Janssen COVID-19 Vaccine

E49854
COVID-19 vaccine pharmaceutical product viral vector vaccine

The Janssen COVID-19 Vaccine is a single-dose, viral vector-based coronavirus vaccine developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, for the prevention of COVID-19.

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All labels observed (4)

Label Occurrences
Janssen COVID-19 Vaccine canonical 5
Janssen single-dose COVID-19 vaccine 1
Johnson & Johnson COVID-19 Vaccine 1

Statements (48)

Predicate Object
instanceOf COVID-19 vaccine ⓘ
pharmaceutical product ⓘ
viral vector vaccine ⓘ
administrationSchedule single intramuscular injection of 0.5 mL ⓘ
administrationSite deltoid muscle ⓘ
ageGroupIndication adults 18 years and older ⓘ
alsoKnownAs Ad26.COV2.S ⓘ
Janssen COVID-19 Vaccine ⓘ
surface form: Johnson & Johnson COVID-19 Vaccine
antigen SARS-CoV-2 spike protein ⓘ
ATCCode J07BX03 ⓘ
belongsToCompany Johnson & Johnson ⓘ
brandOwner Janssen Pharmaceuticals ⓘ
clinicalTrialPhase3 ENSEMBLE trial ⓘ
commonAdverseReactions fatigue ⓘ
headache ⓘ
injection site pain ⓘ
myalgia ⓘ
nausea ⓘ
contraindication known severe allergy to a component of the vaccine ⓘ
severe allergic reaction to a previous dose ⓘ
countryOfFirstAuthorization United States of America ⓘ
surface form: United States
dateOfFirstAuthorization 2021-02-27 ⓘ
developer Janssen Pharmaceuticals ⓘ
Johnson & Johnson ⓘ
doesNotRequire ultra-cold storage ⓘ
doseRegimen single dose ⓘ
efficacyAgainstSevereCOVID19 higher than efficacy against moderate disease ⓘ
efficacyAgainstSymptomaticCOVID19 approximately 66 percent in global phase 3 trial ⓘ
indication prevention of COVID-19 in humans ⓘ
manufacturer Janssen Pharmaceuticals ⓘ
Johnson & Johnson ⓘ
pharmaceuticalForm suspension for injection ⓘ
rareAdverseEvents Guillain–Barré syndrome ⓘ
thrombosis with thrombocytopenia syndrome ⓘ
regulatoryAgency Food and Drug Administration ⓘ
surface form: U.S. Food and Drug Administration
regulatoryStatusChange use restricted in some countries due to safety concerns ⓘ
regulatorySubmissionType Emergency Use Authorization ⓘ
routeOfAdministration intramuscular injection ⓘ
storageRequirement refrigeration ⓘ
storageTemperature 2–8 °C ⓘ
targetDisease COVID-19 vaccines ⓘ
surface form: COVID-19
targetVirus COVID-19 vaccines ⓘ
surface form: SARS-CoV-2
technologyPlatform Ad26 vector platform ⓘ
trialSponsor Janssen Pharmaceuticals ⓘ
usesViralVector human adenovirus serotype 26 (Ad26) ⓘ
vaccineType non-replicating viral vector vaccine ⓘ
worldHealthOrganizationEULDate 2021-03-12 ⓘ
worldHealthOrganizationStatus Emergency Use Listing granted ⓘ

Referenced by (8)

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

Johnson & Johnson → covid19VaccineBrand → Janssen COVID-19 Vaccine ⓘ
Janssen COVID-19 Vaccine → alsoKnownAs → Janssen COVID-19 Vaccine ⓘ
this entity surface form: Johnson & Johnson COVID-19 Vaccine
human adenovirus serotype 26 (Ad26) → usedInProduct → Janssen COVID-19 Vaccine ⓘ
subject surface form: human adenovirus serotype 26
human adenovirus serotype 26 (Ad26) → vectorBackboneUsedBy → Janssen COVID-19 Vaccine ⓘ
subject surface form: human adenovirus serotype 26
human adenovirus serotype 26 (Ad26) → vectorBackboneUsedBy → Janssen COVID-19 Vaccine ⓘ
subject surface form: human adenovirus serotype 26
this entity surface form: Johnson & Johnson COVID-19 vaccine
ENSEMBLE trial → evaluatedVaccine → Janssen COVID-19 Vaccine ⓘ
this entity surface form: Janssen single-dose COVID-19 vaccine
ENSEMBLE trial → relatedTo → Janssen COVID-19 Vaccine ⓘ
Ad26.COV2.S → brandName → Janssen COVID-19 Vaccine ⓘ