases of EVD that occurred between Day 10 and Day 31 post-randomization of the cluster were included in the analysis. Vaccine efficacy was 100% (95% CI, 63.5%-100%); no cases of confirmed EVD were observed in the immediate vaccination clusters, and 10 confirmed cases of EVD were seen in a total of 4 delayed vaccination clusters between Day 10 and Day 31 post-randomization.

    Ervebo Note

    Not Applicable

    Ervebo Patient Counseling

    Patient Counseling

    Advise vaccine recipients of the following:

    • Ervebo has not been demonstrated to provide protection against disease caused by viruses other than Zaire ebolavirus.
    • After vaccination with Ervebo, individuals at risk should continue to protect themselves from exposure to Zaire ebolavirus.
    • Ervebo may not protect all vaccinated individuals.
    • Transmission of vaccine virus is a theoretical possibility.
    • Vaccine virus RNA has been detected in blood, saliva, or urine for up to 14 days after vaccination. The duration of shedding is not known; however, samples taken 28 days after vaccination tested negative. Vaccine virus RNA has been detected in fluid from skin vesicles that appeared after vaccination.

    Instruct vaccine recipients to:

    • Report any adverse reactions to their health care provider.
    • Seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur after vaccination.

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