Vaccine Code Set Update Publication Date: June 17, 2022
The individual filenames included in this distribution contain the publication date (20220617)
Release Notes: This release includes updates for all vaccine codes except core Vaccine Information Statement (VIS) codes. In addition, the COVID-19 US Vaccine Codes Table has been updated to reflect changes in this release.
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 May 24, 2022 through June 16, 2022 reflect the changes and additions in this release.
This release includes the following vaccine code set updates:
COVID-19 Related Code Summary of Updates
- Moderna:
- Changes to CVX code 227 for Pediatric ages 6 years to < 12 years
- Inactivate CVX and associated NDCs
- Use CVX code 221 and its associated NDCs for this age cohort
- Changes and new associations to CVX code 221 for the adult booster 2.5mL vial
- Reflects additional allowable use of product for pediatric primary series dose administration for ages 6 years to < 12 years
- Addition of new CVX 229 for a pre-EUA potential bivalent adult booster vaccine
- Sanofi Pasteur/GSK:
- New NDCs for the GSK AS03 Adjuvant to be mixed with the Sanofi COVID-19 vaccines, once EUA authorized, have been added to the Unit of Sale and Unit of Use NDC files as reference
- NOTE The GSK Adjuvant NDCs have not been associated directly to the Sanofi CVX codes or any other CVX code
Vaccine Code Set Updates Not Related to COVID-19 Summary of Updates
- Smallpox Vaccine
- ACAM2000 smallpox vaccine national stockpile NDCs added to Code Set
- Mapped to existing CVX code 75
- MVX updated to reflect change of ownership for this product
- Measles, Mumps and Rubella (MMR) Vaccine:
- Priorix new MMR vaccine NDCs added
- Mapped to existing CVX code 03
- Product table addition and association to MVX added
- Other code changes:
- Minor updates to retire NDCs
- Applied minor changes to the NDC labeler names
COVID-19 Related Code Update Details
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 new Vaccine Group "COVID-19." CPT codes shown are product codes. CPT administrative codes for doses are available on the AMA website. CPT product codes are added as the AMA approves and makes them available.
- Moderna:
- CVX code 227: Moderna does not plan to manufacture the NDCs currently associated to CVX 227 (identified below). These are expected to still be listed in the EUA Provider Caregiver Fact Sheet for the pediatric ages of 6 years to <12 years, once authorized. There is currently no CPT code or administrative dose codes defined for the Moderna 6 year to < 12 year pediatric vaccine. AMA is working to provide the codes needed which will be mapped to CVX 221 as appropriate.
- CVX Code 221: Moderna has already manufactured vials for the booster 2.5mL NDCs. They have not yet been distributed. The formulation, concentration, and dose volume for the primary series for pediatric ages 6 years to <12 years is the same as for the adult booster NDCs associated to CVX Code 221. The decision has been made, pending final FDA EUA authorization, to allow the adult booster vials to be used for pediatric primary series dose administration for ages 6 years to < 12 years.
The following code updates have been made to reflect the anticipated FDA EUA actions:
CVX Code | Full Vaccine Name | Note | Vaccine Status |
|---|
227 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, pediatric 50 mcg/0.5 mL dose | Temporarily inactivated - Use CVX code 221 for EUA Moderna Pediatric 6yr to<12 yr vaccine 2.5 mL vial, 50 mcg/0.5 mL dose | Inactive |
|---|
CVX VaccineStatus set to Inactive, and note field updated as shown above.
NDCs: NDC Unit of Sale 80777-277-99 and NDC Unit of Use 80777-277-05 associated to CVX 227 have been inactivated with an end date of 6/1/2022. These NDCs are not planned for manufacture and will not be available for ordering.
EUA Fact Sheet with 2D barcodes and GDTI 0886983000509 for the "COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs" association to CVX code 227 has been retained. |
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221 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 50 mcg/0.5 mL dose | FDA EUA Moderna 2.5mL use for both adult booster dose + Peds 6yr to <12 Primary Series | Active |
|---|
NDCs: NDC Unit of Sale 80777-275-99 and NDC Unit of Use 80777-275-05 are associated to CVX 221. These NDCs have been manufactured and are currently authorized by the FDA under EUA for adult booster dose only. It is now anticipated that they will also be authorized for pediatric primary series administration for ages 6 years to <12 years. While the physical labels on these NDC vials state "Booster Only", further healthcare provider guidance is anticipated to be published by the FDA regarding the use of these vials for pediatric administration.
EUA Recipient/Caregiver Fact Sheets/VIS: The existing EUA Fact Sheet 2D barcodes and GDTI 0886983000349 for the "COVID-19 Moderna Vaccine EUA Recipient-Caregiver Adult Fact Sheet" will continue to be associated to this CVX. An additional EUA Fact Sheet with separate 2D barcodes and GDTI 0886983000509 for the "COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet - Pediatric 6yrs to <12yrs" has now been associated to CXV 221.
CPT Code 91309 is currently mapped to CVX code 221. This code applies to the adult booster. No CPT code is available for the pediatric vaccine administration at this time. AMA is currently working to create the appropriate codes and guidance. NCPDP will also provide SCC codes and guidance for pharmacy billing. |
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- New CVX 229 added in anticipation of a Moderna EUA submission for a potential bivalent adult booster vaccine. It is associated to Vaccine Group COVID-19. NDCs and other associations not yet available.
CVX Code | Full Vaccine Name | Note | Vaccine Status |
|---|
229 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent, preservative free, 50 mcg/0.5 mL dose | Pre-EUA Moderna bivalent adult booster original strain + omicron strain | Active |
|---|
- Sanofi Pasteur/GSK:
- New NDCs added for the GSK AS03 Adjuvant. This adjuvant will need to be mixed with the Sanofi COVID-19 vaccine, if Sanofi vaccine is EUA authorized. As shown below, the GSK Adjuvant NDCs have been added for reference, but not associated to the Sanofi CVX codes or any other CVX code.
Description | NDC10 Unit of Sale | NDC10 Unit of Use | CVX Code | MVX Code | Labeler |
|---|
AS03 Adjuvant Solution | 58160-855-19 | 58160-855-01 | None | SKB | GlaxoSmithKline Biologicals SA |
|---|
Vaccine Code Set Updates Not Related to COVID-19
- Smallpox Vaccine: ACAM2000 smallpox vaccine national stockpile NDCs added to Code Set. Product availability and sourcing information not identified at this time. MVX updated for ACAM2000 Product table updated to MIP
Description | NDC10 Unit of Sale | NDC10 Unit of Use | CVX Code | MVX Code | CPT Code |
|---|
Smallpox (Vaccinia) Vaccine, Live (National Stockpile)
Tradename: ACAM2000 | 71665-330-02 | 71665-330-01 | 75 | MIP (Emergent BioSolutions) | N/A |
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- Measles, Mumps and Rubella (MMR) Vaccine: Priorix NDCs added and mapped as follows
Description | NDC10 Unit of Sale | NDC10 Unit of Use | CVX Code | MVX Code | CPT Code |
|---|
Measles, Mumps, and Rubella Vaccine, Live
Tradename: Priorix | 58160-824-15 | 58160-831-03 | 03 | SKB | 90707 |
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- Other code changes: Several minor updates to NDCs in the FDA files have resulted in updates to records in NDC Units of Use and Unit of sale files:
- The following NDC pair has been retired and the end dates set to 6/10/2022:
Description | NDC10 Unit of Sale | NDC10 Unit of Use |
|---|
KINRIX | 58160-812-11 | 58160-812-01 |
|---|
- Multiple NDC Unit of Use and Unit of Sale labeler names were slightly modified in the FDA files from the labeler name of "Merck Sharp & Dohme Corp" to the labeler name of "Merck Sharp & Dohme LLC". These FDA file updates resulted in updates the CDC code set files and the date of last update for each affected record.
