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

• If the patient has no shots on record, 
  • and is < 5 years old, recommend CVX 218 at 5 years old.
  • and is > = 5 years old and < 12 years old, recommend CVX 218 at today's date. 
  • and is > = 12 years old and < 18 years old, recommend CVX 208 at today's date. 
  • and is > = 18 years old, recommend at the vaccine group level at today's date. 

• If the patient has shots on record
  • and is < 5 years old, recommend CVX 218 at 5 years old.
  • and is > = 5 years old and < 12 years old (or will be < 12 years old at the recommended due date), recommend CVX 218 for the next target dose.
  • and is > = 12 years old (or will be >= 12 years old at the recommended due date) and < 18 years old,  recommend CVX 208 for the next target dose. 
  • and is > = 18 years old and is in the following series:
    • Pfizer COVID-19 2-dose Series, recommend CVX 208 for the next target dose.
    • Moderna COVID-19 2-dose Series, recommend CVX 207 for the next target dose.
    • Janssen COVID-19 1-dose Series, recommend CVX 212 for the next target dose. 

Series Completion Special Rule

• Once a patient completes:
  • the Pfizer COVID-19 (5-17) 2-dose series, 
    
    • and is < 18 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 
    • and receives an additional dose¹, the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
  • the Pfizer COVID-19 2-dose series with CVX 208 as Dose 1 and Dose 2,
    • and is >= 65 years old, recommend a booster dose of Pfizer (CVX 208) at Dose 2 + recommended interval (6 months), along with recommendation reason codes BOOSTER_DOSE. (new recommendation reason code)
    • and is >= 18 years and < 65 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
    • and receives an additional dose¹ or booster dose², the Recommendation is Not Recommended and the reason code is COMPLETE.
  • the Pfizer COVID-19 2-dose series where not all doses administered were CVX 208 or the Moderna COVID-19 2-dose series, 
    • the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
    • 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 is >=12 years old, completes a COVID-19 vaccine series via the Pfizer COVID-19 (5-17) 2-dose series and receives an additional shot of CVX 218, CVX 208, 207, or CVX 213:
• at < 28 days - 4 days after series completion, then evaluate the shot as Invalid/ BELOW_MINIMUM_INTERVAL. 
• at >= 28 days - 4 days, then evaluate the shot as Valid. 

Rules for Booster Dose²

• If a patient completes a COVID-19 vaccine series via the Pfizer 2-dose series (with CVX 208 only) and a booster dose² of CVX 208, 
  • 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 completes a COVID-19 vaccine series via the Janssen 1-dose series and a booster dose of CVX 212, CVX 208, CVX 207, or CVX 213, then evaluate the booster dose as Valid.

Rules for Extra Shots After Additional Dose¹and/or Booster Dose²

• For patients that completed the Pfizer COVID-19 Child (5-17) 2-dose Series, 
  • is < 12 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
  • is > = 12 years old and received an Additional Dose, any shots administered afterwards will be evaluated 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. 
• ²Booster Dose - Defined by ACIP to be a dose administered to restore protection after the effectiveness of protection from the primary series has declined. 

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

CVX Code Absolute Maximum Age

• If one of the CVX codes in the table above is administered above the absolute maximum age for that CVX code, then the Evaluation is Invalid and the reason code is ABOVE_MAXIMUM_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
  • 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
  • CVX 502 - COVAXIN

• 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) or at 5 years old, whichever date is later. 
      • 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 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. 
  • 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 5 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 - 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 Child (5-17) 2-dose Series
• Pfizer COVID-19 2-dose Series
• Moderna COVID-19 2-dose Series
• Janssen COVID-19 1-dose Series

Series Selection Rules

There are four series for this vaccine group: the Pfizer COVID-19 Child (5-17) 2-dose Series, 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 patient is < 18 years, and dose 1 is CVX 218 or CVX 208, then the Pfizer COVID-19 Child (5-17) 2-dose series applies. 
• If patient is >= 18 years and 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" rules 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 < 5 years old, 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."

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 < 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 218 (Pfizer COVID-19 Vaccine (5-11))

• If the patient is >= 18 years old and administered Pfizer COVID-19 Vaccine (CVX 218):
  • as Target Dose 1 or Target Dose 2, evaluate as Invalid/ ABOVE_MAXIMUM_AGE_VACCINE. 
    • Ignore the reported CVX 218 when determining the recommended due date for the next target dose due and when evaluating the next shot based on the absolute minimum interval for that target dose. (Note - The ICE General Rule "Earliest, recommended, and past due dates must be on or after the last shot given" applies here.)

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 218 (Pfizer COVID-19 Vaccine (5-11))

• If the patient is >= 18 years old and administered Pfizer COVID-19 Vaccine (CVX 218):
  • as Target Dose 1 or Target Dose 2, evaluate as Invalid/ ABOVE_MAXIMUM_AGE_VACCINE. 
    • Ignore the reported CVX 218 when determining the recommended due date for the next target dose due and when evaluating the next shot based on the absolute minimum interval for that target dose. (Note - The ICE General Rule "Earliest, recommended, and past due dates must be on or after the last shot given" applies here.)

Rule for CVX 207 (Moderna COVID-19 Vaccine) Administered < 18 years old

• If the patient is administered Moderna COVID-19 vaccine (CVX 207):
  • between ages >= 5 years and < 12 years 
    • for Target Dose 1, evaluate the shot as Valid. Recommend CVX 218 for Target Dose 2 at Dose 1 + recommended interval (28 days).
    • for Target Dose 2, evaluate the shot as Valid. Recommend Conditional/ COMPLETE_HIGH_RISK.
  • between ages >= 12 years and < 18 years 
    • for Target Dose 1, evaluate the shot as Valid. Recommend CVX 208 for Target Dose 2 at Dose 1 + recommended interval (28 days).
    • for Target Dose 2, evaluate the shot as Valid. Recommend Conditional/ COMPLETE_HIGH_RISK. 

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."