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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

Important safety information