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Important Safety Information Janssen.com Contact Us Español
Important Safety Information Janssen.com Contact Us Español


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


TO LEARN MORE, CHOOSE THE APPROPRIATE OPTION:

I am a healthcare provider I am NOT a healthcare provider

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. 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.

FD&C Act=Federal Food, Drug, and Cosmetic Act.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known
history of a severe allergic reaction (e.g., anaphylaxis) to any component of
the Janssen COVID-19 Vaccine.


WARNINGS AND PRECAUTIONS

 * Management of Acute Allergic Reactions: Appropriate medical treatment to
   manage immediate allergic reactions must be immediately available in the
   event an acute anaphylactic reaction occurs following administration of the
   Janssen COVID-19 Vaccine.

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate
adverse reactions according to the Centers for Disease Control and Prevention
guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

 * Thrombosis with Thrombocytopenia: Reports of adverse events following use of
   the Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of thrombosis involving the cerebral venous sinuses and other
   sites (including but not limited to the large blood vessels of the abdomen
   and the veins of the lower extremities) combined with thrombocytopenia and
   with onset of symptoms approximately one to two weeks after vaccination. The
   reporting rate of thrombosis with thrombocytopenia following the
   administration of the Janssen COVID-19 Vaccine has been highest in females
   ages 18 through 49 years; some cases have been fatal. The clinical course of
   these events shares features with autoimmune heparin-induced
   thrombocytopenia. Specific risk factors for thrombosis with thrombocytopenia
   following administration of the Janssen COVID-19 Vaccine and the level of
   potential excess risk due to vaccination are under investigation. Based on
   currently available evidence, a causal relationship between thrombosis with
   thrombocytopenia and the Janssen COVID-19 Vaccine is plausible.

Healthcare professionals should be alert to the signs and symptoms of thrombosis
with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine.
In individuals with suspected thrombosis with thrombocytopenia following
administration of the Janssen COVID-19 Vaccine, the use of heparin may be
harmful and alternative treatments may be needed. Consultation with hematology
specialists is strongly recommended. The American Society of Hematology has
published considerations relevant to the diagnosis and treatment of thrombosis
with thrombocytopenia following administration of the Janssen COVID-19 Vaccine
(https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate
medical attention if they develop 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.

 * Guillain-Barré Syndrome: Reports of adverse events following use of the
   Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of Guillain-Barré syndrome during the 42 days following
   vaccination.
 * Altered Immunocompetence: Immunocompromised persons, including individuals
   receiving immunosuppressant therapy, may have a diminished immune response to
   the Janssen COVID-19 Vaccine.
 * Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not
   protect all vaccinated individuals.


ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in a clinical trial following administration of the
Janssen COVID-19 Vaccine include injection site pain, headache, fatigue,
myalgia, nausea, fever, injection site erythema and injection site swelling. In
clinical studies, severe allergic reactions, including anaphylaxis, have been
reported following the administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Severe allergic reactions (including anaphylaxis), thrombosis with
thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been
reported following administration of the Janssen COVID-19 Vaccine during mass
vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent
with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is
responsible for mandatory reporting of the listed events following Janssen
COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System
(VAERS):

 * Vaccine administration errors whether or not associated with an adverse
   event,
 * Serious adverse events (irrespective of attribution to vaccination),
 * Cases of Multisystem Inflammatory Syndrome (MIS) in adults,
 * Cases of COVID-19 that result in hospitalization or death.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program
should complete and submit a VAERS form to FDA using one of the following
methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA”
in the description section of the report as the first line.

 * Complete and submit the report online:
   https://vaers.hhs.gov/reportevent.html, or
 * 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

Report adverse events to Janssen Biotech, Inc. by calling
1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing
1-215-293-9955.


PREGNANCY AND LACTATION

 * Pregnancy: Available data on Janssen COVID-19 Vaccine administered to
   pregnant women are insufficient to inform vaccine-associated risks in
   pregnancy.
 * Lactation: Data are not available to assess the effects of Janssen COVID-19
   Vaccine on the breastfed infant or on milk production/excretion.


DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose
(0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to
complete a vaccination series initiated with another 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.

cp-213942v3

Contact Us Privacy Policy Legal Notice DO NOT SELL MY PERSONAL INFORMATION
Sitemap

For more information from Janssen
Pharmaceutical Companies of
Johnson & Johnson,

please visit Janssen.com

If you have product-related questions,
please contact a specialist:

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

© Janssen Therapeutics, Division of Janssen Products, LP 2021. All rights
reserved. 08/21 cp-201877v10.

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 by our customers and 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.


IMPORTANT SAFETY INFORMATION

 * 
 * 


CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known
history of a severe allergic reaction (e.g., anaphylaxis) to any component of
the Janssen COVID-19 Vaccine.


WARNINGS AND PRECAUTIONS

 * Management of Acute Allergic Reactions: Appropriate medical treatment to
   manage immediate allergic reactions must be immediately available in the
   event an acute anaphylactic reaction occurs following administration of the
   Janssen COVID-19 Vaccine.

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate
adverse reactions according to the Centers for Disease Control and Prevention
guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

 * Thrombosis with Thrombocytopenia: Reports of adverse events following use of
   the Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of thrombosis involving the cerebral venous sinuses and other
   sites (including but not limited to the large blood vessels of the abdomen
   and the veins of the lower extremities) combined with thrombocytopenia and
   with onset of symptoms approximately one to two weeks after vaccination. The
   reporting rate of thrombosis with thrombocytopenia following the
   administration of the Janssen COVID-19 Vaccine has been highest in females
   ages 18 through 49 years; some cases have been fatal. The clinical course of
   these events shares features with autoimmune heparin-induced
   thrombocytopenia. Specific risk factors for thrombosis with thrombocytopenia
   following administration of the Janssen COVID-19 Vaccine and the level of
   potential excess risk due to vaccination are under investigation. Based on
   currently available evidence, a causal relationship between thrombosis with
   thrombocytopenia and the Janssen COVID-19 Vaccine is plausible.

Healthcare professionals should be alert to the signs and symptoms of thrombosis
with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine.
In individuals with suspected thrombosis with thrombocytopenia following
administration of the Janssen COVID-19 Vaccine, the use of heparin may be
harmful and alternative treatments may be needed. Consultation with hematology
specialists is strongly recommended. The American Society of Hematology has
published considerations relevant to the diagnosis and treatment of thrombosis
with thrombocytopenia following administration of the Janssen COVID-19 Vaccine
(https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate
medical attention if they develop 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.

 * Guillain-Barré Syndrome: Reports of adverse events following use of the
   Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of Guillain-Barré syndrome during the 42 days following
   vaccination.
 * Altered Immunocompetence: Immunocompromised persons, including individuals
   receiving immunosuppressant therapy, may have a diminished immune response to
   the Janssen COVID-19 Vaccine.
 * Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not
   protect all vaccinated individuals.


ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in a clinical trial following administration of the
Janssen COVID-19 Vaccine include injection site pain, headache, fatigue,
myalgia, nausea, fever, injection site erythema and injection site swelling. In
clinical studies, severe allergic reactions, including anaphylaxis, have been
reported following the administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Severe allergic reactions (including anaphylaxis), thrombosis with
thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been
reported following administration of the Janssen COVID-19 Vaccine during mass
vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent
with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is
responsible for mandatory reporting of the listed events following Janssen
COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System
(VAERS):

 * Vaccine administration errors whether or not associated with an adverse
   event,
 * Serious adverse events (irrespective of attribution to vaccination),
 * Cases of Multisystem Inflammatory Syndrome (MIS) in adults,
 * Cases of COVID-19 that result in hospitalization or death.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program
should complete and submit a VAERS form to FDA using one of the following
methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA”
in the description section of the report as the first line.

 * Complete and submit the report online:
   https://vaers.hhs.gov/reportevent.html, or
 * 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

Report adverse events to Janssen Biotech, Inc. by calling
1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing
1-215-293-9955.


PREGNANCY AND LACTATION

 * Pregnancy: Available data on Janssen COVID-19 Vaccine administered to
   pregnant women are insufficient to inform vaccine-associated risks in
   pregnancy.
 * Lactation: Data are not available to assess the effects of Janssen COVID-19
   Vaccine on the breastfed infant or on milk production/excretion.


DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose
(0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to
complete a vaccination series initiated with another 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.

cp-213942v3


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.

Gracias por visitar nuestro sitio web.

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