The Janssen COVID-19 Vaccine has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Janssen COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act unless the declaration is terminated or authorization revoked sooner.

 

Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine

 

Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine

 

Authorized Use

 

Emergency Use Authorization Letter (English)

 

EUA Fact Sheets

 

Healthcare Providers
   EUA Fact Sheet for Healthcare Providers (English)

   EUA Fact Sheet for Healthcare Providers (Spanish)

   EUA Fact Sheet for Healthcare Providers (Chinese)

   EUA Fact Sheet for Healthcare Providers (French)

   EUA Fact Sheet for Healthcare Providers (Portuguese)

   EUA Fact Sheet for Healthcare Providers (Tagalog)

   EUA Fact Sheet for Healthcare Providers (Vietnamese)

 

Recipients and Caregivers
   EUA Fact Sheet for Recipients and Caregivers (English)

   EUA Fact Sheet for Recipients and Caregivers (Spanish)

   EUA Fact Sheet for Recipients and Caregivers (Chinese)

   EUA Fact Sheet for Recipients and Caregivers (French)

   EUA Fact Sheet for Recipients and Caregivers (Portuguese)

   EUA Fact Sheet for Recipients and Caregivers (Tagalog)

   EUA Fact Sheet for Recipients and Caregivers (Vietnamese)

 

Contact Information

 

Janssen COVID-19 Vaccine Support Center

      1-800-565-4008 (toll free)
      1-908-455-9922 (toll)
      24 hours a day, 7 days a week

 

Information on How to Obtain the Expiration Date on vaxcheck.jnj

Vaxcheck.jnj How-To Video

 

Report an Adverse Event

 

Report an Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967

Report an Adverse Event to Janssen at 1-800-565-4008 (toll free) or 1-908-455-9922 (toll)

 

Report a Product Quality Complaint

 

Report a Product Quality Complaint to Janssen at 1-800-565-4008 (toll free) or 1-908-455-9922 (toll) 

 

Stability, Storage, and Dosing Administration

 

Janssen COVID-19 Vaccine - Dosing/Administration & Storage/Handling

Janssen COVID-19 Vaccine - Temperature Excursion Interactive Resource

 

Clinical Trials

 

Phase 3

    COV3001 (ENSEMBLE)

• ClinicalTrials.gov - A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)
• Protocol - https://www.jnj.com/coronavirus/ensemble-1-study-protocol
• Clinical Trial Website - www.ensemblestudy.com

    COV3009 (ENSEMBLE2)

• ClinicalTrials.gov - A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)
• Protocol - https://www.jnj.com/coronavirus/ensemble-2-study-protocol
• Clinical Trial Website - www.ensemblestudy.com

Phase 2

   COV2001

• ClinicalTrials.gov - A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults

Phase 1 / 2

   COV1001

• Publication - Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1–2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. (2021)
• ClinicalTrials.gov - A Study of Ad26.COV2.S in Adults
• Protocol - Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1–2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. (2021)

Phase 1

   COV1002

• ClinicalTrials.gov - A Study of Ad26.COV2.S in Adults

 

Preclinical Studies: 

• Publication - Mercado, N.B., Zahn, R., Wegmann, F. et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature (2020).
• Publication - Tostanoski, L.H., Wegmann, F., Martinot A.J., et al. Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters. Nature Med (2020) 

 

Janssen Global Trial Finder

• globaltrialfinder.janssen.com

 

Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting

 

VRBPAC February 26, 2021 Meeting Materials

 

Advisory Committee on Immunization Practices (ACIP) Meeting

 

ACIP April 14, 2021 Meeting Materials

ACIP February 28 - March 1, 2021 Meeting Materials

 

CDC Information About Janssen COVID-19 Vaccine

 

Recommendation to Pause Use of Johnson & Johnson’s Janssen COVID-19 Vaccine

Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety

Understanding Viral Vector COVID-19 Vaccines

 

Johnson & Johnson's Response to COVID-19

 

Johnson & Johnson - Our COVID-19 Response Efforts

Johnson & Johnson Media Center

 

Additional Vaccine Safety Information

 

Vaccine AE Reporting System (VAERS)

Pregnancy Exposure Registry (C-VIPER)

Vaccine Safety Datalink (VSD)

Clinical Immunization Safety Assessment (CISA)

Vaccine Safety Assessment for Essential Workers (V-SAFE)

 

Additional Information About COVID-19 and COVID-19 Vaccines

 

ACIP Vaccine Recommendations

Center for Disease Control and Prevention

CDC Vaccine Playbook

CDC Immunization Information System

Department of Health and Human Services

General Vaccine Availability

HRSA: Countermeasures injury compensation program (CICP)

IDSA and CDC COVID-19 Real-Time Learning Network

Official Government Response to Coronavirus

Official U.S. Federal Government COVID-19

US Food and Drug Administration

Vaccines.gov

World Health Organization