Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

Prior treatment

• Patients who were immunocompromised from 1 year prior to cohort entry OR
• Patients who received any 2024-2025 formulation of the COVID-19 vaccine prior to authorization (22 August 2024) OR
• Patients who had a prior diagnosis of COVID-19 ≤180 days preceding cohort entry OR
• Patients who received any 2024/2025 formulation of the COVID-19 vaccine within 0 to 13 days prior OR 0 to 29 days post index COVID-19 diagnosis (i.e., -13 to +29 days around the index date)
  • Aim 2:
  • By Age, Bivalent (older children, adults)
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• And does not have original vaccine formulation within 2 months before calendar index date
• And does not have a pregnancy start date within 9 months before or any point after calendar entry
• And does not have original vaccine formulation within 2 months before calendar index date.
  • By Age, Bivalent (youngest children)
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• And does not have original vaccine formulation within 2 months before calendar index date.
  • By Disease Status, Bivalent
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• And has continuous medical and pharmacy enrollment for 6 months before the calendar index date
• And has estimated date of pregnancy start date within 9 months before or any point after the calendar entry date (determined using gestational age algorithm)
• And did not receive the bivalent dose prior to pregnancy, if estimated pregnancy start date is after 31 August 2022

Other illness

• And has evidence of ≥2 doses of COVID-19 original vaccine formulation before the calendar index date
• And has evidence of ≥2 doses of COVID-19 original vaccine formulation before the calendar index date
• And has evidence of ≥2 doses of COVID-19 original vaccine formulation before the calendar index date
• And has evidence of 1) moderate/severe immunocompromising condition or separately 2) COVID high-risk condition in a period before the calendar index period (lookback times are dependent on the disease and are provided in variable table below)
• And has evidence of ≥3 doses of COVID-19 original vaccine formulation before the calendar index date.
  • For Pregnant Women, Bivalent
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• And has evidence of ≥2 doses of COVID-19 original vaccine formulation before the pregnancy start date or 31 August 2022, whichever is latest.

Age

• And is age ≥12 years
• And does not have discrepancies in sex and/or year of birth between HealthVerity claims and state Immunization registry datasets.
  • This analysis will be stratified by age: 12-17, 18-49. 50-64, 65-74, 75+, which will be measured as of August 31, 2022.
  • By Age, Bivalent (younger children)
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• And is age 5-11 years
• And is age 6 months-4 years
• And is age >=6 months
• Aged 12-49

Other

• Patients meeting any of the following criteria will not be included in the study:
• Patients who have discrepancies in sex and/or year of birth between HealthVerity claims and state immunization registry datasets OR
• Has medical and pharmacy enrollment in HealthVerity as of August 31, 2022
• With 6 months of continuous medical and pharmacy enrollment before calendar index date
• And does not have evidence of moderate/severe immunocompromise as defined by CDC
• Has medical and pharmacy enrollment in HealthVerity as of 12 October 2022
• With 6 months of continuous medical and pharmacy enrollment before calendar index date
• And does not have evidence of moderate/severe immunocompromise as defined by CDC
• Has medical and pharmacy enrollment in HealthVerity as of 08 December 2022
• With 6 months of continuous medical and pharmacy enrollment before calendar index date
• And does not have evidence of moderate/severe immunocompromise as defined by CDC
• Has medical and pharmacy enrollment in HealthVerity as of 31 August 2022
• Has at least 6 months of medical and pharmacy enrollment in HealthVerity as of 31 August 2022
• And is female sex

• Patients must meet all of the following criteria to be eligible for inclusion in the study:
• Patients are required to have a COVID-19 diagnosis on or after September 5, 2024 AND no later than August 26, 2025
• Patients in HealthVerity database and residing in California or Louisiana as of index date AND
• Have ≥1 year of pharmacy and medical enrollment in HealthVerity prior to cohort entry date, allowing for up to a 30-day gap in enrollment AND
• ≥18 years old as of index date AND
• Have resided only in their respective state (California or Louisiana) for ≥1 year prior to index date

Criteria the registry did not label

• Aim 1: