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About the Janssen COVID-19 Vaccine

About Johnson & Johnson's Janssen COVID-19 Vaccine

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 for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The Janssen COVID-19 Vaccine can cause blood clots with low levels of platelets (blood cells that help your body stop bleeding), which may be fatal.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

For more information about our company, please visit Janssen.com


What Is Johnson & Johnson's Janssen COVID‑19 Vaccine?

The Janssen COVID‑19 Vaccine is an unapproved vaccine that may prevent COVID‑19.

Under an EUA, the FDA has authorized the emergency use of the Janssen COVID‑19 Vaccine to prevent COVID‑19 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID‑19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID‑19 Vaccine because they would otherwise not receive a COVID‑19 vaccine.


Has the Janssen COVID‑19 Vaccine Been Used Before?

The Janssen COVID‑19 Vaccine is an unapproved vaccine. In clinical trials, more than 61,000 individuals 18 years of age and older have received the Janssen COVID‑19 Vaccine. Millions of individuals have received the vaccine under EUA since February 27, 2021.


What to Know About Johnson & Johnson's Janssen COVID‑19 Vaccine

How is it given?

The Janssen COVID‑19 Vaccine will be given to you as an injection into the muscle.

Primary Vaccination: The Janssen COVID‑19 Vaccine is administered as a single dose.

Booster Dose:

  • A single booster dose of the Janssen COVID‑19 Vaccine may be administered at least 2 months after primary vaccination with the Janssen COVID‑19 Vaccine
  • A single booster dose of the Janssen COVID-19 Vaccine may be administered after completing primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding timing of the booster dose.

What are the benefits of the Janssen COVID‑19 Vaccine?

The Janssen COVID‑19 Vaccine has been shown to prevent COVID‑19. 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
  • Swollen lymph nodes
  • Blood clots
  • Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia)
  • Persistent ringing in the ears (tinnitus)
  • Diarrhea, vomiting

Severe Allergic Reactions

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

Blood Clots with Low Levels of Platelets

Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two weeks after vaccination. Blood clots with low levels of platelets following the Janssen COVID-19 Vaccine have been reported in males and females, across a wide age range of individuals 18 years and older; reporting has been highest in females ages 30 through 49 years (about 8 cases for every 1,000,000 vaccine doses administered), and about 1 out of every 7 cases has been fatal. You should seek medical attention right away if you have any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain
  • Severe or persistent headaches or blurred vision
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection

Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia (ITP) is a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets. ITP has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. If you have ever had a diagnosis of ITP, talk to your vaccination provider before you get the Janssen COVID-19 Vaccine. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Easy or excessive bruising or tiny blood spots under the skin beyond the site of the injection
  • Unusual or excessive bleeding

Guillain Barré Syndrome

Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body
  • Difficulty walking
  • Difficulty with facial movements, including speaking, chewing, or swallowing
  • Double vision or inability to move eyes
  • Difficulty with bladder control or bowel function

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.

For more information on the CDC recommendation for use of Johnson & Johnson's Janssen COVID-19 Vaccine, please see the latest update from the CDC.

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 1-800-822-7967 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 the contact information provided below.

US Toll Free: 1-800-565-40081-800-565-4008
US Toll: 1-908-455-99221-908-455-9922

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe

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 anyone receive the vaccine?

FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a 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 after a previous dose of this vaccine
  • Had a severe allergic reaction to any ingredient of this vaccine
  • Had a blood clot along with a low level of platelets (blood cells that help your body stop bleeding) following Janssen COVID-19 Vaccine or following AstraZeneca’s COVID-19 vaccine (not authorized or approved in the United States)

Can I receive the Janssen COVID-19 Vaccine at the same time as other vaccines?

Data have not yet been submitted to FDA on administration of the Janssen COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving the Janssen COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.

Can I be charged an administration fee for receipt of the Janssen COVID‑19 Vaccine?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

COVID-19=coronavirus disease 2019; HRSA=Health Resources and Services Administration; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.