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COVID-19 Emergency Use Authorization (EUA) Recipient/Caregiver VIS Code Set update September 22, 2021
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 for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to 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 VIS code updates and maps as of 09/22/2021.
FDA Provider and Recipient/Caregiver Fact Sheets have been updated following the FDA’s amendment on 9/22/2021 to the EUA previously authorized for Pfizer. This update addresses authorization for a booster dose for certain populations. The authorized populations for the booster are included in the Recipient/Caregiver Fact Sheet and further guidance may be provided by the Advisory Committee on Immunization Practices (ACIP). Information regarding these vaccines as well as both the EUA Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheet are available on the FDA site.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations
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 09/22/2021
The Last Updated Date has been changed to 09/22/2021
The Barcode string has not been changed
The URL has not changed
The CVX Code has not changed
It should be noted that the graphic surrounding the 2D barcode on the last page of the COVID-19 Pfizer BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet cites the date of 08/2021, the scanned 2D barcode string ends in a date of 0521 (May 2021)). The date last updated on the document reads 09/22/2021.
The above updates impact the following two VIS code files and tables:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) in electronic health/medical records (EHRs/EMRs)/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.