Populations Addressed in Vaccines Approved via the European Medicines Agency.

ABSTRACT: Therapeutic and prophylactic agents require robust evidence before patient use. Randomized controlled trials are essential for evaluating safety and efficacy but often exclude specific populations that are also targets for the intervention. This study assessed which populations are included in vaccine registration studies and/or addressed in label indications, and if special populations are considered at any point in the regulatory life cycle of vaccines approved in the European Union. We analyzed product labels, pivotal studies, risk management plans, and post-authorization studies for all vaccines centrally approved via the European Medicines Agency between 2012 and 2022. For the 31 vaccines approved, we identified 90 pivotal studies supporting initial marketing authorizations and 46 stu

SUBMITTER: Graf DD 

PROVIDER: S-EPMC12272308 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature