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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 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.

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

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.


CONTRAINDICATIONS

 * Severe Allergic Reactions: 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.
 * Thrombosis with Thrombocytopenia: 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 vaccines (e.g., AstraZeneca’s COVID-19 vaccine which is not
   authorized or approved in the United States).


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 Syndrome (TTS): Reports to the Vaccine
   Adverse Events Reporting System (VAERS), a passive surveillance system,
   provide evidence for an increased risk of thrombosis with thrombocytopenia
   syndrome (TTS) with onset of symptoms approximately one to two weeks after
   administration of the Janssen COVID-19 Vaccine. An analysis of VAERS reports
   of TTS following the receipt of the Janssen COVID-19 Vaccine used the
   following case definition:
 * a thrombosis in an unusual location for a thrombus (i.e., cerebral vein,
   visceral artery or vein, extremity artery, central artery or vein) and
   new-onset thrombocytopenia (i.e., platelet count <150,000/μL) occurring any
   time after vaccination;
 * or;
 * new-onset thrombocytopenia (i.e., platelet count <150,000/μL), thrombosis in
   an extremity vein or pulmonary artery in the absence of thrombosis at an
   unusual location, and a positive anti-PF4 antibody ELISA test or functional
   Heparin-Induced Thrombocytopenia (HIT) platelet test occurring any time after
   vaccination.

Cases of TTS following administration of the Janssen COVID-19 Vaccine have been
reported in males and females, in a wide age range of individuals 18 years and
older, with the highest reporting rate (approximately 8 cases per 1,000,000
doses administered) in females ages 30-49 years; overall, approximately 15% of
TTS cases have been fatal.

The clinical course of these events shares features with autoimmune
heparin-induced thrombocytopenia. Specific risk factors for TTS following
administration of the Janssen COVID-19 Vaccine and the level of potential excess
risk due to vaccination are under investigation. Currently available evidence
supports a causal relationship between TTS and the Janssen COVID-19 Vaccine.

Healthcare professionals should be alert to the signs and symptoms of TTS in
individuals who receive the Janssen COVID-19 Vaccine. In individuals with
suspected TTS 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 TTS 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.

 * Immune Thrombocytopenia (ITP): Reports of adverse events following use of the
   Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of immune thrombocytopenia (ITP) during the 42 days following
   vaccination. Individuals with a history of ITP should discuss with their
   healthcare provider the risk of ITP and the potential need for platelet
   monitoring following vaccination with the Janssen COVID-19 Vaccine.
 * 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.
 * Syncope: Syncope (fainting) may occur in association with administration of
   injectable vaccines. Procedures should be in place to avoid injury from
   fainting.
 * Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not
   protect all vaccinated individuals.


ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

In study COV3001, the most common local solicited adverse reaction (≥10%)
reported was injection site pain (48.6%). The most common systemic adverse
reactions (≥10%) were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and
nausea (14.2%).

Severe allergic reactions, including anaphylaxis, have been reported following
administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Anaphylaxis and other severe allergic reactions, 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 Error

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 1-800-822-7967 1-800-822-7967 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.


DRUG INTERACTIONS

 * There are no data to assess the concomitant administration of the Janssen
   COVID-19 Vaccine with other vaccines.


USE IN SPECIFIC POPULATIONS

 * 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.
 * Pediatric Use: Emergency Use Authorization of the Janssen COVID-19 Vaccine
   does not include use in individuals younger than 18 years of age.
 * Geriatric Use: Clinical studies of Janssen COVID-19 Vaccine included
   individuals 65 years of age and older and their data contributes to the
   overall assessment of safety and efficacy. No overall differences in safety
   or efficacy were observed between individuals 65 years of age and older and
   younger individuals.



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-213942v9


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.

Contact Us 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: 1-908-455-9922 1-908-455-9922

© Janssen Therapeutics, Division of Janssen Products, LP 2022. All rights
reserved. 06/22 cp-201877v24.

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.

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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


HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES DE LA EUA


SELECCIONE UN IDIOMA PARA VER:

Inglés

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Idiomas adicionales


FDA EUA LETTER FOR THE
JANSSEN COVID‑19 VACCINE


PLEASE SELECT A LANGUAGE TO VIEW:

English

Spanish

French

Portuguese

Chinese

Vietnamese

Tagalog


ATTENTION: FACT SHEET UPDATES (ISSUED MAY 2022)

Emergency Use Authorization (EUA) Fact Sheets and Prescribing Information for
Johnson & Johnson's Janssen COVID-19 Vaccine have been updated. Please download
the updated Fact Sheets and refer to the sections identified below to review the
new information.


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

 * Page 1 and 12: Warning: Thrombosis with Thrombocytopenia Syndrome
 * Page 2 and 12: 1.0 Authorized Use
 * Page 3 and 13: 2.3 Dosing and Schedule
 * Page 5 and 14: 5.2 Thrombosis with Thrombocytopenia Syndrome (TTS)
 * Page 7: Mandatory Requirements for Janssen COVID-19 Vaccine Administration
   Under Emergency Use Authorization
 * Page 9: Available Alternatives
 * Page 9: Authority for issuance of the EUA
 * Page 33: 20.0 Patient Counseling Information


EUA FACT SHEET FOR VACCINE RECIPIENTS AND CAREGIVERS (DOWNLOAD)

 * Page 1: Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to
   Prevent Coronavirus Disease 2019 (COVID-19)
 * Page 2: What is the Janssen COVID-19 Vaccine?
 * Page 3: Who should get the Janssen COVID-19 Vaccine?
 * Page 3: How is the Janssen COVID-19 Vaccine given?
 * Page 4: What are the risks of the Janssen COVID-19 Vaccine?
 * Page 6: What if I decide not to get the Janssen COVID-19 Vaccine?
 * Page 6: Are other vaccines available for preventing COVID-19 besides Janssen
   COVID-19 Vaccine?

For Johnson & Johnson statements on the Janssen COVID-19 Vaccine, please visit
the Janssen US News Center.

CONTINUE TO SITE


ATENCIÓN: ACTUALIZACIONES DE LAS HOJAS INFORMATIVAS (EMITIDAS EN MAYO DE 2022)

Se han actualizado las hojas informativas de la Autorización de uso de
emergencia (Emergency Use Authorization, EUA) y la Información de prescripción
de la vacuna contra la COVID-19 de Janssen de Johnson & Johnson. Descargue las
hojas informativas actualizadas y consulte las secciones identificadas a
continuación para revisar la información nueva.


HOJA INFORMATIVA DE LA EUA PARA PROVEEDORES DE ATENCIÓN MÉDICA QUE ADMINISTRAN
VACUNAS (PROVEEDORES DE VACUNACIÓN) INCLUIDA LA INFORMACIÓN DE PRESCRIPCIÓN
COMPLETA DE LA EUA (DESCARGAR)

 * Páginas 1 y 12: Advertencia: Síndrome de trombosis con trombocitopenia
 * Páginas 2 y 12: 1.0 Uso autorizado
 * Páginas 3 y 13: 2.3 Administración de dosis y cronograma
 * Páginas 5 y 14: 5.2 Síndrome de trombosis con trombocitopenia (STT)
 * Página 7: Requisitos obligatorios para la administración de la vacuna contra
   la COVID-19 de Janssen en virtud de la Autorización de uso de emergencia
 * Página 9: Alternativas disponibles
 * Página 9: Autoridad de emisión de la EUA
 * Página 33: 20.0 Información orientativa para el paciente


HOJA INFORMATIVA DE LA EUA PARA RECEPTORES DE LA VACUNA Y CUIDADORES (DESCARGAR)

 * Página 1: Autorización de uso de emergencia (EUA) de la vacuna contra la
   COVID-19 de Janssen para prevenir la enfermedad por coronavirus de 2019
   (COVID-19)
 * Página 2: ¿Qué es la vacuna contra la COVID-19 de Janssen?
 * Página 3: ¿Quién debe recibir la vacuna contra la COVID-19 de Janssen?
 * Página 3: ¿Cómo se administra la vacuna contra la COVID-19 de Janssen?
 * Página 4: ¿Cuáles son los riesgos de la vacuna contra la COVID-19 de Janssen?
 * Página 6: ¿Qué ocurre si decido no recibir la vacuna contra la COVID-19 de
   Janssen?
 * Página 6: ¿Existen otras vacunas disponibles para prevenir la COVID-19 además
   de la vacuna contra la COVID-19 de Janssen?

Para ver las declaraciones de Johnson & Johnson sobre la vacuna contra la
COVID-19 de Janssen, visite el Centro informativo de Janssen en los EE. UU.

CONTINUAR AL SITIO


ATENCIÓN: ACTUALIZACIONES DE LA HOJA INFORMATIVA (EMITIDA EN MAYO DE 2022)

Se ha añadido nueva información a la hoja informativa de la autorización de uso
de emergencia (EUA) para receptores de la vacuna y cuidadores.


HOJA INFORMATIVA DE LA EUA PARA RECEPTORES DE LA VACUNA Y CUIDADORES (DESCARGAR)

 * Página 1: Autorización de uso de emergencia (EUA) de la vacuna contra la
   COVID‑19 de Janssen para prevenir la enfermedad por coronavirus de 2019
   (COVID‑19)
 * Página 2: ¿Qué es la vacuna contra la COVID‑19 de Janssen?
 * Página 3: ¿Quién debe recibir la vacuna contra la COVID‑19 de Janssen?
 * Página 3: ¿Cómo se administra la vacuna contra la COVID‑19 de Janssen?
 * Página 4: ¿Cuáles son los riesgos de la vacuna contra la COVID‑19 de Janssen?
 * Página 6: ¿Qué ocurre si decido no recibir la vacuna contra la COVID‑19 de
   Janssen?
 * Página 6: ¿Existen otras vacunas disponibles para prevenir la COVID‑19 además
   de la vacuna contra la COVID‑19 de Janssen?

Para ver las declaraciones de Johnson & Johnson sobre la vacuna contra la
COVID-19 de Janssen, visite el centro informativo de Janssen en los EE. UU.

CONTINUAR AL SITIO


ATTENTION: FACT SHEET UPDATES (ISSUED MAY 2022)

New information has been added to the Emergency Use Authorization (EUA) Fact
Sheet for Vaccine Recipients and Caregivers.


EUA FACT SHEET FOR VACCINE RECIPIENTS AND CAREGIVERS (DOWNLOAD)

 * Page 1: Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to
   Prevent Coronavirus Disease 2019 (COVID-19)
 * Page 2: What is the Janssen COVID-19 Vaccine?
 * Page 3: Who should get the Janssen COVID-19 Vaccine?
 * Page 3: How is the Janssen COVID-19 Vaccine given?
 * Page 4: What are the risks of the Janssen COVID-19 Vaccine?
 * Page 6: What if I decide not to get the Janssen COVID-19 Vaccine?
 * Page 6: Are other vaccines available for preventing COVID-19 besides Janssen
   COVID-19 Vaccine?

For Johnson & Johnson statements on the Janssen COVID-19 Vaccine, please visit
the Janssen US News Center.

CONTINUE TO SITE

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.


CONTRAINDICATIONS

 * Severe Allergic Reactions: 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.
 * Thrombosis with Thrombocytopenia: 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 vaccines (e.g., AstraZeneca’s COVID-19 vaccine which is not
   authorized or approved in the United States).


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 Syndrome (TTS): Reports to the Vaccine
   Adverse Events Reporting System (VAERS), a passive surveillance system,
   provide evidence for an increased risk of thrombosis with thrombocytopenia
   syndrome (TTS) with onset of symptoms approximately one to two weeks after
   administration of the Janssen COVID-19 Vaccine. An analysis of VAERS reports
   of TTS following the receipt of the Janssen COVID-19 Vaccine used the
   following case definition:
 * a thrombosis in an unusual location for a thrombus (i.e., cerebral vein,
   visceral artery or vein, extremity artery, central artery or vein) and
   new-onset thrombocytopenia (i.e., platelet count <150,000/μL) occurring any
   time after vaccination;
 * or;
 * new-onset thrombocytopenia (i.e., platelet count <150,000/μL), thrombosis in
   an extremity vein or pulmonary artery in the absence of thrombosis at an
   unusual location, and a positive anti-PF4 antibody ELISA test or functional
   Heparin-Induced Thrombocytopenia (HIT) platelet test occurring any time after
   vaccination.

Cases of TTS following administration of the Janssen COVID-19 Vaccine have been
reported in males and females, in a wide age range of individuals 18 years and
older, with the highest reporting rate (approximately 8 cases per 1,000,000
doses administered) in females ages 30-49 years; overall, approximately 15% of
TTS cases have been fatal.

The clinical course of these events shares features with autoimmune
heparin-induced thrombocytopenia. Specific risk factors for TTS following
administration of the Janssen COVID-19 Vaccine and the level of potential excess
risk due to vaccination are under investigation. Currently available evidence
supports a causal relationship between TTS and the Janssen COVID-19 Vaccine.

Healthcare professionals should be alert to the signs and symptoms of TTS in
individuals who receive the Janssen COVID-19 Vaccine. In individuals with
suspected TTS 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 TTS 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.

 * Immune Thrombocytopenia (ITP): Reports of adverse events following use of the
   Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of immune thrombocytopenia (ITP) during the 42 days following
   vaccination. Individuals with a history of ITP should discuss with their
   healthcare provider the risk of ITP and the potential need for platelet
   monitoring following vaccination with the Janssen COVID-19 Vaccine.
 * 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.
 * Syncope: Syncope (fainting) may occur in association with administration of
   injectable vaccines. Procedures should be in place to avoid injury from
   fainting.
 * Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not
   protect all vaccinated individuals.


ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

In study COV3001, the most common local solicited adverse reaction (≥10%)
reported was injection site pain (48.6%). The most common systemic adverse
reactions (≥10%) were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and
nausea (14.2%).

Severe allergic reactions, including anaphylaxis, have been reported following
administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Anaphylaxis and other severe allergic reactions, 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 Error

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 1-800-822-7967 1-800-822-7967 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.


DRUG INTERACTIONS

 * There are no data to assess the concomitant administration of the Janssen
   COVID-19 Vaccine with other vaccines.


USE IN SPECIFIC POPULATIONS

 * 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.
 * Pediatric Use: Emergency Use Authorization of the Janssen COVID-19 Vaccine
   does not include use in individuals younger than 18 years of age.
 * Geriatric Use: Clinical studies of Janssen COVID-19 Vaccine included
   individuals 65 years of age and older and their data contributes to the
   overall assessment of safety and efficacy. No overall differences in safety
   or efficacy were observed between individuals 65 years of age and older and
   younger individuals.



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-213942v9


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
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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.


CONTRAINDICATIONS

 * Severe Allergic Reactions: 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.
 * Thrombosis with Thrombocytopenia: 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 vaccines (e.g., AstraZeneca’s COVID-19 vaccine which is not
   authorized or approved in the United States).


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 Syndrome (TTS): Reports to the Vaccine
   Adverse Events Reporting System (VAERS), a passive surveillance system,
   provide evidence for an increased risk of thrombosis with thrombocytopenia
   syndrome (TTS) with onset of symptoms approximately one to two weeks after
   administration of the Janssen COVID-19 Vaccine. An analysis of VAERS reports
   of TTS following the receipt of the Janssen COVID-19 Vaccine used the
   following case definition:
 * a thrombosis in an unusual location for a thrombus (i.e., cerebral vein,
   visceral artery or vein, extremity artery, central artery or vein) and
   new-onset thrombocytopenia (i.e., platelet count <150,000/μL) occurring any
   time after vaccination;
 * or;
 * new-onset thrombocytopenia (i.e., platelet count <150,000/μL), thrombosis in
   an extremity vein or pulmonary artery in the absence of thrombosis at an
   unusual location, and a positive anti-PF4 antibody ELISA test or functional
   Heparin-Induced Thrombocytopenia (HIT) platelet test occurring any time after
   vaccination.

Cases of TTS following administration of the Janssen COVID-19 Vaccine have been
reported in males and females, in a wide age range of individuals 18 years and
older, with the highest reporting rate (approximately 8 cases per 1,000,000
doses administered) in females ages 30-49 years; overall, approximately 15% of
TTS cases have been fatal.

The clinical course of these events shares features with autoimmune
heparin-induced thrombocytopenia. Specific risk factors for TTS following
administration of the Janssen COVID-19 Vaccine and the level of potential excess
risk due to vaccination are under investigation. Currently available evidence
supports a causal relationship between TTS and the Janssen COVID-19 Vaccine.

Healthcare professionals should be alert to the signs and symptoms of TTS in
individuals who receive the Janssen COVID-19 Vaccine. In individuals with
suspected TTS 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 TTS 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.

 * Immune Thrombocytopenia (ITP): Reports of adverse events following use of the
   Janssen COVID-19 Vaccine under emergency use authorization suggest an
   increased risk of immune thrombocytopenia (ITP) during the 42 days following
   vaccination. Individuals with a history of ITP should discuss with their
   healthcare provider the risk of ITP and the potential need for platelet
   monitoring following vaccination with the Janssen COVID-19 Vaccine.
 * 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.
 * Syncope: Syncope (fainting) may occur in association with administration of
   injectable vaccines. Procedures should be in place to avoid injury from
   fainting.
 * Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not
   protect all vaccinated individuals.


ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

In study COV3001, the most common local solicited adverse reaction (≥10%)
reported was injection site pain (48.6%). The most common systemic adverse
reactions (≥10%) were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and
nausea (14.2%).

Severe allergic reactions, including anaphylaxis, have been reported following
administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Anaphylaxis and other severe allergic reactions, 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 Error

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 1-800-822-7967 1-800-822-7967 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.


DRUG INTERACTIONS

 * There are no data to assess the concomitant administration of the Janssen
   COVID-19 Vaccine with other vaccines.


USE IN SPECIFIC POPULATIONS

 * 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.
 * Pediatric Use: Emergency Use Authorization of the Janssen COVID-19 Vaccine
   does not include use in individuals younger than 18 years of age.
 * Geriatric Use: Clinical studies of Janssen COVID-19 Vaccine included
   individuals 65 years of age and older and their data contributes to the
   overall assessment of safety and efficacy. No overall differences in safety
   or efficacy were observed between individuals 65 years of age and older and
   younger individuals.



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-213942v9


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


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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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and are committed to providing a website that is accessible to the broadest
possible audience, regardless of ability.

To fulfill this, we aim to adhere as strictly as possible to the World Wide Web
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level. These guidelines explain how to make web content accessible to people
with a wide array of disabilities. Complying with those guidelines helps us
ensure that the website is accessible to blind people, people with motor
impairments, visual impairment, cognitive disabilities, and more.

This website utilizes various technologies that are meant to make it as
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allows persons with specific disabilities to adjust the website’s UI (user
interface) and design it to their personal needs.

Additionally, the website utilizes an AI-based application that runs in the
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individuals with motor impairments.

If you wish to contact the website’s owner please use the website's form

Screen-reader and keyboard navigation

Our website implements the ARIA attributes (Accessible Rich Internet
Applications) technique, alongside various behavioral changes, to ensure blind
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browse and operate your site effectively. Here’s how our website covers some of
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    website operable by the keyboard. This includes the ability to navigate the
    website using the Tab and Shift+Tab keys, operate dropdowns with the arrow
    keys, close them with Esc, trigger buttons and links using the Enter key,
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    Users can also use shortcuts such as “M” (menus), “H” (headings), “F”
    (forms), “B” (buttons), and “G” (graphics) to jump to specific elements.

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   use the website by eliminating the risk of seizures resulting from flashing
   or blinking animations and risky color combinations.
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   accessible to the majority of visual impairments such as Degrading Eyesight,
   Tunnel Vision, Cataract, Glaucoma, and others.
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   (menus), “H” (headings), “F” (forms), “B” (buttons), and “G” (graphics) to
   jump to specific elements.

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