Indications for: ERVEBO

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.

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.

Adult Dosage:

Give by IM inj, preferably in deltoid region of the non-dominant arm. ≥18yrs: administer one (1mL) dose.

Children Dosage:

<18yrs: not established.

ERVEBO Contraindications:

Allergy to rice protein.

ERVEBO 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.

ERVEBO Classification:

Ebola Zaire vaccine.

ERVEBO Interactions:

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

Adverse Reactions:

Inj site reactions (pain, swelling, redness), headache, feverishness, muscle pain, fatigue, joint pain, nausea, arthritis, rash, abnormal sweating.

Generic Drug Availability:


How Supplied:

Single-dose vials—10