Work

Use of Routinely Collected “Real-world” Data for the Postlicensure Safety Assessment of Vaccination During Pregnancy

Year: 2025

Type: article

Abstract: Real-world data can be used to evaluate the postlicensure safety of vaccines during pregnancy. However, these studies often require special design considerations to minimize bias. We offer 4 recommendations for maximizing the use of real-world data for vaccine safety evaluations during pregnancy, including the application of robust methodology, standardized outcome definitions, global collaboration and platforms for data sharing.

Source: The Pediatric Infectious Disease Journal

DOI: 10.1097/inf.0000000000004606

Authors: Annette K. Regan, Stacey L. Rowe

Institutions: University of California, Los Angeles, University of San Francisco, Monash University

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Institute of Allergy and Infectious Diseases