Topic: Vaccine Code Set Release Notes - COVID-19 and Regular Vaccine Code Updates
Vaccine Code Set Update Publication Date: March 21, 2023
The individual filenames included in this distribution contain the publication date (20230321)
Release Notes: This release includes updates for vaccine codes and maps. It also includes COVID-19 Recipient Fact Sheet VIS related codes updates.
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.
General Note Regarding This Release: Codes with “Last Update” dates from 02/21/2023 to 03/16/2023, reflect the changes and additions in this release. This release includes the following code set updates:
Vaccine Code Set Update Summary1. COVID-19 Related Code Updates - VIS edition date updated for Janssen COVID-19 Recipient and Caregiver Fact Sheet
Note: COVID-19 vaccine codes and crosswalks may be provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). Codes will become effective for US vaccine administrations only upon EUA issuance and/or BLA approval of COVID-19 vaccine(s) by the FDA. 2. Vaccine Code Set Updates Not Related to COVID-19 - New Southern Hemisphere Influenza Vaccines for 2023 Season
- Three new NDC pairs added for Fluzone Quadrivalent Southern Hemisphere
- New CVX code 231 added “influenza, seasonal, Southern Hemisphere, high-dose, quadrivalent, 0.7mL dose, preservative free”
- New product name added “FLUZONE High-Dose Quadrivalent Southern Hemisphere”
- Other NDC Code Updates: End dates identified for old IXIARO NDC Pair Unit of Sale and Unit of Use
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Vaccine Code Set Update DetailsThe core CDC IIS vaccine data code sets have been updated to reflect the changes in this release. These can be found at IIS Data Code Sets | CDC. The COVID-19 Related Codes Tables for US Vaccines IIS COVID-19 Vaccine Related Code | CDC and for non-US Vaccines IIS COVID-19 Vaccine Related Code | CDC have been updated to reflect the changes in this release. 1. COVID-19 Related Code Updates 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, 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
- Janssen: On 3/13/2023 the FDA amended the Emergency Use Authorization (EUA) for Janssen to “provide new safety information regarding the serious risks of myocarditis and pericarditis following administration of the Janssen COVID-19 Vaccine in the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and in the Fact Sheet for Recipients and Caregivers for the Janssen COVID-19 Vaccine”
The EUA Recipient/Caregiver Fact Sheet “COVID-19 Janssen Vaccine EUA Recipient-Caregiver Fact Sheet” has updated with a new edition date of 03/13/2023.
Updated Fact Sheet VIS Code Set Fields: “COVID-19 Janssen Vaccine EUA Recipient-Caregiver Fact Sheet”- Existing Barcode String: 253088698300036311210201
- New Edition Date: 03/13/2023
- New Last Updated date: 03/13/2023
- All other information remains the same
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 been updated to reflect these changes.
2. Vaccine Code Updates Not Related to COVID-19 - New Southern Hemisphere Influenza Vaccines for 2023 Season
Three new NDC pairs have been added for Fluzone Quadrivalent Southern Hemisphere products. Note that as of this publication date, there is no pediatric dose listed for the 2023 season.
The Southern Hemisphere 2023 Influenza Season table and downloable Excel file has been updated and is available at IIS Data Code Sets | CDC
Southern Hemisphere 2023 Influenza Season CVX Code | CVX Short Description | Sale Proprietary Name | Sale Labeler | MVX Code | Unit of Sale NDC11 | Unit of Use NDC11 | Presentation |
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201 | influenza, Southern Hemisphere, preservative free | FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE | Sanofi Pasteur Inc. | PMC | 49281-0323-50 | 49281-0323-88 | SYRINGE, 0.5 mL |
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202 | influenza, Southern Hemisphere, quadrivalent, with preservative | FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE | Sanofi Pasteur Inc. | PMC | 49281-0355-15 | 49281-0355-78 | VIAL, MULTI-DOSE, 5 mL |
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231 | influenza, Southern Hemisphere, high-dose, quadrivalent | FLUZONE High-Dose Quadrivalent Southern Hemisphere | Sanofi Pasteur Inc. | PMC | 49281-0379-50 | 49281-0379-88 | SYRINGE, .7 mL |
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The following CVX code 231 has been added:
CVX Code | CVX Short Description | Long Description | Note | CVX Status |
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231 | influenza, Southern Hemisphere, high-dose, quadrivalent | influenza, seasonal, Southern Hemisphere, high-dose, quadrivalent, 0.7mL dose, preservative free | Target population 65 and older, starting Southern Hemisphere season 2023 | Active |
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In addition to the above, a new product name has been added “FLUZONE High-Dose Quadrivalent Southern Hemisphere” to the product to CVX/MVX file. 3. Other NDC Code Updates: End dates of 02/13/2018 have been identified and added for old IXIARO NDC Pair: NDC UoS 42515-001-01 and NDC UoU 42515-001-00. 4. Final Note:
CDC has performed some internal maintenance of CVX code fields that are not visible in the website publications. These updates have impacted the date of last update on the CVX records. The affected eleven CVX code records have a date of last update of 03/09/2023. |
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