Johnson & Johnson’s Janssen COVID-19 Vaccine: Authorized for Emergency Use
The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (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 authorized only 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 FD&C Act, unless the declaration is terminated or authorization revoked sooner.
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FDA EUA Letter
To view the FDA EUA letter, please see:
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EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers
If you are a vaccination provider, please find EUA Fact Sheet and full EUA Prescribing Information here:
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EUA Fact Sheet for Vaccine Recipients and Caregivers
If you are a vaccine recipient or caregiver, please find EUA Fact Sheet for Vaccine Recipients and Caregivers here:
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It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and hospitalized or fatal cases of COVID-19 following vaccination with the Janssen COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Janssen Biotech, Inc.
Visit VAERS for more information and to report adverse events-
If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at
1-800-822-79671-800-822-7967 or send an email to
info@vaers.org
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Contact Janssen Biotech, Inc. at:
US Toll Free: 1-800-565-40081-800-565-4008
US Toll: 1-908-455-99221-908-455-9922
Learn more about expiration tracking and how to check the expiry of the Janssen COVID-19 Vaccine lots that you have received.
Get more information about the coronavirus.
CDC: COVID-19 Website Johns Hopkins Coronavirus Resource Center
Visit the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) websites for resources and guidelines.
ACIP Recommendations Information From NIH CDC's Morbidity and Mortality Weekly Report for COVID-19Ensuring the Authenticity of Johnson & Johnson's Janssen COVID-19 Vaccine
Johnson & Johnson and Janssen Pharmaceuticals are committed to identifying and mitigating the risks of counterfeit healthcare products. Information regarding how we address counterfeiting can be found at healthforhumanityreport.jnj.com
The Janssen COVID-19 Vaccine is to be administered intramuscularly by a healthcare professional.
An authentic Janssen COVID-19 Vaccine includes the Janssen name and logo on the carton. The Janssen COVID-19 Vaccine is supplied in multi-dose vials. The vial stoppers are not made with natural rubber latex.
The Janssen COVID-19 Vaccine is never sold online and is distributed only through government channels. Janssen cannot verify the authenticity of products acquired outside of the legitimate supply chain. If you suspect the Janssen COVID-19 Vaccine you have may be counterfeit, contact us at 1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-9922 1-908-455-9922 (US Toll).
COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act.