COVID-19 Vaccine Code Set Update Publication Date: September 12, 2023
The individual filenames included in this distribution contain the publication date (20230912)
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 Set Updates
On September 12, 2023, the FDA authorized new vaccines for the Fall of 2023 under Emergency Use Authorization (EUA) for the following manufacturers:
- Pfizer: Monovalent vaccines for the Omicron XBB.1.5 virus strain for ages 6 months through 11 years
- Moderna: Monovalent vaccines for the Omicron XBB.1.5 virus strain for ages 6 months through 11 years
The FDA updated information can be found at COVID-19 Vaccines | FDA
CDC’s 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 Vaccine Information Statements for licensed vaccines). Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA.
In addition to the FDA’s EUA Recipients/Caregivers Fact Sheets, 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
The above updates impact the following three VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS URLS
- New EUA Recipient-Caregiver Fact Sheets:
The following new EUA Fact Sheet codes have been added to the VIS Code Set tables. The new documents supersede the prior EUA Fact Sheets for these manufacturers.
- Retired EUA Recipient-Caregiver Fact Sheets:
The following prior EUA Fact Sheet codes have been retired, and the status changed to Historic. These EUA Fact Sheet records have been superseded by the above new records.
- Retired EUA Recipient-Caregiver Fact Sheets – No new authorization:
The FDA has not authorized a Janssen COVID-19 vaccine for the Fall 2023 season. The following Janssen EUA Fact Sheet codes have been retired, and the status changed to Historic.
The table on CDC’s COVID-19 Related Vaccine Codes website: “COVID-19 Emergency Use Authorization Recipient and Caregiver Fact Sheets,” has also 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.
