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 ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
- Associated Therapies
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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 outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Covid-19 Vaccine Janssen Injection, suspension 8.92 log₁₀ Inf. U Intramuscular Janssen Cilag International Nv 2021-03-17 Not applicable EU 
Covid-19 Vaccine Janssen Injection, suspension 8.92 log₁₀ Inf. U Intramuscular Janssen Cilag International Nv 2021-05-04 Not applicable EU Janssen COVID-19 Vaccine Suspension 50000000000 vp / 0.5 mL Intramuscular Janssen Pharmaceuticals 2021-11-23 Not applicable Canada 
Janssen COVID-19 Vaccine Injection, suspension 50000000000 {VP}/0.5mL Intramuscular Janssen Products, LP 2021-01-04 Not applicable US 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- JT2NS6183B
- CAS number
- Not Available
References
- General References
- 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]
- 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]
- Precision Vaccine [Link]
- Johnson & Johnson Announcement [Link]
- Health Canada Product Monograph: Janssen COVID-19 Vaccine [Link]
- Health Canada Public Advisory: Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines [Link]
- EMA COVID-19 Vaccine Safety Update: Janssen COVID-19 Vaccine (Dec 9/21) [Link]
- FDA: Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers [Link]
- External Links
Clinical Trials
- Clinical Trials
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 8.92 log₁₀ Inf. U Injection, suspension Intramuscular 50000000000 {VP}/0.5mL Suspension Intramuscular 50000000000 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