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COVID-19 Emergency Use Authorization (EUA) Recipient/Caregiver Vaccine Information Statement (VIS) Code Set Update August 30, 2021
The CDC VIS Code Set incorporates codes for COVID-19 vaccine EUA Recipient/Caregiver Fact Sheets.
CDC Authored VIS documents will not be available for COVID-19 vaccines while under EUA. Under EUA, the FDA requires a vaccine-specific fact sheet (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers, similar to Vaccine Information Statements for licensed vaccines. Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA. The COVID-19 vaccine related codes in this code set release are provided in anticipation of potential vaccine availability under EUA or to reflect amendments to an existing EUA. If the vaccines are not authorized, these codes will be retired.
Release Notes: This document provides a summary of the VIS code updates and maps as of 08/27/2021.
FDA Provider and Recipient/Caregiver Fact Sheets have been updated following the FDA’s amendments on 8/27/2021 to the EUAs previously authorized for Moderna.
The CDC VIS Code Set has been updated to reflect the following EUA Recipient/Caregiver Fact Sheet changes:
- COVID-19 Moderna Vaccine EUA Recipient/Caregiver Fact Sheet – New Edition Date
The Edition Date has been changed to 08/27/2021
The Last Updated date has been changed to 08/27/2021
The Barcode string has not been changed
The URL has not changed
The CVX Code has not changed
The above updates impact the following two VIS code files and tables:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
Important Considerations:
CDC is working to facilitate documentation of having provided an EUA Recipient/Caregiver Fact Sheet in electronic health/medical records (EHRs/EMRs) and immunization information systems. As such, the VIS Code Set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EHRs/EMRs for use in a manner analogous to the electronic system and workflow documentation of VIS. As with VIS documents, the COVID-19 Vaccine Recipient/Caregiver Fact Sheets may incorporate the CDC’s scannable 2D barcode in the Fact Sheet document. The numeric string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.
