Topic: Vaccine Code Set Release Notes - Regular Vaccine Code Updates
Vaccine Code Set Update Publication Date: June 08, 2023
The individual filenames included in this distribution contain the publication date (20230608)
Release Notes: This release includes updates for regular vaccine codes and maps.
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 05/17/2023 to 06/06/2023, reflect the changes and additions in this release. Summary and detailed descriptions of the changes are included in the following sections.
Vaccine Code Set Update Summary
Vaccine Code Set Updates:
- New Respiratory Syncytial Virus (RSV) Vaccine Codes. FDA has approved the GlaxoSmithKline RSV vaccine Arexvy product for adults 60 years and older. This product comes in 2-component kits. Each kit is for one dose that includes one NDC Unit of Use for the antigen component and another NDC Unit of Use for the adjuvant component. The following codes have been added:
- New Vaccine Group: “RSV”
- New CVX code 303 for the RSV vaccine, and new unspecified RSV vaccine CVX code 304
- New Unit of Sale NDC and a new Unit of Use NDC for the antigen component that has been mapped to CVX code 303 and to manufacturer GlaxoSmithKline MVX code “SKB”
- New AMA CPT code 90679 that has been mapped to CVX code 303
- New NDCs and Crosswalks
- QUADRACEL, a DTAP adsorbed and inactivated poliovirus vaccine (manufactured by Sanofi). This presentation was previously missing from the CDC code sets.
- GARDASIL 9, a recombinant HPV 9-valent vaccine (manufactured by Merck and Co., Inc). This is a new presentation listed under labeler AS-Medication Solutions.
- NDC GTINs added for four Units of Sale and four Units of Use.
- Other Vaccine Updates: Last update date changes – no visible code changes; FDA file changes to fields not published in the CDC code sets have caused “date of last update” to be updated in some NDC records.
Vaccine Code Set Update Details
The 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.
1. New Respiratory Syncytial Virus (RSV) Vaccine Codes
- New Vaccine Group added: “RSV”
- Two new CVX codes added and associated to “RSV” Vaccine Group:
- CVX code 303, Status “Active”, Long Description “Respiratory syncytial virus (RSV), vaccine, recombinant, protein subunit RSV prefusion F, adjuvant reconstituted, 0.5 mL, preservative free”, Short Description “RSV, recombinant, protein subunit RSVpreF, adjuvant reconstituted, 0.5 mL, PF”.
- CVX code 304, Status “Inactive, Long and Short Descriptions “Respiratory syncytial virus (RSV), unspecified” with a status of “Inactive”.
- AMA CPT code 90679 “Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use” has been added and mapped to CVX 303.
- Two new NDC codes (table below) added and mapped to CVX code 303 and manufacturer GlaxoSmithKline MVX code “SKB”. The Unit of Sale Carton NDC and the Unit of Use NDC for the antigen component have been added. Note: CDC does not include the NDCs for diluents or adjuvants included in a kit in the published code sets.
Sale Proprietary Name | Sale Labeler | Sale NDC11 | Use NDC11 | CVX Code | CVX Description | MVX Code |
|---|
Arexvy | GlaxoSmithKline Biologicals SA | 58160-0848-11 | 58160-0723-03 | 303 | RSV, recombinant, protein subunit RSVpreF, adjuvant reconstituted, 0.5 mL, PF | SKB |
|---|
2. New NDCs and Crosswalks
- QUADRACEL, a DTAP adsorbed and inactivated poliovirus vaccine (manufactured by Sanofi). This presentation was previously missing from the CDC code sets.
- GARDASIL 9, a recombinant HPV 9-valent vaccine (manufactured by Merck and Co., Inc). These NDCs are listed under labeler A-S Medication Solutions, but mapped to the MVX code for Merck.
Sale Proprietary Name | Sale Labeler | Sale NDC11 | Use NDC11 | CVX Code | CVX Description | MVX Code |
|---|
QUADRACEL | Sanofi Pasteur Inc. | 49281-0564-10 | 49281-0564-58 | 130 | DTaP-IPV | PMC |
|---|
GARDASIL 9 | A-S Medication Solutions | 50090-4958-01 | 50090-4958-00 | 165 | HPV9 | MSD |
|---|
3. NDC GTINs added for four Units of Sale and four Units of Use.
Sale Proprietary Name | Sale Labeler | Sale NDC11 | Sale GTIN | Use NDC11 | Use GTIN |
|---|
Comirnaty | Pfizer Laboratories Div Pfizer Inc | 00069-2025-10 | 00300692025108 | 00069-2025-01 | 10300692025013 |
|---|
FLUAD QUADRIVALENT | Seqirus, Inc. | 70461-0122-03 | 00370461122031 | 70461-0122-04 | 00370461122048 |
|---|
Flucelvax Quadrivalent | Seqirus Inc. | 70461-0322-03 | 00370461322035 | 70461-0322-04 | 00370461322042 |
|---|
PNEUMOVAX 23 | Merck Sharp & Dohme LLC | 00006-4837-03 | 00300064837032 | 00006-4837-01 | 00300064837018 |
|---|
4. Other Vaccine Updates: Last update date changes – no visible code changes; FDA file changes to fields not published in the CDC code sets have caused date of last update to be updated in some NDC records.
