Safety and Effectiveness of Pediatric COVID-19 Vaccines

The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System

Funding recieved: $288,460

Budget period: 9/1/2022 to 8/31/2023

Project Description & Goals ↗

TResearchers aim to generate real-world evidence (RWE) on the effectiveness and safety of COVID-19 vaccines in children and adolescents under 18 years with a systematic analysis of clinical data from electronic health records (EHR) and linkage to state-wide vaccine records. Researchers will use EHR data from the University of California (UC) Health system, which includes over 1 million richly diverse pediatric patients receiving care across five UC Health centers. These clinical data include SARS-CoV-2 test results, medication orders, vaccination histories, laboratory measurements, medical conditions, patient demographics, and social determinants of health measures. The goals are (1) to link individual patient records with the State of California Department of Public Health COVID-19 vaccine registry and characterize the pediatric population under 18 years of age according to COVID-19 vaccination status and, using these linked records, (2) determine the frequency of unfavorable clinical outcomes (hospitalization, death) and (3) determine the frequency of adverse events of special interest (AESI) among vaccinated and matched unvaccinated individuals in a given time frame. Researchers will consider prior SARS-CoV-2 infection, sex, age, and other characteristics. The results of this work will inform COVID-19 vaccine effectiveness and safety in a large, diverse pediatric population and contribute supporting evidence for regulatory decision-making.

Data

UCSF; UC-Health