Janssen COVID-19 Vaccine: Package Insert and Label Information

JANSSEN COVID-19 VACCINE- ad26.cov2.s injection, suspension
Janssen Products, LP

EMERGENCY USE AUTHORIZATION (EUA) OF THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

See Full EUA Prescribing Information for complete warning.

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.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, the Janssen COVID-19 Vaccine, for active immunization to prevent 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.

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 authorized for use under an EUA for active immunization to prevent 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.

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).

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.

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.

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 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

The Janssen COVID-19 vaccine is authorized for use under an EUA for active immunization to prevent COVID-19 caused by 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

The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL).

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.

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.

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.

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 (see Full EUA Prescribing Information).

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) (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).

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. Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 Vaccine. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. 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). (see Full EUA Prescribing Information).

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

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 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 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 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.
  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.

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-mailFax numberTelephone numbers
JNJvaccineAE@its.jnj.com215-293-9955US 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 CodeFact Sheets WebsiteTelephone numbers

Image

www.janssencovid19vaccine.com.US Toll Free: 1-800-565-4008 US Toll: 1-908-455-9922

AVAILABLE ALTERNATIVES

COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines 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 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 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.

FDA first issued this EUA in February 2021, 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 & JohnsonHorsham, PA 19044, USA

© 2021 Janssen Pharmaceutical Companies

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

Revised: May/05/2022

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
JANSSEN COVID-19 VACCINE
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION: CONTENTS* WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)
1
AUTHORIZED USE
2
DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration
2.3 Dosing and Schedule
3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
4.1 Severe Allergic Reactions
4.2 Thrombosis with Thrombocytopenia
5
WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Thrombosis with Thrombocytopenia Syndrome (TTS)
5.3 Immune Thrombocytopenia (ITP)
5.4 Guillain-Barré Syndrome
5.5 Syncope
5.6 Altered Immunocompetence
5.7 Limitations of Vaccine Effectiveness
6
OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Post Authorization Experience
8
REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
10
DRUG INTERACTIONS
11
USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Lactation
11.3 Pediatric Use
11.4 Geriatric Use
13
DESCRIPTION
14
CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
18
CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Primary Vaccination
18.2 Immunogenicity of a Booster Dose following Primary Vaccination with Janssen COVID-19 Vaccine
18.3 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine
19
HOW SUPPLIED/STORAGE AND HANDLING
20
PATIENT COUNSELING INFORMATION
21
CONTACT INFORMATION

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.2)].

Among reported cases of TTS following administration of the Janssen COVID-19 Vaccine, symptoms began approximately one to two weeks after vaccination [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.2)].

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 [see Contraindications (4.2)].

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