Ad26.COV2.S
E241393
Ad26.COV2.S is a single-dose, adenovirus vector-based COVID-19 vaccine developed by Janssen (Johnson & Johnson) to provide protection against SARS-CoV-2 infection.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Ad26.COV2.S canonical | 3 |
Statements (52)
| Predicate | Object |
|---|---|
| instanceOf |
COVID-19 vaccine
ⓘ
adenovirus vector vaccine ⓘ single-dose vaccine ⓘ viral vector vaccine ⓘ |
| administrationSite | deltoid muscle ⓘ |
| adverseEventOfSpecialInterest |
Guillain–Barré syndrome
ⓘ
thrombosis with thrombocytopenia syndrome ⓘ |
| ageIndication | adults 18 years and older ⓘ |
| antigen | SARS-CoV-2 spike protein ⓘ |
| ATCCode | J07BX03 ⓘ |
| boosterOption |
heterologous booster allowed in some jurisdictions
ⓘ
homologous booster allowed in some jurisdictions ⓘ |
| brandName |
Janssen COVID-19 Vaccine
ⓘ
Jcovden ⓘ |
| clinicalTrialPhase | Phase III completed ⓘ |
| coldChainRequirement | standard vaccine cold chain ⓘ |
| containsGeneticMaterial | DNA ⓘ |
| countryOfOrigin | United States of America ⓘ |
| developer |
Janssen Pharmaceuticals
ⓘ
Janssen Pharmaceuticals ⓘ
surface form:
Janssen Vaccines
Johnson & Johnson ⓘ |
| doesNotContain |
live SARS-CoV-2 virus
ⓘ
mRNA ⓘ |
| doseRegimen | single dose ⓘ |
| efficacyAgainstSevereCOVID19 | approximately 85% in Phase III trial ⓘ |
| efficacyAgainstSymptomaticCOVID19 | approximately 66% in global Phase III trial ⓘ |
| EMAAuthorizationDate | 2021-03-11 ⓘ |
| EMAAuthorizationType | conditional marketing authorization ⓘ |
| EMAStatus | Conditional marketing authorization granted ⓘ |
| EUAStatus | Emergency Use Authorization granted by US FDA ⓘ |
| intendedUse | prevention of COVID-19 infection ⓘ |
| manufacturer |
Janssen Biotech
ⓘ
Janssen Pharmaceuticals ⓘ
surface form:
Janssen Pharmaceuticals Companies of Johnson & Johnson
|
| platform | recombinant adenovirus serotype 26 vector ⓘ |
| regimenType | single primary dose with optional booster ⓘ |
| routeOfAdministration | intramuscular injection ⓘ |
| schedule | 0.5 mL single intramuscular dose ⓘ |
| storageRequirement | refrigeration ⓘ |
| storageTemperature | 2–8 °C ⓘ |
| targetDisease |
COVID-19 pandemic
ⓘ
surface form:
COVID-19
|
| targetVirus | SARS-CoV-2 ⓘ |
| technologyClass | viral vector-based vaccine ⓘ |
| trialDesign | randomized, double-blind, placebo-controlled ⓘ |
| trialName | ENSEMBLE ⓘ |
| USFDAEUAInitialDate | 2021-02-27 ⓘ |
| USFDAEUARestrictionDate | 2022-05-05 ⓘ |
| USFDAEUARestrictionReason | risk of thrombosis with thrombocytopenia syndrome ⓘ |
| USFDAEUAStatus | Authorization limited and later restricted ⓘ |
| USFDAEUAType | Emergency Use Authorization ⓘ |
| vectorType | non-replicating adenovirus vector ⓘ |
| WHOEULDate | 2021-03-12 ⓘ |
| WHOStatus | Emergency Use Listing granted ⓘ |
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
human adenovirus serotype 26