Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis

ObjectiveTo evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017–31 December 2019) and the COVID-19 era (1 March 2020–31 December 2020), before the introduction of COVID-19...

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Bibliographic Details
Published in:BMJ open 2024-07, Vol.14 (7), p.e083947
Main Authors: Banga, Sonja, Khromava, Alena, Serradell, Laurence, Chabanon, Anne-Laure, Pan, Chunshen, Estevez, Irisdaly, Schilsky, Samantha, Kreisberg, Hannah
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Algorithms
Child
Child, Preschool
Clinical trials
Coronaviruses
COVID-19
COVID-19 - epidemiology
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Databases, Factual
Emergency medical care
Female
Health care policy
Humans
Immunization
Immunology (including allergy)
Incidence
Infant
Influenza
Influenza Vaccines - adverse effects
Initiatives
Male
Medicare
Middle Aged
Older people
Patients
Pediatrics
Pregnancy
Retrospective Studies
safety
SARS-CoV-2
United States - epidemiology
vaccination
Womens health
Young Adult
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Summary:ObjectiveTo evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017–31 December 2019) and the COVID-19 era (1 March 2020–31 December 2020), before the introduction of COVID-19 vaccines.DesignObservational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality.Data sourceOptum’s de-identified Clinformatics Data Mart Database (CDM).ParticipantsIndividuals from the US general population and four subgroups of interest: influenza-vaccinated, paediatric (
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-083947