European Commission authorises first safe and effective vaccine against COVID-19

22/12/2020 News Europe 399 Views

Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.

BioNTech and Pfizer made a formal application for a conditional marketing authorisation on 1 December. This followed the analysis of their data in a ‘rolling review’ by EMA as from 6 October. Thanks to this rolling review, EMA managed to assess the conditional marketing authorisation application very rapidly. This procedure, specifically designed for emergency situations, ensures as swift an assessment as possible while ensuring that all requirements in terms of safety, effectiveness and quality of the vaccine are fully and thoroughly evaluated.

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