Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19
December 21, 2020
The European Commission granted a conditional marketing authorisation for Comirnaty, the Pfizer/BioNTech vaccine. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The package leaflet, the summary of product characteristics (SmPC) are already available in English. The translations into Dutch and French and the EPAR (European Public Assessment Report) will be available shortly on the websites of the FAMHP and the EMA.