Vaccine Code Set Update Publication Date: December 05, 2022
The individual filenames included in this distribution contain the publication date (20221205)
Release Notes: This release primarily includes updates for COVID-19 CVX codes related to identifying and recording non-US vaccine administrations. The COVID-19 Non-US Vaccine Codes table has been updated to reflect changes in this release: IIS COVID-19 Vaccine Related Code | CDC
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 Notes Regarding this Release:
Codes with "Last Update" dates from October 24, 2022, through December 1, 2022, reflect the changes and additions in this release.
This release includes the following code set updates:
COVID-19 Related Code Updates
- Updates to current US CVX codes also used to record non-US vaccinations
- New non-US CVX codes considered to count towards immunity in the US
- New non-US COVID-19 codes not considered to count towards immunity in the US
Other Vaccine Code Set Updates Not Related to COVID-19
- Retired NDCs
- GTIN added to UoU
COVID-19 Related Code Updates – Non-US
COVID-19 vaccine codes and crosswalks are 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. All CVX codes are associated to the Vaccine Group "COVID-19."
- Updates to current US CVX codes also used to record non-US vaccinations
Table 1. The following CVX codes have been updated to reflect new non-US tradenames for the same formulations available in other countries. In addition, the CVX Note for the AstraZeneca vaccine has been updated. Updated fields are in red text.
CVX Code | CVX Long Description | CVX Short Description | CVX Note | CVX Status | MVX Code | MVX Manufacturer | Product Tradename |
|---|
211 | SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein-nanoparticle+Matrix-M1 Adjuvant, preservative free, 0.5mL dose | COVID-19, subunit, rS-nanoparticle+Matrix-M1 Adjuvant, PF, 0.5 mL | EUA 07/13/2022, 2-dose vaccine. Used to record Novavax vaccines administered in the US and in non-US locations (includes tradenames NUVAXOVID, COVOVAX) | Active | NVX | Novavax | Novavax COVID-19 Vaccine (Non-US Tradenames NUVAXOVID, COVOVAX) |
|---|
210 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating, recombinant spike protein-ChAdOx1, preservative free, 0.5 mL | COVID-19 vaccine, vector-nr, rS-ChAdOx1, PF, 0.5 mL | WHO authorized pandemic vaccine. Recognized towards immunity in US. AstraZeneca vaccine non-US WHO authorized tradenames/identifiers include VAXZEVRIA, AZD1222, ChAdOx1 nCoV-19, COVISHIELD | Non-US | ASZ | AstraZeneca | AstraZeneca COVID-19 Vaccine (Non-US tradenames include VAXZEVRIA, COVISHIELD) |
|---|
300 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 30 mcg/0.3 mL dose, tris-sucrose formulation | COVID-19, mRNA, LNP-S, bivalent booster, PF, 30 mcg/0.3 mL dose | EUA authorized Pfizer adult bivalent booster ages 12+ yrs, original strain + omicron BA.4/BA.5. Not Authorized by WHO. Non-US Tradename for same formulation (Comirnaty Bivalent) counted toward immunity in US | Active | PFR | Pfizer, Inc | Pfizer-BioNTech COVID-19 Bivalent, Original + BA.4/BA.5 (Non-US Tradename COMIRNATY Bivalent) |
|---|
229 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 50 mcg/0.5 mL or 25 mcg/0.25 mL dose | COVID-19, mRNA, LNP-S, bivalent booster, PF, 50 mcg/0.5 mL or 25mcg/0.25 mL dose | EUA authorized Moderna bivalent booster original strain + omicron BA.4/BA.5 2 dose levels: ages 6 yrs thru 11 yrs 0.25mL dose; 12 years and older 0.5mL dose. Non-US Tradename for same formulation (Spikevax Bivalent) - not authorized by WHO - is authorized by EU and counted toward US immunity | Active | MOD | Moderna US, Inc. | Moderna COVID-19 Bivalent, Original + BA.4/BA.5 (Non-US Tradename Spikevax Bivalent) |
|---|
- New non-US CVX codes considered to count towards immunity in the US.
Table 2. Note that for any non-US CVX code that counts towards immunity in the US there is an MVX code and Product Tradename record.
CVX Code | CVX Long Description | CVX Short Description | CVX Note | CVX Status | MVX Code | MVX Manufacturer | Product Tradename |
|---|
519 | SARS-COV-2 COVID-19 mRNA, bivalent, original/Omicron BA.1, Non-US Vaccine (Spikevax Bivalent), Moderna | COVID-19 mRNA, bivalent, original/Omicron BA.1, Non-US Vaccine (Spikevax Bivalent), Moderna | Pandemic Non-US Vaccine not Authorized by WHO - Is authorized by EU and counted toward immunity in US | Non-US | MOD | Moderna US, Inc. | Moderna COVID-19 Bivalent, Original + BA.1 (Non-US Tradename Spikevax Bivalent) |
|---|
520 | SARS-COV-2 COVID-19 mRNA, bivalent, original/Omicron BA.1, Non-US Vaccine Product (Comirnaty Bivalent), Pfizer-BioNTech | COVID-19 mRNA, bivalent, original/Omicron BA.1, Non-US Vaccine Product (Comirnaty Bivalent), Pfizer-BioNTech | Pandemic Non-US Vaccine. Authorized by WHO - counted toward immunity in US | Non-US | PFR | Pfizer, Inc | Pfizer COVID-19 Bivalent, Original + BA.1 (Non-US Tradename COMIRNATY Bivalent) |
|---|
- New non-US CVX codes – not considered to count towards immunity in the US.
Table 3. Note that MVX code and Tradename record are not added for this category of non-US codes.
CVX Code | CVX Long Description | CVX Short Description | CVX Note | CVX Status | MVX Code | MVX Manufacturer | Product Tradename |
|---|
518 | SARS-COV-2 COVID-19 Inactivated, Non-US Vaccine (VLA2001, Valneva) | COVID-19 Inactivated, Non-US Vaccine (VLA2001, Valneva) | Pandemic Non-US Vaccine not Authorized by WHO - not counted toward immunity in US | Non-US | NA | NA | NA |
|---|
Other Vaccine Code Set Updates Not Related to COVID-19
- Retired NDCs.
Table 4. The following NDCs have been retired effective 11/09/2022 from the FDA files.
Proprietary Name | Sale Labeler | Sale NDC10 and NDC11 | Use NDC10 and NDC11 | CVX Code | MVX Code |
|---|
PENTACEL | Sanofi Pasteur Inc. | 49281-510-05
49281-0510-05 | 49281-560-05
49281-0560-05
49281-548-58
49281-0548-58 | 120 | PMC |
|---|
In addition, the following two updates have been made to NDC records:
- NDC Unit of Use GTIN Added:
- FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE
- NDC10 49281-339-78, NDC11 49281-0339-78
- GTIN added: 00349281339783
