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 Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision

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)
      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

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

Advisory Committee on Immunization Practices (ACIP)

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

Webinar: Triage & Treatment of Patients with Potential Vaccine-induced Immune Thrombocytopenia (VITT) Post J&J COVID-19 Vaccination 

Clinical Trials

Phase 3

    COV3001 (ENSEMBLE)

• Publication - Sadoff J, Gray G, Vandebosch A, et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. (2021)
• 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

   COV3012

• 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.
• ClinicalTrials.gov - Sisonke (Together): Open Label Trial COVID-19 (Sisonke)

Phase 2

   COV2001

• 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)

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) 
• Publication - Solforosi L,  Kuipers H,  Rosendahl Huber SK, et al. Immunogenicity and protective efficacy of one- and two-dose regimens of the Ad26.COV2.S COVID-19 vaccine candidate in adult and aged rhesus macaques. [published online ahead of print January 4, 2021]. bioRxiv.
• Publication - He X,  Chandrashekar A,  Zahn R, et al. Low-dose Ad26.COV2.S protection against SARS-CoV-2 challenge in rhesus macaques. [published online ahead of print January 27, 2021]. bioRxiv.
• Publication - Roozendaal R,  Solforosi L,  Stieh D, et al. SARS-CoV-2 binding and neutralizing antibody levels after vaccination with Ad26.COV2.S predict durable protection in rhesus macaques. [published online ahead of print January 30, 2021]. bioRxiv.
• Publication - van der Lubbe JEM,  Rosendahl Huber SK,  Vijayan A, et al. Ad26.COV2.S-elicited immunity protects against G614 spike protein variant SARS-CoV-2 infection in Syrian hamsters and does not enhance respiratory disease in challenged animals with breakthrough infection after sub-optimal vaccine dosing. [published online ahead of print January 8, 2021]. bioRxiv.
• Publication - Bos R,  Rutten L,  van der Lubbe JEM, et al. Ad26-vector based COVID-19 vaccine encoding a prefusion stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses. NPJ Vaccines. 2020;5:91

Janssen Global Trial Finder

• globaltrialfinder.janssen.com

Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting

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