You are subscribed to one or more CDC code sets email subscription services. Subscription links are available on each of the pages below.
COVID-19 Special Release VIS Code Set additions December 11, 2020
This special release of the CDC VIS Code Set incorporates new preview codes for COVID-19 vaccine Emergency Use Authorization (EUA) Recipient/Caregiver Fact Sheets in anticipation of Emergency Use Authorization (EUA).
CDC Authored VIS documents will not be available for COVID-19 vaccines while under Emergency Use Authorization. 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 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 Emergency Use Authorization. If the vaccines are not authorized, these codes will be retired.
Release Notes: This document provides a summary of the Vaccine Information Statement (VIS) code updates and maps included in this COVID-19 Special Release effective December 11, 2020.
The COVID-19 Vaccines addressed in this release are:
- Pfizer-BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
Additional COVID-19 Special Releases with advance preview codes will be provided as other COVID-19 vaccines near their Emergency Use Authorization request submissions to FDA.
The release includes additions to each of the following code files and tables:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS to Current URL 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 medical records/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. Each Barcode String includes a unique Global Document Identifier (GDTI) that identifies the vaccine and the specific EUA Recipient/Caregiver Fact Sheet edition date for the document.
The URL document links shown in the table below will not be activated until FDA-issued EUA for COVID-19 vaccine with the FDA-authorized EUA Recipient/Caregiver Fact Sheet is available.
The FDA issued Emergency Use Authorization for the Pfizer BioNTech COVID-19 vaccine on Friday December 11, 2020. Information regarding that vaccine as well as both the EUA Provider Fact Sheet and the EUA Recipient and Caregiver Fact Sheets is available on the following FDA web site link:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine
The codes shown below have been developed in advance of potential EUA decision by FDA for each vaccine and can be downloaded from the CDC IIS Vaccine Code Sets web site pages found at https://www.cdc.gov/vaccines/programs/iis/code-sets.html.
