Burk Declaration
- Date
- 2021-12-17
Summary
Document 40-19 in Case 2:21-cv-00702-CLM in the U.S. District Court, N.D. of Alabama, filed December 17, 2021 and labeled Burk Declaration Exhibit 19. The 32-page exhibit reproduces the FDA Fact Sheet for Healthcare Providers Administering Vaccine for the Emergency Use Authorization of the Janssen COVID-19 Vaccine, revised Oct/20/2021. The fact sheet sets out the single-dose (0.5 mL) primary regimen and booster dose for individuals 18 years of age and older, storage and handling, and the contraindication for known severe allergic reactions. It describes warnings on thrombosis with thrombocytopenia and Guillain-Barré syndrome, mandatory reporting to VAERS, and the CDC COVID-19 Vaccination Program. The exhibit closes with Full EUA Prescribing Information, including patient counseling and contact information.
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Case 2:21-cv-00702-CLM Document 40-19 Filed 12/17/21 Page 1 of 32 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA
Burk Declaration
Exhibit 19
Case 2:21-cv-00702-CLM Document 40-19 Filed 12/17/21 Page 2 of 32
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF
THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization
(EUA) to permit the emergency use of the unapproved product, Janssen COVID-19 Vaccine, for
active immunization to prevent COVID-19 in individuals 18 years of age and older.
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all
vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory
Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following
administration of the Janssen COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR
THE JANSSEN COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE
AUTHORIZATION” for reporting requirements.
The Janssen COVID-19 Vaccine is a suspension for intramuscular injection.
Primary Vaccination
The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL)
administered to individuals 18 years of age and older.
Booster Dose
A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months
after primary vaccination with the Janssen COVID-19 Vaccine, to individuals 18 years of age and
older.
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 eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.
See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have
been updated. For the most recent Fact Sheet, please see www.janssencovid19vaccine.com.
For information on clinical trials that are testing the use of the Janssen COVID-19 Vaccine for
active immunization against COVID-19, please see www.clinicaltrials.gov.
DESCRIPTION OF COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus,
SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect
other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild
Revised: Oct/20/2021
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symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus.
Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches;
headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting;
diarrhea.
DOSAGE AND ADMINISTRATION
The storage and handling information in this Fact Sheet supersedes the storage and handling
information on the carton and vial labels.
Storage and Handling
Storage Prior to First Puncture of the Vaccine Vial
Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to
46°F) and protect from light. Do not store frozen.
Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to
77°F) for up to 12 hours.
The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C
to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If
needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature
(maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an
individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.
Storage After First Puncture of the Vaccine Vial
After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to
6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if
vaccine is not used within these times.
Dosing and Schedule
Primary Vaccination
The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL)
administered to individuals 18 years of age and older.
Booster Dose
A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months
after primary vaccination with the Janssen COVID-19 Vaccine, to individuals 18 years of age and
older.
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 eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.
Revised: Oct/20/2021
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Dose Preparation
• The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent
suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and
discoloration prior to administration. If either of these conditions exists, do not administer
the vaccine.
• Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial
by swirling gently in an upright position for 10 seconds. Do not shake.
• Each dose is 0.5 mL. Each vial contains five doses. Do not pool excess vaccine from multiple
vials.
• The Janssen COVID-19 Vaccine does not contain a preservative. Record the date and time
of first use on the Janssen COVID-19 Vaccine vial label. After the first dose has been
withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room
temperature (maximally 25°C/77°F) for up to 2 hours. Discard if vaccine is not used within
these times.
Administration
Visually inspect each dose in the dosing syringe prior to administration. The Janssen COVID-19
Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. During the visual
inspection,
• verify the final dosing volume of 0.5 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
Administer the Janssen COVID-19 Vaccine intramuscularly.
CONTRAINDICATION
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 (see Full
EUA Prescribing Information).
WARNINGS
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).
Revised: Oct/20/2021
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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 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. 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). (see Full EUA Prescribing
Information).
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
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 administration of the Janssen COVID-19 Vaccine (see
Full EUA Prescribing Information).
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
Revised: Oct/20/2021
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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.
USE WITH OTHER VACCINES
There is no information on the co-administration of the Janssen COVID-19 Vaccine with other
vaccines.
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their caregiver, information
consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the
individual to the website www.janssencovid19vaccine.com to obtain the Fact Sheet) prior to the
individual receiving the Janssen COVID-19 Vaccine, including:
• FDA has authorized the emergency use of the Janssen COVID-19 Vaccine, which is not an
FDA approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Janssen COVID-19
Vaccine.
• The significant known and potential risks and benefits of the Janssen COVID-19 Vaccine,
and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those
alternatives.
For information on clinical trials that are testing the use of the Janssen COVID-19 Vaccine to
prevent COVID-19, please see www.clinicaltrials.gov.
Provide a vaccination card to the recipient or their caregiver with the name of the vaccine (“Janssen
COVID-19 Vaccine”) and date of administration to document vaccination.
Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine
recipients to participate 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, visit:
www.cdc.gov/vsafe.
MANDATORY REQUIREMENTS FOR JANSSEN COVID-19 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION
In order to mitigate the risks of using this unapproved product under EUA and to optimize the
potential benefit of the Janssen COVID-19 Vaccine, the following items are required. Use of
Revised: Oct/20/2021
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unapproved Janssen COVID-19 Vaccine for active immunization to prevent COVID-19 under this
EUA is limited to the following (all requirements must be met):
1. The Janssen COVID-19 Vaccine is authorized for use in individuals 18 years of age and
older.
2. The vaccination provider must communicate to the individual receiving the Janssen
COVID-19 Vaccine or their caregiver, information consistent with the “Fact Sheet for
Recipients and Caregivers” prior to the individual receiving the Janssen COVID-19
Vaccine.
3. The vaccination provider must include vaccination information in the state/local
jurisdiction’s Immunization Information System (IIS) or other designated system.
4. The vaccination provider is responsible for mandatory reporting of the following 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, and
• cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html.
For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should
include the words “Janssen COVID-19 Vaccine EUA” in the description section of the
report.
5. The vaccination provider is responsible for responding to FDA requests for information
about vaccine administration errors, adverse events, cases of MIS in adults, and cases of
COVID-19 that result in hospitalization or death following administration of the Janssen
COVID-19 Vaccine to recipients.
* Serious adverse events are defined as:
• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement may
jeopardize the individual and may require medical or surgical intervention to
prevent one of the outcomes listed above.
OTHER ADVERSE EVENT REPORTING TO VAERS AND JANSSEN BIOTECH, INC.
Vaccination providers may report to VAERS other adverse events that are not required to be
reported using the contact information above.
Revised: Oct/20/2021
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To the extent feasible, report adverse events to Janssen Biotech, Inc. using the contact information
below or by providing a copy of the VAERS form to Janssen Biotech, Inc:
e-mail Fax number Telephone numbers
JNJvaccineAE@its.jnj.com 215-293-9955 US Toll Free: 1-800-565-4008
US Toll: (908) 455-9922
ADDITIONAL INFORMATION
For general questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan
the QR code using your device, visit www.janssencovid19vaccine.com or call the telephone
numbers provided below.
QR Code Fact Sheets Website Telephone numbers
www.janssencovid19vaccine.com. US Toll Free: 1-800-565-4008
US Toll: 1-908-455-9922
AVAILABLE ALTERNATIVES
Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved vaccine to prevent COVID-19
caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other
COVID-19 vaccines.
FEDERAL COVID-19 VACCINATION PROGRAM
This vaccine is being made available for emergency use exclusively through the CDC COVID-19
Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in
the Vaccination Program and comply with the provider requirements. Vaccination providers may
not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket
charge for administration. 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). For information regarding provider requirements and enrollment in the CDC
COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-
enrollment.html.
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination
Program requirements are encouraged to report them to the Office of the Inspector General, U.S.
Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
AUTHORITY FOR ISSUANCE OF THE EUA
The Secretary of the Department of Health and Human Services (HHS) declared a public health
emergency that justifies the emergency use of drugs and biological products during the COVID-19
Revised: Oct/20/2021
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pandemic. In response, FDA has issued an EUA for the unapproved product, Janssen COVID-19
Vaccine, for active immunization to prevent COVID-19 in individuals 18 years of age and older.
FDA issued this EUA, based on Janssen Biotech, Inc.’s request and submitted data.
Although limited scientific information is available, based on the totality of the scientific evidence
available to date, it is reasonable to believe that the Janssen COVID-19 Vaccine may be effective
for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing
Information.
This EUA for the Janssen COVID-19 Vaccine will end when the Secretary of HHS determines
that the circumstances justifying the EUA no longer exist or when there is a change in the approval
status of the product such that an EUA is no longer needed.
For additional information about Emergency Use Authorization visit FDA at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization.
THE COUNTERMEASURES INJURY COMPENSATION PROGRAM
The Countermeasures Injury Compensation Program (CICP) is a federal program that has been
created to help pay for related costs of medical care and other specific expenses to compensate
people injured after use of certain medical countermeasures. Medical countermeasures are specific
vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during
a public health emergency or a security threat. For more information about CICP, visit
www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.
Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA
© 2021 Janssen Pharmaceutical Companies
END SHORT VERSION FACT SHEET
Long Version (Full EUA Prescribing Information) Begins On Next Page
Revised: Oct/20/2021
Revised: Oct/20/2021
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FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
JANSSEN COVID-19 VACCINE
FULL EMERGENCY USE AUTHORIZATION 11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
(EUA) PRESCRIBING INFORMATION: 11.2 Lactation
CONTENTS* 11.3 Pediatric Use
11.4 Geriatric Use
13 DESCRIPTION
1 AUTHORIZED USE
14 CLINICAL PHARMACOLOGY
2 DOSAGE AND ADMINISTRATION
14.1 Mechanism of Action
2.1 Preparation for Administration
18 CLINICAL TRIAL RESULTS AND SUPPORTING
2.2 Administration
DATA FOR EUA
2.3 Dosing and Schedule
18.1 Efficacy of Primary Vaccination
3 DOSAGE FORMS AND STRENGTHS
18.2 Immunogenicity of a Booster Dose following Primary
4 CONTRAINDICATIONS
Vaccination with Janssen COVID-19 Vaccine
5 WARNINGS AND PRECAUTIONS
18.3 Immunogenicity of a Booster Dose Following Primary
5.1 Management of Acute Allergic Reactions
Vaccination with Another Authorized or Approved
5.2 Thrombosis with thrombocytopenia
COVID-19 Vaccine
5.3 Guillain-Barré Syndrome
19 HOW SUPPLIED/STORAGE AND HANDLING
5.4 Syncope
20 PATIENT COUNSELING INFORMATION
5.5 Altered Immunocompetence
21 CONTACT INFORMATION
5.6 Limitations of Vaccine Effectiveness
6 OVERALL SAFETY SUMMARY
*Sections or subsections omitted from the full prescribing information are not
6.1 Clinical Trials Experience
listed.
6.2 Post Authorization Experience
8 REQUIREMENTS AND INSTRUCTIONS FOR
REPORTING ADVERSE EVENTS AND VACCINE
ADMINISTRATION ERRORS
10 DRUG INTERACTIONS
Revised: Oct/20/2021
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FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
1 AUTHORIZED USE
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.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
2.1 Preparation for Administration
• The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent
suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and
discoloration prior to administration. If either of these conditions exists, do not administer
the vaccine.
• Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial
by swirling gently in an upright position for 10 seconds. Do not shake.
• Each dose is 0.5 mL. Each vial contains five doses. Do not pool excess vaccine from multiple
vials.
• The Janssen COVID-19 Vaccine does not contain a preservative. Record the date and time
of first use on the Janssen COVID-19 Vaccine vial label. After the first dose has been
withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room
temperature (maximally 25°C/77°F) for up to 2 hours. Discard if vaccine is not used within
these times.
2.2 Administration
Visually inspect each dose in the dosing syringe prior to administration. The Janssen COVID-19
Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. During the visual
inspection,
• verify the final dosing volume of 0.5 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
Administer the Janssen COVID-19 Vaccine intramuscularly.
Revised: Oct/20/2021
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2.3 Dosing and Schedule
Primary Vaccination
The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL)
administered to individuals 18 years of age and older.
Booster Dose
A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months
after primary vaccination with the Janssen COVID-19 Vaccine, to individuals 18 years of age and
older.
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 eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.
3 DOSAGE FORMS AND STRENGTHS
Janssen COVID-19 Vaccine is a suspension for intramuscular injection. A single-dose is 0.5 mL.
4 CONTRAINDICATIONS
Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of severe
allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine [see
Description (13)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment used 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).
5.2 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 [see Overall Safety Summary (6.2)]. The reporting rate of
thrombosis with thrombocytopenia following 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.
Revised: Oct/20/2021
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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.
5.3 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.
5.4 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures
should be in place to avoid injury from fainting.
5.5 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may
have a diminished immune response to the Janssen COVID-19 Vaccine.
5.6 Limitations of Vaccine Effectiveness
The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.
6 OVERALL SAFETY SUMMARY
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. Please see the
REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND
VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS or
Janssen Biotech, Inc.
Revised: Oct/20/2021
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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%) (see Tables 1 to 4).
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.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.
Safety Primary vaccination
The safety of the Janssen COVID-19 Vaccine has been assessed in an ongoing Phase 3 Study,
COV3001 (NCT04505722) (Study 1). A total of 43,783 individuals were enrolled in this study, of
whom 21,895 adults aged 18 years and older received the Janssen COVID-19 Vaccine [Full
Analysis Set (FAS)]. This study is being conducted in the United States (n=19,302), Brazil
(n=7,278), South Africa (n=6,576), Colombia (n=4,248), Argentina (n=2,996), Peru (n=1,771),
Chile (n=1,133), Mexico (n=479). In this study, 45.0% were female, 54.9% were male, 58.7%
were White, 19.4% were Black or African American, 45.3% were Hispanic or Latino, 3.3% were
Asian, 9.5% were American Indian/Alaska Native and 0.2% were Native Hawaiian or other Pacific
Islander, 5.6% were from multiple racial groups and 1.4% were unknown races (see Table 5). The
median age of individuals was 52.0 years (range: 18-100). There were 4,217 (9.6%) individuals
who were SARS-CoV-2 seropositive at baseline and who were included in the study. In the United
States, 838 of 19,302 (4.3%) individuals were SARS-CoV-2 seropositive. Demographic
characteristics were similar among individuals who received the Janssen COVID-19 Vaccine and
those who received saline placebo.
The safety subset includes 6,736 individuals (3,356 from the Janssen COVID-19 Vaccine group,
3,380 from the placebo group). The demographic profile in the safety subset was similar in terms
of age and gender compared to the FAS. A larger percentage of individuals in the safety subset
were White (83.4%) compared to the FAS (58.7%). Geographically, the safety subset was limited
to individuals from the United States (51.4%), Brazil (38.5%) and South Africa (10.2%). Fewer
individuals in the safety subset compared to the FAS were SARS-CoV-2 seropositive at baseline,
4.5% vs. 9.6%, and had at least one comorbidity 34.1% vs 40.8%.
Safety monitoring in the clinical study consisted of monitoring for: (1) solicited local and systemic
reactions occurring in the 7 days following vaccination in a subset of individuals (safety subset),
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(2) unsolicited adverse events (AEs) occurring in the 28 days following vaccination in the safety
subset, (3) medically-attended AEs (MAAEs) occurring in the 6 months following vaccination in
the entire study population (FAS), (4) serious AEs (SAEs) and AEs leading to study
discontinuation for the duration of the study in the entire study population.
Solicited adverse reactions
Shown below are the frequencies of solicited local adverse reactions (Tables 1 and 2) and systemic
adverse reactions (Tables 3 and 4) reported in adults by age group in the 7 days following
vaccination in Study 1.
Table 1: Study 1: Solicited Local Adverse Reactions Reported in the 7 Days Following Primary
Vaccination - Individuals 18 to 59 Years of Age
Janssen COVID-19 Vaccine Placebo
N=2,036 N=2,049
Adverse Reactions n(%) n(%)
Injection Site Pain
Any 1,193 (58.6) 357 (17.4)
Grade 3a 8 (0.4) 0
Injection Site Erythema
Any (≥25 mm) 184 (9.0) 89 (4.3)
Grade 3b 6 (0.3) 2 (0.1)
Injection Site Swelling
Any (≥25 mm) 142 (7.0) 32 (1.6)
Grade 3b 5 (0.2) 2 (0.1)
a
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain
reliever.
b
Grade 3 injection site swelling and erythema: Defined as >100 mm.
Table 2: Study 1: Solicited Local Adverse Reactions Reported in the 7 Days Following Primary
Vaccination - Individuals 60 Years of Age and Older
Adverse Reactions Janssen COVID-19 Vaccine Placebo
N=1,320 N=1,331
n(%) n(%)
Injection Site Pain
Any 439 (33.3) 207 (15.6)
Grade 3a 3 (0.2) 2 (0.2)
Injection Site Erythema
Any (≥25 mm) 61 (4.6) 42 (3.2)
Grade 3b 1 (0.1) 0
Injection Site Swelling
Any (≥25 mm) 36 (2.7) 21 (1.6)
Grade 3b 2 (0.2) 0
a
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain
reliever.
b
Grade 3 injection site swelling and erythema: Defined as >100 mm.
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Table 3: Study 1: Solicited Systemic Adverse Reactions Reported in the 7 Days Following Primary
Vaccination - Individuals 18 to 59 Years of Age
Adverse Reactions Janssen COVID-19 Vaccine Placebo
N=2,036 N=2,049
n(%) n(%)
Headache
Any 905 (44.4) 508 (24.8)
Grade 3a 18 (0.9) 5 (0.2)
Fatigue
Any 891 (43.8) 451 (22.0)
Grade 3b 25 (1.2) 4 (0.2)
Myalgia
Any 796 (39.1) 248 (12.1)
Grade 3b 29 (1.4) 1 (<0.1)
Nausea
Any 315 (15.5) 183 (8.9)
Grade 3b 3 (0.1) 3 (0.1)
Feverc
Any 261 (12.8) 14 (0.7)
Grade 3 7 (0.3) 0
Use of antipyretic or pain medication 538 (26.4) 123 (6.0)
a
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social
activities; use of narcotic pain reliever.
b
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or
cancellation of social activities; use of narcotic pain reliever.
c
Fever of any grade: Defined as body temperature ≥38 C/100.4 F. Grade 3 fever: Defined as 39.0 C - 40.0 C (102.1 F - 104.0 F).
Table 4: Study 1: Solicited Systemic Adverse Reactions Reported in the 7 Days Following Primary
Vaccination - Individuals 60 Years of Age and Older
Adverse Reactions Janssen COVID-19 Vaccine Placebo
N=1,320 N=1,331
n(%) n(%)
Headache
Any 401 (30.4) 294 (22.1)
Grade 3a 5 (0.4) 4 (0.3)
Fatigue
Any 392 (29.7) 277 (20.8)
Grade 3b 10 (0.8) 5 (0.4)
Myalgia
Any 317 (24.0) 182 (13.7)
Grade 3b 3 (0.2) 5 (0.4)
Nausea
Any 162 (12.3) 144 (10.8)
Grade 3b 3 (0.2) 3 (0.2)
Feverc
Any 41 (3.1) 6 (0.5)
Grade 3 1 (0.1) 0
Use of antipyretic or pain medication 130 (9.8) 68 (5.1)
a
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social
activities; use of narcotic pain reliever
b
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or
cancellation of social activities; use of narcotic pain reliever.
c
Fever of any grade: Defined as body temperature ≥38 C/100.4 F. Grade 3 fever: Defined as 39.0 C - 40.0 C (102.1 F - 104.0 F).
Solicited local and systemic adverse reactions reported following administration of the Janssen
COVID-19 Vaccine had a median duration of 1 to 2 days.
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Unsolicited adverse events
Individuals within the safety subset in Study 1 (N=6,736) were monitored for unsolicited adverse
events (AEs) for 28 days following vaccination with 99.9% (N= 6,730) of individuals completing
the full 28 days of follow-up. The proportion of individuals who reported one or more unsolicited
AEs was similar among those in the Janssen COVID-19 Vaccine group (13.1%) and those in the
placebo group (12.0%).
Serious Adverse Events (SAEs) and other events of interest
In Study 1, up to a cut-off date of January 22, 2021, 54.6% of individuals had follow-up duration
of 8 weeks. The median follow-up duration for all individuals was 58 days. SAEs, excluding those
related to confirmed COVID-19, were reported by 0.4% (n=83) of individuals who received the
Janssen COVID-19 Vaccine (N= 21,895) and 0.4% (n=96) of individuals who received placebo
(N= 21,888).
Additional adverse events of interest, including but not limited to allergic, neurologic,
inflammatory, vascular, and autoimmune disorders, were analyzed among all adverse events
collected through protocol-specified safety monitoring procedures as well as unsolicited reporting.
Urticaria (all non-serious) was reported in five vaccinated individuals and 1 individual who
received placebo in the 7 days following vaccination. In addition, an SAE of hypersensitivity, not
classified as anaphylaxis, was reported in 1 vaccinated individual with urticaria beginning
two days following vaccination and angioedema of the lips with no respiratory distress beginning
four days following vaccination. The event was likely related to the vaccine.
An SAE of severe pain in the injected arm, not responsive to analgesics, with immediate onset at
time of vaccination, and that was ongoing 74 days following vaccination was reported in an
individual who received the Janssen COVID-19 Vaccine. An SAE of severe generalized weakness,
fever, and headache, with onset on the day following vaccination and resolution three days
following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine.
Both SAEs are likely related to the vaccine.
Numerical imbalances, with more events in vaccine than placebo recipients, were observed for the
following serious and other adverse events of interest in individuals receiving the vaccine or
placebo, respectively:
• Thromboembolic events:
• Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs.
2 events (1 serious; 2 within 28 days of vaccination).
• Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event
(serious and within 28 days of vaccination).
• Transverse sinus thrombosis with thrombocytopenia: 1 event (serious, with onset of
symptoms 8 days post- vaccination) vs. 0.
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• Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and
0 within 28 days following vaccination).
• Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of
vaccination) vs. 0.
For these events, a causal relationship with the Janssen COVID-19 vaccine could not be
determined based on Study 1. The assessment of causality was confounded by the presence of
underlying medical conditions that may have predisposed individuals to these events. However,
taking into consideration post-authorization experience, a causal relationship with Janssen
COVID-19 Vaccine is plausible for thrombosis with thrombocytopenia [see Warnings and
Precautions (5.2) and Overall Safety Summary (6.2)].
There were no additional notable patterns or numerical imbalances between treatment groups for
specific categories of serious adverse events (including neurologic, neuro-inflammatory, and
cardiovascular events) that would suggest a causal relationship to the Janssen COVID-19 Vaccine.
Booster Dose Following Primary Vaccination with Janssen COVID-19 Vaccine
Overall, in 5 clinical studies conducted in Belgium, Brazil, Colombia, France, Germany, Japan,
Netherlands, Philippines, South Africa, Spain, United Kingdom and United States, approximately
9,000 participants have received 2 doses of the Janssen COVID-19 Vaccine, administered at least
2 months apart and approximately 2,700 participants had at least 2 months of safety follow-up
after the booster dose.
A randomized, double-blind, placebo-controlled Phase 2 study, COV2001 (NCT04535453)
(Study 2), evaluated the frequency and severity of local and systemic adverse reactions within
7 days of administration of a booster dose of the Janssen COVID-19 Vaccine administered
approximately 2 months after the primary vaccination in healthy adults 18 through 55 years of age
and adults 65 years and older in good or stable health. A total of 141 individuals received at least
one dose of the vaccine and 137 received both the primary vaccination and the booster dose at an
interval of 2 months. The median age of individuals was 48 years, and 48 individuals (34%) were
65 years of age and older. Data on solicited adverse reactions after the primary vaccination and
after a booster dose are shown in Tables 5-8.
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Solicited adverse reactions
Table 5: Study 2 - Solicited Local Adverse Reactions Reported in the 7 Days Following the
Primary Vaccination or the Booster Dose - Individuals 18 through 55 Years of Age
Primary Vaccination Booster Dose
N=93 N=89
Adverse Reactions n(%) n(%)
Injection Site Pain
Any 58 (62.4%) 53 (59.6%)
Grade 3a 0 1 (1.1%)
Injection Site Erythema
Any (≥25 mm) 1 (1.1%) 1 (1.1%)
Grade 3b 0 0
Injection Site Swelling
Any (≥25 mm) 1 (1.1%) 0
Grade 3b 0 0
a
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain
reliever.
b
Grade 3 injection site swelling and erythema: Defined as >100 mm.
Table 6: Study 2 - Solicited Local Adverse Reactions Reported in the 7 Days Following the
Primary Vaccination or the Booster Dose - Individuals 65 Years of Age and Older
Adverse Reactions Primary Vaccination Booster Dose
N=48 N=48
n(%) n(%)
Injection Site Pain
Any 17 (35.4%) 10 (20.8%)
Grade 3a 0 0
Injection Site Erythema
Any (≥25 mm) 0 0
Grade 3b 0 0
Injection Site Swelling
Any (≥25 mm) 0 0
Grade 3b 0 0
a
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain
reliever.
b
Grade 3 injection site swelling and erythema: Defined as >100 mm.
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Table 7: Study 2 - Solicited Systemic Adverse Reactions Reported in the 7 Days Following the
Primary Vaccination or the Booster Dose - Individuals 18 through 55 Years of Age
Adverse Reactions Primary Vaccination Booster Dose
N=93 N=89
n(%) n(%)
Headache
Any 49 (52.7%) 37 (41.6%)
Grade 3a 2 (2.2%) 1 (1.1%)
Fatigue
Any 55 (59.1%) 46 (51.7%)
Grade 3b 1 (1.1%) 0
Myalgia
Any 44 (47.3%) 32 (36.0%)
Grade 3b 3 (3.2%) 2 (2.2%)
Nausea
Any 13 (14.0%) 9 (10.1%)
Grade 3b 1 (1.1%) 0
Feverc
Any 13 (14.0%) 5 (5.6%)
Grade 3 1 (1.1%) 0
a
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social
activities; use of narcotic pain reliever.
b
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or
cancellation of social activities; use of narcotic pain reliever.
c
Fever of any grade: Defined as body temperature ≥38 C/100.4 F. Grade 3 fever: Defined as 39.0 C - 40.0 C (102.1 F - 104.0 F).
Table 8: Study 2 - Solicited Systemic Adverse Reactions Reported in the 7 Days Following the
Primary Vaccination or the Booster Dose - Individuals 65 Years of Age and Older
Adverse Reactions Primary Vaccination Booster Dose
N=48 N=48
n(%) n(%)
Headache
Any 9 (18.8%) 13 (27.1%)
Grade 3a 0 0
Fatigue
Any 9 (18.8%) 16 (33.3%)
Grade 3b 0 0
Myalgia
Any 4 (8.3%) 5 (10.4%)
Grade 3b 0 0
Nausea
Any 0 1 (2.1%)
Grade 3b 0 0
Feverc
Any 1 (2.1%) 0
Grade 3 0 0
a
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social
activities; use of narcotic pain reliever
b
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or
cancellation of social activities; use of narcotic pain reliever.
c
Fever of any grade: Defined as body temperature ≥38 C/100.4 F. Grade 3 fever: Defined as 39.0 C - 40.0 C (102.1 F - 104.0 F).
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Unsolicited adverse events
An overall assessment of Janssen’s safety analyses from studies evaluating 2 doses of Janssen
COVID-19 Vaccine did not reveal new safety concerns following a booster dose, as compared
with adverse reactions reported following the single-dose primary vaccination.
Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-
19 Vaccine
The safety of a Janssen COVID-19 Vaccine booster dose in individuals who completed primary
vaccination with another authorized or approved COVID-19 Vaccine (heterologous booster dose)
is inferred from the safety of a Janssen COVID-19 Vaccine booster dose administered following
completion of Janssen COVID-19 Vaccine primary vaccination (homologous booster dose) and
from data from an independent Phase 1/2 open-label clinical trial (NCT04889209) conducted in
the United States that evaluated a heterologous booster dose of the Janssen COVID-19 Vaccine.
In this study, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine
2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech
COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported
no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of
three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech
COVID-19 Vaccine. Adverse events were assessed through 28 days after the booster dose. An
overall review of adverse reactions reported following the Janssen COVID-19 Vaccine
heterologous booster dose did not identify any new safety concerns, as compared with adverse
reactions reported following a Janssen COVID-19 Vaccine primary vaccination or homologous
booster dose.
6.2 Post Authorization Experience
The following adverse reactions have been identified during post-authorization use of the Janssen
COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to
reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Blood and Lymphatic System Disorders: Thrombosis with thrombocytopenia,
Lymphadenopathy, Immune thrombocytopenic purpura.
Cardiac disorders: Myocarditis, Pericarditis.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Diarrhea, Vomiting.
Immune System Disorders: Allergic reactions, including anaphylaxis.
Nervous System Disorders: Guillain-Barré syndrome, Syncope, Paresthesia, Hypoesthesia.
Vascular Disorders: Capillary leak syndrome, Thrombosis with thrombocytopenia, Venous
thromboembolism (with or without thrombocytopenia).
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8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE
EVENTS AND VACCINE ADMINISTRATION ERRORS
See Overall Safety Summary (Section 6) for additional information.
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.
* Serious Adverse Events are defined as:
• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement may
jeopardize the individual and may require medical or surgical intervention to prevent
one of the outcomes listed above.
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:
• 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 or send an email to info@vaers.org.
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS,
please complete the entire form with detailed information. It is important that the
information reported to FDA be as detailed and complete as possible. Information to include:
• Patient demographics, (e.g., patient name, date of birth),
• Pertinent medical history,
• Pertinent details regarding admission and course of illness,
• Concomitant medications,
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• Timing of adverse event(s) in relationship to administration of Janssen COVID-19 vaccine,
• Pertinent laboratory and virology information,
• Outcome of the event and any additional follow-up information if it is available at the time
of the VAERS report. Subsequent reporting of follow-up information should be completed
if additional details become available.
The following steps are highlighted to provide the necessary information for safety tracking:
1. In Box 17, provide information on Janssen COVID-19 Vaccine and any other vaccines
administered on the same day; and in Box 22, provide information on any other vaccines
received within one month prior.
2. In Box 18, description of the event:
a. Write “Janssen COVID-19 Vaccine EUA” as the first line.
b. Provide a detailed report of vaccine administration error and/or adverse event. It is
important to provide detailed information regarding the patient and adverse
event/medication error for ongoing safety evaluation of this unapproved vaccine.
Please see information to include listed above.
3. Contact information:
a. In Box 13, provide the name and contact information of the prescribing healthcare
provider or institutional designee who is responsible for the report.
b. In Box 14, provide the name and contact information of the best doctor/healthcare
professional to contact about the adverse event.
c. In Box 15, provide the address of the facility where vaccine was given (NOT the
healthcare provider’s office address).
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to be
reported using the contact information above.
To the extent feasible, report adverse events to Janssen Biotech, Inc. using the contact information
below or by providing a copy of the VAERS form to Janssen Biotech, Inc:
e-mail Fax number Telephone numbers
JNJvaccineAE@its.jnj.com 215-293-9955 US Toll Free: 1-800-565-4008
US Toll: (908) 455-9922
10 DRUG INTERACTIONS
There are no data to assess the concomitant administration of the Janssen COVID-19 Vaccine with
other vaccines.
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11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to
Janssen COVID-19 Vaccine during pregnancy. Women who are vaccinated with Janssen
COVID-19 Vaccine during pregnancy are encouraged to enroll in the registry by visiting
https://c-viper.pregistry.com.
Risk Summary
All Pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general
population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to
inform vaccine-associated risks in pregnancy.
In a reproductive developmental toxicity study female rabbits were administered 1 mL of the
Janssen COVID-19 Vaccine (a single human dose is 0.5 mL) by intramuscular injection 7 days
prior to mating and on Gestation Days 6 and 20 (i.e., one vaccination during early and late
gestation, respectively). No vaccine related adverse effects on female fertility, embryo-fetal or
postnatal development up to Postnatal Day 28 were observed.
11.2 Lactation
Risk Summary
Data are not available to assess the effects of Janssen COVID-19 Vaccine on the breastfed infant
or on milk production/excretion.
11.3 Pediatric Use
Emergency Use Authorization of the Janssen COVID-19 Vaccine does not include use in
individuals younger than 18 years of age.
11.4 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 [see Overall Safety Summary
(6.1) and Clinical Trial Results and Supporting Data for EUA (18)]. Of the 21,895 individuals
who received a single-dose of the Janssen COVID-19 Vaccine in COV3001, 19.5% (n=4,259)
were 65 years of age and older and 3.7% (n=809) were 75 years of age and older. No overall
differences in safety or efficacy were observed between individuals 65 years of age and older and
younger individuals.
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13 DESCRIPTION
The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent sterile
suspension for intramuscular injection. It contains no visible particulates. The vaccine consists of
a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe
acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein in a stabilized
conformation.
The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells, in media
containing amino acids and no animal-derived proteins. After propagation, the vaccine is
processed through several purification steps, formulated with inactive ingredients and filled into
vials.
Each 0.5 mL dose of Janssen COVID-19 Vaccine is formulated to contain 5×1010 virus particles
(VP) and the following inactive ingredients: citric acid monohydrate (0.14 mg), trisodium citrate
dihydrate (2.02 mg), ethanol (2.04 mg), 2-hydroxypropyl-β-cyclodextrin (HBCD) (25.50 mg),
polysorbate-80 (0.16 mg), sodium chloride (2.19 mg). Each dose may also contain residual
amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng).
Janssen COVID-19 Vaccine does not contain a preservative.
The vial stoppers are not made with natural rubber latex.
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
The Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human
adenovirus type 26 vector that, after entering human cells, expresses the SARS-CoV-2 spike (S)
antigen without virus propagation. An immune response elicited to the S antigen protects against
COVID-19.
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Primary Vaccination
A primary analysis (cut-off date January 22, 2021) of a multicenter, randomized, double-blind,
placebo-controlled Phase 3 Study (Study 1) was conducted in the United States, South Africa,
Brazil, Chile, Argentina, Colombia, Peru and Mexico to assess the efficacy, safety, and
immunogenicity of a single-dose of the Janssen COVID-19 Vaccine for the prevention of COVID-
19 in adults aged 18 years and older. Randomization was stratified by age (18-59 years, 60 years
and older) and presence or absence of comorbidities associated with an increased risk of
progression to severe COVID-19. The study allowed for the inclusion of individuals with stable
pre-existing medical conditions, defined as disease not requiring significant change in therapy
during the 3 months preceding vaccination, as well as individuals with stable human
immunodeficiency virus (HIV) infection.
A total of 44,325 individuals were randomized equally to receive Janssen COVID-19 Vaccine or
saline placebo. Individuals are planned to be followed for up to 24 months, for assessments of
safety and efficacy against COVID-19.
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The primary efficacy analysis population of 39,321 individuals (19,630 in the Janssen COVID-19
Vaccine group and 19,691 in the placebo group) included 38,059 SARS-CoV-2 seronegative
individuals at baseline and 1,262 individuals with an unknown serostatus. Demographic and
baseline characteristics were similar among individuals who received the Janssen COVID-19
Vaccine and those who received placebo (see Table 9).
Table 9: Summary of Demographics and Baseline Characteristics - Primary Efficacy Analysis
Population
Janssen COVID-19 Vaccine Placebo
(N=19,630) (N=19,691)
n (%) n (%)
Sex
Male 10,924 (55.6) 10,910 (55.4)
Female 8,702 (44.3) 8,777 (44.6)
Age (years)
Mean (SD) 51.1 (15.0) 51.2 (15.0)
Median 52.0 53.0
Min, max (18; 100) (18; 94)
Age group
≥18 to 59 years of age 12,830 (65.4) 12,881 (65.4)
≥60 years of age 6,800 (34.6) 6,810 (34.6)
≥65 years of age 3,984 (20.3) 4,018 (20.4)
≥75 years of age 755 (3.8) 693 (3.5)
Racea
White 12,200 (62.1) 12,216 (62.0)
Black or African American 3,374 (17.2) 3,390 (17.2)
Asian 720 (3.7) 663 (3.4)
American Indian/Alaska Nativeb 1,643 (8.4) 1,628 (8.3)
Native Hawaiian or other Pacific Islander 54 (0.3) 45 (0.2)
Multiple 1,036 (5.3) 1,087 (5.5)
Unknown 262 (1.3) 272 (1.4)
Not reported 341 (1.7) 390 (2.0)
Ethnicity
Hispanic or Latino 8,793 (44.8) 8,936 (45.4)
Not Hispanic or Latino 10,344 (52.7) 10,259 (52.1)
Unknown 173 (0.9) 162 (0.8)
Not reported 319 (1.6) 333 (1.7)
Region
Northern America (United States) 9,185 (46.8) 9,171 (46.6)
Latin America 7,967 (40.6) 8,014 (40.7)
Southern Africa (South Africa) 2,478 (12.6) 2,506 (12.7)
Comorbiditiesc
Yes 7,830 (39.9) 7,867 (40.0)
No 11,800 (60.1) 11,824 (60.0)
a
Some individuals could be classified in more than one category.
b
Including 175 individuals in the United States, which represents 1% of the population recruited in the United States.
c
Number of individuals who have 1 or more comorbidities at baseline that increase the risk of progression to severe/critical COVID-19:
Obesity defined as BMI ≥30 kg/m2 (27.5%), hypertension (10.3%), type 2 diabetes (7.2%), stable/well-controlled HIV infection (2.5%),
serious heart conditions (2.4%), asthma (1.3%), and in ≤1% of individuals: cancer, cerebrovascular disease, chronic kidney disease, chronic
obstructive pulmonary disease, cystic fibrosis, immunocompromised state (weakened immune system) from blood or organ transplant, liver
disease, neurologic conditions, pulmonary fibrosis, sickle cell disease, thalassemia and type 1 diabetes, regardless of age.
Revised: Oct/20/2021
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Efficacy Against COVID-19
The co-primary endpoints evaluated the first occurrence of moderate to severe/critical COVID-19
with onset of symptoms at least 14 days and at least 28 days after vaccination. Moderate to
severe/critical COVID-19 was molecularly confirmed by a central laboratory based on a positive
SARS-CoV-2 viral RNA result using a polymerase chain reaction (PCR)-based test.
• Moderate COVID-19 was defined based on the following criteria: the individual must have
experienced any one of the following new or worsening signs or symptoms: respiratory rate
≥20 breaths/minute, abnormal saturation of oxygen (SpO2) but still >93% on room air at sea
level, clinical or radiologic evidence of pneumonia, radiologic evidence of deep vein
thrombosis (DVT), shortness of breath or difficulty breathing OR any two of the following
new or worsening signs or symptoms: fever (≥38.0°C or ≥100.4°F), heart rate
≥90 beats/minute, shaking chills or rigors, sore throat, cough, malaise, headache, muscle
pain (myalgia), gastrointestinal symptoms, new or changing olfactory or taste disorders, red
or bruised appearing feet or toes.
• Severe/critical COVID-19 was defined based on the following criteria: the individual must
have experienced any one of the following at any time during the course of observation:
clinical signs at rest indicative of severe systemic illness (respiratory rate
≥30 breaths/minute, heart rate ≥125 beats/minute, oxygen saturation (SpO2) ≤93% on room
air at sea level, or partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2)
<300 mmHg), respiratory failure (defined as needing high-flow oxygen, non-invasive
ventilation, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]),
evidence of shock (defined as systolic blood pressure <90 mmHg, diastolic blood pressure
<60 mmHg, or requiring vasopressors), significant acute renal, hepatic, or neurologic
dysfunction, admission to intensive care unit (ICU), death.
Final determination of severe/critical COVID-19 cases were made by an independent adjudication
committee.
Primary analysis
The median length of follow up for efficacy for individuals in the study was 8 weeks
post-vaccination. Vaccine Efficacy (VE) for the co-primary endpoints against moderate to
severe/critical COVID-19 in individuals who were seronegative or who had an unknown serostatus
at baseline was 66.9% (95% CI: 59.0; 73.4) at least 14 days after vaccination and 66.1% (95% CI:
55.0; 74.8) at least 28 days after vaccination (see Table 10).
Revised: Oct/20/2021
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Table 10: Analyses of Vaccine Efficacy Against Centrally Confirmed Moderate to Severe/Critical
COVID-19 – With Onset at Least 14 Days and at Least 28 Days Post-Vaccination - Primary
Efficacy Analysis Population
Janssen COVID-19 Vaccine Placebo
N=19,630 N=19,691
COVID-19 COVID-19 % Vaccine
Cases Cases Efficacy
Subgroup (n) Person-Years (n) Person-Years (95% CI)
14 days post-vaccination
All subjectsa 116 3116.6 348 3096.1 66.9
(59.0; 73.4)
18 to 59 years of age 95 2106.8 260 2095.0 63.7
(53.9; 71.6)
60 years and older 21 1009.8 88 1001.2 76.3
(61.6; 86.0)
28 days post-vaccination
All subjectsa 66 3102.0 193 3070.7 66.1
(55.0; 74.8)b
18 to 59 years of age 52 2097.6 152 2077.0 66.1
(53.3; 75.8)
60 years and older 14 1004.4 41 993.6 66.2
(36.7; 83.0)
a
Co-primary endpoint.
b
The adjusted CI implements type I error control for multiple testing and is presented upon meeting the prespecified testing conditions.
Vaccine efficacy against severe/critical COVID-19 at least 14 days after vaccination was 76.7%
(95% CI: 54.6; 89.1) and 85.4% (95% CI: 54.2; 96.9) at least 28 days after vaccination (see
Table 11).
Table 11: Analyses of Vaccine Efficacy: Secondary Endpoints of Centrally Confirmed Severe/Critical
COVID-19 – in Adults 18 Years of Age and Older With Onset at Least 14 Days and at Least 28
Days Post-Vaccination – Primary Efficacy Analysis Population
Janssen COVID-19 Vaccine Placebo
N=19,630 N=19,691
COVID-19 COVID-19 % Vaccine
Cases Cases Efficacy
Subgroup (n) Person-Years (n) Person-Years (95% CI)
14 days post-vaccination
Severe/critical 76.7
14 3125.1 60 3122.0 (54.6; 89.1)a
28 days post-vaccination
Severe/critical 85.4
5 3106.2 34 3082.6 (54.2; 96.9)a
a
The adjusted CI implements type I error control for multiple testing and is presented upon meeting the prespecified testing conditions.
Among all COVID-19 cases with onset at least 14 days post vaccination, including cases diagnosed
by a positive PCR from a local laboratory and still awaiting confirmation at the central laboratory
(as of January 22, 2021), there were 2 COVID-19 related hospitalizations in the vaccine group
(with none after 28 days) and 29 in the placebo group (with 16 after 28 days).
Revised: Oct/20/2021
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As of the primary analysis cut-off date of January 22, 2021, there were no COVID-19-related
deaths reported in Janssen COVID-19 Vaccine recipients compared to 5 COVID-19-related deaths
reported in placebo recipients, who were SARS-CoV-2 PCR negative at baseline.
Janssen COVID-19 Vaccine Efficacy in Countries With Different Circulating SARS-CoV-2
Variants.
Exploratory subgroup analyses of vaccine efficacy against moderate to severe/critical COVID-19
and severe/critical COVID-19 for Brazil, South Africa, and the United States were conducted (see
Table 12). For the subgroup analyses, all COVID-19 cases accrued up to the primary efficacy
analysis data cut-off date, including cases confirmed by the central laboratory and cases with
documented positive SARS-CoV-2 PCR from a local laboratory which are still awaiting
confirmation by the central laboratory, were included. The concordance rate observed up to the
data cut-off date between the PCR results from the local laboratory and the central laboratory was
90.3%.
Table 12: Summary of Vaccine Efficacy against Moderate to Severe/Critical and Severe/Critical
COVID-19 for Countries With >100 Reported Moderate to Severe/Critical Cases
Severity
Moderate to
Severe/Critical Severe/Critical
Onset Point estimate (95% CI) Point estimate (95% CI)
US at least 14 days after vaccination 74.4% (65.0; 81.6) 78.0% (33.1; 94.6)
at least 28 days after vaccination 72.0% (58.2;81.7) 85.9% (-9.4; 99.7)
Brazil at least 14 days after vaccination 66.2% (51.0; 77.1) 81.9% (17.0; 98.1)
at least 28 days after vaccination 68.1% (48.8; 80.7) 87.6% (7.8; 99.7)
South Africa at least 14 days after vaccination 52.0% (30.3; 67.4) 73.1% (40.0; 89.4)
at least 28 days after vaccination 64.0% (41.2; 78.7) 81.7% (46.2; 95.4)
Strain sequencing was conducted on available samples with sufficient viral load from centrally
confirmed COVID-19 cases (one sequence per case). As of February 12, 2021, samples from
71.7% of central laboratory confirmed primary analysis cases had been sequenced [United States
(73.5%), South Africa (66.9%) and Brazil (69.3%)]. In the United States, 96.4% of strains were
identified as the Wuhan-H1 variant D614G; in South Africa, 94.5% of strains were identified as
the 20H/501Y.V2 variant (B.1.351 lineage); in Brazil, 69.4% of strains were identified to be a
variant of the P.2 lineage and 30.6% of strains were identified as the Wuhan-H1 variant D614G.
As of February 12, 2021, SARS-CoV-2 variants from the B1.1.7 or P.1 lineages were not found in
any of the sequenced samples.
18.2 Immunogenicity of a Booster Dose following Primary Vaccination with Janssen
COVID-19 Vaccine
In Study 2, individuals 18 through 55 years of age and 65 years and older received a booster dose
of the Janssen COVID-19 Vaccine approximately 2 months after the primary vaccination.
Immunogenicity was assessed by measuring neutralizing antibodies to SARS-CoV-2
Victoria/1/2020 strain using a qualified wild-type virus neutralization assay (wtVNA).
Immunogenicity data are available from 39 individuals, of whom 15 were 65 years of age and
older, and are summarized in Table 13. Based on a limited number of individuals from this study,
a similar fold-rise in neutralizing antibody titers from pre-booster to 14 and 28 days post-booster
Revised: Oct/20/2021
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was observed between individuals 18 through 55 years of age and individuals 65 years of age and
older.
Table 13. Study 2 - SARS-CoV-2 Neutralization Wild Type VNA-VICTORIA/1/2020 (IC50), , Per
Protocol Immunogenicity Set*
28 Days Post-
Primary Pre-Booster 14 Days Post- 28 Days Post-
Baseline Vaccination Dose Booster Dose Booster Dose
(Day 1) (Day 29) (Day 57) (Day 71) (Day 85)
N 38 39 39 39 38
Geometric mean titer <LLOQ
(95% CI) (<LLOQ, 260 (196, 346) 212 (142, 314) 518 (354, 758) 424 (301, 597)
<LLOQ)
Geometric mean fold
3.7 8.8 7.4
increase (95% CI) n/a 4.4 (3.3, 5.7)
(2.6, 5.2) (6.1, 12.8) (5.4, 10.2)
from baseline
Geometric mean fold
increase (95% CI) n/a n/a 0.9 (0.7; 1.1) 2.0 (1.5; 2.7) 1.6 (1.2; 2.1)
from day 29
Geometric mean fold
2.3 1.8
increase (95% CI) n/a n/a n/a
(1.7, 3.1) (1.4, 2.4)
from pre-booster
LLOQ = lower limit of quantification
*
PPI set: The per protocol immunogenicity population includes all randomized and vaccinated participants for whom immunogenicity data
are available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. In addition,
samples obtained after missed vaccinations or participants with SARS-CoV-2 infection occurring after screening were excluded from the
analysis.
18.3 Immunogenicity of a Booster Dose Following Primary Vaccination with Another
Authorized or Approved COVID-19 Vaccine
Effectiveness of a Janssen COVID-19 Vaccine booster dose in individuals who completed primary
vaccination with another authorized or approved COVID-19 Vaccine (heterologous booster dose)
is inferred from immunogenicity data supporting effectiveness of a Janssen COVID-19 Vaccine
booster dose administered following completion of Janssen COVID-19 Vaccine primary
vaccination and from immunogenicity data from an independent Phase 1/2 open-label clinical trial
(NCT04889209) conducted in the United States that evaluated a heterologous booster dose of the
Janssen COVID-19 Vaccine. In this study, adults who had completed primary vaccination with a
Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose
(N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior
to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to
receive a booster dose of one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-
19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine. Neutralizing antibody titers, as measured by
a pseudovirus neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein
with D614G mutation, were assessed on Day 1 prior to administration of the booster dose and on
Day 15 after the booster dose. A booster response to the Janssen COVID-19 Vaccine was
demonstrated regardless of primary vaccination.
19 HOW SUPPLIED/STORAGE AND HANDLING
Janssen COVID-19 Vaccine is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15).
A maximum of 5 doses can be withdrawn from the multi-dose vial.
Revised: Oct/20/2021
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The storage and handling information in this Fact Sheet supersedes the storage and handling
information on the carton and vial labels.
Storage Prior to First Puncture of the Vaccine Vial
Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to
46°F) and protect from light. Do not store frozen.
Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to
77°F) for up to 12 hours.
The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C
to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If
needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature
(maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an
individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.
Storage After First Puncture of the Vaccine Vial
After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to
6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if
vaccine is not used within these times.
20 PATIENT COUNSELING INFORMATION
Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.
The vaccination provider must include vaccination information in the state/local jurisdiction’s
Immunization Information System (IIS) or other designated system. Advise recipient or caregiver
that more information about IISs can be found at:
https://www.cdc.gov/vaccines/programs/iis/about.html.
21 CONTACT INFORMATION
For general questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan
the QR code using your device, visit www.janssencovid19vaccine.com or call the telephone
numbers provided below.
QR Code Fact Sheets Website Telephone numbers
www.janssencovid19vaccine.com. US Toll Free: 1-800-565-4008
US Toll: 1-908-455-9922
This Full EUA Prescribing Information may have been updated. For the most recent Full EUA
Prescribing Information, please see www.janssencovid19vaccine.com.
Revised: Oct/20/2021
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Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA
Revised: Oct/20/2021
© 2021 Janssen Pharmaceutical Companies
Revised: Oct/20/2021
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