The Janssen COVID-19 Vaccine may help your body develop immunity to SARS-CoV-2. However, this vaccine has not been approved to prevent or treat coronavirus or COVID-19 and is no longer available.

The Janssen COVID-19 vaccine is used in people 18 years and older:

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The COVID-19 vaccine is used to help prevent severe disease and death from COVID-19 caused by SARS-CoV-2.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, Janssen COVID-19 Vaccine may not provide protection in every person.

Some people have had blood clots after receiving this vaccine, but the risk of this side effect is very remote. Becoming infected with COVID-19 is much more dangerous to your health than receiving Janssen COVID-19 Vaccine.

Janssen COVID-19 Vaccine is given as an injection (shot) into a muscle. The Janssen COVID-19 vaccine is given as a single dose. You should not receive this vaccine as a second shot for another type of COVID-19 vaccine (such as the Moderna or Pfizer types).

The first booster dose is given at least 2 months after you received your vaccine. You should preferably receive Pfizer or Moderna COVID-19 vaccine for your booster dose. People who had blood clots after receiving the Janssen vaccine should not receive a Janssen booster dose.

A second booster dose of Pfizer or Moderna COVID-19 vaccine is given at least 4 months after the first booster dose to people 50 years and older or to people 18 years and older who have received an organ transplant or have certain types of immunosuppression.

Your doctor or vaccination provider will determine which COVID-19 vaccine you will receive as a booster dose.

You will receive a vaccination card showing the date and type of COVID-19 vaccine you received.

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a Janssen COVID-19 Vaccine will not cause you to test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. Janssen COVID-19 Vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

Usual Adult Dose for COVID-19:

0.5 mL IM once.

The FDA has issued an EUA for a single booster dose to be given at least 2 months after the primary dose, for people 65 years of age and older, and individuals 18 - 64 years old who are at high risk of severe COVID-19; and individuals 18 - 64 years old whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Comments:
-This vaccine is not approved by the FDA to prevent COVID-19. The FDA has issued an EUA for the use of this vaccine.
-No data is available regarding use of the Janssen COVID-19 Vaccine to complete a coronavirus disease 2019 (COVID-19) vaccine series initiated with another vaccine.
Use: Active immunization to prevent COVID-19 disease caused by SARS-CoV-2

You should not receive the Janssen COVID-19 vaccine if you had an allergic reaction after a previous dose of this vaccine or if you had a blood clot with a low level of platelets after receiving this vaccine or the AstraZeneca COVID-19 vaccine (not authorized or approved in the United States).

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive Janssen COVID-19 Vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving Janssen COVID-19 Vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

To make sure Janssen COVID-19 Vaccine is safe for you, tell your doctor if:

• you have a fever;

• you have any allergies;

• you have ever had a history of low levels of platelets in your blood, if you have bleeding problems, or if you use a blood thinner (heparin, warfarin, Coumadin, Jantoven);

• you have a weak immune system caused by disease or by using certain medicine;

• you are pregnant or breastfeeding;

• you've received any other COVID-19 vaccine; or

• you have fainted after receiving an injection.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but Janssen COVID-19 Vaccine is likely to be less harmful than becoming infected with COVID-19 during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Janssen COVID-19 Vaccine on the baby.

The Janssen COVID-19 vaccine is used as a single dose and it is unlikely you would miss a dose.

An overdose of Janssen COVID-19 Vaccine is unlikely to occur.

Avoid receiving other vaccines without first seeking medical advice.

Get emergency medical help if you have signs of an allergic reaction to Janssen COVID-19 Vaccine: hives; dizziness, weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction is more likely to occur within a few minutes to 1 hour after you receive the vaccine. You will be treated quickly if you have a reaction.

Becoming infected with COVID-19 is much more dangerous to your health than receiving Janssen COVID-19 Vaccine.

Some people had blood clots 1 to 2 weeks after receiving Janssen COVID-19 Vaccine, but the risk of this side effect is remote. Seek medical attention right away if you have:

• bruising or tiny red spots under your skin;

• severe headaches or blurred vision;

• chest pain, shortness of breath; or

• stomach pain, leg pain or swelling.

Some people receiving Janssen COVID-19 Vaccine had nervous system problems within 42 days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

• weakness or tingling;

• trouble speaking or swallowing;

• problems with balance or eye movement; or

• loss of bladder or bowel control.

Capillary leak syndrome is a rare but serious side effect. Call your doctor right away if you have signs of this condition: stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Not all possible side effects are known.

Common Janssen COVID-19 Vaccine side effects may include:

• fever;

• pain, redness, or swelling where the shot was given;

• nausea;

• headache, muscle pain; or

• feeling tired.

Other side effects, mild or serious, may occur with more widespread use of COVID-19 vaccine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine.

Before receiving Janssen COVID-19 Vaccine, tell your vaccination provider about all other vaccines you have received and all medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.