A Computable Phenotype Algorithm for Postvaccination Myocarditis/Pericarditis Detection Using Real-World Data: Validation Study.

ABSTRACT:

Background

Adverse events (AEs) associated with vaccination have traditionally been evaluated by epidemiological studies. More recently, they have gained attention due to the emergency use authorization of several COVID-19 vaccines. As part of its responsibility to conduct postmarket surveillance, the US Food and Drug Administration continues to monitor several AEs of interest to ensure the safety of vaccines, including those for COVID-19.

Objective

This study is part of the Biologics Effectiveness and Safety Initiative, which aims to improve the US Food and Drug Administration's postmarket surveillance capabilities while minimizing the burden of collecting clinical data on suspected postvaccination AEs. The objective of this study was to enhance active surveillance efforts

SUBMITTER: Deady M 

PROVIDER: S-EPMC11629037 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature