COVID-19 Vaccine Code Set Update Publication Date: April 19, 2023
The individual filenames included in this distribution contain the publication date (20230419)
Release Notes: This release includes updates for COVID-19 related Recipient/Caregiver Fact Sheet Vaccine Information Statement (VIS) codes and maps.
Release notes are designed as a guide to highlight changes that have been made to the vaccine codes since the last publication. They should not be used as the primary source of code information. The vaccine code files themselves should be utilized.
COVID-19 Related VIS Code Updates
FDA EUA Action 04/18/2023: The FDA has amended the Emergency Use Authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to amend the authorized doses and schedules for ages 6 months and older. All mRNA COVID-19 vaccine doses are now to be administered from the currently available bivalent products. This FDA EUA update also rescinds use of the Pfizer and Moderna monovalent products.
EUAs for Janssen and Novavax products remain unchanged.
In addition to the FDA’s EUA Fact Sheets for Recipients/Caregivers, CDC may provide additional or updated clinical guidance for products under EUA. See the following link for the latest CDC COVID-19 vaccine clinical guidance: Clinical Guidance for COVID-19 Vaccination | CDC
Summary of Changes
- Pfizer:
- Moderna:
- CDC Vaccine Code Set and Table Updates:
- VIS Codes: New CDC EUA Recipient/Caregiver Fact Sheet/VIS document codes and URLs have been added for the new documents with an edition date of 4/18/2023. Prior Fact Sheet/VIS codes have been retired.
- CDC COVID-19 Related US Codes table IIS COVID-19 Vaccine Related Code | CDC has been updated to reflect updates to the Pfizer and Moderna bivalent vaccine product dosing and to identify rescission of the previously authorized monovalent vaccines.
- CDC COVID-19 Related EUA Recipient/Caregiver Fact Sheet table IIS COVID-19 Vaccine Related Code | CDC has been updated.
NOTE: The retirement (addition of end dates) for the monovalent NDCs and the inactivation of the associated CVX codes for the monovalent vaccines will be made in a subsequent code set release. In that release, CDC will also include minor changes to CVX descriptions of the bivalent vaccine codes to remove the word “booster” and updates to the CVX notes field for all CVX codes impacted by the FDA action.
CDC’s VIS Code Set incorporates codes for COVID-19 vaccine Emergency Use Authorization (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 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. If the vaccines are not authorized, these codes will be retired.
Vaccine Code Set Change Details
1. Two New Recipient/Caregiver Fact Sheets Added:
The above new Fact Sheets consolidated and replaced the following prior editions and documents which are now set to “historic” status”:
VIS Document Type Description / Concept Name | VIS Fully-encoded text string | VIS GDTI document code / Concept code | Edition Status | Last Updated Date |
|---|
COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older | 253088698300033211210501 | 0886983000332 | Historic | 04/18/2023 |
|---|
COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs | 253088698300042411211001 | 0886983000424 | Historic | 04/18/2023 |
|---|
COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric <5 yrs | 253088698300048611220101 | 0886983000486 | Historic | 04/18/2023 |
|---|
COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet - 6 yrs and older | 253088698300034911220901 | 0886983000349 | Historic | 04/18/2023 |
|---|
COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6mo to <6yrs | 253088698300051611220501 | 0886983000516 | Historic | 04/18/2023 |
|---|
The above updates impact the following three VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS URL Table
The table on CDC’s COVID-19 Related Vaccine Codes website: “COVID-19 Emergency Use Authorization Recipient and Caregiver Fact Sheets,” has been updated to reflect these changes.
Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients/Caregivers in electronic medical records/immunization information systems (EMRs/IISs). 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 will 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.
