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):
- The Janssen COVID-19 Vaccine is authorized for use in individuals 18 years of age and older
- 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
- The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system
The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
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.
*Serious adverse events are defined as:
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.:
COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act.