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 6

How this entity was disambiguated

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 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 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 ⓘ
linked to: COVID-19 pandemic
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 ⓘ

How these facts were elicited

Referenced by (6)

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

human adenovirus serotype 26 → usedInProduct → Ad26.COV2.S ⓘ
Jcovden → brandNameOf → Ad26.COV2.S ⓘ
Jcovden → hasAlternativeName → Ad26.COV2.S ⓘ
ENSEMBLE → evaluatedProduct → Ad26.COV2.S ⓘ