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
- Moderna: On 10/12/2022 the FDA amended the Emergency Use Authorization (EUA) for Moderna to extend authorization to include bivalent boosters for ages 12 years through 17 years for the adult dose and 6 years through 11 years for a pediatric dose. This is reflected in both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheet. All EUA Recipient/Caregiver Fact Sheets for ages 6 years and older have been consolidated into one Recipient/Caregiver Fact Sheet.
- Pfizer: On 10/12/2022 the FDA amended the EUA for Pfizer to extend authorization to include bivalent boosters for ages 5 years through 11 years. This is reflected in both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheet. The FDA has also made minor updates to the EUA Fact Sheet for 12 years and older.
- Sanofi: The manufacturer has advised CDC that they will not be submitting a COVID-19 vaccine for EUA at this time. The CDC Codes and EUA Fact Sheet records associated to the pre-EUA authorization of a Sanofi vaccine are being retired.
Information and links to the COVID-19 Provider and Recipient-Caregiver Fact Sheets as well as the EUA authorization Letter and Dear Healthcare Provider Letters 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:
- New Fact Sheet: "COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet - 6 yrs and older"
Note: This edition supersedes the following two EUA Fact Sheets, "COVID-19 Moderna Vaccine EUA Recipient-Caregiver Adult Fact Sheet" and "COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs"
The following two Moderna EUA Fact Sheets have been updated:
COVID-19 Moderna Vaccine EUA Recipient-Caregiver Adult Fact Sheet
- Document Barcode String: 253088698300034911210601
- Last Updated date: 10/12/2022
- Edition Status: Historic
COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs
- Document Barcode String: 253088698300050911220501
- Last Updated date: 10/12/2022
- Edition Status: Historic
- Updated Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs"
- Document Barcode String: 253088698300042411211001
- Edition Date: 10/12/2022
- Last Updated date: 10/12/2022
- All other information remains the same
- Updated Fact Sheet Edition Date: "COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet-12 years and older"
- Document Barcode String: 253088698300033211210501
- Edition Date: 10/12/2022
- Last Updated date: 10/12/2022
- All other information remains the same
- Retired Fact Sheet Edition Date: "COVID-19 Sanofi-GSK EUA Recipient-Caregiver Fact Sheet - Booster"
- Document Barcode String: 253088698300052311220401
- Edition Status: Historic
- Last Updated date: 09/28/2022
- No new edition will replace this retired edition
The above updates impact the following three VIS code files:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS URLs
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.
