Page contents Current versionDocument historyRelated contentThis 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 approvalAdoptedReference Number: EMA/592928/2020 English (EN) (205.33 KB - PDF)First published: 19/11/2020View Document history EMA considerations on COVID-19 vaccine approvalAdoptedReference Number: EMA/592928/2020 English (EN) (205.33 KB - PDF)First published: 19/11/2020View Related content Multidisciplinary: vaccinesGuidance for medicine developers and other stakeholders on COVID-19Treatments and vaccines for COVID-19COVID-19 vaccines: development, evaluation, approval and monitoringConcept paper on the revision of the COVID-19 vaccines guidance documentsShare this page