COVID-19 Vaccine Code Set Update Publication Date: December 08, 2022
The individual filenames included in this distribution contain the publication date (20221208)
Release Notes: This release updates to COVID-19 related Recipient/Caregiver Fact Sheet Vaccine Information Statement (VIS) and adds new CVX to VIS 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
Summary and Background
Information and links to the COVID-19 Provider and Recipient/Caregiver Fact Sheets for all manufacturers can be found on the following FDA site: COVID-19 Vaccines | FDA
Updates in this release include:
- Pfizer EUA Recipient/Caregiver Fact Sheet Edition Dates updated for three Fact Sheets and one new CVX to VIS/Fact Sheet association.
- Moderna EUA Recipient/Caregiver Fact Sheet Edition Dates updated for two Fact Sheets and one new CVX to VIS/Fact Sheet association.
On December 08, 2022, the FDA amended the Pfizer EUA and the Moderna EUA to authorize bivalent vaccines for the ages 6 months to < 5 years (Pfizer) and 6 months to < 6 years (Moderna). As part of this action, the FDA made updates and added guidance regarding all bivalent vaccines and other updates to the following:
Pfizer: Pfizer-BioNTech COVID-19 Vaccines | FDA
- Five Pfizer EUA Healthcare Provider Fact Sheets covering ages 6 months through adults
- Three Pfizer EUA Recipient/Caregiver Fact Sheets covering ages 6 months through adults
- New Pfizer Dear Healthcare Provider Letter, "Subject: Pfizer BioNTech COVID-19 Vaccine and Pfizer BioNTech COVID-19 Vaccine, Bivalent – Change in Third Dose of 3-Dose Primary Series for Individuals 6 months through 4 Years of Age"
- In addition, FDA authorized lot expiration extensions for some lots/products
Moderna: Moderna COVID-19 Vaccines | FDA
- Five Moderna EUA Healthcare Provider Fact Sheets for vaccine products covering ages 6 months through adults
- Two Moderna EUA Recipient/Caregiver Fact Sheets covering ages 6 months through adults
- New Dear Healthcare Provider Letter, "Subject: Moderna COVID-19 Vaccine, Bivalent – New Vial Presentation Available to Provide Booster Doses for Ages 6 Months Through 5 Years of Age"
CDC VIS Code Set Update Details
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
The following updates have been made to the vaccine code set VIS files:
- Updated EUA Recipient Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric <5 yrs"
- Existing Barcode String: 253088698300048611220101
- Updated Edition Date: 12/08/2022
- Updated Last Updated date: 12/08/2022
- Added association of CVX code 302 to this VIS
- All other information remains the same
- Updated EUA Recipient Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs"
- Existing Barcode String: 253088698300042411211001
- Updated Edition Date: 12/08/2022
- Updated Last Updated date: 12/08/2022
- All other information remains the same
- Updated EUA Recipient Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older"
- Existing Barcode String: 253088698300033211210501
- Updated Edition Date: 12/08/2022
- Updated Last Updated date: 12/08/2022
- All other information remains the same
- Updated EUA Recipient Fact Sheet Edition Date: "COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6mo to <6yrs"
- Existing Barcode String: 253088698300051611220501
- Updated Edition Date: 12/07/2022
- Updated Last Updated date: 12/08/2022
- Added association of CVX code 230 to this VIS
- Updated URL Redirect: Now points to the FDA site URL for this document
- All other information remains the same
- Updated EUA Recipient Fact Sheet Edition Date: "COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet - 6 yrs and older"
- Existing Barcode String: 253088698300034911220901
- Updated Edition Date: 12/08/2022
- Updated Last Updated date: 12/08/2022
- All other information remains the same
Note: The Edition Date reflects the actual revision date printed on the document. This date may differ slightly from the FDA authorization date. For all the above the Last Updated date reflects the EUA authorization amendment date.
The above updates impact the following VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS URL file – no changes
The above updates are also reflected on updates to the following COVID-19 related tables:
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.
