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RecommendCVXorGroupLevel RecommendCVXorGroupLevel

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 at the vaccine group level 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 the series is not complete,
  • 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 at the vaccine group level for the next target dose. 
  • and is > = 18 years old and is in the following series:
    • Pfizer COVID-19 2-dose Series, recommend at the vaccine group level for the next target dose.
    • Moderna COVID-19 2-dose Series, recommend at the vaccine group level for the next target dose.
    • Janssen COVID-19 1-dose Series, recommend at the vaccine group level for the next target dose. 

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SeriesCompletionSpecialRule SeriesCompletionSpecialRule

Series Completion Special Rule

• Once a patient completes:
  • the Pfizer COVID-19 2-dose series, Moderna COVID-19 2-dose series, a COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 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, 
    • recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (6 5 months) or at recommended age (18 12 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.  
    • and receives an additional dose¹, the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
    • and receives a booster dose², the Recommendation is Not Recommended and the reason code is COMPLETE.
  • the Pfizer COVID-19 (5-17) 2-dose series, 
    
    • and is >= 16 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (6 5 months) or at recommended age (18 12 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE
    • and is < 16 years < 12 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.
    • and receives a booster dose², the Recommendation is Not Recommended and the reason code is COMPLETE.
  • the Janssen COVID-19 1-dose series, 
    • and is >= 18 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), along with recommendation reason code BOOSTER_DOSE.  
    • and is < 18 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 
    • and receives a booster dose², the Recommendation is Not Recommended and the reason code is COMPLETE.

Rules for an Additional Dose¹

• If a patient completes a COVID-19 vaccine series via the Pfizer COVID-19 2-dose series, Moderna COVID-19 2-dose series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 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 and receives an additional shot of CVX 208, CVX 217, CVX 207, or CVX 213:
  • at < 28 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 interval of 28 days required for an Additional Dose for immunocompromised patients or the minimum interval of 6 5 months required for a Booster Dose."
  • at >= 28 days and < 6 5 months 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 interval of 6 5 months required for a Booster Dose."
  • at >= 6 5 months after series completion, then evaluate the shot as Valid. 

• If a patient is >=

• 5 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, CVX 217, CVX 207, or CVX 213:
• at < 28 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 interval of 28 days required for an Additional Dose for immunocompromised patients or the minimum interval of

• 5 months required for a Booster Dose."
• at >= 28 days and <

• 5 months 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 interval of

• 5 months required for a Booster Dose."
• at >=

• 5 months after series completion, then evaluate the shot as Valid. 

Rules for Booster Dose²

Any of the FDA-Approved COVID-19 vaccines (except CVX 218) can be used for booster vaccination, regardless of the vaccine product used for primary vaccination. When a heterologous or “mix and match” booster dose is administered, the eligible population and dosing intervals are those of the vaccine used for primary vaccination.

Recommendation Rules for Booster Dose

• Recommend at the Vaccine Group Level (along with recommendation reason code BOOSTER_DOSE)
• Recommended Age =

•  12 years
• Minimum Age =

• 12 years
• Recommended Interval
  • After completion of Pfizer 2-dose series, Moderna 2-dose series, Pfizer COVID-19 Child (5-17) 2-dose series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 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 =

• • 5 months
  • After completion of Janssen 1-dose series = 8 weeks

Evaluation Rules for Booster Dose

• Any of the FDA-Approved COVID-19 vaccines (except CVX 218) are allowed for the Booster Dose.
• Absolute Minimum Interval = 0 days
• If a patient completes a COVID-19 vaccine series via the Pfizer 2-dose series, Moderna 2-dose series, Pfizer COVID-19 Child (5-17) 2-dose series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 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 and receives a Booster Dose² of CVX 208, CVX 217, CVX 207, CVX 212, or CVX 213: 
  • at < 28 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 interval of 28 days required for an Additional Dose for immunocompromised patients or the minimum interval of

• • 5 months required for a Booster Dose."
  • at >= 28 days and <

• • 5 months 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 interval of

• • 5 months required for a Booster Dose."
  • at >=

• • 5 months 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 receives a Booster Dose² of CVX 208, CVX 217, CVX 207, CVX 212, or CVX 213:
  • at < 8 weeks 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 interval of 8 weeks required for a Booster Dose."
  • at >= 8 weeks after series completion, then evaluate the shot as Valid.

Rules for Extra Shots After Additional Dose¹and/or Booster Dose²

• For patients that completed the Pfizer COVID-19 2-dose series, Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 
• For patients that completed the Pfizer COVID-19 Child (5-17) 2-dose Series, 
  • is < 12 5 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
  • is > = 12 5 years old and < 16 12 years old and received an Additional Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
  • is > = 16 12 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 
• For patients that completed the Moderna COVID-19 2-dose series, Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 
• For patients that completed Janssen COVID-19 1-dose series and Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 
• For patients that completed either the 1) COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 2) 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, Additional Dose and/or Booster Dose, any shots administered after the primary series is evaluated as Accepted/EXTRA_DOSE.

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.
    • Recommended interval = 28 days
    • Recommended age = 5 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

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

• 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 Valid (if eligible for an Additional Dose or Booster Dose) or Accepted/ EXTRA_DOSE (if NOT eligible for an Additional Dose or Booster 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:

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
  • CVX 211- Novavax COVID-19 Vaccine

• 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)
  • Recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (6 months), along with recommendation reason code BOOSTER_DOSE.  
• 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

clinical trial of a COVID-19 vaccine are:

• Note - Currently, there are no COVID-19 vaccines that fall into this category. 
• 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)
  • Recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months), along with recommendation reason code BOOSTER_DOSE.  
• 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 Valid.
  • 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 for Target Dose 2 at CVX 210 at last shot administered + 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.or at 5years old, whichever date is later, in addition to returning recommendation reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The vaccine administered should be a single dose of a Pfizer COVID-19 vaccine."
    • Once the patient has received the recommended COVID-19 vaccine, the series is complete. Recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months), along with recommendation reason code BOOSTER_DOSE. 

• 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.

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.

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 based on the Series Completion Special Rule. 
  • between ages >= 12 years and < 18 years 
    • for Target Dose 1, evaluate the shot as Valid. Recommend at the vaccine group level for Target Dose 2 at Dose 1 + recommended interval (28 days).
    • for Target Dose 2, evaluate the shot as Valid.

• • •  Recommend based on the Series Completion Special Rule.