Europe – Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants

Today, as an immediate action under the HERA Incubator, the new European bio-defence preparedness plan against COVID-19 variants, the Commission is introducing a measure to speed up the authorisation of adapted COVID-19 vaccines. It will make provisions in the relevant EU legislation to allow companies to focus on gathering the necessary evidence in time and enable the authorisation of adapted vaccines with a smaller set of additional data submitted to the European Medicines Agency.

President of the European Commission, Ursula von der Leyen, said: “The HERA Incubator is to strengthen and accelerate the EU response to variants. We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus.”…