Drug updated on 4/11/2024
| Dosage Form | Injection (intramuscular; 0.5mL) |
| Drug Class | Immnunological agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Authorized for use under an 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.
Summary
- The drug identified is the Janssen COVID-19 Vaccine (also known as Janssen COVID-19 Vaccine). This vaccine has been authorized for use under an Emergency Use Authorization (EUA) to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
- According to a systematic review, long-term effectiveness of the Janssen vaccine was evaluated along with Pfizer/BioNTech, Moderna, or AstraZeneca vaccines. It was found that these vaccines are effective in preventing both COVID-19 and hospitalization due to this disease over a long period.
- Another study indicated that at least one dose of the vaccine significantly reduced post-COVID conditions among vaccinated individuals compared to those unvaccinated. However, it also noted that more studies are needed on third doses and mixing different types of vaccines.
- In terms of safety profile comparison across various platforms including RNA-based BNT162b2 & mRNA1273; non-replicating vector Ad26.COV2.S; protein subunit BBIBP-CorV; DNA NVX-CoV23730; virus-like particle CoronaVac - local reactions were lower for Ad26.COV2.S than RNA-based ones but higher than protein subunit & DNA based ones.
- There were nine Systematic Reviews / Meta-Analyses documents reviewed which provided insights into efficacy against symptomatic/severe disease and adverse events related to vaccination with Janssen's product amongst others.
- One meta-analysis suggested no statistically significant difference between various available vaccines including Johnson & Johnson’s Ad26.COV2.S (J&J/Jansen), Pfizer-BioNtech’s BNT162b12, Moderna’s mRNA1273 etc., in their ability to prevent symptomatic disease within elderly population.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Janssen COVID-19 Vaccine Prescribing Information. | 2022 | Janssen Biotech, Inc., Horsham, PA |