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 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 COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. 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.

Media Statement (5/5/22): Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet

Media Statement (5/5/22): Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet

Emergency Use Authorization

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)
      8am-8pm ET, 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

Janssen COVID-19 Vaccine - Storage, Dosage and Administration Video

Centers for Disease Control & Prevention (CDC)

MMWR: Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021

Press Release: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume

Health Alert Network (HAN): Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine

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

Janssen COVID-19 Vaccine (Johnson & Johnson) Questions

Understanding Viral Vector COVID-19 Vaccines

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States

Advisory Committee on Immunization Practices (ACIP)

ACIP December 16, 2021 Meeting Materials

ACIP October 21, 2021 Meeting Materials

ACIP August 13, 2021 Meeting Materials

ACIP July 22, 2021 Meeting Materials

ACIP May 12, 2021 Meeting Materials

ACIP April 23, 2021 Meeting Materials

ACIP April 14, 2021 Meeting Materials

ACIP February 28 - March 1, 2021 Meeting Materials

American Society of Hematology (ASH) Resources

Vaccine-induced Immune Thrombotic Thrombocytopenia: Frequently Asked Questions

Janssen Global Trial Finder

• globaltrialfinder.janssen.com

Clinical Trials

Phase 3

    COV3001 (ENSEMBLE)

• Publication - Sadoff J,  Gray G,  Vandebosch A, et al. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. [published online ahead of print February 09, 2022]. N Eng J Med. doi:10.1056/NEJMoa2117608.
• 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

    COV3009 (ENSEMBLE2)

• Publication - Hardt K, Vandebosch A, Sadoff J, et al. Efficacy and Safety of a Booster Regimen of Ad26.COV2.S Vaccine against Covid-19. medRxiv 2022.01.28.22270043
• 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

   COV3012

• Publication - Bekker LG,  Garrett N,  Goga A, et al. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3b, implementation study. Lancet. 2022;399(10330):1141-1153
• Publication - Takuva S, Takalani A Garrett N, et al. Thromboembolic Events in the South African Ad26.COV2.S Vaccine Study. [published online ahead of print June 2, 2021] N Engl J Med.
• Publication - Takuva S et al. Safety of the single-dose Ad26.CoV2.S vaccine among healthcare workers in the phase 3b Sisonke study in South Africa. medRxiv. 2021.12.20.21267967
• Publication - Goga A et al. Breakthrough Covid-19 infections during periods of circulating Beta, Delta and Omicron variants of concern, among health care workers in the Sisonke Ad26.COV2.S vaccine trial, South Africa. medRxiv. 2021.12.21.21268171
• ClinicalTrials.gov - Sisonke (Together): Open Label Trial COVID-19 (Sisonke)

   COV3021

• Publication - Gray G et al.  Vaccine effectiveness against hospital admission in South African health care workers who received a homologous booster of Ad26.COV2 during an Omicron COVID19 wave: Preliminary Results of the Sisonke 2 Study. medRxiv. 2021.12.28.21268436v1
• ClinicalTrials.gov - Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study. (Sisonke Boost)

Phase 2/3

   COV3006

• ClinicalTrials.gov - A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)

Phase 2

   COV2001

• Publication - Sadoff J,  Le Gars M,  Cardenas V, et al. Durability of antibody responses elicited by a single dose of Ad26.COV2.S and substantial increase following late boosting. [preprint posted online August 26, 2021]. medRxiv. 2021
• ClinicalTrials.gov - A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

   COV2004

• ClinicalTrials.gov - A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (HORIZON 1)

   COV2008

• ClinicalTrials.gov - A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2

Phase 1 / 2

   COV1001

• Publication - Sadoff J,  Le Gars M,  Cardenas V, et al. Durability of antibody responses elicited by a single dose of Ad26.COV2.S and substantial increase following late boosting. [preprint posted online August 26, 2021]. medRxiv. 2021
• 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)
• Publication - Barouch DH,  Stephenson KE,  Sadoff J, et al. Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination. N Engl J Med. (2021)
• Publication - Stephenson K.E,  M Le Gars,  Sadoff J, et al. Immunogenicity of the Ad26.COV2.S vaccine for COVID-19 [published online ahead of print March 11, 2021]. JAMA. doi:10.1001/jama.2021.3645  
• Publication - Alter G, Yu J, Liu J, et al. Immunogenicity of Ad26.COV2.S vaccine against SARS-CoV-2 variants in humans. Nature (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

Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting

VRBPAC October 15, 2021 Meeting Materials

VRBPAC February 26, 2021 Meeting Materials

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

Center for Disease Control and Prevention

CDC Vaccine Playbook

CDC Immunization Information System

Department of Health and Human Services

Vaccine Finder

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

World Health Organization