Page contentsPage contents Current version Document history Related content This document provides guidance for developers of potential COVID-19 vaccines on the clinical evidence to include in marketing authorisation applications. Keywords: COVID-19, SARS-CoV-2, vaccine, clinical requirements, clinical efficacy, clinical safety Current version EMA considerations on COVID-19 vaccine approvalAdopted Reference Number: EMA/592928/2020 English (EN) (205.33 KB - PDF)First published: 19/11/2020 View Document history EMA considerations on COVID-19 vaccine approvalAdopted Reference Number: EMA/592928/2020 English (EN) (205.33 KB - PDF)First published: 19/11/2020 View Related content Multidisciplinary: vaccines Guidance for medicine developers and other stakeholders on COVID-19 Treatments and vaccines for COVID-19 COVID-19 vaccines: development, evaluation, approval and monitoring Concept paper on the revision of the COVID-19 vaccines guidance documents Share this page