Topic: Vaccine Code Set Release Notes - COVID-19 and Regular Vaccine Code Updates
Vaccine Code Set Update Publication Date: March 02, 2023
The individual filenames included in this distribution contain the publication date (20230302)
Release Notes: This release includes updates for vaccine codes and maps. It also includes one VIS related codes update, the CVX to VIS map.
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 01/20/2023 to 02/22/2022, reflect the changes and additions in this release. This release includes the following code set updates:
Vaccine Code Set Update SummaryVaccine Code Set Updates Not Related to COVID-19 1. COVID-19 Related Code Updates - New COVID-19 NDCs for Novavax product added in anticipation of FDA EUA.
- Non-US Vaccines. One new CVX code added.
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
CVX Code Updates
- Three active CVX code short descriptions updated for clarity and differentiation.
NDC Code Updates:
- New NDCs added for Rotarix new prefilled single dose oral applicator.
- New Unit of Sale and Unit of Use NDCs added and associated to CVX code 119.
- Existing NDCs for Rotarix kit presentation updated – NDC description updated to add phrase “ORAL KIT”.
- NDCs retired – end date identified for old PREVNAR 13 NDC Unit of Sale.
- NDCs reactivated – NDCs retired on FDA files in error reactivated.
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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 - New COVID-19 NDCs for Novavax Added:
The following new NDCs have been added for the existing formulation of the Novavax COVID-19 vaccine. The NDCs represent a smaller vial of 5 doses. FDA EUA for this new presentation is pending. The following Novavax NDCs are published in anticipation of potential authorization. The same CVX and CPT codes will be utilized for these NDCs.
Unit of Sale NDC11 | Unit of Sale | Unit of Use NDC11 | Unit of Use | CVX Code | CVX Description | MVX Code | CPT Code |
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80631-0102-10 | CARTON, 10 VIAL, MULTI-DOSE | 80631-0102-01 | VIAL, MULTI-DOSE, 2.5 mL | 211 | COVID-19, subunit, rS-nanoparticle+Matrix-M1 Adjuvant, PF, 0.5 mL | NVX | 91304 |
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- New Non-US Vaccine CVX Code Added:
CVX code 521, "SARS-COV-2 (COVID-19) vaccine SP, protein-based, adjuvanted, B.1.351 strain (VidPrevtyn Beta), Sanofi-GSK" has been added for a GSK-Sanofi product authorized in multiple countries, but not authorized by WHO. This vaccine is not recognized by ACIP to count towards immunity in the US at this time. CVX code is not associated to an MVX code or Product Tradename record in the vaccine code sets. The CVX code table and the COVID-19 Non-US Vaccine Code table on the website have been updated.
2. Vaccine Code Updates Not Related to COVID-19 - CVX Code Updates:
- CVX code 56 "dengue fever vaccine, tetravalent" description has been updated to include the word "tetravalent" for additional specificity. This CVX code is associated only to the DENGVAXIA vaccine at this time, a tetravalent product.
- CVX code 203 "meningococcal polysaccharide (groups A, C, Y, W-135) tetanus toxoid conjugate vaccine 0.5mL dose, preservative free" has had the short description modified to include the recognized abbreviation for this vaccine antigen combination for additional clarity and quick reference. The updated short name is now "meningococcal conjugate quadrivalent, MenACWY-TT (MCV4)".
- CVX code 206 "Vaccinia, smallpox monkeypox vaccine, live attenuated, preservative free, subcutaneous or intradermal injection" has had the short description modified to introduce the preferred use of Mpox to describe this virus. The new CVX short description is "Vaccinia, smallpox Mpox vaccine live, PF, SQ or ID injection". CDC will be migrating the CVX code long description and other CDC references to use Mpox in lieu of monkeypox over time.
Note: The above CVX description changes impact all vaccine code set files where the CVX description is shown.
- New NDCs for Rotarix:
The following new NDC pair for Rotarix has been added. This represents a new pre-mixed/pre-filled single dose oral applicator presentation that includes both components that are separately provided in the other kit presentation of Rotarix. A new CVX code has not been added. The NDC descriptions for the existing kit form of Rotarix have been modified to differentiate by adding the phrase "ORAL KIT" to the original NDC description. The NDC description for the new product presentation is "ROTAVIRUS VACCINE, LIVE, ORAL, PRE-FILLED APPLICATOR".
New NDCs for Rotarix added and mapped to existing CVX and MVX codes
Sale Proprietary Name | Sale Labeler | Unit of Sale NDC11 | Unit of Use NDC11 | CVX Code | CVX Description | MVX Code |
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Rotarix | GlaxoSmithKline Biologicals SA | 58160-740-21 | 58160-740-02 | 119 | rotavirus, live, monovalent vaccine | SKB |
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- Retired NDC for PREVNAR 13
The following NDC Unit of Sale code for PREVNAR 13 was retired years ago, but CDC did not have an end date. After research, the end date has been set to 07/29/2016.
Sale Proprietary Name | Sale Labeler | Unit of Sale NDC11 | Unit of Use NDC11 |
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PREVNAR 13 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc. | 0005-1971-04 | N/A |
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- Reactivated NDCs
In January 2023, the CDC received files from the FDA that incorrectly retired a number of NDCs. At that time the CDC added end dates to each NDC based on the files received. These were published in the January 26, 2023, vaccine code set release. In February 2023, corrected records were received from the FDA, which reactivated the NDCs. In this release, CDC has removed the previously published end dates from the following NDCs.
Sale Proprietary Name | Sale Labeler | Unit of Sale NDC11 | Unit of Use NDC11 |
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DENGVAXIA | Sanofi Pasteur Inc. | 49281-0605-01 | 49281-0606-58 |
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HEPLISAV-B | Dynavax Technologies Corporation | 43528-0003-05 | 43528-0003-01 |
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IMOVAX RABIES | Sanofi Pasteur Inc. | 49281-0252-51 | 49281-0246-58 |
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Menactra | Sanofi Pasteur Inc. | 49281-0589-05 | 49281-0589-58 |
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RabAvert | Bavarian Nordic A/S | 50632-0010-01 | 50632-0013-01 |
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TENIVAC | Sanofi Pasteur Inc. | 49281-0215-10 | 49281-0215-58 |
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TENIVAC | Sanofi Pasteur Inc. | 49281-0215-15 | 49281-0215-88 |
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Typhim Vi | Sanofi Pasteur Inc. | 49281-0790-20 | 49281-0790-38 |
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Typhim Vi | Sanofi Pasteur Inc. | 49281-0790-51 | 49281-0790-88 |
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YF-VAX | Sanofi Pasteur Inc. | 49281-0915-01 | 49281-0915-58 |
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YF-VAX | Sanofi Pasteur Inc. | 49281-0915-05 | 49281-0915-68 |
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- Final Note:
In addition to the NDC updates listed above, FDA files received and processed by CDC included files that initially retired, then correctly reactivated a large number of NDCs. Unfortunately, these changes reset the date of last update that we publish for each NDC even though there was no discernable change to the other CDC published NDC information. The affected records are all units of use and have a date of last update of 02/01/2023.
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