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Date Last Updated: 05/06/2022
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
Emergency Use Authorization Letter (English)
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)
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
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 to Janssen at 1-800-565-4008 (toll free) or 1-908-455-9922 (toll)
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
CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume
Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety
Janssen COVID-19 Vaccine (Johnson & Johnson) Questions
Understanding Viral Vector COVID-19 Vaccines
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
Vaccine-induced Immune Thrombotic Thrombocytopenia: Frequently Asked Questions
VRBPAC October 15, 2021 Meeting Materials
VRBPAC February 26, 2021 Meeting Materials
Johnson & Johnson - Our COVID-19 Response Efforts
Johnson & Johnson Media Center
Vaccine AE Reporting System (VAERS)
Pregnancy Exposure Registry (C-VIPER)
Clinical Immunization Safety Assessment (CISA)
Vaccine Safety Assessment for Essential Workers (V-SAFE)
Center for Disease Control and Prevention
CDC Immunization Information System
Department of Health and Human Services
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