Janssen COVID-19 Vaccine

Overview

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 infection 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 monkeys 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.

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. 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.

Associated Conditions

Coronavirus Disease 2019 (COVID‑19)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention	2023/05/06	NCT05844202	Phase 1	Completed	Alvea Holdings, LLC
Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.	2022/08/25	NCT05515042	Phase 2	Active, not recruiting	The Aurum Institute NPC
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients	2022/04/12	NCT05324319	Phase 2	UNKNOWN	Medical University of Vienna
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults	2021/10/25	NCT05091307	Phase 3	Completed	Janssen Vaccines & Prevention B.V.
A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil	2021/09/22	NCT05052307	N/A	Completed	Hospital Moinhos de Vento
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive	2021/08/16	NCT05007080	Phase 2	Completed	Janssen Vaccines & Prevention B.V.
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2	2021/08/10	NCT04999111	Phase 2	Completed	Janssen Vaccines & Prevention B.V.
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults	2021/06/01	NCT04908722	Phase 3	Completed	Janssen Vaccines & Prevention B.V.
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines	2021/05/17	NCT04889209	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)	2021/02/21	NCT04765384	Phase 2	Completed	Janssen Vaccines & Prevention B.V.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
JCOVDEN	Janssen Inc	02513153	Suspension - Intramuscular	50000000000 VP / 0.5 ML	11/23/2021

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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