EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU

News Category: Regulatory news

Date: 06/01/2021

The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that the EMA has recommended for authorisation.

The EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

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 COVID-19 Vaccine Moderna 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 also 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