VIS Code Set Release - Update 7/30/2021

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Vaccine Code Set Update Publication Date: July 30, 2021

 The individual filenames included in this distribution contain the publication date (20210730)

  

Release Notes: This release includes updates for all vaccine codes including Vaccine Information Statement (VIS) codes and maps.

 
General Note regarding this release: Codes with “Last Update” dates after May 17, 2021 and before July 30, 2021 reflect the changes and additions in this release. This is a large release and includes the following code set updates:

  1. Vaccine Code Set Updates Not Related to COVID-19
    • New and retired codes for seasonal influenza vaccines
    • Other vaccine code additions and changes
  2. COVID-19 Related Code Updates
    • Non-U.S. COVID-19 vaccine code additions and updates
    • Other COVID-19 Related Code Changes

Vaccine Code Set Updates

 

1. Vaccine Code Updates Not Related to COVID-19

  •  New 2021/2022 Seasonal Influenza Vaccines

Vaccine codes for the 2021/2022 seasonal influenza vaccines have been added as shown in Table 1 below. Also updated are the two website tables “2021/2022 Seasonal Influenza Codes and Crosswalk” and “Southern Hemisphere 2021 Seasonal Influenza Codes.” The two tables are available on the CDC website table using the following link:  https://www.cdc.gov/vaccines/programs/iis/code-sets.html

 

Table 1: Seasonal Influenza NDCs Added for the 2021/2022 Influenza Season


Sale Proprietary Name

Sale Labeler

Sale NDC11

Use NDC11

Presentation

CVX Code

MVX Code

Flulaval Quadrivalent

ID Biomedical Corporation of Quebec

19515-0818-52

19515-0818-41

SYRINGE, .5 mL

150

IDB

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0421-10

49281-0421-58

VIAL, .5 mL, SINGLE-DOSE

150

PMC

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0421-50

49281-0421-88

SYRINGE, .5 mL

150

PMC

FLUARIX QUADRIVALENT

GlaxoSmithKline Biologicals SA

58160-0887-52

58160-0887-41

SYRINGE, .5 mL

150

SKB

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0635-15

49281-0635-78

VIAL, 5 mL, MULTI-DOSE

158

PMC

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0521-25

49281-0521-00

SYRINGE, .25 mL

161

PMC

FLUCELVAX QUADRIVALENT

Seqirus Inc.

70461-0321-03

70461-0321-04

SYRINGE, .5 mL

171

SEQ

Flublok Quadrivalent Northern Hemisphere

Sanofi Pasteur Inc.

49281-0721-10

49281-0721-88

SYRINGE, .5 mL

185

PMC

FLUCELVAX QUADRIVALENT

Seqirus Inc.

70461-0421-10

70461-0421-11

VIAL, 5 mL, MULTI-DOSE

186

SEQ

FLUZONE High-Dose Quadrivalent Northern Hemisphere

Sanofi Pasteur Inc.

49281-0121-65

49281-0121-88

SYRINGE, .7 mL

197

PMC

FLUAD QUADRIVALENT

Seqirus, Inc.

70461-0121-03

70461-0121-04

SYRINGE, .5 mL

205

SEQ

 

Waiting on the following information (not included in this release):

  1. FLUAD (trivalent) NDC codes have not been provided as of this release for the 2021/2022 season
  2. Flumist NDC codes have not been provided as of this release for the 2021/2022 season
  3. Afluria NDC codes have not been provided as of this release for the 2021/2022 season
  • Retired 2020/2021 Seasonal Influenza NDCs

Table 2 below identifies the influenza vaccine NDC codes that have been retired for the 2020/2021 season.


Table 2: 2020/2021 Seasonal Influenza NDCs Retired


Sale Proprietary Name

Sale Labeler

Sale NDC11

Use NDC11

FLUAD QUADRIVALENT

Seqirus, Inc.

70461-0120-03

70461-0120-04

FLUARIX QUADRIVALENT

GlaxoSmithKline Biologicals SA

58160-0885-52

58160-0885-41

Flublok Quadrivalent Northern Hemisphere

Sanofi Pasteur Inc.

49281-0720-10

49281-0720-88

FLUCELVAX QUADRIVALENT

Seqirus Inc.

70461-0420-10

70461-0420-11

FLUCELVAX QUADRIVALENT

Seqirus Inc.

70461-0320-03

70461-0320-04

Flulaval Quadrivalent

ID Biomedical Corporation of Quebec

19515-0816-52

19515-0816-41

FLUZONE High-Dose Quadrivalent Northern Hemisphere

Sanofi Pasteur Inc.

49281-0120-65

49281-0120-88

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0420-50

49281-0420-88

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0420-10

49281-0420-58

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0520-25

49281-0520-00

FLUZONE QUADRIVALENT

Sanofi Pasteur Inc.

49281-0633-15

49281-0633-78

  • Other Vaccine Code Additions and Changes

Non-Influenza Vaccine NDCs Added: The following new Vaccine NDCs have been added for RabAvert.

 

Table 3: New Vaccine NDCs


Sale Proprietary Name

Sale Labeler

Sale NDC11

Use NDC11

Presentation

CVX Code

MVX Code

RabAvert

Bavarian Nordic A/S

50632-0010-01

50632-0013-01

VIAL, SINGLE-DOSE, 1 mL

176

SKB

 

MVX Code Changes: The following NDCs have had a change to their associated MVX Code (new MVX Codes shown)

 
Table 4: MVX Changes for Existing NDCs


Sale Proprietary Name

Sale Labeler

Sale NDC11

Use NDC11

MVX Code

Vaxelis

MSP Vaccine Company

663361-0243-10

663361-0243-58

MSP

Vaxelis

MSP Vaccine Company

663361-0243-15

663361-0243-88

MSP

BCG VACCINE

Merck Sharp & Dohme Corp.

00052-0603-01

0052-0603-02

MSD

 

MVC Code Changes: The following additional manufacturer MVX code additions and updates have been made.  

  • New Manufacturer MVX Code Added

MSP

MSP Vaccine Company - (partnership Merck and Sanofi Pasteur)

U.S. Based - Joint manufacturing partnership, initial vaccine Vaxelis 10/2020

  • Retired MVX Code

OTC

Organon Teknika Corporation

Subsidiary of Merck. Sold by Merck 6/8/2021.
Effective June 2021 Merck is now labeler for the TICE BCG product.

  • Manufacturer Name Change for Existing MVX Code

PAX

Emergent Travel Health, Inc (Formerly PaxVax)

Emergent Biosolutions acquired PaxVax 8/2021,
U.S. Vaccines starting to label under Emergent Travel Health Ins.

 

2. COVID-19 Related Code Updates

  • Non-U.S. COVID-19 Vaccine Code Additions and Updates

The CDC has added and updated CVX codes, MVX and Product Tradename codes to support documentation of non-U.S. COVID-19 vaccine administration history records. 

 

During the pandemic, multiple COVID-19 vaccines have been developed and are being administered internationally. 

   
In this release, COVID-19 Non-U.S. CVX codes, associated MVX and Product Codes have been added or updated in the main code set data files to provide additional codes for use in documenting historic non-U.S. administration. A new table located on the CDC website, “COVID-19 Related Codes,” specifically identifies all CVX codes that might be used for non-U.S. vaccinations. This website table, “Preview Posting of COVID-19 Vaccine Codes and Crosswalks to be used for non-U.S. vaccine administration,” provides all the new/updated CVX codes in one place including associated code notes that can provide guidance for documenting COVID-19 vaccines administered outside of U.S. jurisdiction. The on-line table and downloadable files are available on this link: https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html#codes

 
Additional Notes: The list of vaccines not authorized by the WHO may be incomplete. The list of vaccines indicated to be WHO-authorized will be updated periodically as the CDC monitors WHO-published information. All the COVID-19 related CVX codes are associated to the Vaccine Group "COVID-19."


Updates and additions to the CVX codes for COVID-19 include:

  • Six existing COVID-19 CVX codes have had the Notes field updated to provide non-U.S. tradenames and use guidance, one code has changed status (see AstraZeneca below)
  • Twelve new COVID-19 non-U.S. CVX codes have been added to reflect vaccines known to be available in the global market. Two of these are indicated as WHO-authorized vaccines which will be counted toward U.S. immunity. For the two WHO-authorized vaccines, new MVX codes and Product table codes have been added and associated to those CVX codes.

Two MVX codes have been added for the WHO authorized COVID-19 non-US vaccines:

 


MVX Code

Manufacturer

Notes

Status

SPH

Sinopharm-Biotech

Non-US COVID-19 Vaccine Manufacturer - WHO Authorized

Active

SNV

Sinovac

Non-US COVID-19 Vaccine Manufacturer - WHO Authorized (Sinovac, CoronaVac)

Active

 

Five CDC Product Tradename table records have been updated or added to incorporate international tradenames that may appear on non-US vaccine record for U.S. and WHO authorized vaccines:

 


Product Tradename(s)

CVX Code

MVX Code

AstraZeneca COVID-19 Vaccine (Non-US tradenames include VAXZEVRIA, COVISHIELD)

210

ASZ

Coronavac (Sinovac) COVID-19 Vaccine

511

SNV

Moderna COVID-19 Vaccine (non-US Spikevax)

207

MOD

Sinopharm (BIBP) COVID-19 Vaccine

510

SPH

Pfizer-BioNTech COVID-19 Vaccine (Non-US COMIRNATY)

208

PFR

  • Other COVID-19 Related Code Changes

AstraZeneca COVID-19 vaccine NDC codes have been temporarily inactivated pending U.S. regulatory submission and FDA review. The end dates for Unit of Sale NDC11 00310-1222-15 and Unit of Use NDC11 00310-1222-10 have been set to 7/31/2021. The following changes have also been made.

  • CVX Code 210 for AstraZeneca COVID-19 vaccine; status has been changed to “non-US” from “active” to reflect that this vaccine is currently only available outside the U.S.
  • The VIS Edition Status for the EUA Recipient Fact Sheet has been changed to “Historic” from “Current”

 



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