Ervebo

E414773

Ervebo is a recombinant, live-attenuated vaccine developed to protect humans against infection by the Zaire ebolavirus.

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All labels observed (1)

Label Occurrences
Ervebo canonical 2

Statements (51)

Predicate Object
instanceOf Ebola vaccine
live-attenuated vaccine
recombinant vaccine
vaccine
hasAdministrationSchedule single-dose regimen
hasAdministrationSite deltoid muscle
hasATCCode J07BX02
hasClinicalTrialPhase Phase 3 completed
hasCommonAdverseEffect arthralgia
fatigue
fever
headache
injection site pain
injection site swelling
myalgia
hasComponent Zaire ebolavirus glycoprotein
vesicular stomatitis virus glycoprotein G deletion
hasDeveloper Merck & Co.
NewLink Genetics
Public Health Agency of Canada
hasDosageForm suspension for injection
hasEfficacy high efficacy against Zaire ebolavirus in clinical trials
hasGenericName rVSV-ZEBOV
rVSV-ZEBOV
surface form: rVSVΔG-ZEBOV-GP
hasIndication pre-exposure prophylaxis against Ebola virus disease caused by Zaire ebolavirus
protection of individuals at high risk of exposure to Zaire ebolavirus
hasMarketingAuthorizationHolder Merck & Co.
surface form: Merck Sharp & Dohme Corp.
hasRegulatoryApproval European Commission
Health Canada
Food and Drug Administration
surface form: U.S. Food and Drug Administration

World Health Organization prequalification
multiple African national regulatory authorities
hasRouteOfAdministration intramuscular injection
hasStorageRequirement frozen storage
hasStorageTemperature -60°C to -80°C (original formulation)
hasViralVector recombinant vesicular stomatitis virus
hasWHOClassification Ebola Zaire vaccine
isAttenuated true
isIndicatedForAgeGroup 18 years and older
isLive true
isRecombinant true
isReplicationCompetent true
isUsedInOutbreakResponse true
targetsDisease Ebola virus disease
targetsVirus Zaire ebolavirus NERFINISHED
wasApprovedInEUOn 2019-11-11
wasApprovedInUSOn 2019-12-19
wasInitiallyDevelopedBy Public Health Agency of Canada
wasPrequalifiedByWHOIn 2019
wasUsedInOutbreak 2014–2016 West Africa Ebola outbreak
2018–2020 Ebola outbreak in the Democratic Republic of the Congo

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

rVSV-ZEBOV alsoKnownAs Ervebo