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COVID-19 Emergency Use Authorization (EUA) Recipient/Caregiver Vaccine Information Statements (VIS) Code Set update August 23, 2021
The CDC VIS Code Set incorporates codes for COVID-19 vaccine EUA Recipient/Caregiver Fact Sheets.
At this time, 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 for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to the VIS 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. If the vaccines are not authorized, these codes will be retired.
Release Notes: This document provides a summary of the COVID-19 EUA Recipient/Caregiver VIS code updates and maps as of 08/23/2021.
FDA Provider and Recipient/Caregiver Fact Sheets have been updated following the FDA’s approval of a Biologics License Application (BLA) for Pfizer’s COMIRNATRY (COVID-19 Vaccine, mRNA). The BLA approval is for adults 16 years and older and EUA for adolescents will continue to cover adolescents ages 12 years of age through 15 years of age. At this time, it has been decided to continue using the EUA Fact Sheet format in the near term instead of a VIS document. The FDA amendments and BLA documents for Pfizer have been updated as of 8/23/2021.
Additional information is available on the FDA site:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
The CDC VIS Code Set has been updated to reflect the EUA Recipient/Caregiver Fact Sheet changes:
- COVID-19 Pfizer BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet - New Edition Date
The Edition Date has been changed to 08/23/2021
The Last Updated date has been changed to 08/23/2021
The Barcode string has not been changed and still is dated 5/1/2021
- It should be noted that the box graphic surrounding the 2D barcode on the Recipient/Caregiver Fact Sheet document was updated to reflect a date of 8/2021, but code still scans as 5/1/2021
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 medical/health records (EMRs/EHRs)/immunization information systems. As such, the VIS Code Set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EMRs/EHRs for use in a manner analogous to the electronic system and workflow documentation of VIS. As with VIS documents, the COVID-19 Vaccine EUA 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 Recipient/Caregiver Fact Sheet record in the data code set for this release.
