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COVID-19 EUA Recipient/Caregiver VIS Code Set update October 29, 2021
The CDC VIS Code Set incorporates codes for COVID-19 vaccine Emergency Use Authorization (EUA) Recipient/Caregiver Fact Sheets.
CDC-authored Vaccine Information Statements (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 VIS 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 Emergency Use Authorization. If the vaccines are not authorized, these codes will be retired.
Release Notes: This document provides a summary of VIS code updates as of 10/29/2021.
On 10/29/2021 the FDA authorized a new Pfizer vaccine for children ages 5 to <12 years of age. The FDA also amended the Pfizer EUA authorization for ages 12 years and older to add a new tris-sucrose formulation of the same dose and strength. The VIS document code Edition Dates have been updated to reflect the FDA EUA amended Recipient/Caregiver Fact Sheets. In addition, CVX to VIS Maps have been updated to reflect the new product authorizations.
Further information regarding the FDA EUA amendments of 10/29/2021 as well as both the EUA Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets are available on the FDA site.
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age | FDA
The following specific CDC VIS code set changes are included in this VIS code set update in support of EUA Recipient/Caregiver Fact Sheet updates:
The VIS Code files updated in this release are
- VIS Barcode Lookup Table
- CVX Mapped to VIS
No changes were made to the VIS to Current URL Table, however the URL for the children’s vaccine has now been activated.
Please note that the 2D barcode appearing on the EUA Recipient Fact sheet correctly scans to the codes listed below. However on both fact sheets the text below the barcode indicates that the barcode date is 9/30/2021. This date is incorrect and should be ignored.
The following VIS records have been updated
- Pfizer-BioNTech:
- COVID-19 Pfizer-BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet (this is the fact sheet for ages 12 years and older)
- Updated: The Edition Date has been changed to 10/29/2021
- The Last Updated Date has been changed to 10/29/2021
- CVX Code 217 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3mL dose, tris-sucrose formulation”, has been mapped to this VIS. CVX 208 also continues to be mapped to this VIS.
- The Barcode string has not been changed
- The URL has not changed
- COVID-19 Pfizer BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet – Pediatric (this is the fact sheet for ages 5 to <12 years)
- Updated: The Edition Date has been changed to 10/29/2021
- The Last Updated Date has been changed to 10/29/2021
- CVX Code 218 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 10 mcg/0.2mL dose, tris-sucrose formulation”, has been mapped to this VIS.
- The Barcode string has not been changed
- The URL has not changed, but the redirect to the actual document has been activated
Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Recipient/Caregiver Fact Sheet in electronic medical records/immunization information systems. 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 barcode string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.
