Important Safety Information Janssen.com Medical Inquiries Go to Consumer Site

EUA Fact Sheet for Recipients & Caregivers

COVID‑19 Resources

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. 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

EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers
Download information for healthcare providers about the Janssen COVID-19 Vaccine.
Download
EUA Fact Sheet for Vaccine Recipients and Caregivers
Download information for vaccine recipients and their caregivers about receiving the Janssen COVID-19 Vaccine.
Download
FDA EUA Letter
Download the EUA letter that grants the Emergency Use Authorization of the Janssen COVID-19 Vaccine.
Download
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
  or
- Contact Janssen Biotech, Inc. at:
  US Toll Free: 1-800-565-40081-800-565-4008
  US Toll: 1-908-455-99221-908-455-9922
Storage, Dosage and Administration Guide
Download information regarding storage, dosage and administration of the Janssen COVID-19 Vaccine.
Download
Expiry Dates
Check the expiry of the Janssen COVID-19 Vaccine lots that you have received.
Get Info
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

COVID-19 Vaccine Information and Guidelines
Visit the Centers for Disease Control (CDC) and National Institutes of Health (NIH) websites for resources and guidelines.
CDC Guidelines Information From NIH CDC's Morbidity and Mortality Weekly Report for COVID-19
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.
C-VIPER
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.

About the
Vaccine

Find out more
about the mechanism
of action

FAQs

Concise answers
to the most-asked
questions

About
COVID-19

Facts
about the
virus

Important safety information

CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine.

WARNINGS AND PRECAUTIONS

Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 Vaccine.

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Janssen COVID-19 Vaccine.
Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Error

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the listed events following Janssen COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System (VAERS):

Vaccine administration errors whether or not associated with an adverse event,
Serious adverse events (irrespective of attribution to vaccination),
Cases of Multisystem Inflammatory Syndrome (MIS) in adults,
Cases of COVID-19 that result in hospitalization or death.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
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

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

Pregnancy: Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
Lactation: Data are not available to assess the effects of Janssen COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

cp-213942v1