Vaccine Code Set Release Notes 11/19/2021

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Vaccine Code Set Update Publication Date: November 19, 2021
The individual filenames included in this distribution contain the publication date (20211119)


Release Notes: This release includes updates for all vaccine codes including COVID-19 related Recipient/Caregiver Fact Sheet Vaccine Information Statement (VIS) 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 October 04, 2021 through November 19, 2021 reflect the changes and additions in this release.


This release includes the following code set updates:


Vaccine Code Set Updates Not Related to COVID-19

  1. New Product, NDCs, Codes and Related Maps
  2. Other Vaccine Code Updates
  3. NDC GTIN Additions
COVID-19 Related VIS Code Updates
  1. Pfizer U.S. COVID-19 Updated Recipient/Caregiver Fact Sheet VIS Edition Date
  2. Moderna U.S. COVID-19 Updated Recipient/Caregiver Fact Sheet VIS Edition Date
  3. COVID-19 Non-U.S. Vaccine Update
Vaccine Code Set Updates Not Related to COVID-19
  1. New TicoVac Vaccine Product for Tick-borne Encephalitis Added:
    • New Vaccine Group added, “Tick-borne encephalitis”
    • Existing CVX code 77, “tick-borne encephalitis” vaccine status changed from Non-US to Active, and mapped to new vaccine group above
    • CPT code 90627, “Tick-borne encephalitis virus vaccine, inactivated; 0.5 mL dosage, for intramuscular use” mapped to CVX code 77 "tick-borne encephalitis vaccine"
    • New NDCs added: NDC Unit of Sale 0069-0411-10 for carton of 10 syringes, and new NDC Unit of Sale 0069-0411-02 for carton of 1 syringe "associated to new NDC Unit of Use 0069-0411-01"
      • Mapped to MVX code PFR "Pfizer"
      • Mapped to CVX code 77 "tick-borne encephalitis" vaccine
    • New Product Table Record for TICOVAC added and mapped to MVX code PFR and CVX code 77
  2. Other Vaccine updates:
    • VAXNEUVANCE: NDC Units of Sale 0006-4329-03 and 0006-4329-02; NDC Unit of Use 0006-4329-01: Start Dates changed to 7/16/2021
    • RabAvert: NDC Unit of Sale 58160-964-12 reactivated by FDA. End Date removed. NDC Unit of Use was already active, no change needed
  3. GTIN additions and updates to NDC Units of Use and Units of Sale
    CDC received confirmation from manufacturers and added GTINs for those NDCs that have 2D barcoding on the nits of Sale cartons or Units of Use.
    • NDC Units of Sale: 36 new GTINs were added to existing NDCs
    • NDC Units of Use: 10 new GTINs were added to existing NDCs

COVID-19 Related VIS Code Updates


The CDC VIS Code Set incorporates codes for COVID-19 vaccine EUA Recipient/Caregiver Fact Sheets.


CDC Authored VIS documents will not be available for COVID-19 vaccines while under Emergency Use Authorization. Under EUA, the FDA requires a vaccine-specific Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to Vaccine Information Statements for licensed vaccines). Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA. The COVID-19 vaccine related codes in this code set release are provided in anticipation of potential vaccine availability under Emergency Use Authorization. If the vaccines are not authorized, these codes will be retired.


FDA Provider and Recipient/Caregiver Fact Sheets have been updated following the FDA’s amendments on 11/19/2021 to the EUAs previously authorized for both Pfizer and Moderna.  This update addresses expansion of the eligibility for booster doses. Further information regarding these vaccines as well as both the EUA Provider Fact Sheet and the EUA Recipient/Caregiver Fact Sheets are available on the FDA site.


https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine


https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine


The CDC VIS Code Set has been updated to reflect the EUA Recipient/Caregiver Fact Sheet Changes:

  • COVID-19 Moderna Vaccine EUA Recipient/Caregiver Fact Sheet – New Edition Date The Edition Date has been changed to 11/19/2021
    The Last Updated date has been changed to 11/19/2021
    The Barcode string has not been changed
    The URL has not changed
    The CVX Code has not changed
  • COVID-19 Pfizer BioNTech Vaccine EUA Recipient/Caregiver Fact Sheet - New Edition Date The Edition Date has been changed to 11/19/2021
    The Last Updated date has been changed to 11/19/2021
    The Barcode string has not been changed
    The URL has not changed
    The CVX Code has not changed
The above updates impact the following two VIS code files and tables:
  • CVX Mapped to VIS
  • VIS Barcode Lookup Table

Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients/Caregivers in electronic medical records/immunization information systems (EMRs/IISs).  As such, the VIS code set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EHRs/EMRs for use in a manner analogous to the electronic system and workflow documentation of VIS.  As with VIS documents, the COVID-19 Vaccine Recipient/Caregiver Fact Sheets will incorporate the CDC’s scannable 2D barcode in the Fact Sheet document.  The numeric string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.


COVID-19 Non-U.S. Vaccine Update


COVAXIN, a non-U.S. COVID-19 vaccine was authorized by the WHO on 10/20/2021.  The following updates have been made:

  • CVX code 502, “SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (COVAXIN)” code notes have been updated to reflect the WHO authorization
  • MVX code BBI, “Bharat Biotech International Limited” has been added
  • New Product Table Record has been added for tradename “COVAXIN (Bharat) COVID-19 Vaccine”. It has been associated to CVX code “502” and MVX code “BBI"
  



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