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

• If the patient has no shots on record, 

  • and is < 6 months old, recommend at the vaccine group level.

  • otherwise, 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 < 6 months old, recommend at the vaccine group level at 6 months old, or at recommended interval, whichever date is later. 

  • otherwise, recommend at the vaccine group level at the recommended due date.

Series Completion Special Rule

• Once a patient completes: 
  • the Pfizer COVID-19 Series,
    
    • and is < 5 years old:
      • if the execution date is < 3/17/2023, the recommendation is Not Recommended and the reason code is COMPLETE.
      • if the execution date is >= 3/17/2023 and a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520) has not been administered, recommend a dose of COVID-19 at the vaccine group level and recommended interval (8 weeks) or on 3/17/2023, whichever date is latest, along with recommendation reasons ADMINISTER_COVID19_BIVALENT_VACCINE and SUPPLEMENTAL_TEXT and Descriptive Text: "Patients who previously completed a 3-dose monovalent primary series are recommended to receive 1 bivalent booster dose, at least 8 weeks after completion of the monovalent primary series.
    • and is >= 5 years old:
      • if the execution date is >= 4/19/2023:
        • See Section "Rules for Booster Dose", Bullet Point: "After completion of the Pfizer COVID-19 Series, the execution date is >= 3/17/2023, and the patient is < 5 years of age"
    • if the execution date is < 9/2/2022:
      • and is >= 5 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months) or at recommended age (5 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.

    • if the execution date is >= 9/2/2022 and is < 4/19/2023:

      • and is >= 5 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks) or at recommended age (5 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.

    • See “Rules for Booster Dose” for booster dose recommendations for the Pfizer COVID-19 Series.

  • the Mixed Product or Moderna COVID-19 Series,
    • if the execution date is >= 4/19/2023:
      • See Section "Rules for Booster Dose", Bullet Point: "After completion of the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen COVID-19 Series or Novavax COVID-19 Series, and the execution date is >= 4/19/2023"
    • if the execution date is >= 12/9/2022 and < 4/19/2023:
      • and is >= 6 months of age, recommend a booster dose of COVID-19 at recommended interval (8 weeks), recommended age (6 months) or on 12/9/2022, whichever date is latest, along with recommendation reason code BOOSTER_DOSE.
    • if the execution date is >= 10/12/2022 and < 12/9/2022:
      • and is >= 5 years and < 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), recommended age (5 years) or on 10/12/2022, whichever date is latest, along with recommendation reason code BOOSTER_DOSE.
    • if the execution date is >= 9/2/2022:
      • and is < 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
      • and is >= 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), recommended age (12 years) or on 9/2/2022, whichever date is latest, along with recommendation reason code BOOSTER_DOSE.

    • See “Rules for Booster Dose” for booster dose recommendations for the Moderna COVID-19 Series.

  • the Janssen COVID-19 Series, 
    • If the execution date is >= 4/19/2023:
      • See Section "Rules for Booster Dose", Bullet Point: "After completion of the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen COVID-19 Series or Novavax COVID-19 Series, and the execution date is >= 4/19/2023"
    • Otherwise:
      • and is >= 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 < 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 

      • See “Rules for Booster Dose” for booster dose recommendations for the Janssen COVID-19 Series.

  • the Novavax COVID-19 Series,
    • If the execution date is >= 4/19/2023:
      • See Section "Rules for Booster Dose", Bullet Point: "After completion of the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen COVID-19 Series or Novavax COVID-19 Series, and the execution date is >= 4/19/2023"
    • Otherwise: 
      • and is < 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
      • and is >= 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks) or at recommended age (12 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.

  • 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, 

    • if the execution date is < 9/2/2022:

      • recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months) or at recommended age (12 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.

    • if the execution date is >= 10/12/2022:

      • and is >= 5 years and < 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), recommended age (5 years) or on 10/12/2022, whichever date is latest, along with recommendation reason code BOOSTER_DOSE.

    • if the execution date is >= 9/2/2022:

      • and is < 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.

      • and is >= 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), recommended age (12 years), or on 9/2/2022, whichever date is latest, along with recommendation reason code BOOSTER_DOSE.

    • See “Rules for Booster Dose” for booster dose recommendations for the these series.

Rules for an Additional Dose¹

• If a patient completes a COVID-19 vaccine series via the Moderna COVID-19 Series or 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 207, CVX 208, CVX 211, CVX 212, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520:
  
  • if the execution date is < 9/2/2022: 
    • at < 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 the 1st Booster Dose."
    • at >= 5 months after series completion, then evaluate the shot as Valid. 
  • if the execution date is >= 9/2/2022 and < 4/19/2023: 
    • 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 the 1st Booster Dose."
    • at >= 8 weeks after series completion, then evaluate the shot as Valid. 

• If a patient completes the COVID-19 vaccine series via the Pfizer COVID-19 Series or the Mixed Product COVID-19 Series and receives an additional shot of CVX 207, CVX 208, CVX 211, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520:
  

  • if the patient is >= 5 years old and < 12 years old, or if the patient is >= 12 years old and the execution date is < 9/2/2022:

    • at < 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 the 1st Booster Dose."

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

  • if the patient is >= 12 years old and the execution date is >= 9/2/2022 and < 4/19/2023:

    • 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 the 1st Booster Dose."

    • at >= 8 weeks after series completion, then evaluate the shot as Valid.

• If a patient completes a COVID-19 vaccine series via the Janssen COVID-19 Series or Novavax COVID-19 Series, and receives an additional shot is administered < 4/19/2023 of CVX 207, CVX 208, CVX 211, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520:

  • 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 the 1st Booster Dose."

  • at >= 8 weeks 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 or Requirement for a Dose with a Bivalent Vaccine

• Recommend at the Vaccine Group Level (along with recommendation reason code BOOSTER_DOSE)
• After completion of the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen COVID-19 Series, or Novavax COVID-19 Series, and the execution date is >= 4/19/2023:
  
  • If the patient is >= 65 years of age and has had 2 or more prior doses with a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520) or 2 or more doses at >= 4/19/2023, recommend Not Recommended / COMPLETE.
  • If the patient is >= 65 years of age and has had 1 prior dose with a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520) or 1 prior dose at >= 4/19/2023, recommend Not Recommended / COMPLETE_HIGH_RISK.
  • If the patient is < 65 years of age and has had at least 1 prior dose with a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520) or at least 1 dose administered at >= 4/19/2023, recommend Not Recommended / COMPLETE.
  • If the patient has not had any bivalent doses (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520) or any doses administered at >= 4/19/2023, recommend a bivalent vaccine along with recommendation reason ADMINISTER_COVID19_BIVALENT_VACCINE (new recommendation reason code).
    
    • Minimum Age = 6 months
    • Recommended Age = 6 months
    • Recommended Interval = 8 weeks
• After completion of the Pfizer COVID-19 Series, the execution date is >= 3/17/2023, and the patient is < 5 years of age:
  
  • If the patient has had at least 1 prior dose with a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520), recommend Not Recommended / COMPLETE.
  • If the patient has not had at least one prior bivalent doses (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520), recommend a bivalent vaccine along with recommendation reason ADMINISTER_COVID19_BIVALENT_VACCINE:
    
    • Minimum Age = 6 months
    • Recommended Age = 6 months
    • Recommended Interval = 8 weeks
• After completion of the Mixed Product COVID-19 Series or Moderna COVID-19 Series with execution date < 4/19/2023, Pfizer COVID-19 Series with execution date < 3/17/2023, or Janssen series, Novavax series, or 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: 

  • After completion of the First Booster Dose: 

    • After completion of the Moderna COVID-19 Series

      • If the execution date is < 9/2/2022:

        • Recommended Age = 18 years

        • Minimum Age = 18 years

        • Recommended Interval = 5 months

      • If the execution date is >= 9/2/2022 and < 12/9/2022:
        • Minimum Age = 5 years
        • Recommended Age = 5 years
        • Recommended Interval = 8 weeks
      • If the execution date is >= 12/9/2022:
        • Minimum Age = 6 months
        • Recommended Age = 6 months
        • Recommended Interval = 8 weeks

    • After completion of the Pfizer COVID-19 Series or Mixed Product COVID-19 Series

      • Minimum Age = 5 years

      • Recommended Age = 5 years

      • If the execution date is < 9/2/2022:

        • Recommended Interval = 5 months

      • If the execution date is >= 9/2/2022:
        • Recommended Interval = 8 weeks

    • After completion of Janssen COVID-19 Series

      • If the patient is >= 5 years of age and < 12 years of age:

        • Recommend Not Recommended / COMPLETE_HIGH_RISK.

      • Otherwise:

        • Recommended Age = 12 years

        • Minimum Age = 12 years

        • Recommended Interval = 8 weeks

    • After completion of 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

      • Recommended Age = 12 years

      • Minimum Age = 12 years

      • If the execution date is < 9/2/2022:

        • Recommended Interval = 5 months

      • If the execution date is >= 9/2/2022:
        • Recommended Interval = 8 weeks

    • After completion of the Novavax COVID-19 Series

      • If the patient is < 12 years of age:

        • Recommend Not Recommended / COMPLETE_HIGH_RISK.

      • Otherwise:

        • Minimum Age = 12 years

        • Recommended Age = 12 years

        • Recommended Interval = 8 weeks

  • Second Booster Dose:

    • After completion of the first booster in the Moderna COVID-19 Series

      • If the execution date is < 9/2/2022:

        • If the patient is < 50 years of age, recommend Conditional / COMPLETE_HIGH_RISK.

        • Otherwise:

          • Minimum Age = 50 years

          • Recommended Age = 50 years

          • Recommended Interval = 4 months

      • If the execution date is >= 9/2/2022:

        • If a prior booster dose was administered >= 9/2/2022 and the patient is >= 12 years of age, recommend Not Recommended / COMPLETE.

        • If a prior booster dose was administered >= 10/12/2022 and < 12/9/2022, and the patient is >= 5 years of age and < 12 years of age, recommend Not Recommended / COMPLETE.

        • If a prior booster dose was administered >= 12/9/2022, and the patient is >= 6 months of age, recommend Not Recommended / COMPLETE.

        • If execution date is < 12/9/2022:

          • Minimum Age = 5 years

          • Recommended Age = 5 years

          • Recommended Interval = 8 weeks

        • If the execution date is >= 12/9/2022:
          • Minimum Age = 6 months
          • Recommended Age = 6 months
          • Recommended Interval = 8 weeks
    •  After completion of the first booster dose in the Pfizer COVID-19 Series or Mixed Product COVID-19 Series
      • If the execution date is < 9/2/2022:
        • Minimum Age = 12 years
        • Recommended Age = 12 years
        • Recommended Interval = 4 months
      • If the execution date is >= 9/2/2022:
        • If a prior booster dose was administered >= 9/2/2022 and the patient is >= 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.
        • If a prior booster dose was administered >= 10/12/2022 and the patient is >= 5 years of age and < 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.
        • Otherwise:
          • Minimum Age = 5 years
          • Recommended Age = 5 years
          • Recommended Interval = 8 weeks

    • After completion of first booster dose in the Janssen COVID-19 Series:

      • If the patient is >= 5 years of age and < 18 years of age:

        • Recommend Not Recommended / COMPLETE_HIGH_RISK.

      • If the execution date is < 9/2/2022:

        • If the patient is >= 18 years of age and < 50 years of age:

          • if the first booster dose was a mRNA vaccine (CVX 207, CVX 208, CVX 213, CVX 217, or CVX 221), recommend Conditional / COMPLETE_HIGH_RISK.

          • if the first booster dose was the Janssen vaccine (CVX 212):

            • Recommended Age = 18 years

            • Recommended Interval = 4 months

        • If the patient is >= 50 years of age:

          • if the first booster dose was a mRNA vaccine (CVX 207, CVX 208, CVX 213, CVX 217, or CVX 221):

            • Recommended Age = 50 years

            • Recommended Interval = 4 months

          • if the first booster dose was the Janssen vaccine (CVX 212):

            • Recommended Age = 18 years

            • Recommended Interval = 4 months

      • If the execution date is >= 9/2/2022:

        • If a prior booster dose was administered >= 9/2/2022, recommend Not Recommended / COMPLETE_HIGH_RISK.

        • Otherwise:

          • Minimum Age = 18 years

          • Recommended Age = 18 years

          • Recommended Interval = 8 weeks

    • After completion of the first booster in 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:

      • If the execution date is < 9/2/2022:

        • If the patient is < 50 years of age, recommend Conditional / COMPLETE_HIGH_RISK.

        • Otherwise:

          • Minimum Age = 50 years

          • Recommended Age = 50 years

          • Recommended Interval = 4 months

        • If the execution date is >= 9/2/2022:

          • If a prior booster dose was administered >= 9/2/2022 and the patient is >= 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

          • If a prior booster dose was administered >= 10/12/2022 and the patient is >= 5 years of age and < 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

          • Otherwise:

            • Minimum Age = 5 years

            • Recommended Age = 5 years

            • Recommended Interval = 8 weeks

    • After completion of the 1st booster dose in the Novavax COVID-19 Series:

      • Recommend Not Recommended / COMPLETE.

  • Third Booster Dose
    • After completion of the second booster in the Moderna COVID-19 series:

      • If the execution date is < 9/2/2022:

        • Recommend Conditional / COMPLETE_HIGH_RISK.

      • If the execution date is >= 9/2/2022:

        • If a prior booster dose was administered >= 9/2/2022 and the patient is >= 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

        • If a prior booster dose was administered >= 10/12/2022 and < 12/9/2022, and the patient is >= 5 years of age and < 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

        • If a prior booster dose was administered >= 12/9/2022, and the patient is >= 6 months of age, recommend Not Recommended / COMPLETE_HIGH_RISK.
        • If execution date is < 12/9/2022:

          • Minimum Age = 5 years

          • Recommended Age = 5 years

          • Recommended Interval = 8 weeks

        • If the execution date is >= 12/9/2022:
          • Minimum Age = 6 months
          • Recommended Age = 6 months
          • Recommended Interval = 8 weeks

    • After completion of the second booster in the Pfizer COVID-19 Series, Mixed Product Series, Janssen COVID-19 Series, or 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:

      • If the execution date is < 9/2/2022:

        • Recommend Conditional / COMPLETE_HIGH_RISK.

      • If the execution date is >= 9/2/2022:

        • If a prior booster dose was administered >= 9/2/2022 and the patient is >= 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

        • If a prior booster dose was administered >= 10/12/2022 and the patient is >= 5 years of age and < 12 years of age, recommend Not Recommended / COMPLETE_HIGH_RISK.

        • Otherwise:

          • Minimum Age = 5 years

          • Recommended Age = 5 years

          • Recommended Interval = 8 weeks

• After completion of needed bivalent doses and/or booster doses² (must be bivalent mRNA), the Recommendation is Not Recommended and the reason code is COMPLETE.

Evaluation Rules for Booster Dose

• Absolute Minimum Interval = 0 days
• After completion of either the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen COVID-19 Series, Novavax COVID-19 Series, or 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 a shot is administered >= 4/19/2023
  
  
  
  
  
  
  
  • If the patient has not received any bivalent doses by having previously received a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520) as either a booster dose at >= 9/2/2022 or as a dose in the primary series, or a prior dose administered was not administered >= 4/19/2023:

    • 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."

    • at >= 8 weeks after series completion, then evaluate the shot as Valid

  • Otherwise:
    • If the patient is < 65 years of age:
      • If 1 or more previous doses that are bivalent vaccines (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520) were administered as either a booster dose at >= 9/2/2022 or as a dose in the primary series, or, alternatively, a prior dose was administered >= 4/19/2023, evaluate the shot as Accepted / EXTRA_DOSE. (See Extra Shots section.)
    • If the patient is >= 65 years of age:
      
      • If 2 or more previous doses that are bivalent vaccines (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520) were administered as either a booster dose at >= 9/2/2023 or as a dose in the primary series, or, alternatively, a prior dose was administered >= 4/19/2023, evaluate the shot as Accepted / EXTRA_DOSE. (See Extra Shots section.) 
      • If 1 previous bivalent dose that is a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520) was administered as either a booster dose at >= 9/2/2023 or as a dose in the primary series, or, alternatively, a prior dose was administered >= 4/19/2023
        

        • at < 4 months after the most recent shot, 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 4 months." 

        • at >= 4 months after the most recent shot, then evaluate the shot as Valid.

• After completion of the Pfizer COVID-19 Series, Mixed Product COVID-19 Series, Moderna COVID-19 Series, Janssen series, Novavax series, or 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 a shot is administered < 4/19/2023:
  • First Booster Dose:
    • If a patient completes a COVID-19 vaccine series via the Pfizer COVID-19 Series, Moderna COVID-19 Series, Mixed Product COVID-19 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 207, CVX 208, CVX 211, CVX 212, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520: 
      • if the shot administration date is < 9/2/2022: 
        • at < 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 the 1st Booster Dose."
        • at >= 5 months after series completion, then evaluate the shot as Valid. 
      • if the shot administration date is >= 9/2/2022:

        • 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 the 1st Booster Dose."

        • at >= 8 weeks after series completion, then evaluate the shot as Valid

    • If a patient completes a COVID-19 vaccine series via the Janssen COVID-19 Series or Novavax COVID-19 Series and receives a booster dose² of CVX 207, CVX 208, CVX 211, CVX 212, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, CVX 520:
      • 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 the 1st Booster Dose."
      • at >= 8 weeks after series completion, then evaluate the shot as Valid.
  • Second Booster Dose:

    • If a patient completes a COVID-19 vaccine series via the Pfizer COVID-19 Series, Moderna COVID-19 Series, Mixed Product COVID-19 Series, Janssen COVID-19 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 207, CVX 208, CVX 211, CVX 212, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 230, CVX 300, CVX 301. CVX 302, CVX 519, or CVX 520:
      

      • If the first booster dose was administered >= 9/2/2022, evaluate the shot as Accepted / EXTRA_DOSE. (See Extra Shots section.)

      • If the second booster was administered < 9/2/2022:

        • at < 4 months after the first booster dose, 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 4 months required for the 2nd Booster Dose."

        • at >= 4 months after the first booster dose, evaluate the shot as Valid.

      • If the second booster was administered >= 9/2/2022:

        • 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 the 1st Booster Dose."

        • at >= 8 weeks after series completion, then evaluate the shot as Valid.

  • Third Booster Dose:

    • If a patient completes a COVID-19 vaccine series via the Pfizer COVID-19 Series, Moderna COVID-19 Series, Mixed Product COVID-19 Series, Janssen COVID-19 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 third booster dose² of CVX 207, CVX 208, CVX 211, CVX 212, CVX 213, CVX 217, CVX 218, CVX 219, CVX 221, CVX 227, CVX 228, CVX 229, CVX 230, CVX 300, CVX 301, CVX 302, CVX 519, or CVX 520:
      

      • If a prior booster dose was a bivalent booster vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 302), evaluate the shot as Accepted / EXTRA_DOSE. (See Extra Shots section.)

      • Otherwise:

        • If the third booster dose is administered at < 8 weeks - 4 days after the second booster dose, evaluate the shot as Invalid / BELOW_MINIMUM_INTERVAL.

        • If the third booster dose is administered at >= 8 weeks - 4 days after the 2nd booster dose, evaluate the shot as Valid.

Rules for Evaluation of Extra Shots After Additional Dose¹ and/or Booster Doses and/or Needed Bivalent Dose²   

• For patients that completed the Pfizer COVID-19 Series or Mixed Product Series:

  • If the shot is administered < 9/2/2022:

    • is > = 5 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

    • is >= 50 years of age and Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • and Additional Dose and/or 1st Booster Dose and 2nd Booster Dose, any shots administered afterwards will be Accepted/EXTRA_DOSE.

  • If the shot is administered >= 9/2/2022 and < 4/19/2023:
    • is >= 5 years old and < 12 years old and received an Additional Dose and/or Booster Dose >= 10/12/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • is >= 12 years old and an Additional Dose and/or a Booster Dose was administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • is >= 6 months of age and received an Additional Dose and/or Booster Dose >= 3/17/2023 and < 4/19/2023, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
  • If the shot is administered >= 4/19/2023:
    • is >= 6 months old and < 65 years old and received an Additional Dose and/or a Booster Dose administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
    • is >= 65 years old and received two or more Additional Dose(s) and/or a Booster Dose(s) administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
  • Any shots administered afterwards will be evaluated as Accepted / EXTRA_DOSE.
• For patients that completed the Janssen or Novavax series:  
  
  • if the patient is < 5 years old in Novavax and Janssen Series, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • If the shot is administered < 9/2/2022:

    • is > = 5 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

    • is >= 50 years of age and Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • and Additional Dose and/or 1st Booster Dose and 2nd Booster Dose, any shots administered afterwards will be Accepted/EXTRA_DOSE.

  • If the shot is administered >= 9/2/2022:

    • is >= 5 years old and < 12 years old and received an Additional Dose and/or Booster Dose >= 10/12/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • is >= 12 years old and received an Additional Dose and/or a Booster Dose was administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • Any shots administered afterwards will be evaluated as Accepted / EXTRA_DOSE.

• For patients that completed the Moderna COVID-19 series:

  • If the shot is administered < 9/2/2022:
    • is < 5 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

    • is >= 5 years old and < 18 years old and received an Additional Dose, any shots administered afterwards at < 18 years of age will be evaluated as Accepted/EXTRA_DOSE

    • is > = 18 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

    • is >= 50 years of age and received an Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • If the shot is administered >= 9/2/2022 and < 4/19/2023:
    
    •  is >= 6 months old and received an Additional Dose and/or Booster Dose >= 12/9/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • is >= 5 years old and < 12 years old and received an Additional Dose and/or Booster Dose >= 10/12/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

    • is >= 12 years old and received an Additional Dose and/or a Booster Dose was administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • If the shot is administered >= 4/19/2023:
    • is >= 6 months old and < 65 years old and received an Additional Dose and/or a Booster Dose administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.
    • is >= 65 years old and received two or more Additional Dose(s) and/or a Booster Dose(s) administered >= 9/2/2022, any shots administered afterwards will be evaluated as Accepted/EXTRA_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 3 Booster Dose, any shots administered after the primary series is 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 218, CVX 219, CVX 227, CVX 228, CVX 229, CVX 230, CVX 301, CVX 302

• If the vaccine administered (CVX 218, CVX 219, CVX 227, CVX 228, CVX 229, CVX 230, CVX 301, or CVX 302) is evaluated as Invalid with reason code ABOVE_MAXIMUM_AGE_VACCINE:

  • Ignore the reported shot 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 Bivalent Vaccines (CVX 229, CVX 230, CVX 300, CVX 301, CVX 301, CVX 519, CVX 520)

• If a bivalent vaccine (CVX 229, CVX 230, CVX 300, CVX 301, CVX 301, CVX 519, CVX 520) is administered < 9/2/2022, evaluate the shot as Invalid / VACCINE_NOT_YET_AVAILABLE_ON_DATE_SPECIFIED.

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 = 6 months
      
  • 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 a primary series Target Dose 2, the Janssen COVID-19 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.

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 includes:

  • CVX 210 - AstraZeneca COVID-19 Vaccine

  • CVX 510 - BIBP, Sinopharm COVID-19 Vaccine
  • CVX 511 - CoronaVac, Sinovac
  • CVX 502 - COVID-19 IV Non-US Vaccine (COVAXIN)
  • CVX 519 - COVID-19, bivalent, Non-US Vaccine (Spikevax Bivalent), Moderna

  • CVX 520 - COVID-19, bivalent, Non-US Vaccine Product (Comirnaty Bivalent), Pfizer

• 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 includes:

  • CVX 512 - COVID-19 VLP Non-US Vaccine (Medicago, Covifenz)
• 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 at last shot administered + recommended interval (28 days) or at 6 months, whichever date is later.
    • 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 if the execution date is < 9/2/2022 or 8 weeks if the execution date is >= 9/2/2022), along with recommendation reason code BOOSTER_DOSE.

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

  • 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)

  • CVX 513 - COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom, Zifivax)

  • CVX 514 - COVID-19 DNA Non-US Vaccine (Zydus Cadila, ZyCoV-D)

  • CVX 515 - COVID-19 PS Non-US Vaccine (Medigen, MVC-COV1901)

  • CVX 516 - COVID-19 Inactivated Non-US Vaccine (Minhai Biotechnology Co, KCONVAC)

  • CVX 517 - COVID-19 PS Non-US Vaccine (Biological E Limited, Corbevax)

  • CVX 518 - COVID-19 Inactivated Non-US Vaccine (VLA2001, Valneva)
  • CVX 521 - COVID-19 SP, protein-based, adjuvanted (VidPrevtyn Beta), Sanofi-GSK
• 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 Series

• Moderna COVID-19 Series

• Mixed Product COVID-19 Series

• Janssen COVID-19 Series

• Novavax COVID-19 Series

Series Selection Rules

There are five series for this vaccine group: Pfizer COVID-19 Series, Moderna COVID-19 Series, Mixed Product COVID-19 Series, Janssen COVID-19 Series, and Novavax COVID-19 Series. The rules for determining which series applies are:

• If there are no doses on record, then the Mixed Product COVID-19 Series applies.
• If there are doses on record:
  • If dose 1 is CVX 212, then the Janssen COVID-19 1-dose series applies.
  • If all administered primary series doses are a Pfizer vaccine, then the Pfizer COVID-19 Series applies.
  • If all administered primary series doses are a Moderna vaccine, then the Moderna COVID-19 Series applies.
  • If all administered primary series doses are a Novavax vaccine, then the Novavax COVID-19 Series applies.
  • If none of the above four conditions is true, then the Mixed Product COVID-19 Series applies.
  • If a series selected via one of the above conditions is not complete but another series is complete, select the complete series.
  • If a series selected via one of the above conditions is complete but another series is also complete at an earlier date, select the series that completed at the earlier date.

Series Special Rules

• If the patient receives a shot at < 6 months 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."

• If Moderna bivalent vaccine (CVX 230) is inadvertently administered for the primary series, the shot is INVALID with reason code VACCINE_NOT_ALLOWED_FOR_THIS_DOSE. Ignore the bivalent vaccine (CVX 230) 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.

• If the patient receives a (valid) dose at >= 6 years of age and the shot was administered >= 4/19/2023, the series is complete. 
• If the patient receives a (valid) dose with a bivalent vaccine at >= 6 years, the series is complete.

Vaccine to Recommend

• Recommend at the vaccine group level.

Rule for CVX 212 (Janssen COVID-19 vaccine)

• If CVX 212 (Janssen COVID-19 vaccine) is reported for Target Dose 2 or Target Dose 3, the Janssen COVID-19 Series applies and the series is complete. Therefore,  
  • evaluate the Target Dose (CVX 212) as Valid.
  • evaluate prior Target Doses as Accepted and the reason code is VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.

Series Special Rules

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."