About the 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. There is no FDA-approved vaccine to prevent COVID‑19.
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 the Janssen COVID‑19 Vaccine?
The Janssen COVID‑19 Vaccine is an unapproved vaccine that may prevent COVID‑19. There is no FDA-approved vaccine to prevent COVID‑19.
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 under an Emergency Use Authorization (EUA).
Has the Janssen COVID‑19 Vaccine Been Used Before?
The Janssen COVID‑19 Vaccine is an unapproved vaccine. In an ongoing clinical trial, 21,895 individuals 18 years of age and older have received the Janssen COVID‑19 Vaccine.
What to Know About the Janssen COVID‑19 Vaccine
How is it 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 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 1 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 1-800-822-79671-800-822-7967 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 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?
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 under an Emergency Use Authorization (EUA).
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.
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.
