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. 2023 May 1;6(5):e2313512.
doi: 10.1001/jamanetworkopen.2023.13512.

Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies

Affiliations

Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies

Karen L Schneider et al. JAMA Netw Open. .

Erratum in

  • Errors in Byline and Affiliation.
    [No authors listed] [No authors listed] JAMA Netw Open. 2023 Jun 1;6(6):e2321247. doi: 10.1001/jamanetworkopen.2023.21247. JAMA Netw Open. 2023. PMID: 37310745 Free PMC article. No abstract available.

Abstract

Importance: Safety and effectiveness studies of COVID-19 vaccines are being conducted using clinical data, including administrative claims. However, claims data only partially capture administered COVID-19 vaccine doses for numerous reasons, such as vaccination at sites that do not generate claims for reimbursement.

Objective: To evaluate the extent to which Immunization Information Systems (IIS) data linked to claims data enhances claims-based COVID-19 vaccine capture for a commercially insured population and to estimate the magnitude of misclassification of vaccinated individuals as having unvaccinated status in the linked IIS and claims data.

Design, setting, and participants: This cohort study used claims data from a commercial health insurance database and obtained vaccination data from IIS repositories in 11 US states. Participants were individuals younger than 65 years who resided in 1 of 11 states of interest and who were insured in health plans from December 1, 2020, through December 31, 2021.

Main outcomes and measures: Estimated proportion of individuals with at least 1 dose of any COVID-19 vaccine and proportion of individuals with a completed vaccine series based on general population guidelines. Vaccination status estimates were calculated and compared using claims data alone and linked IIS and claims data. Remaining misclassification of vaccination status was assessed by comparing linked IIS and claims data estimates with estimates from external surveillance data sources (Centers for Disease Control and Prevention [CDC] and state Department of Health [DOH]) and capture-recapture analysis.

Results: This cohort study included 5 112 722 individuals (mean [SD] age, 33.5 [17.6] years; 2 618 098 females [51.2%]) from 11 states. Characteristics of those who received at least 1 vaccine dose and those who completed a vaccine series were similar to the overall study population. The proportion with at least 1 vaccine dose increased from 32.8% using claims data alone to 48.1% when the data were supplemented with IIS vaccination records. Vaccination estimates using linked IIS and claims data varied widely by state. The percentage of individuals who completed a vaccine series increased from 24.4% to 41.9% after the addition of IIS vaccine records and varied across states. The percentages of underrecording using linked IIS and claims data were 12.1% to 47.1% lower than those using CDC data, 9.1% to 46.9% lower than the state DOH, and 9.2% to 50.9% lower than capture-recapture analysis.

Conclusion and relevance: Results of this study suggested that supplementing COVID-19 claims records with IIS vaccination records substantially increased the number of individuals who were identified as vaccinated, yet potential underrecording remained. Improvements in reporting vaccination data to IIS infrastructures could allow frequent updates of vaccination status for all individuals and all vaccines.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Zhou reported being an employee of the US Food and Drug Administration (FDA) during the conduct of the study (and is no longer employed by the FDA) and being a former employee of Pfizer. Ms Yang reported holding stock options with UnitedHealth Group outside the submitted work. Dr Seeger reported receiving grants from the FDA. No other disclosures were reported.

Figures

Figure.
Figure.. Attrition of the Study Population
IIS indicates Immunization Information Systems.

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Cited by

  • Errors in Byline and Affiliation.
    [No authors listed] [No authors listed] JAMA Netw Open. 2023 Jun 1;6(6):e2321247. doi: 10.1001/jamanetworkopen.2023.21247. JAMA Netw Open. 2023. PMID: 37310745 Free PMC article. No abstract available.

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