On 6 January 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended that the COVID-19 vaccine from Moderna be granted a conditional marketing authorisation for the EU. That way, a second mRNA vaccine may be about to be authorised. An authorisation is granted by the European Commission, and usually follows the CHMP’s recommendations. The European Commission’s decision is expected shortly.
EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the European Commission conditional marketing authorisation (CMA) for the COVID-19 vaccine mRNA-1273 from Moderna on 6 January 2021. A CMA is linked to conditions such as confirmation of safety and effectiveness even after the marketing authorisation. The recommendation by the was preceded by a data evaluation process accelerated by the rolling review. The Paul-Ehrlich-Institut is represented by an expert in the CHMP and is actively involved in the evaluations within the framework of the European authorisation process.
Based on the CHMP recommendation, the European Commission consults the member states in the Standing Committee on medicinal products for human use. In the event of a positive decision, the European Commission grants a marketing authorisation for the entire European Union and generally follows the recommendations of the CHMP. A decision by the European Commission on the COVID-19 vaccine is expected soon.
Updated: 06.01.2021
