FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older for the prevention of COVID-19.

The Janssen COVID-19 Vaccine is administered as a single dose, into the muscle.

Janssen has put together a Janssen COVID-19 Vaccine Information Sheet which provides details about the vaccine and important safety information. Below are some frequently asked questions from the fact sheet. Remember, talk to your doctor if you have additional questions.

Janssen COVID-19 Vaccine FAQs

WHAT ARE COMMON SIDE EFFECTS?

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects occurred within 1-2 days following vaccination and were mild to moderate in severity and lasted 1-2 days. 

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:

• have any allergies,
• have a fever,
• have a bleeding disorder or are on a blood thinner,
• are immunocompromised or are on a medicine that affects your immune system,
• are pregnant or plan to become pregnant,
• are breastfeeding, or
• have received another COVID-19 vaccine.

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

You should not get the Janssen COVID-19 Vaccine if you had a severe allergic reaction to any ingredient of this vaccine.

WILL THE JANSSEN COVID-19 VACCINE GIVE ME COVID-19?

No. The Janssen COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.

CAN I RECEIVE THE JANSSEN COVID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Janssen COVID-19 Vaccine with other vaccines.

WHAT ARE THE BENEFITS OF THE JANSSEN COVID-19 VACCINE?

In an ongoing clinical trial, the Janssen COVID-19 Vaccine has been shown to prevent COVID-19 following a single dose. The duration of protection against COVID-19 is currently unknown.

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

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

• Injection site reactions: pain, redness of the skin and swelling.
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.

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:

• Difficulty breathing,
• Swelling of your face and throat,
• A fast heartbeat,
• A bad rash all over your body,
• Dizziness and weakness.

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 1-800-822-7967 or report side effects online. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form.