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FDA EUA Letter EUA Fact Sheet for HCPs EUA Fact Sheet for Recipients &
Caregivers
Janssen.com
Janssen.com
FDA EUA Letter EUA Fact Sheet for HCPs EUA Fact Sheet for Recipients &
Caregivers

Janssen Infectious Diseases and Vaccines is committed to providing critical
updates and education related to COVID-19 and the Emergency Use Authorization of
the Janssen COVID-19 Vaccine. Janssen, in close collaboration with the FDA,
frequently updates Fact Sheets and guidance on the utilization of the Janssen
COVID-19 Vaccine.

 

This site has been optimized to provide the most up-to-date information with
links to resources.


JOHNSON & JOHNSON’S JANSSEN COVID-19 VACCINE: AUTHORIZED FOR EMERGENCY USE

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 emergency use of this product is authorized only for the duration
of the declaration that circumstances exist justifying the authorization of the
emergency use of the medical product under Section 564(b)(1) of the FD&C Act,
unless the declaration is terminated or authorization revoked sooner.

FDA EUA Letter for the Janssen COVID-19 Vaccine

EUA FACT SHEET AND FULL EUA PRESCRIBING INFORMATION FOR VACCINATION PROVIDERS

EUA FACT SHEET FOR VACCINE RECIPIENTS AND CAREGIVERS

 * FDA EUA Letter
   
   To view the FDA EUA letter, please see:
   
   Download
 * EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers
   
   If you are a vaccination provider, please find EUA Fact Sheet and full EUA
   Prescribing Information here:
   
   Download
 * EUA Fact Sheet for Vaccine Recipients and Caregivers
   
   If you are a vaccine recipient or caregiver, please find EUA Fact Sheet for
   Vaccine Recipients and Caregivers here:
   
   Download

Reporting Vaccine Adverse Events

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event
Reporting System (VAERS) all vaccine administration errors, all serious adverse
events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and
hospitalized or fatal cases of COVID-19 following vaccination with the Janssen
COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to
Janssen Biotech, Inc.

Visit VAERS for more information and to report adverse events
 * If you are unable to submit this form electronically, you may fax it to VAERS
   at 1-877-721-0366. If you need additional help submitting a report, you may
   call the VAERS toll-free information line at 1-800-822-79671-800-822-7967 or
   send an email to info@vaers.org
   or

 * Contact Janssen Biotech, Inc. at:
   
   US Toll Free: 1-800-565-40081-800-565-4008
   US Toll: 1-908-455-99221-908-455-9922

Expiry Dates

Learn more about expiration tracking and how to check the expiry of the Janssen
COVID-19 Vaccine lots that you have received.

Go to Vaxcheck.jnj
Coronavirus Education

Get more information about the coronavirus.

CDC: COVID-19 Website Johns Hopkins Coronavirus Resource Center
COVID-19 Vaccine Information and Guidelines

Visit the Centers for Disease Control and Prevention (CDC) and National
Institutes of Health (NIH) websites for resources and guidelines.

ACIP Recommendations Information From NIH CDC's Morbidity and Mortality Weekly
Report for COVID-19


ENSURING THE AUTHENTICITY OF JOHNSON & JOHNSON'S JANSSEN COVID-19 VACCINE

Johnson & Johnson and Janssen Pharmaceuticals are committed to identifying and
mitigating the risks of counterfeit healthcare products. Information regarding
how we address counterfeiting can be found at healthforhumanityreport.jnj.com

The Janssen COVID-19 Vaccine is to be administered intramuscularly by a
healthcare professional.

An authentic Janssen COVID-19 Vaccine includes the Janssen name and logo on the
carton. The Janssen COVID-19 Vaccine is supplied in multi-dose vials. The vial
stoppers are not made with natural rubber latex.

The Janssen COVID-19 Vaccine is never sold online and is distributed only
through government channels. Janssen cannot verify the authenticity of products
acquired outside of the legitimate supply chain. If you suspect the Janssen
COVID-19 Vaccine you have may be counterfeit, contact us at
1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-9922 1-908-455-9922 (US
Toll).

COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C
Act=Federal Food, Drug, and Cosmetic Act.

SELECT IMPORTANT SAFETY INFORMATION


WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome
(TTS) which may be life-threatening.

TTS may involve thrombosis at unusual locations for a thrombus (i.e., cerebral
vein, visceral artery or vein, extremity artery, central artery or vein) or in
an extremity vein or pulmonary artery.

Among reported cases of TTS following administration of the Janssen COVID-19
Vaccine, symptoms began approximately one to two weeks after vaccination.

Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention
for shortness of breath, chest pain, leg swelling, persistent abdominal pain,
neurological symptoms (including severe or persistent headaches or blurred
vision), or petechiae beyond the site of vaccination.

The clinical course of TTS following administration of the Janssen COVID-19
Vaccine shares features with autoimmune heparin-induced thrombocytopenia. In
individuals with suspected TTS, the use of heparin may be harmful and
alternative treatments may be needed.

Do not administer the Janssen COVID-19 Vaccine to individuals with a history of
thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any
other adenovirus-vectored COVID-19 vaccine.



This is not a complete list of all safety information for the Janssen COVID-19
Vaccine. Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) including full EUA
Prescribing Information available at
www.JanssenCOVID19Vaccine.com/EUA-factsheet.


AUTHORIZATION OF USE

The Janssen COVID-19 Vaccine is authorized for use under an Emergency Use
Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) 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.

 * Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose
   (0.5 mL).
 * A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered
   at least 2 months after the primary vaccination with the Janssen COVID-19
   Vaccine.
 * A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be
   administered as a heterologous booster dose following completion of primary
   vaccination with another authorized or approved COVID-19 vaccine. The dosing
   interval for the heterologous booster dose is the same as that authorized for
   a booster dose of the vaccine used for primary vaccination.

 * FDA EUA Letter
   
 * EUA Fact Sheet for HCPs
   
 * EUA Fact Sheet for Recipients & Caregivers
   

Janssen.com

For medical inquiries or
product-related questions:


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

© Janssen Therapeutics, Division of Janssen Products, LP 2022. All rights
reserved. 12/22 cp-201875v25.

This site is published by Janssen Therapeutics, Division of Janssen Products,
LP, which is solely responsible for its contents. The material on this site is
intended only as informational or as an educational aid and it is not intended
to be taken as medical advice. The ultimate responsibility for patient care
resides with a healthcare professional.

This information is intended for use of healthcare providers in the United
States and its territories only. Laws, regulatory requirements, and medical
practices for pharmaceutical products vary from country to country. The
Prescribing Information included here may not be appropriate for use outside the
United States and its territories.

Third-party trademarks used herein are trademarks of their respective owners.

Cookie Policy

Cookies Settings
 * Privacy Policy
 * Do Not Sell or Share My Personal Information
 * Legal Notice


EUA FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION
PROVIDERS) INCLUDING THE FULL EUA PRESCRIBING INFORMATION


PLEASE SELECT A LANGUAGE TO VIEW:

English

Spanish


EUA FACT SHEET FOR RECIPIENTS
AND CAREGIVERS


PLEASE SELECT A LANGUAGE TO VIEW:

English

Spanish

Additional Languages


FDA EUA LETTER FOR THE
JANSSEN COVID‑19 VACCINE


PLEASE SELECT A LANGUAGE TO VIEW:

English

Spanish

French

Portuguese

Chinese

Vietnamese

Tagalog


English
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SELECT IMPORTANT SAFETY INFORMATION


WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome
(TTS) which may be life-threatening.

TTS may involve thrombosis at unusual locations for a thrombus (i.e., cerebral
vein, visceral artery or vein, extremity artery, central artery or vein) or in
an extremity vein or pulmonary artery.

Among reported cases of TTS following administration of the Janssen COVID-19
Vaccine, symptoms began approximately one to two weeks after vaccination.

Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention
for shortness of breath, chest pain, leg swelling, persistent abdominal pain,
neurological symptoms (including severe or persistent headaches or blurred
vision), or petechiae beyond the site of vaccination.

The clinical course of TTS following administration of the Janssen COVID-19
Vaccine shares features with autoimmune heparin-induced thrombocytopenia. In
individuals with suspected TTS, the use of heparin may be harmful and
alternative treatments may be needed.

Do not administer the Janssen COVID-19 Vaccine to individuals with a history of
thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any
other adenovirus-vectored COVID-19 vaccine.



This is not a complete list of all safety information for the Janssen COVID-19
Vaccine. Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) including full EUA
Prescribing Information available at
www.JanssenCOVID19Vaccine.com/EUA-factsheet.


AUTHORIZATION OF USE

The Janssen COVID-19 Vaccine is authorized for use under an Emergency Use
Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) 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.

 * Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose
   (0.5 mL).
 * A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered
   at least 2 months after the primary vaccination with the Janssen COVID-19
   Vaccine.
 * A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be
   administered as a heterologous booster dose following completion of primary
   vaccination with another authorized or approved COVID-19 vaccine. The dosing
   interval for the heterologous booster dose is the same as that authorized for
   a booster dose of the vaccine used for primary vaccination.


YOU ARE LEAVING JOHNSON & JOHNSON'S JANSSEN COVID‑19 VACCINE WEBSITE

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third-party website is not controlled by Janssen or subject to our Privacy
Policy.

Thank you for visiting our site.

Continue Return


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JOHNSON & JOHNSON.

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sitio web externo no está controlado por Janssen ni está sujeto a nuestra
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third-party website is not controlled by Janssen or subject to our Privacy
Policy.

Thank you for visiting our site.

Continue Return


ESTÁ SALIENDO DEL SITIO WEB DE LA VACUNA CONTRA LA COVID‑19 DE JANSSEN DE
JOHNSON & JOHNSON.

Usted está siendo dirigido a un sitio web externo. Tenga en cuenta que este
sitio web externo no está controlado por Janssen ni está sujeto a nuestra
Política de privacidad.

Gracias por visitar nuestro sitio web.

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SELECT IMPORTANT SAFETY INFORMATION


WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome
(TTS) which may be life-threatening.

TTS may involve thrombosis at unusual locations for a thrombus (i.e., cerebral
vein, visceral artery or vein, extremity artery, central artery or vein) or in
an extremity vein or pulmonary artery.

Among reported cases of TTS following administration of the Janssen COVID-19
Vaccine, symptoms began approximately one to two weeks after vaccination.

Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention
for shortness of breath, chest pain, leg swelling, persistent abdominal pain,
neurological symptoms (including severe or persistent headaches or blurred
vision), or petechiae beyond the site of vaccination.

The clinical course of TTS following administration of the Janssen COVID-19
Vaccine shares features with autoimmune heparin-induced thrombocytopenia. In
individuals with suspected TTS, the use of heparin may be harmful and
alternative treatments may be needed.

Do not administer the Janssen COVID-19 Vaccine to individuals with a history of
thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any
other adenovirus-vectored COVID-19 vaccine.



This is not a complete list of all safety information for the Janssen COVID-19
Vaccine. Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) including full EUA
Prescribing Information available at
www.JanssenCOVID19Vaccine.com/EUA-factsheet.


AUTHORIZATION OF USE

The Janssen COVID-19 Vaccine is authorized for use under an Emergency Use
Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) 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.

 * Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose
   (0.5 mL).
 * A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered
   at least 2 months after the primary vaccination with the Janssen COVID-19
   Vaccine.
 * A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be
   administered as a heterologous booster dose following completion of primary
   vaccination with another authorized or approved COVID-19 vaccine. The dosing
   interval for the heterologous booster dose is the same as that authorized for
   a booster dose of the vaccine used for primary vaccination.


YOU ARE LEAVING JOHNSON & JOHNSON'S JANSSEN COVID‑19 VACCINE WEBSITE

You are being directed to a third-party website. Please note that this
third-party website is not controlled by Janssen or subject to our Privacy
Policy.

Thank you for visiting our site.

Continue Return


ESTÁ SALIENDO DEL SITIO WEB DE LA VACUNA CONTRA LA COVID‑19 DE JANSSEN DE
JOHNSON & JOHNSON.

Usted está siendo dirigido a un sitio web externo. Tenga en cuenta que este
sitio web externo no está controlado por Janssen ni está sujeto a nuestra
Política de privacidad.

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YOU ARE LEAVING JOHNSON & JOHNSON'S JANSSEN COVID‑19 VACCINE WEBSITE

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third-party website is not controlled by Janssen or subject to our Privacy
Policy.

Thank you for visiting our site.

Continue Return


ESTÁ SALIENDO DEL SITIO WEB DE LA VACUNA CONTRA LA COVID‑19 DE JANSSEN DE
JOHNSON & JOHNSON.

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sitio web externo no está controlado por Janssen ni está sujeto a nuestra
Política de privacidad.

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functions and ads. This information may also be used for the purposes of
personalized advertisements about products, programs and services which may be
considered sensitive in your state. You may visit our site’s privacy policy for
details about sensitive personal information, which may include, but are not
limited to health related information. For more information (including data
sharing with partners) or to adjust your preferences, see “Cookie Settings”.
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When you visit any website, it may store or retrieve information on your
browser, mostly in the form of cookies. This information might be about you,
your preferences or your device and is mostly used to make the site work as you
expect it to. The information does not usually directly identify you, but it can
give you a more personalized web experience. This information may also be shared
with third parties. The cookies are set to expire when the information is no
longer needed or after a set maximum period. Because we respect your right to
privacy, you can choose not to allow some types of cookies. Click on the
different category headings to find out more (including the cookies used, their
purposes, their retention period and our partners) and change our default
settings. However, blocking some types of cookies may impact your experience of
the site and the services we are able to offer. You can read further information
on how we process your personal data and your privacy rights in our privacy
policy.
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These cookies are necessary for the website to function and cannot be switched
off in our systems. They are usually only set in response to actions made by
you, which amount to a request for services, such as setting your privacy
preferences, logging in or filling in forms. You can set your browser to block
or alert you about these cookies, but some parts of the site will then not work.

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PERFORMANCE COOKIES

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These cookies allow us to count visits and traffic sources so we can measure and
improve the performance of our site. They help us to know which pages are the
most and least popular and see how visitors move around the site. If you do not
allow these cookies we will not know when you have visited our site, and will
not be able to monitor its performance. You can set your browser to block or
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TARGETING COOKIES

Targeting Cookies

These cookies may be set through our site by our advertising partners. They may
be used by those companies to build a profile of your interests and show you
relevant adverts on other sites. They do not store directly personal
information, but are based on uniquely identifying your browser and internet
device. If you do not allow these cookies, you will experience less targeted
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