Vaccine Code Set Update Publication Date: July 11, 2022
The individual filenames included in this distribution contain the publication date (20220711)
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
- On 7/8/2022 the FDA amended the Pfizer BioNtech COMIRNATY Biologics License Application (BLA) to expand the age group to include individuals 12 years through 15 years of age for the primary series and associated immunocompromised (IC) and booster doses. Recipient/Caregiver Fact Sheets for the Pfizer BioNtech COVID-19 vaccines for individuals 12 years and older have been updated to reflect this amendment. Thus, the age groups for both the BLA licensed and Emergency Use Authorization (EUA) vaccines are in alignment and both cover ages 12 years and older. There is an updated edition of the Fact Sheets for both the Healthcare Provider Fact Sheet and the Recipient/Caregiver Fact Sheet. The edition date for the “COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older” has been updated.
Information and links to the COVID-19 Provider and Recipient/Caregiver Fact Sheets can be found on the following FDA site: COVID-19 Vaccines | FDA
The CDC 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.
In addition to the FDA’s EUA Fact Sheets for Recipients/Caregivers, the 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
Update Details:
- Updated Fact Sheet Edition Date: “COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older”
- Edition Date: 07/08/2022
- Last Updated date: 07/08/2022
- All other information remains the same
The above updates impact the following two VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
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.
