What Is COVID-19?

About COVID-19

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.

What Is COVID-19?

COVID‑19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID‑19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID‑19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus.

Common symptoms may include:
  • Fever or chills
  • Cough
  • Shortness of breath
  • Fatigue
  • Muscle or body aches
  • Headache
  • New loss of taste or smell
  • Sore throat
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea

How Do COVID‑19 Vaccines Work?

According to the Centers for Disease Control and Prevention at CDC.gov:

COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness. Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of “memory” T-lymphocytes as well as B-lymphocytes that will remember how to fight that virus in the future.

It typically takes a few weeks for the body to produce T-lymphocytes and B-lymphocytes after vaccination.

Sometimes after vaccination, the process of building immunity can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building immunity.

MORE INFORMATION ABOUT COVID‑19 VACCINES AND HOW THEY WORK
Learn more about how vaccine works

COVID-19=coronavirus disease 2019; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

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