Rules for Recommending at the CVX Code vs. Vaccine Group Level 

• When recommending in the Pfizer COVID-19 2-dose Series, recommend CVX 208 for the next target dose.
• When recommending in the Moderna COVID-19 2-dose Series, recommend CVX 207 for the next target dose.
• When recommending in the Janssen COVID-19 1-dose Series, recommend CVX 212 for the next target dose. 
• If patient has no shots on record, 
  • and is > = 12 years old, recommend at the vaccine group level at today's date. 
  • and is < 12 years old, recommend at the vaccine group level at 12 years old.

Series Completion Special Rule

• Once a patient completes:
  • either the Pfizer COVID-19 2-dose series or the Moderna COVID-19 2-dose series, the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 
  • either the Pfizer COVID-19 2-dose series or the Moderna COVID-19 2-dose series AND receives an additional dose¹, the Recommendation is Not Recommended and the reason code is COMPLETE.
  • either the 1) Janssen COVID-19 1-dose series, 2) COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 3) COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine, the Recommendation is Not Recommended/ COMPLETE_HIGH_RISK.

Rules for an Additional Dose¹

• If a patient completes a COVID-19 vaccine series via the Pfizer 2-dose series or Moderna 2-dose series and receives an additional shot of CVX 208, CVX 207, or CVX 213:
  • at < 28 days - 4 days after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age and/or minimum interval."
  • at >= 28 days - 4 days after series completion, then evaluate the shot as Valid.
• If a patient receives a subsequent shot(s) after they have received an additional dose¹, then evaluate that shot(s) as Accepted/ EXTRA_DOSE. 

Notes

• ¹Additional Dose - Defined by ACIP to be a dose administered when the immune response to a standard primary vaccine series is likely not to be protective. 

CVX Code Specific Rules

CVX Code Absolute Minimum Age

• If one of the CVX codes in the table above is administered below the absolute minimum age for that CVX code, then the Evaluation is Invalid and the reason code is BELOW_MINIMUM_AGE_VACCINE

Rule for CVX 213

• If the patient receives CVX 213 for:
  • Target Dose 1, evaluate the shot as Valid.
    • Recommend Target Dose 2 at Vaccine Group level
    • Recommended interval = 28 days
    • Recommended age = 18 years
  • Target Dose 2, evaluate the shot as Valid. 
  • If the patient receives CVX 213 for Target Dose 1 and CVX 212 (Janssen COVID-19 Vaccine) is reported for Target Dose 2, the Janssen COVID-19 1-dose Series applies and the series is complete. Therefore,  
    • evaluate Target Dose 2 (CVX 212) as Valid.
    • evaluate Target Dose 1 as Accepted and the reason code is VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.
  • If the patient has CVX 213 on their patient record AND receives all recommended doses of a 1) COVID-19 vaccine not authorized by the FDA, but authorized by the WHO or 2) COVID-19 vaccine not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine, then 
    • evaluate CVX 213 shots given before series completion as Accepted/ VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.
      • Example Scenario #1 - Patient receives the following shots (listed in order): CVX 213, CVX 210 (AstraZeneca), CVX 210 (AstraZeneca) 
        • CVX 213 shot is evaluated as Accepted/ VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN
        • Both CVX 210 shots are evaluated as Valid (series is complete via AstraZeneca 2-dose series)
      • Example Scenario #2 - Patient receives the following shots (listed in order): CVX 210 (AstraZeneca), CVX 213, CVX 210 (AstraZeneca) 
        • CVX 213 shot is evaluated as Accepted/ VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN
        • Both CVX 210 shots are evaluated as Valid (series is complete via AstraZeneca 2-dose series)
    • evaluate CVX 213 shots given after series completion as Accepted/ EXTRA_DOSE. 
      • Example Scenario #1 - Patient receives the following shots (listed in order): CVX 210 (AstraZeneca), CVX 210 (AstraZeneca), CVX 213 
        • Both CVX 210 shots are evaluated as Valid (series is complete via AstraZeneca 2-dose series)
        • CVX 213 is evaluated as Accepted/ EXTRA_DOSE

Rules for COVID-19 Vaccines Not Authorized by FDA²

The following set of rules apply to 1) COVID-19 Vaccines Not Authorized by FDA, but Authorized by WHO and, 2) COVID-19 Vaccines Not Authorized by FDA or WHO, but is an Active COVID-19 Vaccine Candidate as part of a U.S.-based Clinical Trial of a COVID-19 Vaccine. 

• The list of COVID-19 Vaccines Not Authorized by the FDA, but Authorized by the WHO are:

  • CVX 210 - AstraZeneca COVID-19 Vaccine

  • CVX 510 - BIBP, Sinopharm COVID-19 Vaccine
  • CVX 511 - CoronaVac, Sinovac

• The list of COVID-19 Vaccines Not Authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine are:

  • CVX 211- Novavax COVID-19 Vaccine

• If the patient has received all recommended doses of the COVID-19 vaccine, then: 
  • Evaluate the shots as Valid; (Absolute Minimum Interval = 0 days; Absolute Minimum Age = 0 days)
  • No additional doses of COVID-19 vaccine are needed; Recommendation: Not Recommended/ COMPLETE_HIGH_RISK.
• If the patient has received one or more doses, but has not received all the recommended doses for that COVID-19 vaccine, then:
  • Evaluate the shot(s) as Accepted/ VACCINE_NOT_APPROVED_IN_US. 
  • Recommendation:
    • If one of the above listed COVID-19 vaccine is the last COVID-19 shot administered, then recommend COVID-19 at the vaccine group level at last shot administered + recommended interval (28 days). 
      • Example #1: Patient has 1 shot of CVX 210 (AstraZeneca) on record.
        • Evaluate CVX 210 as Accepted/ VACCINE_NOT_APPROVED_IN_US.
        • Recommend COVID-19 at the vaccine group level for Target Dose 1 at CVX 210 + recommended interval (28 days). 
      • Example #2: Patient has 1 shot of CVX 208 (Pfizer), then 1 shot of CVX 210 (AstraZeneca) on record. 
        • Evaluate CVX 208 as Valid and CVX 210 as Accepted/ VACCINE_NOT_APPROVED_IN_US.
        • Recommend COVID-19 at the vaccine group level for Target Dose 2 at CVX 210 + recommended interval (28 days). 
    • If one of the above listed COVID-19 vaccine is NOT the last COVID-19 shot administered, recommend based on the series that applies for the last COVID-19 shot administered.
      • Example: If CVX 208 (Pfizer) is given after CVX 210 (AstraZeneca), then recommend based on the Pfizer COVID-19 2-dose Series.

• The list of COVID-19 Vaccines Not Authorized by the FDA or WHO are:

  • CVX 500 - COVID-19 Non-US Vaccine, Product Unknown 
  • CVX 501 - COVID-19 IV Non-US Vaccine (QAZCOVID-IN)
  • CVX 502 - COVID-19 IV Non-US Vaccine (COVAXIN)
  • CVX 503 - COVID-19 LAV Non-US Vaccine (COVIVAC) 
  • CVX 504 - COVID-19 VVnr Non-US Vaccine (Sputnik Light) 
  • CVX 505 - COVID-19 VVnr Non-US Vaccine (Sputnik V)
  • CVX 506 - COVID-19 VVnr Non-US Vaccine (CanSino Biological Inc./Beijing Institute of Biotechnology)
  • CVX 507 - COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbology Chinese academy of Sciences)
  • CVX 508 - COVID-19 PS Non-US Vaccine (Jiangsu Province Centers for Disease Control and Prevention)
  • CVX 509 - COVID-19 PS Non-US Vaccine (EpiVacCorona)
• If the patient has received a COVID-19 vaccine not authorized by the FDA or WHO for all or some or the recommended doses of the COVID-19 vaccine, then: 
  • Evaluate the shot(s) as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO. (new reason code)
  • Recommendation:
    • If one of the above listed COVID-19 vaccine is the last COVID-19 shot administered, then recommend COVID-19 at the vaccine group level at last shot administered + recommended interval (28 days) or at 12 years old, whichever date is later.  
      • Example #1: Patient has 1 shot of CVX 501 on record.
        • Evaluate CVX 501 as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO.
        • Recommend COVID-19 at the vaccine group level for Target Dose 1 at CVX 501 + recommended interval (28 days). 
      • Example #2: Patient has 1 shot of CVX 208 (Pfizer), then 1 shot of CVX 501 on record. 
        • Evaluate CVX 208 as Valid and CVX 501 as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO.
        • Recommend COVID-19 at the vaccine group level for Target Dose 2 at CVX 501 + recommended interval (28 days). 
    • If one of the above listed COVID-19 vaccine is NOT the last COVID-19 shot administered, recommend based on the series that applies for the last COVID-19 shot administered.
      • Example: If CVX 208 (Pfizer) is given after CVX 501, then recommend based on the Pfizer COVID-19 2-dose Series.

Notes

• ²Rules for COVID-19 Vaccines Not Authorized by FDA were created to handle all other COVID-19 vaccine shots reported on patient records. The ICE rules were created and sourced from published guidance from the CDC, updated September 15, 2021 - Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. As CDC guidance for COVID-19 evolves, ICE will be updated as necessary.

Series Name

• Pfizer COVID-19 2-dose Series
• Moderna COVID-19 2-dose Series
• Janssen COVID-19 1-dose Series

Series Selection Rules

There are three series for this vaccine group: the Pfizer COVID-19 2-dose series, Moderna COVID-19 2-dose series, and Janssen COVID-19 1-dose series. The rules for determining which series applies are:

• If dose 1 is CVX 208, then the Pfizer COVID-19 2-dose series applies.
• If dose 1 is CVX 207, then the Moderna COVID-19 2-dose series applies. 
• If dose 1 is CVX 212, then the Janssen COVID-19 1-dose series applies. 
• If dose 1 is CVX 213, reference the "Rule for CVX 213" rule above. 
• If no shots are on patient record, reference the "Rules for Recommending at the CVX Code vs. Vaccine Group Level" rules above. 

Series Special Rules

• If the patient receives a shot at < 12 years - 4 days of age and/or < 21 days - 4 days interval between dose 1 and 2, evaluate the shot as Valid, with reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age and/or minimum interval."

Rule for CVX 212 (Janssen COVID-19 Vaccine)

• If CVX 212 (Janssen COVID-19 Vaccine) is reported for Target Dose 2, the Janssen COVID-19 1-dose Series applies and the series is complete. Therefore,  
  • evaluate Target Dose 2 (CVX 212) as Valid.
  • evaluate Target Dose 1 as Accepted and the reason code is VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.

Series Special Rules

• If the patient receives a shot at < 18 years - 4 days of age and/or < 28 days - 4 days interval between dose 1 and 2, evaluate the shot as Valid, with reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age and/or minimum interval."

Rule for CVX 212 (Janssen COVID-19 Vaccine)

• If CVX 212 (Janssen COVID-19 Vaccine) is reported for Target Dose 2, the Janssen COVID-19 1-dose Series applies and the series is complete. Therefore,  
  • evaluate Target Dose 2 (CVX 212) as Valid.
  • evaluate Target Dose 1 as Accepted and the reason code is VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.

Series Special Rules

• If the patient receives a shot at < 18 years - 4 days of age, evaluate the shot as Valid, with reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age and/or minimum interval."