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CDC Immunizations Information Systems (IIS) Vaccine Information Statements (VIS) Code Set Release Notes
COVID-19 EUA Recipient/Caregiver VIS Code Set update October 20, 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 10/20/2021.
The FDA amended EUA authorizations on 10/20/2021 for Janssen (J&J) and Moderna to authorize booster doses. In addition, the FDA incorporated amendments to all three manufacturer vaccines under EUA (Pfizer-BioNTech, Moderna, and Janssen) to allow heterologous (mix and match) dosing across vaccines. The following code updates provide new or updated VIS code records to reflect the new FDA EUA amended Recipient/Caregiver Fact Sheets.
Further information regarding the FDA EUA amendments of 10/20/2021 as well as both the EUA Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets are available on the FDA site.
In addition to the code updates reflecting the above 10/20/2021 FDA action, a new VIS record has been added in anticipation of potential FDA EUA authorization for a Pfizer-BioNTech vaccine for children 5 through 11 years of age.
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
- VIS to Current URL Table
The following records have been updated- Moderna:
- COVID-19 Moderna Vaccine EUA Recipient/Caregiver Fact Sheet
- Retired: VIS Barcode string record for edition dated 08/27/2021 in no longer active. Status has been changed to “Historic”
- Added: New VIS Barcode string record with edition date of 10/20/2021 and status of “Current” has been added
- Janssen (J&J):
- COVID-19 Janssen Vaccine EUA Recipient/Caregiver Fact Sheet
- Updated: The Edition Date has been changed to 10/20/2021
- The Last Updated Date has been changed to 10/20/2021
- The Barcode string has not been changed
- The URL has not changed
- Pfizer-BioNTech:
- COVID-19 Pfizer-BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet
- Updated: The Edition Date has been changed to 10/20/2021
- The Last Updated Date has been changed to 10/20/2021
- 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 a new potential EUA Fact Sheet for a pediatric vaccine for children 5 through 11 years of age. If authorized, this new VIS record will be active concurrently with the existing fact sheet described above. The new URLs will not be activated until the FDA authorizes this vaccine under EUA and publishes a Recipient/Caregiver Fact Sheet for this vaccine.
- Added: New VIS Barcode string record with a placeholder Edition Date of 10/20/2021 and status of “Current” has been added
Note: The Edition Date will be updated upon authorization as needed to reflect the actual document date
- New GDTI and associated URLs have been added, pending FDA EUA for activation and redirect to the document
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.
