EMA considerations on COVID-19 vaccine approval - Scientific guideline

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 approval

Adopted Reference Number: EMA/592928/2020

Document history

EMA considerations on COVID-19 vaccine approval

Adopted Reference Number: EMA/592928/2020