COVID-19 Resources

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. There is no FDA-approved vaccine to prevent COVID‑19.

The following resources are intended to provide information or guidance related to the Janssen COVID‑19 Vaccine and COVID‑19.

Janssen Resources

EUA Fact Sheet for Recipients and Caregivers

Download the EUA Fact Sheet for the Janssen COVID-19 Vaccine.

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FDA EUA Letter for the Janssen COVID-19 Vaccine

Download the FDA's EUA Letter for the Janssen COVID-19 Vaccine.

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External Resources

Facts About COVID-19

Get the facts about COVID-19 from the Centers for Disease Control (CDC).

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Johns Hopkins University Information About the Disease

Get more information about COVID-19 from Johns Hopkins University.

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COVID-19 Vaccine Facts

Access helpful resources and COVID-19 Vaccine FAQs.

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The Benefits of Getting Vaccinated

Find out how vaccines may help keep you from getting COVID-19 and may help build protection.

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Vaccine Finder

Find out where and which COVID-19 vaccines are available near you.

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COVID-19=coronavirus disease 2019.

Important safety information

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you:

WHO SHOULD NOT GET THE JANSSEN COVID‑19 VACCINE

You should not get the Janssen COVID-19 Vaccine if you:

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID‑19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9‑1‑1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-79671-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech Inc. at 1-800-565-40081-800-565-4008.


Please read Emergency Use Authorization (EUA) Fact Sheet for Recipients and Caregivers available at www.JanssenCOVID19vaccine.com/EUA-Recipient-factsheet and discuss any questions you have with the vaccination provider.

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Important safety information

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you:

WHO SHOULD NOT GET THE JANSSEN COVID‑19 VACCINE

You should not get the Janssen COVID-19 Vaccine if you:

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID‑19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9‑1‑1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-79671-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech Inc. at 1-800-565-40081-800-565-4008.


Please read Emergency Use Authorization (EUA) Fact Sheet for Recipients and Caregivers available at www.JanssenCOVID19vaccine.com/EUA-Recipient-factsheet and discuss any questions you have with the vaccination provider.

cp-213941v1