Resources for Johnson & Johnson's Janssen COVID-19 Vaccine and COVID-19 Education
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.
Janssen Resources
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EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers
Download information for healthcare providers about the Janssen COVID-19 Vaccine.
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EUA Fact Sheet for Vaccine Recipients and Caregivers
Download information for vaccine recipients and their caregivers about receiving the Janssen COVID-19 Vaccine.
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FDA EUA Letter
Download the EUA letter that grants the Emergency Use Authorization of the Janssen COVID-19 Vaccine.
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Reporting Vaccine Adverse Events
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
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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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Storage, Dosage and Administration Guide
Download information regarding storage, dosage and administration of the Janssen COVID-19 Vaccine.
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Expiry Dates
Learn more about expiration tracking and how to check the expiry of the Janssen COVID-19 Vaccine lots that you have received.
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Medical Information Center
Thank you for your interest in contacting Janssen Pharmaceuticals, Inc. For additional information, please contact Janssen Medical Information by using one of the following methods:
Phone: Call 1-800-565-40081-800-565-4008
Email: Submit questions via our askjanssenmedinfo.com site
Visit:
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.vaers.hhs.gov/reportevent.html or call the Vaccine Adverse Events Reporting System (VAERS) at 1-800-822-79671-800-822-7967
External Resources and Support
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COVID-19 Vaccine Information and Guidelines
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-19 -
About Thrombosis With Thrombocytopenia
Get more information about the background, diagnosis, and clinical management of this emerging syndrome from experts at the American Society of Hematology (ASH) and the CDC.
ASH/CDC Summary and FAQs -
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Janssen COVID-19 Vaccine during pregnancy. Women who are vaccinated with the Janssen COVID‑19 Vaccine during pregnancy are encouraged to enroll in the registry.
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Coronavirus Education
Get more information about the coronavirus.
Johns Hopkins Coronavirus Resource Center CDC: COVID-19 Website -
COVID-19 Response — US Department of Health & Human Services
Get more information about the around-the-clock effort to develop a vaccine in the face of the COVID-19 pandemic.
Learn More -
Coding and Billing Resources
Get more information about billing and reimbursement for COVID-19 vaccines.
American Medical Association (AMA) CDC Centers for Medicare and Medicaid Services (CMS)
COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act.
