EMA recommends first COVID-19 vaccine for authorisation in the EU

News Category: Regulatory news

Date: 21/12/2020

The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

The EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.

View EMA Press Release

The CHMP incorporates scientific expertise from all the national competent authorities in Europe, including the HPRA. 

Further information
The product information approved by the CHMP for Comirnaty contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why the EMA recommended its authorisation in the EU.

« Back