Mandatory Requirements for Janssen COVID-19 Vaccine Administration Under Emergency Use Authorization

Mandatory Requirements for Janssen COVID‑19 Vaccine Administration Under Emergency Use Authorization

The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

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
  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
    • 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 1-800-822-79671-800-822-7967. 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.:

    Phone icon Contact Janssen Biotech, Inc. at:

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

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

Important safety information

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

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).

ADVERSE REACTIONS

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

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

Reporting Adverse Events and Vaccine Administration Error

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

Instructions for Reporting to VAERS

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

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

PREGNANCY AND LACTATION

DOSING AND SCHEDULE

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

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

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

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Important safety information

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

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).

ADVERSE REACTIONS

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

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

Reporting Adverse Events and Vaccine Administration Error

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

Instructions for Reporting to VAERS

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

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

PREGNANCY AND LACTATION

DOSING AND SCHEDULE

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

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

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

cp-213942v1