Vaccine Code Set Update Publication Date: June 21, 2022
The individual filenames included in this distribution contain the publication date (20220617)
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 June 17, 2022 the FDA provided the following 4 authorizations under Emergency Use Authorization (EUA):
- EUA for the Pfizer 6 month to < 5 year old vaccine. This is reflected in initial editions of both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets. In addition, the FDA published a Dear Healthcare Provider Letter providing additional information regarding this vaccine. The edition date for the “COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric <5 yrs” has been updated in CDC code sets.
- EUA for the Moderna 6 month to < 6 year old vaccine. This is reflected in initial editions of both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets. In addition, the FDA published a Dear Healthcare Provider Letter providing additional information regarding this vaccine. The edition date for the “COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6 mo to <6 yrs” has been updated in CDC code sets.
- EUA for the Moderna 6 year to < 12 year old vaccine. This is reflected in initial editions of both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets. In addition, the FDA published a Dear Healthcare Provider Letter providing additional information regarding this vaccine. The edition date for the “COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6 yr to <12 yrs” has been updated in CDC code sets.
- EUA amended for the adult Moderna vaccine to extend ages eligible to include ages 12 years through 17 years. This is reflected in new editions of both the EUA Healthcare Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets. The edition date for the “COVID-19 Moderna EUA Recipient-Caregiver Adult Fact Sheet” has been updated in CDC code sets.
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
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. 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, 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- Pediatric <5 yrs”
- Edition Date: 6/17/2022
- Last Updated date: 6/17/2022
- URL links activated. All other information previously published remains the same.
- Updated Fact Sheet Edition Date: “COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6mo to <6yrs”
- Edition Date: 6/17/2022
- Last Updated date: 6/17/2022
- URL links activated. All other information previously published remains the same.
- Updated Fact Sheet Edition Date: “COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs”
- Edition Date: 6/17/2022
- Last Updated date: 6/17/2022
- CVX code 221 "COVID-19, mRNA, LNP-S, PF, 50 mcg/0.5 mL dose" now mapped to this VIS code (*)
- URL links activated. All other information previously published remains the same.
- Updated Fact Sheet Edition Date: “COVID-19 Moderna Vaccine EUA Recipient-Caregiver Adult Fact Sheet”
- Edition Date: 6/17/2022
- Last Updated date: 6/17/2022
- CVX code 221 "COVID-19, mRNA, LNP-S, PF, 50 mcg/0.5 mL dose" now mapped to this VIS code and to the VIS code for the “COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs” (*)
- All other information previously published remains the same.
(*) The Moderna vaccine for ages 6 years to < 12 years will be administered using the same vial as the adult booster dose of the same concentration and dose and documented using CVX code 221. The NDCs and CVX code 227 which were previously associated to this age cohort have been inactivated.
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.
