Janssen COVID-19 Vaccine

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Summary

Janssen COVID-19 Vaccine is an adenovirus-based vaccine used for active immunization against COVID-19 caused by SARS-CoV-2 infection.

Generic Name
Janssen COVID-19 Vaccine
DrugBank Accession Number
DB15857
Background

The Janssen COVID-19 vaccine (Ad26.COV2.S) is a recombinant vaccine that contains an adenovirus serotype 26 (Ad26) vector expressing a stabilized SARS-CoV-2 spike protein. The vaccine was created in collaboration with Johnson and Johnson (J&J), Janssen Pharmaceutical, and the Beth Israel Deaconess Medical Center. A preclinical study in hamsters infected with SARS-COV-2 infection1 showed a single immunization with the vaccine-elicited neutralizing responses and protected against SARS-CoV-2 induced pneumonia and mortality, providing protection against the disease progression. Follow-up preclinical studies in rhesus monkeys2 showed that the Ad26 vaccine produced a robust response and provided near perfect protection in nasal swabs and bronchoalveolar lavage following SARS-COV-2 challenge. As of June 2020, a Phase 1/2 clinical trial in adult humans was announced to evaluate the safety, immunogenicity, and efficacy of the ad26.COV.S vaccine in 1045 healthy adults between the ages of 18-55 (NCT04436276). The Janssen COVID-19 vaccine is available under an Emergency Use Authorization (EUA) in the US.8

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Recombinant
Synonyms
  • Ad26.COV2.S
  • AD26.COV2.S [RECOMBINANT]
  • Ad26COVS1
External IDs
  • Ad26.COV2.S
  • JNJ-78436735

Pharmacology

Indication

Janssen COVID-19 Vaccine is indicated for active immunization for the prevention of coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus in individuals 18 years of age and older.5

In the US, Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID19 Vaccine because they would otherwise not receive a COVID-19 vaccine.8

Reduce drug development failure rates
Build, train, & validate machine-learning models
with evidence-based and structured datasets.
See how
Build, train, & validate predictive machine-learning models with structured datasets.
See how
Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Prevention ofCoronavirus disease 2019 (covid‑19)••• •••••••••••••••••••• ••••••••••• ••••••••• ••••••••••••••••
Prevention ofCoronavirus disease 2019 (covid‑19)•••••••••••••••••••••• ••••••••••
Associated Therapies
Contraindications & Blackbox Warnings
Prevent Adverse Drug Events Today
Tap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.
Learn more
Avoid life-threatening adverse drug events with our Clinical API
Learn more
Pharmacodynamics

Not Available

Mechanism of action

The Janssen COVID-19 Vaccine comprises a recombinant, replication-incompetent human adenovirus type 26 vector that encodes a SARS-CoV-2 Spike (S) protein in a stabilized conformation.5 Immunization with the vaccine results in the expression of SARS-CoV-2 spike proteins in the recipient, which stimulates antibody formation and cellular immune responses directed against the S antigen and ultimately conferring immunological protection to the SARS-CoV-2 virus.

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
Improve decision support & research outcomes
With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!
See the data
Improve decision support & research outcomes with our structured adverse effects data.
See a data sample
Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of Janssen COVID-19 Vaccine can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Janssen COVID-19 Vaccine can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Janssen COVID-19 Vaccine can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Janssen COVID-19 Vaccine can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Janssen COVID-19 Vaccine can be decreased when used in combination with Alemtuzumab.
Food Interactions
No interactions found.

Products

Drug product information from 10+ global regions
Our datasets provide approved product information including:
dosage, form, labeller, route of administration, and marketing period.
Access now
Access drug product information from over 10 global regions.
Access now
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Covid-19 Vaccine JanssenInjection, suspension8.92 log₁₀ Inf. UIntramuscularJanssen Cilag International Nv2021-05-04Not applicableEU flag
Covid-19 Vaccine JanssenInjection, suspension8.92 log₁₀ Inf. UIntramuscularJanssen Cilag International Nv2021-03-17Not applicableEU flag
Janssen COVID-19 VaccineInjection, suspension50000000000 {VP}/0.5mLIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag
JcovdenSuspension50000000000 vp / 0.5 mLIntramuscularJanssen Pharmaceuticals2021-11-232023-06-30Canada flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
JT2NS6183B
CAS number
Not Available

References

General References
  1. Tostanoski LH, Wegmann F, Martinot AJ, Loos C, McMahan K, Mercado NB, Yu J, Chan CN, Bondoc S, Starke CE, Nekorchuk M, Busman-Sahay K, Piedra-Mora C, Wrijil LM, Ducat S, Custers J, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Jacob-Dolan C, Lin Z, Mahrokhian SH, Nampanya F, Nityanandam R, Pessaint L, Porto M, Ali V, Benetiene D, Tevi K, Andersen H, Lewis MG, Schmidt AG, Lauffenburger DA, Alter G, Estes JD, Schuitemaker H, Zahn R, Barouch DH: Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters. Nat Med. 2020 Sep 3. pii: 10.1038/s41591-020-1070-6. doi: 10.1038/s41591-020-1070-6. [Article]
  2. Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJG, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH: Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020 Jul 30. pii: 10.1038/s41586-020-2607-z. doi: 10.1038/s41586-020-2607-z. [Article]
  3. Precision Vaccine [Link]
  4. Johnson & Johnson Announcement [Link]
  5. Health Canada Product Monograph: Janssen COVID-19 Vaccine [Link]
  6. Health Canada Public Advisory: Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines [Link]
  7. EMA COVID-19 Vaccine Safety Update: Janssen COVID-19 Vaccine (Dec 9/21) [Link]
  8. FDA: Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers [Link]
RxNav
2479830
Wikipedia
Johnson_%26_Johnson_COVID-19_vaccine

Clinical Trials

Clinical Trials

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntramuscular8.92 log₁₀ Inf. U
Injection, suspensionIntramuscular50000000000 {VP}/0.5mL
SuspensionIntramuscular50000000000 vp / 0.5 mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at September 17, 2020 21:13 / Updated at June 03, 2022 07:24